F04.15 - Material Test Methods

SIGNIFICANCE AND USE
5.1 This standard guide may be used by medical device manufacturers as part of their design plan and implementation of the validation of the cleaning instructions of their reusable medical devices.  
5.2 This guide helps medical device manufacturers to identify the appropriate method(s) for detecting and quantifying markers for the simulated-use test soil (see Guide F3208), thereby evaluating whether the medical device can be adequately cleaned.  
5.3 This guide describes various test methods for the different analytes.  
5.4 This guide specifies the validation criteria for analyte detection methods.
SCOPE
1.1 This standard guide provides methods and considerations for detecting and quantifying test soil(s) from reusable medical device(s) that result from simulated-use testing of medical devices during validation of the cleaning procedures as described in the instructions for use (IFU) provided by the medical device manufacturer.  
1.2 The methods described are for detecting and measuring markers (analytes) that are components within the most common test soils and are relevant to the clinical use of the device. Appropriate test soils without protein, carbon, or carbohydrates (for example, bone) will require other methods.  
1.3 This is a part of a series of ASTM standard guides for validating cleaning instructions. The scope of the first guide in the series is selecting appropriate test soils (Guide F3208). The second in the series (Guide F3293) describes methods for inoculating medical devices with test soil. The third in the series (Guide F3321) describes methods for extracting soils for measuring residual soil on medical devices after the performance of cleaning process. This is the fourth guide in the series and describes the methods of detecting and quantifying residual analytes on the device.  
1.4 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 The crystallinity of UHMWPE will influence its mechanical properties, such as creep and stiffness. The reported crystallinity will depend on the integration range used to determine the heat of fusion, and the theoretical heat of fusion of 100 % crystalline polyethylene used to calculate the percent crystallinity in an unknown specimen. Differential scanning calorimetry is an effective means of accurately measuring both heat of fusion and melting temperature.  
5.2 This test method is useful for both process control and research.
SCOPE
1.1 This quantitative test method discusses the measurement of the heat of fusion and the melting point of ultra-high molecular weight polyethylene (UHMWPE), and the subsequent calculation of the percentage of crystallinity. The method uses a differential scanning calorimeter and can be performed in the laboratory or in the field.  
1.2 This test method can be used for UHMWPE in powder form, consolidated form, finished product, or a used product. It can also be used for irradiated or chemically crosslinked UHMWPE.  
1.3 This test method does not suggest a desired range of crystallinity or melting points for specific applications.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SCOPE
1.1 This guide provides a general guide to transportation, including packaging and shipping, of possibly infectious materials, tissues, and fluids that have been removed from patients during revision surgery, at postmortem, or as part of animal studies, including packaging and shipping.  
1.2 This guide does not address any materials, tissues, or fluids that may contain prions.  
1.3 Individuals must be properly trained prior to shipping possibly infectious materials.  
1.4 This guide is a compilation of national and international regulations and guidelines that apply to the packaging and shipment of possibly infectious materials.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 This test method provides a rapid, economical method for determination of transformation temperatures.  
5.2 Measurement of the specimen motion closely parallels many shape memory applications and provides a result that is applicable to the function of the material.  
5.3 This test method uses a wire, tube, strip specimen, or a wire, tube, or strip specimen extracted from a component; thus, it provides an assessment of a nickel titanium product in its semifinished or finished form.  
5.4 This test method may be used on annealed samples to determine the transformation temperatures and ensure the alloy formulation, since chemical analysis is not precise enough to adequately determine the nickel-to-titanium ratio of shape memory alloys.  
5.5 In general, the transformation temperatures measured by this method will not be the same as those measured by the DSC method defined in Test Method F2004. Therefore, the results of DSC and BFR cannot be compared directly.  
5.5.1 The BFR method measures the transformation temperatures by tracking shape recovery of stress-induced martensite deformed below the R′s temperature or the As temperature. In contrast, the DSC method measures the start, peak, and finish temperatures of the thermal transformation of martensite to R-phase or to austenite. See Refs (1-4).  
5.6 The test method is applicable to shape memory alloys with Af temperatures in the range of approximately –25 to 90 °C.
SCOPE
1.1 This test method describes a procedure for quantitatively determining the martensite-to-austenite or the martensite to R-phase transformation temperature of annealed, aged, shape-set, or tempered nickel-titanium alloy specimens by deforming the specimen in bending and measuring the deformation recovered during heating through the thermal transformation (BFR method). See 3.1.1.
Note 1: For aged, shape-set, or tempered specimens the transformation may be from martensite to austenite or from martensite to R-phase. See Reference (1)2 for details.  
1.2 The test specimen may be wire, tube, or strip or a specimen extracted from a semifinished or finished component.  
1.2.1 For specimens not in the form of a wire, tube, or strip that are extracted from semifinished or finished components, a wire, tube, or strip shaped test specimen shall be made from the component such that the deformation mode in the test specimen is pure bending.  
1.2.2 Other specimen geometries or displacements resulting in a more complex strain state, such as bending with torsion or buckling, are beyond the scope of this standard.  
1.3 Ruggedness tests have demonstrated that sample Af must be limited to obtain good test results. See 5.6 for details. Ruggedness tests have demonstrated that deformation strain, deformation temperature, and equilibration time at the deformation temperature must be controlled to obtain good test results. See 9.1, 9.2, and 9.4 for details.  
1.4 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with this standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
4.1 Linear displacement sensor systems play an important role in orthopedic applications to measure micromotion during simulated use of joint prostheses.  
4.2 Linear displacement sensor systems must be calibrated for use in the laboratory to ensure reliable conversions of the system’s electrical output to engineering units.  
4.3 Linear displacement sensor systems should be calibrated before initial use, at least annually thereafter, after any change in the electronic configuration that employs the sensor, after any significant change in test conditions using the sensor that differ from conditions during the last calibration, and after any physical action on the sensor that might affect its response.  
4.4 Verification of sensor performance in accordance with calibration should be performed on a per use basis both before and after testing. Such verification can be done with a less accurate standard than that used for calibration, and may be done with only a few points.  
4.5 Linear displacement sensor systems generally have a working range within which voltage output is linearly proportional to displacement of the sensor. This procedure is applicable to the linear range of the sensor. Recommended practice is to use the linear displacement sensor system only within its linear working range.
SCOPE
1.1 This practice covers the procedures for calibration of linear displacement sensors and their corresponding power supply, signal conditioner, and data acquisition systems (linear displacement sensor systems) for use in measuring micromotion. It covers any sensor used to measure displacement that gives an electrical voltage output that is linearly proportional to displacement. This includes, but is not limited to, linear variable differential transformers (LVDTs) and differential variable reluctance transducers (DVRTs).  
1.2 This calibration procedure is used to determine the relationship between output of the linear displacement sensor system and displacement. This relationship is used to convert readings from the linear displacement sensor system into engineering units.  
1.3 This calibration procedure is also used to determine the error of the linear displacement sensor system over the range of its use.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 This test method is designed to produce data indicative of the degree of crosslinking in ultra high molecular weight polyethylene that has been crosslinked chemically or by ionizing radiation.  
5.2 The results are sensitive to the test temperature, solvent, and method used. For the comparison of data between institutions, care must be taken to have the same test conditions and reagents.  
5.3 The data can be used for dose uniformity analysis, fundamental research, and quality assurance testing.
SCOPE
1.1 This test method describes how the crosslink density, molecular weight between crosslinks, and number of repeat units between crosslinks in ultra high molecular weight polyethylene (UHMWPE) crosslinked by ionizing radiation or by chemical means can be determined by measuring the swelling ratio of samples immersed in o-xylene. Examples of experimental techniques used to make these measurements are discussed herein.  
1.2 The test method reported here measures the change in height of a sample specimen while it is immersed in the solvent. Volumetric swell ratios assume that the sample is crosslinked isotropically, and that the change in dimension will be uniform in all directions. This technique avoids uncertainty induced by solvent evaporation or temperature change.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 This guide describes the use of test methods in Guide F3276 to assess the compatibility of a brush part with the material substrates used in the construction of medical devices.  
5.2 By providing objective, repeatable methods for evaluating performance under test conditions, this standard can improve the ability to assess the effectiveness of various brush part designs.
SCOPE
1.1 This guide describes methods for assessing the compatibility, under prescribed laboratory conditions, of a cleaning brush part with substrate materials used in the construction of medical devices. The method utilizes a force tester to mechanically actuate a brush part at a constant rate. This action continues until there is any level of visible degradation, including but not limited to scratching or shaving of the substrate material.  
1.2 The test methods utilized in this guide are those described in Guide F3276. In this guide, the number of repetitions is determined by the demonstrable degradation, if any, of the substrate, up to a specified maximum number of repetitions.  
1.3 Brushes designed to clean medical devices after clinical use play an important role in the effective reprocessing of those medical devices. Instructions for use from the brush manufacturer should supply information related to the compatibility, or more importantly, incompatibility with materials that make up the composition of a medical device. This may be stated in terms of being suitable for specific materials, not suitable for specific materials, or suitable for a limited number of uses for specific materials.  
1.4 Selecting the correct brush for the medical device to be cleaned is always a key factor to achieve effective cleaning. One of the significant factors when selecting a brush is selecting one that will not cause damage to the medical device, including the material the medical device is constructed of. Assessing if a brush part could damage a medical device because of the material the device is made of is an important step in determining the appropriate (and inappropriate) use of a brush.  
1.5 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
4.1 Interactions of items with the MR environment have resulted in serious injuries and death of patients and other individuals. This practice lists hazards that may be present in the MR environment. It specifies marking of items anticipated to enter the MR environment and recommends information that should be included in the associated labeling.  
4.2 This practice provides a uniform system of visual icons and terms for marking items for use in the MR environment.
SCOPE
1.1 This practice applies to medical devices and other items that are anticipated to enter the magnetic resonance (MR) environment.
Note 1: “Medical devices and other items” will be referred to as “items” for the remainder of this practice.  
1.2 The practice specifies the marking of items anticipated to enter the MR environment by means of terms and icons, and recommends information that should be included in the labeling.  
1.3 MR image artifacts are not in the scope of the mandatory portions of this practice because they do not present a direct safety issue resulting from specific characteristics of the MR examination (see X1.12).  
1.4 The values stated in SI units are to be regarded as standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 Multi-axis force measuring platforms are used to measure the ground reaction forces produced at the interface between a subject's foot or shoe and the supporting ground surface. These platforms are used in various settings ranging from research laboratories to healthcare facilities. The use of force platforms has become particularly important in gait analysis where clinical evaluations have become a billable clinical service.  
5.2 Of particular importance is the application of force platforms in the treatment of cerebral palsy (CP) (1, 2).3 An estimated 8000 to 10 000 infants born each year will develop CP (3) while today’s affected population is over 764 000 patients (4). Quantitative gait analysis, using force platforms and motion capture systems, provides a valuable tool in evaluating the pathomechanics of children with CP. This type of mechanical evaluation provides a quantitative basis for treating neuromuscular conditions. In other words, surgical decisions are in part guided by information gained from the use of force platform measurements (5, 6).  
5.3 Another application is treatment of spina bifida. According to the Gait and Clinical Movement Analysis Society (GCMAS) (7), an instrumented gait analysis is the standard of expert care for children with gait abnormalities secondary to spina bifida. The main objective of diagnostic gait analysis is to define the pathological consequences of neural tube defects as they relate to gait. The use of instrumented gait analysis allows physicians to determine which surgical or non-surgical interventions would provide the best outcome.  
