iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
ASTM

ASTM F2038-00(2011)

(Guide)

Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials

Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials

SIGNIFICANCE AND USE
4.1 This guide is intended to provide guidance for the specification and selection of silicone materials for medical device applications.
Silicone manufacturers supplying materials to the medical device industry should readily provide information regarding non-proprietary product formulation to their customers either directly, or through the US FDA master file program.
SCOPE
1.1 This guide is intended to educate potential users of silicone elastomers, gels, and foams relative to their formulation and use. It does not provide information relative to silicone powders, fluids, and other silicones. The information provided is offered to guide users in the selection of appropriate materials, after consideration of the chemical, physical, and toxicological properties of individual ingredients or by-products. This guide offers general information about silicone materials typically used for medical applications. Detail on the crosslinking and fabrication of silicone materials is found in Part II of this guide.
1.2 Fabrication and properties of elastomers is covered in the companion document, F604, Part II. This monograph addresses only components of uncured elastomers, gels, and foams.
1.3 Silicone biocompatibility issues can be addressed at several levels, but ultimately the device manufacturer must assess biological suitability relative to intended use.
1.4 Biological and physical properties tend to be more reproducible when materials are manufactured in accordance with accepted quality standards such as ANSI ISO 9001 and current FDA Quality System Regulations/Good Manufacturing Practice Regulations.
1.5 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.
1.6 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 and health practices and determine the applicability of regulatory limitations prior to use. Users are also advised to refer to Material Safety Data Sheets provided with uncured silicone components.

General Information

Status
Historical
Publication Date
30-Nov-2011
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.11 - Polymeric Materials
Current Stage
Ref Project

Relations

Replaces
ASTM F2038-00(2005) - Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
Effective Date
01-Dec-2011
Referred By
ASTM F703-18(2022) - Standard Specification for Implantable Breast Prostheses
Effective Date
01-Dec-2011
Referred By
ASTM F2042-18 - Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
Effective Date
01-Dec-2011
Referred By
ASTM F1441-03(2022) - Standard Specification for Soft-Tissue Expander Devices
Effective Date
01-Dec-2011
Referred By
ASTM F1781-21 - Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
Effective Date
01-Dec-2011