5.4 More recently, force platforms have been used for pre- and post-surgical evaluation of TKA (total knee arthroplasty) and THA (total hip arthroplasty) patients. Such data provides an objective measure of the mechanical outcome of the surgical procedure.  
5.5 In addition to the clinical applications there are numerous medical and human performance research activities which r...
SCOPE
1.1 This standard recommends practices for performance verification of multi-axis force platforms commonly used for measuring ground reaction forces during gait, balance, and other activities.  
1.1.1 This standard provides a method to quantify the relationship between applied input force and force platform output signals across the manufacturer’s defined spatial working surface and specified force operating range.  
1.1.2 This standard provides definitions of the critical parameters necessary to quantify the behavior of multi-axis force measuring platforms and the methods to measure the parameters.  
1.1.3 This standard presents methods for the quantification of spatially distributed errors and absolute measuring performance of the force platform at discrete spatial intervals and discrete force levels on the working surface of the platform.  
1.1.4 This standard further defines certain important derived parameters, notably COP (center of pressure) and methods to quantify and report the measuring performance of such derived parameters at spatial intervals and force levels across the working range of the force platform.  
1.1.5 This standard defines the requirements for a report suitable to characterize the force platform’s performance and provide traceable documentation to be distributed by the manufacturer or calibration facility to the users of such platforms.  
1.1.6 Dynamic characteristics and applications where the force platform is incorporated in other equipment, such as instrumented treadmills and stairs, are beyond the scope of this standard.  
1.1.7 This standard is written for purposes of multi-axis force platform verification. However, the methods and procedures are applicable to calibration of force platforms by manufacturers.  
1.2 The values stated in SI units are to be regarded as the standard. Other metric and inch-pound values are regarded as equivalent when required.  
1.3 This standard does n...

SIGNIFICANCE AND USE
5.1 These methods are intended to determine whether a material, product, or part of a product has the degree of radiopacity desired for its application as a medical device in the human body. This method allows for comparison with or without the use of a body mimic. Comparisons without the use of a body mimic should be used with caution as the relative radiopacity can be affected when imaging through the human body.  
5.2 These methods allow for both qualitative and quantitative evaluation in different comparative situations.
SCOPE
1.1 These test methods cover the determination of the radiopacity of materials and products utilizing X-ray based techniques, including fluoroscopy, angiography, CT (computed tomography), and DEXA (dual energy X-ray absorptiometry), also known as DXA, The results of these measurements are an indication of the likelihood of locating the product within the human body.  
1.2 Radiopacity is determined by (a) qualitatively comparing image(s) of a test specimen and a user-defined standard, with or without the use of a body mimic; or (b) quantitatively determining the specific difference in optical density or pixel intensity between the image of a test specimen and the image of a user-defined standard, with or without the use of a body mimic.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
4.1 This practice summarizes a method that may be used to accelerate the oxidation of UHMWPE components using elevated temperature and elevated oxygen pressure. Under real-time conditions, such as shelf aging and implantation, oxidative changes to UHMWPE after sterilization using high-energy radiation may take months or years to produce changes that may result in deleterious mechanical performance. The method outlined in this practice permits the evaluation of oxidative stability in a relatively short period of time (for example, weeks).  
4.2 This practice may also be used to oxidize UHMWPE test specimens and joint replacement components prior to characterization of their physical, chemical, and mechanical properties. In particular, this practice may be used for accelerated aging of UHMWPE components prior to evaluation in a hip or knee joint wear simulator as outlined in Guide F1714 (hip wear), Guide F1715 (knee wear), ISO 14242 (hip wear), or ISO 14243 (knee wear), or combination thereof.
SCOPE
1.1 It is the intent of this practice to permit an investigator to evaluate the oxidative stability of UHMWPE materials as a function of processing and sterilization method. This practice describes a laboratory procedure for accelerated aging of ultra-high molecular weight polyethylene (UHMWPE) specimens and components for total joint prostheses. The UHMWPE is aged at elevated temperature and at elevated oxygen pressure, to accelerate oxidation of the material and thereby allow for the evaluation of its long-term chemical and mechanical stability.  
1.2 Although the accelerated aging method described by this practice will permit an investigator to compare the oxidative stability of different UHMWPE materials, it is recognized that this method may not precisely simulate the degradative mechanisms for an implant during real-time shelf aging and implantation.  
1.3 The accelerated aging method specified herein has been validated based on oxidation levels exhibited by certain shelf-aged UHMWPE components packaged in air and sterilized with gamma radiation. The method has not been shown to be representative of shelf aging when the UHMWPE is packaged in an environment other than air. For example, this practice has not been directly correlated with the shelf life of components that have been sealed in a low-oxygen package, such as nitrogen. This practice is not intended to simulate any change that may occur in UHMWPE following implantation.  
1.4 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are for information only and are not considered standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 This guide describes an approach to validate a cleaning system for a medical device. It is based on the manufacturer’s accurate and comprehensive understanding of their internal manufacturing and cleaning processes.  
5.2 This guide is not intended to provide a detailed plan or road map, but will provide considerations that can be used by the device manufacturer to develop a detailed plan for performing cleaning validation.  
5.3 In cleaning validation, as with other types of validations, there are multiple ways to achieve a compliant, scientifically sound, and practical cleaning validation program.  
5.4 There are several reference documents identified in Appendix X3 that describe cleaning validation approaches for non-medical devices (including cleaning for oxygen-enriched environments, pharmaceuticals, and semiconductors). Any of these reference documents could provide guidance for a well-defined process for establishing a manufacturer’s minimum expectation of a specific cleaning validation program.  
5.5 This guidance specifically targets cleaning validation for medical devices, in-process and at terminal cleaning so that the result is a consistently clean medical device that meets the performance expectations for that device.
SCOPE
1.1 This guide provides considerations for validating cleaning processes for medical devices during initial fabrication and assembly prior to initial use. Validated cleaning processes are important for achieving consistency in function and consistency in biocompatibility. The considerations include but are not limited to: validation approach, equipment design, procedures and documentation, analytical methods, sampling, development of limits, and other issues.  
1.2 Inclusions:  
1.2.1 This guide describes the validation of critical cleaning processes for medical devices to reduce contaminants to acceptable levels prior to packaging.  
1.3 Exclusions—The following items / medical devices / processes are excluded from the scope of this document:  
1.3.1 Reusable medical devices.
1.3.1.1 Validation of cleaning operations for reusable medical devices is not within the scope of this standard guide. Although cleaning of reusable medical devices is beyond the scope of this guide, many of the principles outlined in this guide may be applicable to the validation of cleaning operations for reusable devices.  
1.3.2 Cleaning of medical devices in health care facilities.
1.3.2.1 Validation of cleaning processes in patient/health care facilities is not within the scope of this standard guide.  
1.4 This standard does not purport to be a replacement for biological safety testing.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 This test method provides a means to evaluate the resistance to particle shedding of a thermal spray coating. Such particle shedding might occur during surgical insertion of an implant or as the result of micromotion of the implant after insertion.  
5.2 This abrasion test method may be useful for quality control analysis of a coating, and it can be used to evaluate the effects of processing variables, such as substrate preparation before coating, surface texture, coating technique variables, or postcoating treatments, any of which may influence the susceptibility of the coating to particle shedding.  
5.3 This abrasion test method is for flat plate-shaped specimens of a size sufficient that the wheels of the abrader do not leave the surface of the specimen. It is not recommended for devices with other shapes or sizes.
SCOPE
1.1 This test method quantifies the abrasion resistance of metallic coatings produced by thermal spray processes on flat metallic surfaces. It is intended as a means of characterizing coatings used on surgical implants.  
1.2 This test uses the Taber Abraser,2 which generates a combination of rolling and rubbing to cause wear to the coating surface. Wear is quantified as cumulative weight loss.  
1.3 This test method is limited to flat, rigid specimens that do not react significantly with water and do not undergo a phase transformation or chemical reaction between room temperature and 100 °C in air.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 Tension tests provide information on the strength and the elastic and plastic properties of materials under uniaxial tensile stresses.  
5.2 Tension tests, as described in this test method, also provide information on the superelasticity, as defined in Terminology F2005, of the material at the test temperature.
SCOPE
1.1 This test method covers the tension testing of superelastic nickel-titanium (nitinol) materials, specifically the methods for determination of upper plateau strength, lower plateau strength, residual elongation, tensile strength, and elongation.  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
4.1 This practice summarizes two methods that may be used to precondition UHMWPE by the absorption of lipids to differentiate the simulated in vitro oxidative stability of UHMWPEs, after lipid exposure.  
4.1.1 Procedure A, High Squalene Absorption—This method of preconditioning with lipids may be used for comparative oxidative stability testing to screen different materials under aggressive conditions.  
4.1.2 Procedure B, Mixed Lipid Absorption—This method of preconditioning may be used for comparative oxidative stability testing under mild conditions that more closely simulate in-vivo conditions.  
4.2 This practice may be used to accelerate the oxidation of UHMWPE components when using elevated temperature and elevated oxygen pressure according to the methods of Practice F2003. Under real-time conditions such as implantation, oxidative changes to UHMWPE formulations may take months or years to produce changes that may result in deleterious mechanical performance. The method outlined in this practice permits the preparation of UHMWPE for evaluation of oxidative stability in a relatively short period of time (for example, weeks).  
4.3 This practice may also be used to precondition UHMWPE test specimens prior to characterization of their physical and chemical properties. In particular, this practice may be used for preconditioning with lipids prior to oxidation induction time (OIT) testing as outlined in Test Method D3895.
SCOPE
1.1 It is the intent of this practice to permit an investigator to incorporate lipids found in the synovial environment into polymeric specimens. This can be used as a preconditioning step to evaluate the oxidative stability of ultra-high-molecular-weight polyethylene (UHMWPE) materials. This practice describes a laboratory procedure for preconditioning of UHMWPE specimens.  
1.2 The preconditioned UHMWPE can be aged at elevated temperature and at elevated oxygen pressure following methods of accelerated aging described in Practice F2003, to accelerate oxidation of the material and thereby allow for the evaluation of its long-term chemical stability.  
1.3 The preconditioned UHMWPE can be tested without further aging using a method to evaluate oxidative stability such as oxidation induction time as described in Test Method D3895.  
1.4 The methods of this practice may be used on any type of UHMWPE material intended for use in total joint arthroplasty in a synovial joint (for example, conventional, cross-linked, antioxidant stabilized, etc.). See Appendix X1.  
1.5 Although the preconditioning method followed by accelerated aging described by this practice will permit an investigator to compare the oxidative stability of different UHMWPE materials, it is recognized that this method is not known to simulate the degradative mechanisms for an implant during real-time shelf aging or in vivo. The described methods have not been evaluated for mechanical testing under cyclic loading.  
1.6 The preconditioning and accelerated aging methods specified herein are intended to rank the resistance to oxidation of materials as a result of the absorption of lipids, which may occur in UHMWPE following implantation, and to determine susceptibility to oxidative changes. The methods have not been evaluated for use in preconditioning of UHMWPE components for subsequent testing of mechanical or wear properties. Procedure A should not be used for preconditioning of UHMWPE components for subsequent testing of mechanical or wear properties.  
1.7 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are for information only and are not considered standard.  
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and...

SIGNIFICANCE AND USE
5.1 This guide provides two test methods for evaluating the performance characteristics of a brush part designed to clean external surface(s) of a medical device by utilizing force testers.  
5.1.1 The first test method utilizes a force tester to measure the force required to actuate a brush part across a surface. This is an indicator of the friction a brush exerts on a surface, a parameter of cleaning effectiveness.  
5.1.2 The second test method measures the removal of soil from a surface by a brush part actuated across the surface. This is a further indicator of the effectiveness of a brush part to loosen and remove soil from a surface.  
5.2 By providing objective, repeatable methods for evaluating performance under test conditions, this guide can improve the ability to assess the effectiveness of various brush part designs
SCOPE
1.1 This guide describes methods for characterizing the efficacy, under prescribed laboratory conditions, of a brush part designed to clean the external surface of a medical device. The method utilizes force testers to mechanically actuate a brush part across a surface at a constant rate and constant pressure. In the first method, the force required to actuate across the surface is measured. In the next method, which utilizes the same force testers and protocol (actuation motion), the brush part is actuated on a soiled surface and the amount of soil removed is measured, as another indicator of performance.  
1.2 Brushes designed to clean medical devices after clinical use play an important role in the effective reprocessing of those medical devices.  
1.3 Inclusions:  
1.3.1 This guide describes objective, quantifiable, and reproducible methods for evaluating the cleaning characteristics of a brush part, under prescribed laboratory conditions, with a test method that simulates the cleaning challenge of a defined target area(s) of a medical device. This also makes it possible to compare one brush part design to another.  
1.3.2 By use of this guide, manufacturers of cleaning brushes will be able to evaluate and characterize the cleaning performance of their brushes for the target area(s) of medical device(s) and evaluate modifications to design and construction that might improve performance.  
1.3.3 By use of this guide, this information can also be shared with the users of the brushes (medical device reprocessors) to help them evaluate the performance of commercially available brushes.  
1.4 Exclusions:  
1.4.1 This guide is not intended to be used for brushes designed to clean medical devices using rotational motion.  
1.4.2 This guide does not assess potential damage that may be inflicted by the brush, or degradation of the brush that may occur during repeated use. Brushes with rigid bristles (for example, stainless steel or other metals) are predicted to be more likely to damage medical devices than brushes with flexible bristles (for example, nylon); damage from rigid-bristled brushes should be assessed. Assessing repeated use would require a greatly increased number of test repetitions than what is described in this guide.  
1.4.3 This guide does not specify acceptance criteria, and the results will be dependent on the specific parameters that are tested (for example, test soil, drying time, surface area, and materials, etc.) that are tested.  
1.4.4 This guide is not intended to constitute all steps required to conduct validation of cleaning instructions for a medical device, including use of brushes for this purpose, but provides methods that may be part of a broader protocol to conduct a complete cleaning instructions validation. Separate medical device cleaning instruction validation studies must be conducted.  
1.5 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated...

SIGNIFICANCE AND USE
5.1 This guide provides test methods for evaluating the performance characteristics of a brush part designed to clean internal channel(s) of a medical device.  
5.1.1 The force required to move a brush part within a tube, an indicator of the friction a brush exerts on a surface, is a parameter of cleaning effectiveness and should be measured.  
5.1.2 The removal of soil from a tube by a brush part moved in a tube is a further indicator of the effectiveness of a brush to loosen and remove soil from a tube and should be measured.  
5.2 By providing objective, repeatable methods for evaluating performance, this guide can improve the ability to assess the effectiveness, under test conditions, of various brush part designs.
SCOPE
1.1 Brushes used to clean a medical device after clinical use play an important role in effective reprocessing. This guide describes methods for characterizing, under prescribed laboratory conditions, the efficacy of brush parts designed to clean the internal channels of medical devices. The methods utilize a force tester to mechanically actuate a brush part within a channel: (1) Methods to measure, at an established speed, the force required to move a brush within a channel; (2) Methods utilize the same force tester and protocols to measure soil removal from a soiled tube, another indicator of performance.  
1.2 Inclusions:  
1.2.1 This guide describes objective, quantifiable, and reproducible methods for evaluating the cleaning characteristics of a brush part under prescribed laboratory conditions, with test methods that simulate the cleaning challenge of a defined target area(s) of a medical device. This also makes possible the comparison of one design of a brush part to another.  
1.2.2 In this guide, a brush part is one that is intended to be moved within a tube.  
1.2.3 Tubes used for testing described in this guide are cylindrical and uniform in diameter. The test methods describe may not apply to non-cylindrical tubes.  
1.2.4 By use of this guide, medical device manufacturers can characterize the brush part designed for cleaning their device.  
1.2.5 By use of this guide, manufacturers of cleaning brushes can evaluate and characterize the cleaning performance of their brushes for the target area(s) of medical device(s), including allowing a comparison with existing brush part designs offered on the market. Further, they are able to evaluate modifications to designs and construction that might improve performance.  
1.2.6 This information can also be shared with the users of the brushes (medical device reprocessors) to help them evaluate the performance of commercially available brushes.  
1.3 Exclusions:  
1.3.1 This guide does not assess potential damage that may be inflicted by the brush. For instance, brushes with rigid bristles (for example, stainless steel or other metals) or other abrasive materials are more likely to damage medical devices than brushes with flexible bristles (for example, nylon) or more pliable materials. Potential damage from more abrasive materials should be assessed.  
1.3.2 This guide does not specify acceptance criteria, and the results will be dependent on the specific parameters (for example, test soil, drying time, channel inside diameter and material, and so forth) that are tested.  
1.3.3 This guide is not intended to constitute all steps required to conduct validation of cleaning instructions for a medical device, including the use of brushes for this purpose, but provides methods that may be part of a broader protocol to conduct a complete cleaning instructions validation.  
1.3.4 If a brush is intended to clean a specific device(s), cleaning validation shall include testing with that device(s).  
1.4 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 This standard does not purport to address all of the safety concerns, if an...

SIGNIFICANCE AND USE
4.1 The process of coiling wire causes the wire to take on a curvature from the process of being mechanically deformed into a coiled geometry. The curvature in the wire is permanent unless the wire is straightened. It will affect how the coiled wire will react when it is subjected to additional wire forming operations. In addition, residual stresses induced from the coiling operation can cause elastic recoil or spring back in subsequent wire forming operations unless the material is straightened and stress relieved prior to forming. These residual stresses can create wide variations in the dimensions of components and/or parts that have been built using the coiled wire (cast).  
4.2 The direction that the wire has been coiled affects how the wire will be taken off of the coil for subsequent wire forming operations (helix direction).  
4.3 Lift or spacing between adjacent coils also affects how the wire will be taken off of the coil and can also affect the dimensions of components and/or parts that have been built using the coiled wire due to residual stresses (helix).
SCOPE
1.1 This test method covers the various standard methods that are used for measuring camber, cast, helix, and helix direction. The wire may be coiled with or without a spool.  
1.2 This test method applies to round wire that has a diameter between 0.0127 to 4.78 mm [0.0005 to 0.188 in.]. It also applies to flat or shaped wire.  
1.3 This test method does not apply to superelastic nitinol wire. It does apply to the as-drawn condition of nitinol wire.  
1.4 This test method does not apply to the measurement of the straightness of straightened to length wire and tubing.  
1.5 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 This test method is one of those required to determine if the presence of a medical device may cause injury to individuals during an MR examination or in the MR environment. Other safety issues which should be addressed include, but may not be limited to: magnetically induced torque (see Test Method F2213) and radiofrequency (RF) heating (see Test Method F2182). The terms and icons in Practice F2503 should be used to mark the device for safety in the magnetic resonance environment.  
5.2 If the maximum magnetically induced displacement force for the specified magnetic field conditions (see Appendix X3) is less than the force on the device due to gravity (its weight), it is assumed that any risk imposed by the application of the magnetically induced force is no greater than any risk imposed by normal daily activity in the Earth’s gravitational field. This statement does not constitute an acceptance criterion; it is provided as a conservative reference point. It is possible that a greater magnetically induced displacement force can be acceptable and would not harm a patient or other individual in a specific case.
Note 2: For instance, in the case of an implanted device that is or could be subjected to a magnetic displacement force greater than the force due to gravity, the location of the implant, surrounding tissue properties, and means of fixation within the body may be considered. For a non-implanted device with a magnetically induced force greater than the gravitational force, consideration should be given to mitigate the projectile risk which may include fixing or tethering the device or excluding it from the MR environment so that it does not become a projectile.  
5.3 The maximum static magnetic field strength and spatial field gradient vary for different MR systems. Appendix X3 provides guidance for calculating the allowable static magnetic field strength and spatial field gradient.  
5.4 This test method alone is not sufficient for determining if a d...
SCOPE
1.1 This test method covers the measurement of the magnetically induced displacement force produced by static magnetic field gradients (spatial field gradient) on medical devices and the comparison of that force to the weight of the medical device.  
1.2 This test method does not address other possible safety issues which include, but are not limited to: issues of magnetically induced torque, radiofrequency (RF) heating, induced heating, acoustic noise, interaction among devices, and the functionality of the device and the magnetic resonance (MR) system.  
1.3 This test method is intended for devices that can be suspended from a string. Devices which cannot be suspended from a string are not covered by this test method. The weight of the string from which the device is suspended during the test must be less than 1 % of the weight of the tested device.  
1.4 This test method shall be carried out in a horizontal bore MR system with a static magnetic field oriented horizontally and parallel to the MR system bore.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
4.1 This test method is designed solely for determining comparative laboratory indices of performance. The results may be used for ranking alloys in order of increasing resistance to pitting and crevice corrosion under the specific conditions of this method. It should be noted that the method is intentionally designed to reach conditions that are sufficiently severe to cause breakdown of at least one alloy (Type 316 L stainless steel) currently considered acceptable for surgical implant use, and that those alloys which suffer pitting or crevice corrosion during the more severe portions of the test do not necessarily suffer localized corrosion when placed within the human body as a surgical implant.
SCOPE
1.1 This test method covers the determination of resistance to either pitting or crevice corrosion of metals and alloys from which surgical implants will be produced. It is a modified version of an established test2 and is used as a screening test to rank surgical implant alloys in order of their resistance to localized corrosion.  
1.2 This test method applies only to passive metals and alloys. Nonpassive alloys (other than noble alloys) are susceptible to general corrosion and are not normally suitable for implant use.  
1.3 This test method is intended for use as a laboratory screening test for metals and alloys which undergo pitting or crevice corrosion, or both.  
1.4 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 This guide describes the use of test methods in Guides F3275 and F3276 to assess the service life of a brush part intended to clean a medical device.  
5.2 In the case of a brush part intended to clean a lumen, the force required to move a brush part within a tube, an indicator of the friction a brush exerts on a surface, is a measurable parameter that can change over time and will decrease as the brush part loses integrity.  
5.3 In the case of a brush part intended to clean the external surface, the force required to move the brush across a surface and the pressure the brush exerts on that surface are measurable parameters that can change over time and will decrease as the brush part loses integrity.  
5.4 By providing objective, repeatable methods for evaluating performance under test conditions, this guide can improve the ability to assess the effectiveness of various brush part designs.
SCOPE
1.1 This guide describes methods for assessing the service life, under prescribed laboratory conditions, of a brush part designed to clean a medical device. The method utilizes force testers to mechanically actuate a brush part at a constant rate. This action continues until the brush part demonstrates a significant reduction in cleaning power as measured by the force exerted during testing.  
1.2 The test methods utilized in this guide are those described in Guides F3275 and F3276. In this guide, the number of repetitions is open-ended and determined by the measurable fatigue of the brush part as measured by a reduction in force, as well as any observation of wear or damage to the brush part.  
1.3 Brushes designed to clean medical devices after clinical use play an important role in the effective reprocessing of those medical devices. Instructions for use from the brush manufacturer should supply information related to the service life of the brush. This may be stated in terms of (1) a time period; (2) the number of uses; (3) inspection of the brush for wear and damage.  
1.4 Inspection for wear should always be a part of the instructions for use of a brush. Application of this guide can help to determine like mode(s) of observable failure of a brush part.  
1.5 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
4.1 Implants, particularly orthopedic devices, are usually exposed to dynamic forces. Thus, implant materials must have high fatigue resistance in the physiological environment.  
4.1.1 This practice provides a procedure for fatigue testing in a simulated physiological environment. Axial tension-tension fatigue tests in an environmental test chamber are recommended as a standard procedure. The axial fatigue loading shall comply with Practices E466 and E467.
4.1.1.1 Bending and rotating bending beam fatigue tests or torsion tests may be performed in a similar environmental cell.  
4.1.2 This practice is intended to assess the fatigue and corrosion fatigue properties of materials that are employed or projected to be employed for implants. This practice is suitable for studying the effects of different material treatments and surface conditions on the fatigue behavior of implant materials. The loading mode of the actual implants may be different from that of this practice. Determining the fatigue behavior of implants and implant components may require separate tests that consider the specific design and loading mode.  
4.1.3 As a substitute for body fluid, 0.9 % saline solution is recommended as a standard environment. One of the various Ringer's solutions or another substitute for body fluid may also be suitable for particular tests. However, these various solutions may not give equal fatigue endurance results. The chloride ions are the most critical constituent in these solutions for initiating corrosion fatigue.  
4.1.4 Because implants are manufactured from highly corrosion-resistant materials, no visible corrosion may be detectable when inspected by means of optical microscopy or scanning electron microscopy. Only a decrease of fatigue strength in the high cycle range may be noticeable. Therefore, S-N curves covering a broad fatigue loading range should be generated in the test solution and in air. Comparison of fatigue curves generated in air and saline sol...
SCOPE
1.1 This practice covers the procedure for performing corrosion fatigue tests to obtain S-N (3.2.1) fatigue curves or statistically derived fatigue strength values, or both, for metallic implant materials. This practice describes the testing of axially loaded fatigue specimens subjected to a constant amplitude, periodic forcing function in saline solution at 37°C and in air at room temperature. The environmental test method for implant materials may be adapted to other modes of fatigue loading such as bending or torsion. While this practice is not intended to apply to fatigue tests on implantable components or devices, it does provide guidelines for fatigue tests with standard specimens in an environment related to physiological conditions.  
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
4.1 Mechanical properties of PEEK polymers, such as stiffness or yield strength, are influenced by the level of crystallinity.5 The reported crystallinity index determined by this test method has been correlated with percent crystallinity in PEEK polymers by wide-angle X-ray scattering (WAXS) experiments.2, 3  
4.2 This test method may be useful for both process development, process control, product development, and research.
SCOPE
1.1 This test method describes the collection of absorption spectra of polyetheretherketone (PEEK) polymer in filled and unfilled grades, as supplied by a vendor, and the subsequent calculation of the percent crystallinity. The material is evaluated by infrared spectroscopy. The intensity (height) of the absorbance peaks is related to the amount of crystalline regions present in the material.  
1.2 This test method can be used for PEEK consolidated forms, such as injection molded parts, as long as the samples are optically flat and smooth.  
1.3 The applicability of the infrared method to industrial and medical grade PEEK materials has been demonstrated by scientific studies.2, 3 Percentage of crystallinity is related to R-FTIR measurement by calibration through wide-angle x-ray scattering (WAXS) crystallinity measurements.2, 3 It is anticipated that this test method, involving the peak heights near 1305 cm-1 and 1280 cm-1, will be evaluated in an Interlaboratory Study (ILS) conducted according to Test Method E691.  
1.4 This test method does not suggest a desired range of crystallinity for specific applications.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 This test method describes a uniaxial, constant amplitude, fully reversed fatigue test to characterize the fatigue performance of a uniform cylindrical waisted specimen manufactured from acrylic bone cement.  
5.2 This test method considers two approaches to evaluating the fatigue performance of bone cement:  
5.2.1 Testing is conducted at three stress levels to characterize the general fatigue behavior of a cement over a range of stresses. The stress level and resultant cycles to failure of the specimens can be plotted on an S-N diagram.  
5.2.2 Another approach is to determine the fatigue life of a particular cement. The fatigue life for orthopaedic bone cement is to be determined up to 5 million (5 × 106) cycles.  
5.3 This test method does not define or suggest required levels of performance of bone cement. This fatigue test method is not intended to represent the clinical use of orthopaedic bone cement, but rather to characterize the material using standard and well-established methods. The user is cautioned to consider the appropriateness of this test method in view of the material being tested and its potential application.  
5.4 It is widely reported that multiple clinical factors affect the fatigue performance of orthopaedic bone cement; however, the actual mechanisms involves multiple factors. Clinical factors which may affect the performance of bone cement include: temperature and humidity, mixing method, time of application, surgical technique, bone preparation, implant design, anatomical site, and patient factors, among others. This test method does not specifically address all of these clinical factors. The test method can be used to compare different acrylic bone cement formulations and products and different mixing methods and environments (that is, mixing temperature, vacuum, centrifugation, and so forth).
SCOPE
1.1 This test method describes test procedures for evaluating the constant amplitude, uniaxial, tension-compression uniform fatigue performance of acrylic bone cement materials.  
1.2 This test method is relevant to orthopedic bone cements based on acrylic resins, as specified in Specification F451 and ISO 16402. The procedures in this test method may or may not apply to other surgical cement materials.  
1.3 It is not the intention of this test method to define levels of performance of these materials. It is not the intention of this test method to directly simulate the clinical use of these materials, but rather to allow for comparison between acrylic bone cements to evaluate fatigue behavior under specified conditions.  
1.4 A rationale is given in Appendix X2.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
3.1 Implantable medical devices can be made of dissimilar metals or come into electrical contact with dissimilar metals leading to the potential for galvanic corrosion, which may result in the release of corrosion products with harmful biological consequences or a compromise of structural integrity of the device. Therefore, it is important to determine the susceptibility of these types of devices to galvanic corrosion.  
3.2 Use of this test method is intended to provide information on the possible galvanic component of corrosion of two dissimilar metals in contact with one another. The dissimilar metals in contact may be on the same implantable medical device or as component parts of individual medical implant devices.  
3.3 This test method has been designed to accommodate a wide variety of device shapes and sizes encountered by allowing the use of a variety of holding devices.  
3.4 This standard is presented as a test method for conducting galvanic corrosion tests in a simulated physiological environment. Adherence to this test method should aid in avoiding some of the inherent difficulties in such testing. Other standards such as Guide G71 are general and, while they provide valuable background information, do not provide the necessary details or specificity for testing medical device implants.
SCOPE
1.1 This test method covers conducting galvanic corrosion tests to characterize the behavior of two dissimilar metals in electrical contact that are to be used in the human body as medical implants or as component parts to medical implants. Examples of the types of devices that might be assessed include overlapping stents of different alloys, stent and stent marker combinations, orthopedic plates and screws where one or more of the screws are of a different alloy than the rest of the device, and multi-part constructs where two or more alloys are used for the various component parts. Devices which are to be partially implanted, but in long-term contact within the body (such as external fixation devices) may also be evaluated using this method.  
1.2 This test method covers the selection of specimens, specimen preparation, test environment, method of exposure, and method for evaluating the results to characterize the behavior of galvanic couples in an electrolyte.  
1.3 Devices and device components are intended to be tested in their finished condition, as would be implanted (that is, the metallurgical and surface condition of the sample should be in or as close as possible to the same condition as in the finished device).  
1.4 This test method does not address other types of corrosion and degradation damage that may occur in a device such as fretting, crevices, or the effect of any galvanically induced potentials on stress corrosion and corrosion fatigue. Surface modifications, such as from scratches (possibly introduced during implantation) or effects of welding (during manufacture), are also not addressed. These mechanisms are outside of the scope of this test method.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 Warning—Mercury has been designated by many regulatory agencies as a hazardous substance that can cause serious medical issues. Mercury, or its vapor, has been demonstrated to be hazardous to health and corrosive to materials. Use caution when handling mercury and mercury-containing products. See the applicable product Safety Data Sheet (SDS) for additional information. The potential exists that selling mercury or mercury-containing products, or both, is prohibited by local or national law. Users must determine legality of sales in their location.  
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and dete...

SIGNIFICANCE AND USE
5.1 This guide provides information on how to select the test soil(s) that best simulates clinical use for devices. The test soil(s) selected for the validation should be clinically relevant and simulate what the device/component will come into contact with during the clinical procedure.  
5.2 This guide will help standardize the test soils used by medical device manufacturers when validating the cleaning procedures of reusable medical devices and reprocessing equipment  
5.3 For devices that come into contact with blood, the simulated test soils are blood-based soils, such as those described under 7.1.1-7.1.2.  
5.4 For devices that come into contact with mucus, the simulated test soils are those described under 7.1.3.  
5.5 For devices that come in contact with soils of a source other than the patient (e.g., bone cement), the simulated test soils should be similar to those described in 7.2. These can be used alone or in combination with 7.1.  
5.6 A combination of test soils may be used (e.g., blood with mucus) to simulate clinical soiling. For example, flexible endoscopes may come in contact with a different combination of sources of soiling (e.g., gastrointestinal (GI) tract, vasculature for biopsies) during clinical use.  
5.7 Any simulated test soil(s) or formulations can be used for simulated use testing but shall be scientifically justified by the medical device manufacturer.
SCOPE
1.1 This guide describes methods for selecting test soils for cleaning validations based upon the characteristics of the soil, the physical characteristics of the device, and the clinical use of the device.  
1.2 This guide describes the preparation and use of some test soils for the validation of cleaning instructions for reusable medical devices.  
1.3 Reusable medical devices such as endoscopes, arthroscopic shavers, surgical instruments, and suction tubes are exposed to biological soils during clinical use. Preparation of these devices for reuse requires cleaning and disinfection and/or sterilization as applicable. Adequate cleaning is the first step in a process intended to prevent contaminant transfer to the next patient and medical practitioner. The soils, if inadequately removed, can interfere with disinfection and sterilization processes, as well as performance of the device. Acceptance criteria are based either on a visual assessment or quantitatively specified marker(s) endpoint(s) of the soil or both (ISO/TS 15883-5, Section 1). Endpoints after cleaning should be based upon possible interference with disinfection/sterilization, risk to the patient or health care worker from the contaminant during further handling, and endpoints for cleaning established in the scientific literature.  
1.4 The test soils are designed to simulate the contaminants that medical devices are likely to come in contact with during clinical use. The test soils discussed in this guide are a mixture of constituents that simulate what is commonly found in human secretions, blood, tissue, and bone fragments/shavings as well as non-patient derived soil (e.g., bone cement, lubricants, and dyes) during clinical procedures. The test soils also simulate the physical parameters (e.g., viscosity, adhesion) of clinical material to which the medical devices will be exposed.  
1.5 Exclusion:  
1.5.1 This guide does not include methods to validate cleaning processes to remove residues from manufacturing  
1.5.2 This guide does not describe the soil/inoculum used for validation of disinfection or sterilization instructions. Disinfection or sterilization validation requires separate testing that is independent of cleaning validation studies.  
1.5.3 Test soils described are not intended for use by health care facilities to verify the effectiveness of their cleaning process.  
1.5.4 The test soil recipes are not intended to encompass every biological residue with which a medical device is likely to come into contact.  
1.6...

SIGNIFICANCE AND USE
4.1 Miniature specimen testing techniques are used to characterize the mechanical behavior of polymer stock materials and surgical implants after manufacture, sterilization, shelf aging, radiation crosslinking, thermal treatment, filler incorporation, and implantation (1-3). Furthermore, experimental materials can be evaluated after accelerated aging, fatigue testing, and hip, knee, or spine wear simulation. Consequently, the small punch test makes it possible to examine relationships between wear performance and mechanical behavior. This test method can also be used to rank the mechanical behavior relative to a reference control material.  
4.2 Small punch testing results may vary with specimen preparation and with the speed and environment of testing. Consequently, where precise comparative results are desired, these factors must be carefully controlled.
SCOPE
1.1 This test method covers the determination of mechanical behavior of polymeric biomaterials by small punch testing of miniature disk specimens (0.5 mm in thickness and 6.4 mm in diameter). The test method has been established for characterizing surgical materials after ram extrusion or compression molding (1-3)2; for evaluating as-manufactured implants and sterilization method effects (4, 5); as well as for testing of implants that have been retrieved (explanted) from the human body (6, 7).  
1.2 The results of the small punch test, namely the peak load, ultimate displacement, ultimate load, and work to failure, provide metrics of the yielding, ultimate strength, ductility, and toughness under multiaxial loading conditions. Because the mechanical behavior can be different when loaded under uniaxial and multiaxial loading conditions (8), the small punch test provides a complementary mechanical testing technique to the uniaxial tensile test. However, it should be noted that the small punch test results may not correlate with uniaxial tensile test results.  
1.3 In addition to its use as a research tool in implant retrieval analysis, the small punch test can be used as a laboratory screening test to evaluate new materials with minimal material waste (1).  
1.4 The small punch test has been applied to other polymers, including polymethyl methacrylate (PMMA) bone cement, polyacetal, and high density polyethylene (HDPE), ultra high molecular weight polyethylene (UHMWPE), and polyetheretherketone (PEEK) (2, 3, 5, 9, 10). This standard outlines general guidelines for the small punch testing of implantable polymers.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 Materials used in medical devices are selected in part for their biocompatibility, meaning that they have been demonstrated to have an acceptable biological response for the intended application. During manufacturing, most devices are exposed to a variety of processing steps and materials that have the potential to adversely affect the inherent biocompatibility of the device if they are not adequately removed prior to use.  
Note 1: For a fine powder, depending upon application, a new biological risk assessment may be required.  
5.2 In additive manufacturing, components are in most cases built layer-by-layer, allowing unprecedented freedom to design complex devices. This makes it possible to build devices that are very difficult to clean, such as topological optimized parts, small internal channels, lattice structures, and especially reticulated porous structures for bone ingrowth and fixation.  
5.3 Powdered fusion AM presents additional challenges. Components come out of the build volume with residual powder filling all open spaces within the device. The majority of the excess powder is typically removed by a combination of vibratory shaking, blowing with compressed gas, vacuuming, and ultrasonic cleaning in a solvent. However, the particles are typically very small and can become lodged in internal features such as pores, making removal difficult. Furthermore, particles that were immediately adjacent to the component during manufacturing can be partially sintered to the surface. Those particles can be extremely difficult to remove, are indistinguishable from loose particles when observed by most techniques, and may be at risk of detaching during the intended use of the device.  
5.4 This guide provides specific evaluation techniques for measuring the effectiveness of residue removal processes, as they should be able to yield consistent results that meet the respective performance and cleanliness criteria for the intended use.
SCOPE
1.1 This standard provides guidance for assessing the manufacturing material residues in medical devices fabricated using additive manufacturing (AM) techniques, specifically, from powder bed fusion AM technologies.  
1.1.1 Some of the techniques discussed in this guide may be applicable to devices fabricated by other types of AM equipment (e.g., stereolithography). Given each AM technique’s characteristics and post-processing challenges, there could be additional risks or considerations associated with some AM techniques or materials that are not addressed by this guide.  
1.2 This guide covers several qualitative and quantitative assessments of the presence and amount of residue remaining in or obtained by extraction in aqueous or organic solvents from powder bed fusion AM medical components.  
1.2.1 This guide identifies techniques to qualitatively determine the presence of residue and a technique to quantitatively assess it. It does not set acceptance criteria or acceptable limits for residues remaining in built parts. These methods are not the only methods to determine the presence or quantity of residual material in additive manufactured medical components.  
1.3 This guide pertains to devices in their finished state (after post-processing and subsequent manufacturing processes), as applicable. This guide may also be used to evaluate the effectiveness of cleaning processes between critical steps in the manufacturing process, to ensure minimal AM residue remains for cleaning processes downstream.  
1.4 This guide is not intended to evaluate the residue level in medical components that have been cleaned for reuse.  
1.5 Different cleaning methods, including high energy processes, can potentially damage small structures in AM parts. This guide does not address measurement or mitigation of this risk.  
1.6 This guide does not address the manufacturing occupational health issues of working with small particles (e.g., breathing hazards).  
1....

SIGNIFICANCE AND USE
4.1 It is well known from examination of implants after use that plates and screws used for osteosynthesis are subjected to metal loss due to corrosion at the plate-screw interfaces. One of the mechanisms of this corrosive attack is fretting corrosion due to relative motion (micromotion) between the screw heads and plate-hole countersinks.  
4.2 It is also known that release of corrosion products into the tissues surrounding an implant may have adverse effects on local tissue or have systemic effects. Thus, it is important to minimize the amount of tissue exposure to corrosion products.  
4.3 Screws and plates are available in different configurations in accordance with Specifications F543 and F382. This test method may be used to evaluate the effects of different combinations of screw and plate designs. As new materials and device designs are developed for use in the treatment of fractured bones, it is important to determine the effects these developments have on the amount of metal loss due to fretting corrosion.  
4.4 This test method provides a standardized screening test for ranking metal plates and screws in terms of resistance to fretting corrosion and for determining the influence of different solutions on fretting corrosion rates.  
4.5 This test method may also be used to generate corrosion products either for chemical analysis of the products or for testing for biological reactions to corrosion products using animal or cell culture methods.  
4.6 It is well known that fretting corrosion rates depend on normal load or pressure, frequency, sliding amplitude, materials, surface treatments, and environmental factors. (4) Therefore, when determining the effect of changing one of these parameters (for example, material or environment), all others must be kept constant to facilitate interpretation of the results.
SCOPE
1.1 This test method provides a screening test for determining the amount of metal loss from plates and screws used for osteosynthesis (internal fixation of broken bones) due to fretting corrosion in the contact area between the screw head and the plate hole countersink area. The implants are used in the form they would be used clinically. The machine described generates a relative motion between plates and screws which simulates one type of motion pattern that can occur when these devices are used clinically.  
1.2 Since the environmental and stress conditions used in this test method may not be identical to those experienced by bone plates in the human body, this test method may produce fretting corrosion rates that are lower or higher than those experienced in practice. The recommended axial load of 400 N was selected as being in a range where the amount of fretting corrosion is not sensitive to small changes in axial load (1).2 The combination of the recommended load and angular displacement are such that a measurable amount of fretting corrosion of surgical alloys occurs in a comparatively short period of time (7 to 14 days). (Refs 1-3)  
1.3 The device is designed so as to facilitate sterilization of the test specimens and test chambers to permit testing with proteinaceous solutions that would become contaminated with microbial growth in nonsterile conditions.  
1.4 The specimens used can be standard osteosynthesis implants or can be materials fabricated into the appropriate shapes.  
1.5 This test method may be used for testing the fretting corrosion of metal plates and screws of similar or different alloy compositions, or it may be used for testing the fretting corrosion of metal-nonmetal combinations. This test method may also be used for wear or degradation studies of nonmetallic materials. This test method may be used as a screening test to rank the corrosivities of saline or proteinaceous solutions, or to rank metal-to-metal couples for resistance to fretting corrosion, or to study other material combinations.  
1.6 The values stated in either SI unit...

SIGNIFICANCE AND USE
4.1 Published literature shows that the yield of radiolytic reactions that occur during radiation treatment increases with radiation dose level. Measurement of the products of these reactions can be used as an internal dosimeter.  
4.2 Trans-vinylene unsaturations are formed during ionization treatment by abstraction of a hydrogen molecule, and to a lesser extent by the recombination of two adjacent alkyl free radicals that reside on the same chain.  
4.3 Previous work generated calibration curves of trans-vinylene absorption area as a function of absorbed radiation dose, yielding a linear relationship for both gamma- and electron beam-irradiated polyethylene.  
4.4 This data can be used to determine received dose as a function of position, assuming a calibration curve (TVI versus radiation dose level) is known for the particular material and radiation conditions used, and can be used to determine uniformity of dose level in irradiated polyethylene.
SCOPE
1.1 This test method describes the measurement of the number of trans-vinylene groups in ultra-high molecular weight polyethylene (UHMWPE) intended for use in medical implants. The material is analyzed by infrared spectroscopy.  
1.2 This test method is based on Guide F2102.  
1.3 The applicability of the infrared method has been demonstrated in other literature reports. This particular method, using the intensity (area) of the C-H absorption centered at 1370 cm-1 to normalize for the sample’s thickness, will be validated by an Interlaboratory Study (ILS) conducted according to Practice E691.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 This guide may be used by medical device manufacturers as part of their design plan and implementation of the validation of the cleaning instructions of their reusable medical devices.  
5.2 This guide helps medical device manufacturers to identify the best method(s) for extracting simulated-use test soil (see Guide F3208), thereby evaluating whether the medical device can be adequately cleaned.  
5.3 Methods describing various techniques for extracting soil are given.  
5.4 Guidance is further given as to how to validate the method(s) for extraction.
SCOPE
1.1 This guide provides methods and considerations for extracting test soil(s) from reusable medical device(s) that occurs during simulated use validation, clinical use of the device(s) and after the device(s) have been through a cleaning process.  
1.2 This is a part of a series of ASTM guides for validating cleaning instructions. The scope of the first guide in the series is regarding selecting appropriate test soils (Guide F3208). The second in the series (Guide F3293) describes methods that are used to inoculate medical devices with simulated-use test soil(s). This third in the series describes methods for extracting test soils in order to measure residual soil remaining on medical devices after the performance of cleaning procedures.  
1.3 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 This test method describes a test procedure for evaluating the ∆T associated with RF power deposition during an MR procedure, involving a specific frequency of RF irradiation of a passive implant. The method allows characterization of the heating propensity of an implant rather than the prediction of heating during a specific MR procedure in a patient. The results may be used as an input to a computational model for estimating ∆T due to the presence of that implant in a patient. The combination of the test results and the computational model results may then be used to help assess the safety of a patient with the implant during an MR examination.
SCOPE
1.1 This test method covers measurement of radio frequency (RF)-induced heating on or near a passive medical implant within a phantom during magnetic resonance imaging (MRI). The test method does not specify levels of heating considered to be safe to the patient and relies on users to define their own acceptance criteria.  
1.2 This test method does not address other possible safety issues which include, but are not limited to: issues of magnetically-induced displacement, magnetically-induced torque, image artifact, acoustic noise, tissue heating, interaction among devices, and the functionality of the device and the MR system.  
1.3 The amount of RF-induced temperature rise (∆T) for a given incident electric field will depend on the RF frequency, which is dependent on the static magnetic field strength of the MR system. While the focus in this test method is on 1.5 tesla (T) or 3 T MR systems, the ∆T for an implant in MR systems of other static magnetic field strengths or magnet designs can be evaluated by suitable modification of the method described herein.  
1.4 This test method assumes that testing is done on devices that will be entirely inside the body. Testing for devices with other implantation conditions (e.g., external fixation devices, percutaneous needles, catheters or tethered devices such as ablation probes) is beyond the scope of this standard; for such devices, modifications of this test method may be necessary.
Note 1: RF-heating induced by any electrically conductive implanted device may be impacted by the presence of other metallic or otherwise electrically conductive devices present nearby.  
1.5 This test method is written for several possible RF exposure systems, including Volume RF transmit coils. The exposure system needs to be properly characterized, within the stated uncertainties, in term of local background RF exposure for the implants which are tested.  
1.6 The values stated in SI units are to be regarded as standard.  
1.7 A device with deployed dimensions of less than 2 cm in all directions may not need to be tested with respect to RF-induced heating, as it is expected to generate ∆T of less than 2°C over 1 h of exposure at 1.5 T/64-MHz or 3 T/128-MHz frequencies (1, 2)2 and ANSI/AAMI/ISO 14708-3:2017). This condition is not valid when multiple replicas of the device (e.g., multiple anchors) are implanted within 3 cm of the device.
Note 2: The above values were derived from existing data and literature. The 3 cm distance is recommended to avoid any RF coupling with other neighboring devices.  
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
4.1 Reusable medical devices have a range of cleanability. The equipment, effort, and time expended for cleaning devices should be feasible in the intended setting. For that reason, it is essential that cleanability be considered during the design phase.  
4.2 The next section highlights features that either have a tendency to retain debris and/or make removing contamination difficult. Individually, the criteria listed in this document may not render a device difficult to clean. Furthermore, it is the manufacturer’s responsibility to consider feasibility and ease of cleaning the device in the clinical environment when designing their device. Although it may not be feasible to remove or modify all of the problematic design features from a device, device manufacturers should be aware of challenging designs for cleaning and take appropriate action for minimizing the impact of these features on cleaning. For example, disassembly may be necessary to thoroughly clean a device, or it may be determined that a device cannot be adequately cleaned, in which case that device would be designated single-use only. In addition, manufacturers should consider the compatibility of their device design with subsequent sterilization or disinfection.
SCOPE
1.1 This guide is intended to provide manufacturers of reusable medical devices design feature guidance to minimize debris retention after use and increase ease of removal of contaminants and cleaning product residuals from devices during cleaning/rinsing and also prepare for subsequent processing steps (for example, sterilization or disinfection).  
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 Components of implanted medical devices can release ions, which may lead to adverse biological effects if released in sufficient quantities. Therefore, it may be necessary to characterize the ion release behavior over time to verify that a medical device or device components, or both, will not pose an unacceptable risk to patients. Some examples of when time-dependent ion release testing should be considered include:  
5.1.1 New materials,  
5.1.2 New applications (for example, different in-vivo environments or new designs) that may degrade corrosion resistance,  
5.1.3 Manufacturing processes that may lead to increased ion release susceptibility,  
5.1.4 Results of other corrosion testing (for example, Test Methods F2129 and F3044) indicate high susceptibility to corrosion.  
5.2 Forming and finishing steps used to create an implantable device may have significant effects on the ion release behavior of the material from which the device is fabricated. Preconditioning can impact the ion release behavior of implants; therefore, prior to testing, devices should be subjected to preconditioning that is appropriate to their application. A justification shall be provided if preconditioning is omitted. Additional information on preconditioning is found in Appendix X1. Substitute test articles (tubes, plates, wires, device subcomponents, etc.) may be used for testing with adequate justification, if all processing steps, including sterilization and preconditioning, are comparable to the finished device.  
5.3 To accommodate the wide variety of device shapes and sizes likely to be encountered, various sizes and shapes of containers manufactured from various materials can be used. The container material choice should be justified.  
5.4 Note that the test conditions described in this test method may not completely simulate those encountered in vivo (cells, proteins, mechanical loading, and other specifics of the in-vivo environment); however, the results of this tes...
SCOPE
1.1 This test method assesses metal or other ions released from single-use, metallic, implantable medical devices, or components thereof, by exposing the device to solutions simulating the in-vivo environment and temperature in a container for a predetermined time frame with regular sampling at adequate intervals. Examples of device types that may be evaluated by this test method include, but are not limited to: cardiovascular devices, endovascular devices, and orthopedic implants. Devices which are to be partially implanted, but in long-term contact within the body (such as external fixation devices) may also be evaluated using this method.  
1.2 This test method is used to assess devices or device components, or both, in their final form and finish, as they would be implanted. For modular implants, consideration should be given to individual testing of every part.  
1.3 This test method covers the selection of specimens, specimen preparation, test environment, method of exposure, and method for evaluating the results to characterize ion release. Because of the variety of configurations and sizes of implants, a variety of specimen container configurations may be used.  
1.4 This test method is not intended for ions only adsorbed onto the surface of the samples.  
1.5 This test method does not apply to absorbable metallic implants (for example, magnesium-based stents, bone screws, etc.) that are intentionally designed to degrade in-vivo.  
1.6 This test method does not cover the required subsequent chemical analysis, for example, by inductively coupled plasma mass spectrometry (ICP-MS), or the validation of the analytical instrumentation.  
1.7 This test method does not cover the influence of dynamic loading and associated surface damage or wear on ion release. Ion release may change under dynamic loading conditions and wear. Additional testing may be required, depending on the application and outcome of this test ...

SIGNIFICANCE AND USE
5.1 Corrosion of implantable medical devices can have deleterious effects on the device performance or may result in the release of corrosion products with harmful biological consequences; therefore it is important to determine the general corrosion behavior as well as the susceptibility of the devices to localized corrosion.  
5.2 The forming and finishing steps used to create an implantable device may have significant effects on the corrosion resistance of the material out of which the device is fabricated. During the selection process of a material for use as an implantable device, testing the corrosion resistance of the material is an essential step; however, it does not necessarily provide critical data regarding device performance.  
5.3 To accommodate the wide variety of device shapes and sizes encountered, a variety of holding devices can be used.  
5.4 Note that the method is intentionally designed to reach conditions that are sufficiently severe to cause breakdown and deterioration of the medical devices and that these conditions may not necessarily be encountered in vivo. The results of this corrosion test conducted in artificial physiological electrolytes can provide useful data for comparison of different device materials, designs, or manufacturing processes. However, note that this test method does not take into account the effects of cells, proteins, and so forth, on the corrosion behavior in vivo.
SCOPE
1.1 This test method assesses the corrosion susceptibility of small, metallic, implant medical devices, or components thereof, using cyclic (forward and reverse) potentiodynamic polarization. Examples of device types that may be evaluated by this test method include, but are not limited to, vascular stents, ureteral stents (Specification F1828), filters, support segments of endovascular grafts, cardiac occluders, aneurysm or ligation clips, staples, and so forth.  
1.2 This test method is used to assess a device in its final form and finish, as it would be implanted. These small devices should be tested in their entirety. The upper limit on device size is dictated by the electrical current delivery capability of the test apparatus (see Section 6). It is assumed that test methods, such as Reference Test Method G5 and Test Method G61 have been used for material screening.  
1.3 Because of the variety of configurations and sizes of implants, this test method provides a variety of specimen holder configurations.  
1.4 This test method is intended for use on implantable devices made from metals with a relatively high resistance to corrosion.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 The investigation of retrieved implantable medical devices and adjacent tissues can be of value in the assessment of clinical complications associated with the use of a specific prosthetic device design; can expand the knowledge of clinical implant performance and interactions between implants and the body; provide information on implant performance and safety; and thus further the development of biocompatible implant materials and devices with improved performance. Comparison of wear patterns and wear particle morphology observed with retrievals and those observed with in vitro joint simulator tests can provide valuable insight into the validity of the in vitro simulation.  
5.2 A significant portion of the information associated with a retrieved implant is obtained with detailed studies of the device-tissue interface healing response. Appropriate methods are provided to facilitate a study of the particles in the tissues, and chemical analysis for the byproducts of degradation of the implant, and histologic evaluation of the cellular response to the implant.  
5.3 For the analysis to be accurate, it is essential that the device and associated tissues be removed minimizing as best as possible alteration of their form and structure. It is also essential that the tissues be handled in such a way as to avoid microbial or viral contamination of the work place or the investigator. The tissue-device interface may need to be stabilized with chemical fixation prior to separation of the device from it’s in-situ position. It is also highly recommended to document detailed information about the tissue specimens, including location of extraction. Standard protocols for the examination and collection of data are provided for retrieval and handling of implantable medical devices, as well as for specific types of materials in relation to their typical applications. For particular investigational programs, additional, more specific, protocols may be required. If special analy...
SCOPE
1.1 This practice covers recommendations for the retrieval, handling, and analysis of implanted medical devices and associated specimens that are removed from human and animal subjects during revision surgery and at postmortem. This practice may be used for the analysis of any implant including inert, bioactive, resorbable, and tissue engineered products. This practice can also be used for analysis of specimens and fluids from in vitro tests, including those from wear tests and joint simulators. The aim is to provide guidance to minimize iatrogenic damage during the recovery and handling of the associated specimens which could obscure the investigational results. This practice is also intended to provide guidance as to gathering data at the proper time and circumstance.  
1.2 This practice offers guidelines for the analysis of retrieved implants to limit damage to them, and to allow comparisons between investigational results from different studies. The protocols are divided into three stages, where Stage I is the minimum non-destructive analysis, Stage II is more complete non-destructive analysis, and Stage III is destructive analysis. Standard protocols for the examination and collection of data are provided for specific types of materials in relation to their typical applications. For particular investigational programs, additional, more specific, protocols may be required. If special analytical techniques are employed, the appropriate handling procedures must be specified. Note that regulations for handling of patient information, tissues, and retrieved devices will vary by geography.  
1.3 This practice should be applied in accordance with pertinent regulations or legal requirements regarding the handling of patient data as well as the handling and analysis of retrieved implants and excised tissues, especially with regard to handling devices which may become involved in litigation, as in accordance with Practice E...

SIGNIFICANCE AND USE
5.1 This standard provides an itemization of potential in vitro test methods to evaluate the degradation of absorbable metals. The provided approach defers to the user of this standard to pick most appropriate method(s) based on the specific requirements of the intended application. However, a minimum of at least two different corrosion evaluation methods is considered necessary for basic profiling of the material or device, with additional methods potentially needed for an adequate characterization. However, in some instances there may be only one method that correlates to in vivo degradation results.  
5.2 It is recognized that not all test methods will be meaningful for every situation. In addition, some methods carry different potential than others regarding their relative approximation to the in vivo conditions within which actual use is to occur. As a result, some discussion and ranking of the relevance of the described methods is provided by this guidance.  
5.3 It should be noted that degradation of absorbable metals is not linear. Thus, precautions should be taken that evaluations of the degradation profile of a metal or metal device are appropriately adapted to reflect the varying stages and rates of degradation. Relevant factors can include the amount or percentage (%) of tissue coverage of the implanted device and the metabolic rate of surrounding tissue, which is not necessarily accompanied by a high perfusion rate.  
5.4 It is recognized that in vivo environments will impart specialized considerations that can directly affect the corrosion rate, even when compared with other in vivo locations. Thus, a basic understanding of the biochemistry and physiology of the specific targeted implant location (e.g. hard tissue; soft tissue; high, low or zero perfusion areas/tissue; high, low or zero loading environments) is needed to optimize in vitro and in vivo evaluations.  
5.5 Within the evaluation of absorbable metals, rate uniformity is considered to be ...
SCOPE
1.1 The purpose of this standard is to outline appropriate experimental approaches for conducting an initial evaluation of the in vitro degradation properties of a device or test sample fabricated from an absorbable metal or alloy.  
1.2 The described experimental approaches are intended to control the corrosion test environment through standardization of conditions and utilization of physiologically relevant electrolyte fluids. Evaluation of a standardized degradation control material is also incorporated to facilitate comparison and normalization of results across laboratories.  
1.3 The obtained test results may be used to screen materials and/or constructs prior to evaluation of a more refined fabricated device. The described tests may also be utilized to define a device’s performance threshold prior to more extensive in vitro performance evaluations (e.g. fatigue testing) or in vivo evaluations.  
1.4 This standard is considered to be applicable to all absorbable metals, including magnesium, iron, and zinc-based metals and alloys.  
1.5 The described tests are not considered to be representative of in vivo conditions and could potentially provide a more rapid or slower degradation rate than an absorbable metal’s actual in vivo corrosion rate. The herein described test methods are to be used for material comparison purposes only and are not to act as either a predictor or substitute for evaluation of the in vivo degradation properties of a device.  
1.6 This standard only provides guidance regarding the in vitro degradation of absorbable metals and does not address any aspect regarding either in vivo or biocompatibility evaluations.  
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limit...

SIGNIFICANCE AND USE
5.1 This standard guide may be used by medical device manufacturers as part of their design plan and implementation of the validation of the cleaning instructions of their reusable medical devices.  
5.2 It may help medical device manufacturers identify the most inaccessible locations on their device for inoculation with clinically relevant, simulated-use test soil (see ASTM F3208), thereby allowing testing to evaluate whether or not the medical device can be adequately cleaned.  
5.3 Methods described include pipetting, brushing, immersing, spraying, handling, and other techniques for applying soil.  
5.4 Guidance is given as to how to identify the clinically relevant areas of the device to soil, the time allowed for the soil to dry, and other conditioning considerations based upon assessment of worst-case clinical conditions.
SCOPE
1.1 This guide provides methods and considerations for simulated soiling of reusable medical devices for the purpose of validating cleaning instructions. Techniques for application of soil, as well as incorporation of soil by various means (e.g., actuation of devices) will be described in order to assure worst-case contamination of the surface geometry of medical devices.  
1.2 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 Consideration of the flexural stiffness of medical textiles is important, as these devices often need to possess properties that allow them to conform readily to the anatomic structures they are designed to support or protect. This test method outlines the materials and methods for the determination of flexural properties along the different textile directions (that is, machine and cross-machine) and for the effects of textile surface orientation (that is, face and back orientations).  
5.2 This test method can be used for quality control purposes.  
5.3 This test method can be used for non-absorbable, absorbable, and partially absorbable medical textiles including films and membranes. Testing should be performed on both dry and appropriately conditioned specimens. If the specimen is fabricated from a hydrolytically degradable absorbable material or contains an absorbable component, testing after hydrolytic conditioning at appropriate time intervals should be undertaken using Test Method F1635. For partially absorbable textiles, testing should be performed through at least two time intervals that exceed the point where the absorbable component no longer contributes to the specimen’s measurable mechanical properties.  
5.4 If flexural rigidity values are found to show effects related to planar and surface orientation, results from this test method could potentially help in determining if devices should be implanted or used only at specific textile directions and surface orientations. Considerations for determining device planar and surface orientations for use would include, but are not limited to, primary direction of bending once implanted or during use, anatomic structures that will interact with the device, and physiologic loads (normal, pathological, and worst-case) the device would experience during use.  
5.5 No evidence has been found showing that bending length is dependent on the width. However, the tendency for specimens to curl or twist can affect...
SCOPE
1.1 This test method covers the measurement of flexural stiffness properties of medical textiles (for example, surgical mesh, films, and membranes). Bending length is measured and flexural rigidity is calculated.  
1.2 This test method may be used for absorbable or non-absorbable medical textiles.  
1.3 This test method measures the flexural stiffness at room temperature in air and, if used directly, may not provide an accurate measure of in-vivo behavior for implantable medical textiles.  
1.4 This test method is not suitable for testing tubular samples.  
1.5 The values stated in SI units are to be regarded as standard. Values in parentheses are for information only.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
3.1 This test method provides corrosion test methodologies and means of evaluation that serve as indicators of proper material selection and proper processing by the manufacturer.  
Note 1: It is recommended that instruments be chemically passivated according to one of the treatments in Specification A967, electropolished according to Specification B912, or both, prior to evaluating the corrosion resistance according to this test method. The likelihood of failure may be higher for non-passivated instruments.
SCOPE
1.1 This test method covers general test procedures and evaluation criteria for the corrosion resistance of new and reusable surgical instruments fabricated from stainless steel alloys, such as, but not limited to, those listed in Specification F899.  
1.2 Instruments containing stainless steel materials that are exclusive to the following shall use the boil test and the copper sulfate test: austenitic materials (Class 3), precipitation hardening materials (Class 5), and ferritic materials (Class 6) containing equal or greater than 16 % chromium.  
1.3 Instruments containing any of the following stainless steel materials shall use the boil test: martensitic materials (Class 4) and ferritic materials (Class 6) containing less than 16 % chromium.  
1.4 The copper sulfate test is used to detect the presence of free iron on the surface of materials.  
1.5 The copper sulfate test as described in 6.2 is not recommended for martensitic materials or for ferritic materials containing less than 16% chromium because these steels may give a positive indication irrespective of the presence or absence of anodic surface contaminants (see X1.5).  
1.6 The boil test is applicable to martensitic, austenitic, ferritic, and precipitation hardening materials to detect surface imperfections, free iron, or other anodic surface contaminants on stainless steel.  
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 This test method is suitable for determination of the total amount of extractable residue in metallic medical components. Extractable residue includes aqueous and non-aqueous residue, as well as non-soluble residue.  
5.2 This test method recommends the use of a sonication technique to extract residue from the medical component. Other techniques, such as solvent reflux extraction, could be used but have been shown to be less efficient in some tests, as discussed in X1.2.  
5.3 This test method is not applicable for evaluating the extractable residue for the reuse of a single-use component (SUD).
SCOPE
1.1 This test method covers the quantitative assessment of the amount of residue obtained from metallic medical components when extracted with aqueous or organic solvents.  
1.2 This test method does not advocate an acceptable level of cleanliness. It identifies two techniques to quantify extractable residue on metallic medical components. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables.  
1.3 Although these methods may give the investigator a means to compare the relative levels of component cleanliness, it is recognized that some forms of component residue may not be accounted for by these methods.  
1.4 The applicability of these general gravimetric methods have been demonstrated by many literature reports; however, the specific suitability for applications to all-metal medical components will be validated by an Interlaboratory Study (ILS) conducted according to Practice E691.  
1.5 This test method is not intended to evaluate the residue level in medical components that have been cleaned for reuse. This test method is also not intended to extract residue for use in biocompatibility testing.
Note 1: For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO 10993–12.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.7 This standard may involve hazardous or environmentally-restricted materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 The shear test method is recommended for shear testing of calcium phosphate and metallic/substrate combinations and can provide information on the adhesive or cohesive strength of coatings under a uniaxial shear stress.  
5.2 The test method may be useful for comparative evaluation of adhesive or cohesive strengths of a variety of types of coatings. Information developed using this test method may be useful for certain quality control and design purposes.  
5.3 The test method should not be considered to provide an intrinsic values for utilization directly in making calculations such as determining the ability of a coating to withstand specified environmental stresses.  
5.4 Processing variables, such as substrate preparation prior to coating, surface texture, coating technique variables or post-coating heat treatment, or heat may introduce a significant effect on the results of the shear test. The specimen being evaluated must be representative of the actual end-use coating.
SCOPE
1.1 This test method covers shear testing of continuous calcium phosphate coatings and metallic coatings adhering to dense metal substrates at ambient temperatures. It assesses the degree of adhesion of coatings to substrates, or the internal cohesion of a coating in shear, parallel to the surface plane.  
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 The shear and bending fatigue tests are used to determine the effect of variations in material, geometry, surface condition, stress, and so forth, on the fatigue resistance of coated metallic materials subjected to direct stress for up to 107 cycles. These tests may be used as a relative guide to the selection of coated materials for service under condition of repeated stress.  
5.2 In order that such basic fatigue data be comparable, reproducible, and can be correlated among laboratories, it is essential that uniform fatigue practices be established.  
5.3 The results of the fatigue test may be used for basic material property design. Actual components should not be tested using these test methods.
SCOPE
1.1 This test method covers the procedure for determining the shear and bending fatigue performance of calcium phosphate coatings and of porous and nonporous metallic coatings and for determining the bending fatigue performance of metallic coatings over sprayed with calcium phosphate. This test method has been established based on plasma-sprayed titanium and plasma-sprayed hydroxylapatite coatings. The efficacy of this test method for other coatings has not been established. In the shear fatigue mode, this test method evaluates the adhesive and cohesive properties of the coating on a metallic substrate. In the bending fatigue mode, this test method evaluates both the adhesion of the coating as well as the effects that the coating may have on the substrate material. These methods are limited to testing in air at ambient temperature. These test methods are not intended for application in fatigue tests of components or devices; however, the test method which most closely replicates the actual loading configuration is preferred.  
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 Differential scanning calorimetry provides a rapid method for determining the transformation temperature(s) of nickel-titanium shape memory alloys.  
5.2 This test method uses small, stress-free, annealed samples to determine whether a sample of nickel-titanium alloy containing nominally 54.5 to 57.0 % nickel by weight is austenitic or martensitic at a particular temperature. Since chemical analysis of these alloys does not have sufficient precision to determine the transformation temperature by measuring the nickel-to-titanium ratio of the alloy, direct measurement of the transformation temperature of an annealed sample of known thermal history is recommended.  
5.3 This test method is useful for quality control, specification acceptance, and research.  
5.4 Transformation temperatures derived from differential scanning calorimetry (DSC) may not agree with those obtained by other test methods due to the effects of strain and load on the transformation. For example, transformation temperatures measured in accordance with Test Method F2082 will differ from those measured by the current standard.  
5.5 The use of this test method for finished or semi-finished components without annealing (as in 8.2) shall be agreed upon between the purchaser and the supplier.
SCOPE
1.1 This test method defines procedures for determining the transformation temperatures of nickel-titanium shape memory alloys, produced in accordance with Specification F2063, by differential scanning calorimetry.  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and to determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 The quality and consequently the clinical performance of implants may be affected by residues. Residues may induce no tissue response, minor tissue irritations, or they may lead to local inflammation of tissues surrounding the implant which may lead to failure in short-term or long-term use. Residues may also cause harm at locations away from the implant. Residues may originate from manufacturing materials used in the course of processing or from the manufacturing environment, or may be the result of handling and packaging (1-3).10  
5.2 This practice shall be used to report the results of testing for residue. All residues cannot necessarily be detected. It suggests standard techniques that may be applied for analysis, and provides suggestions for how limit values may be set.  
5.3 Residues may be of inorganic, organic, or biological nature. They may exhibit as surface-bound substance, or as adsorbates (for example, electrostatically held), efflorescence, or mechanically held substances. Residues may be soluble in aqueous media, soluble in organic solvents, or may be insoluble particulates.  
5.4 Data generated in validation processes (that is, cleaning validation or sterility validation) may be used as results or as basis for setting acceptance criteria in the report.
SCOPE
1.1 The purpose of this practice is to describe how the cleanliness of single-use implants as manufactured shall be reported. This practice proposes how to approach the identification of critical compounds and suggests different analytical methods.  
1.2 The practice does not address substances which are intrinsic to the implant properties or design. In particular, it does not address substances released during implant resorption, implant coatings, or leachables by design.  
1.3 This practice does not address the cleanliness of implants which are re-processed, re-cleaned after unpacking for re-use in the hospital or by the manufacturer.  
1.4 This practice does not establish limit values for residues.  
1.5 This practice suggests appropriate test methods for the general specification of residues and residue requirements of implants and single-use sterile instruments. This practice may also be used to characterize semi-finished components for implants.  
1.6 The test methods suggested and described herein refer to established analytical methods and to existing standard methods for chemical, biochemical, or biological analysis.  
1.7 This practice is intended solely to provide guidance regarding suitable test methods and reporting conventions for residues, which may or may not affect implant biocompatibility. This practice does not suggest or recommend test methods for biocompatibility, which may be found in Practice F748 or in ISO 10993-1.  
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ABSTRACT
This guide covers method for evaluating the relative extent of oxidation in ultra-high-molecular-weight polyethylene fabricated forms intended for surgical implants. Equipments for this method shall include an infrared spectrometer, specimen holder, and microtome. Specimen shall be tested with infrared spectrometer in accordance to the procedure of test specimen preparation, spectrometer setup, and test specimen configuration. Oxidation peak area, normalization peak area, oxidation index, oxidation index depth locator, oxidation index profile, surface oxidation index, bulk oxidation index, and maximum oxidation index shall be calculated from the spectra. Report shall include material information, sample information, spectrometer information, and data analysis information.
SCOPE
1.1 This guide covers a method for the measurement of the relative extent of oxidation present in HDPE homopolymers and ultra-high-molecular-weight polyethylene (UHMWPE) intended for use in medical implants. The material is analyzed by infrared spectroscopy. The intensity (area) of the carbonyl absorptions (>C=O) centered near 1720 cm-1 is related to the amount of chemically bound oxygen present in the material. Other forms of chemically bound oxygen (C-O-C, C-O-O-C, C-O-H, and so forth) are not captured by this guide.  
1.2 Although this guide may give the investigator a means to compare the relative extent of carbonyl oxidation present in various UHMWPE samples, it is recognized that other forms of chemically bound oxygen may be important contributors to these materials' characteristics.  
1.3 The applicability of the infrared method has been demonstrated by many literature reports. This particular method, using the intensity (area) of the C-H absorption centered near 1370 cm-1 to normalize for the sample’s thickness, has been validated by an Interlaboratory Study (ILS) conducted according to Practice E691.
FIG. 1 Typical FTIR Spectra of Oxidized UHMWPE, Showing the Definition of an Area-Based Oxidation Index Based on Normalization Using the 1370-cm-1 Peak
FIG. 2 FTIR Spectra Showing the Carbonyl Absorption Bands  
Note 1: Note that both reagents effectively extracted the lipids (the lipid absorption peak is centered at approximately 1740 cm-1). The tibial insert was fabricated from highly crosslinked and remelted UHMWPE followed by terminal sterilization in EtO gas (Ref. 1).  
1.4 The following precautionary caveat pertains only to the test method portion, Section 5, of this specification: This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
4.1 This test method is intended to be performed in conjunction with pin-on-flat wear machines or similar machines that are designed to evaluate simplified specimen geometries.
Note 1: See Haider & Baykal (1)3 for useful considerations and potential pitfalls in conducting pin on disk testing, interpreting test results and the complex and sometimes conflicting effects of lower stress and higher contact area on wear.  
4.2 This test method is designed to evaluate combinations of materials with respect to the amount of polymer wear, where quantifiable wear occurs primarily on the polymeric component. With some combinations of materials, significant wear of the counterface may occur, with subsequent embedding of counterface debris particles in the polymer. Such an occurrence will render the weight loss of the polymer specimen unreliable as an indicator of the polymer wear.  
4.3 Wear is reported as volume loss of the polymeric specimen as a function of sliding distance; however, if the sliding distance is not constant across the polymeric specimen surface due to complex motion patterns, wear may be reported as volume loss of the polymeric specimen as a function of wear cycles (in which case a “wear cycle” shall be defined). Volume loss of the polymer specimen is determined by dividing the experimental weight loss by the density of the polymer. For ease of interpretation, wear should be reported as a function of both the number of wear cycles and the sliding distance, when possible.  
4.4 The reference for the comparative evaluation of candidate materials shall be the wear rate of ultra-high-molecular-weight polyethylene (UHMWPE) conforming to Specification F648 bearing against counterfaces of cobalt-chromium-molybdenum alloy (in accordance with Specifications F75, F799, or F1537), having prosthetic-quality surface finish and lubricated with bovine blood serum (see 5.2).
SCOPE
1.1 This test method describes a laboratory method for evaluating the wear properties of combinations of materials that are being considered for use as bearing surfaces of human total joint prostheses. The body of this test method contains general methods which apply to all types of prosthesis wear applications while individual annexes describe specific wear test methods and clinical validation criteria tailored to each distinct wear application (for example, linear reciprocating motion, ball-cup (“hip-type”) wear, delamination wear, and so forth). It is the intent of this test method to rank materials, within each wear application, for polymer wear rates under simulated physiological conditions. It must be recognized, however, that contact geometries and wear motions are simplified using such methods. This test method, therefore, represents only an initial stage in the full wear characterization of a candidate material.  
1.2 All candidate materials should be tested in an appropriate joint simulator apparatus using prototype prostheses before being used in clinical trials in patients. The tests described in this test method are used to quickly and reliably screen material combinations for wear performance in different orthopaedic wear applications prior to committing them to more expensive and time-consuming joint simulator testing. In addition, these simplified tests can be used to relate material, surface finish, or other parameters to wear behavior on a more practical basis than is possible in joint simulator tests.  
1.3 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Developmen...

SIGNIFICANCE AND USE
5.1 This test method is one of those required to determine if the presence of a medical device may cause injury in the magnetic resonance environment. Other safety issues which should be addressed include but may not be limited to magnetically induced force (see Test Method F2052), RF heating (see Test Method F2182), and image artifact (see Test Method F2119). ISO TS 10974 addresses hazards produced by active implantable medical devices in the MR Environment.  
5.2 The terms MR Conditional, MR Safe, and MR Unsafe together with the corresponding icons in Practice F2503 shall be used to mark the device for safety in the MR environment.  
5.3 The acceptance criterion associated with this test shall be justified. If the maximum magnetically induced torque is less than the product of the longest dimension of the medical device and its weight, then the magnetically induced torque is less than the worst case torque on the device due to gravity. For this condition, it is assumed that any risk imposed by the application of the magnetically induced torque is no greater than any risk imposed by normal daily activity in the Earth's gravitational field. This is conservative. It is possible that greater torques also would not pose a hazard. (For example, device position with respect to adjacent tissue, tissue ingrowth, or other mechanisms may act to prevent device movement or forces produced by a magnetically induced torque that are greater than the torque due to gravity from causing harm to adjacent tissue.)  
5.4 This test method alone is not sufficient for determining if an implant is safe in the MR environment.  
5.5 The magnetically induced torque considered in this standard is the magneto-static torque due to the interaction of the MRI static magnetic field with the magnetization in the implant. The dynamic torque due to interaction of the static field with eddy currents induced in a rotating device is not addressed in this test method. Currents in lead wires may induce...
SCOPE
1.1 This test method covers the measurement of the magnetically induced torque produced by the static magnetic field in the magnetic resonance environment on medical devices and the comparison of that torque a user-specified acceptance criterion.  
1.2 This test method does not address other possible safety issues which may include, but are not limited to, magnetically induced deflection force, tissue heating, device malfunction, imaging artifacts, acoustic noise, interaction among devices, and the functionality of the device and the MR system.  
1.3 The torque considered here is the magneto-static torque due to the interaction of the MRI static magnetic field with the magnetization of the implant. The dynamic torque due to interaction of the static field with eddy currents induced in a rotating device is not addressed in this test method. Torque induced by currents in lead wires is not addressed by this standard.  
1.4 The methods in this standard are applicable for MR systems with a horizontal magnetic field. Not all of the methods described in this standard are applicable for use in an MR system with a vertical magnetic field. The Suspension Method and the Low Friction Surface Method require gravity to be orthogonal to the magnetically induced torsion and may not be performed using a vertical magnetic field. The Torsional Spring and Pulley Methods can be adapted to work in a vertical magnetic field, however the example apparatus are not appropriate for use in a vertical magnetic field. The Calculation Based on Measured Displacement Force Method is independent of the MR system and thus could be used for an MR system with a vertical magnetic field.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the u...

SIGNIFICANCE AND USE
5.1 The tensile test method is recommended for tension testing of calcium phosphate/substrate or porous metal coating/substrate combinations and can provide information on the adhesive or cohesive strength of coatings under (uniaxial) tensile stress.  
5.2 The test method may be useful for comparative evaluation of adhesive or cohesive strengths of a variety of types of coatings. Coatings may be applied using a variety of methods, including, but not limited to, plasma-spraying and sintering. Information developed using this test method may be useful for certain quality control and design purposes.  
5.3 The test should not be considered to provide an intrinsic value for utilization directly in making calculations such as determining the ability of a coating to withstand specified environmental stresses.  
5.4 Processing variables such as substrate preparation prior to coating, surface texture, coating technique variables or postcoating heat treatment variables may introduce a significant effect on the results of the tension test. The specimen being evaluated must be representative of the actual end-use coating.
SCOPE
1.1 This test method covers tension testing of calcium phosphate and metallic porous coatings adhering to dense metal substrates at ambient temperatures. It assesses the degree of adhesion of coatings to substrates, or the internal cohesion of a coating in tension normal to the surface plane.  
1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 This test method is intended to help assess the degradation rates (that is, the mass loss rate) and changes in material or structural properties, or both, of HDP materials used in surgical implants. Polymers that are known to degrade primarily by hydrolysis include but are not limited to homopolymers and copolymers of l-lactide, d-lactide, d,l-lactide glycolide, caprolactone, and p-dioxanone.7  
5.2 This test method may not be appropriate for all types of implant applications or for all known absorbable polymers. The user is cautioned to consider the appropriateness of the test method in view of the materials being tested and their potential application (see X1.1.1).  
5.3 Since it is well known that mechanical loading can increase the degradation rate of absorbable polymers, the presence and extent of such loading needs to be considered when comparing in vitro behavior with that expected or observed in vivo.  
5.3.1 Mechanically Unloaded Hydrolytic Evaluation—Conditioning of a hydrolysable device under mechanically unchallenged hydrolytic conditions at 37°C in buffered saline is a common means to obtain a first approximation of the degradation profile of an absorbable material or device. It does not necessarily represent actual in vivo service conditions, which can include mechanical loading in a variety of forms (for example. static tensile, cyclic tensile, shear, bending, and so forth). If the performance of a device under its indicated use includes loading, hydrolytic aging alone is NOT sufficient to fully characterize the device.  
5.3.2 Mechanically Loaded Hydrolytic Evaluation—The objective of loading is to approximate (at 37°C in buffered saline) the actual expected device service conditions so as to better understand potential physicochemical changes that may occur. Such testing can be considered as necessary if loading can be reasonably expected under in vivo service conditions. When feasible, test specimens should be loaded in a manner that simul...
SCOPE
1.1 This test method covers in vitro degradation of hydrolytically degradable polymers (HDP) intended for use in surgical implants.  
1.2 The requirements of this test method apply to HDPs in various forms:  
1.2.1 Virgin polymer resins, or  
1.2.2 Any form fabricated from virgin polymer such as a semi-finished component of a finished product, a finished product, which may include packaged and sterilized implants, or a specially fabricated test specimen.  
1.3 This test method provides guidance for mechanical loading or fluid flow, or both, when relevant to the device being evaluated. The specifics of loading type, magnitude, and frequency for a given application are beyond the scope of this test method.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.