Buy Standard

ASTM F2038-00(2011) - Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured MaterialsASTM F2038-00(2011) - Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
PreviousNext
Guide
ASTM F2038-00(2011) - Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
English language
6 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2038 − 00 (Reapproved 2011)
Standard Guide for
Silicone Elastomers, Gels, and Foams Used in Medical
1
Applications Part I—Formulations and Uncured Materials
This standard is issued under the fixed designation F2038; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
2
1.1 This guide is intended to educate potential users of 2.1 ASTM Standards:
silicone elastomers, gels, and foams relative to their formula- D1566 Terminology Relating to Rubber
tionanduse.Itdoesnotprovideinformationrelativetosilicone F813 Practice for Direct Contact Cell Culture Evaluation of
powders, fluids, and other silicones. The information provided Materials for Medical Devices
3
is offered to guide users in the selection of appropriate
2.2 Sterility Standards:
materials, after consideration of the chemical, physical, and
ANSI/AAMI ST41 Good Hospital Practice: Ethylene Oxide
toxicological properties of individual ingredients or by-
Sterilization and Sterility Assurance
products. This guide offers general information about silicone
ANSI/AAMI ST50 Dry Heat (Heated Air) Sterilizers
materials typically used for medical applications. Detail on the
ANSI/AAMIST29 RecommendedPracticeforDetermining
crosslinking and fabrication of silicone materials is found in
Ethylene Oxide in Medical Devices
Part II of this guide.
ANSI/AAM1 ST30 Determining Residual Ethylene Chlo-
rohydrin and Ethylene Glycol in Medical Devices
1.2 Fabrication and properties of elastomers is covered in
AAMI 13409-251 Sterilization of Health Care Products—
the companion document, F604, Part II. This monograph
Radiation Sterilization—Substantiation of 25kGy as a
addresses only components of uncured elastomers, gels, and
Sterilization Dose for Small or Infrequent Production
foams.
Batches
1.3 Silicone biocompatibility issues can be addressed at
AAMI TIRS-251 Microbiological Methods for Gamma Irra-
several levels, but ultimately the device manufacturer must
diation Sterilization of Medical Devices
assess biological suitability relative to intended use.
4
2.3 Quality Standards :
1.4 Biological and physical properties tend to be more
ANSI/ASQC Q9001 Quality Systems—Model for Quality
reproducible when materials are manufactured in accordance
Assurance in Design, Development Production,
with accepted quality standards such as ANSI ISO 9001 and
Installation, and Servicing
current FDAQuality System Regulations/Good Manufacturing
21 CFR 820 Quality System Regulation (current revision)
Practice Regulations.
21 CFR 210 Current Good Manufacturing Practice in
Manufacturing, Processing, Packing or Holding of Drugs;
1.5 The values stated in inch-pound units are to be regarded
General (current revision)
as standard. The values given in parentheses are mathematical
21 CFR 211 Current Good Manufacturing Practice for Fin-
conversions to SI units that are provided for information only
ished Pharmaceuticals (current revision)
and are not considered standard.
1.6 This standard does not purport to address all of the
3. Terminology
safety concerns, if any, associated with its use. It is the
3.1 Additional pertinent definitions can be found in Termi-
responsibility of the user of this standard to establish appro-
nology D1566.
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use. Users are also
advised to refer to Material Safety Data Sheets provided with
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
uncured silicone components.
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
1
This specification is under the jurisdiction of ASTM Committee F04 on the ASTM website.
3
Medical and Surgical Materials and Devices and is the direct responsibility of Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
Subcommittee F04.11 on Polymeric Materials. 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Current edition approved Dec. 1, 2011. Published January 2012. Originally AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
published in 2000. Last previous edition approved in 2005 as F2038 – 00 (2005). 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
DOI: 10.1520/F2038-00R11. www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2038 − 00 (2011)
3.2 Definitions: 3.2.10.1 high con
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

ASTM
ASTM F2777-23(Test Method)
Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion

SIGNIFICANCE AND USE
4.1 This test method can be used to describe the effects of materials, manufacturing, and design variables on the fatigue/cyclic creep performance of UHMWPE bearing components subject to substantial rotation in the transverse plane (relative to the tibial tray) for a relatively large number of cycles.  
4.2 The loading and kinematics of bearing component designs in vivo will, in general, differ from the loading and kinematics defined in this test method. The results obtained here cannot be used to directly predict in vivo performance. However, this test method is designed to enable comparisons between the fatigue performance of different bearing component designs when tested under similar conditions.  
4.3 The test described is applicable to any bicompartmental knee design, including mobile bearing knees that have mechanisms in the tibial articulating component to constrain the posterior movement of the femoral component and a built-in retention mechanism to keep the articulating component on the tibial plate.
SCOPE
1.1 This standard specifies a test method for determining the endurance properties and deformation, under specified laboratory conditions, of ultra high molecular weight polyethylene (UHMWPE) tibial bearing components used in bicompartmental or tricompartmental knee prosthesis designs.  
1.2 This test method is intended to simulate near posterior edge loading similar to the type of loading that would occur during high flexion motions such as squatting or kneeling.  
1.3 Although the methodology described attempts to identify physiological orientations and loading conditions, the interpretation of results is limited to an in vitro comparison between knee prosthesis designs and their ability to resist deformation and fracture under stated test conditions.  
1.4 This test method applies to bearing components manufactured from UHMWPE.  
1.5 This test method could be adapted to address unicompartmental total knee replacement (TKR) systems, provided that the designs of the unicompartmental systems have sufficient constraint to allow use of this test method. This test method does not include instructions for testing two unicompartmental knees as a bicompartmental system.  
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 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.

  • Standard
    8 pages
    English language
    sale 15% off
  • Standard
    8 pages
    English language
    sale 15% off
ASTM
ASTM F2886-17(2023)(Specification)
Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications

ABSTRACT
This specification covers chemical, mechanical, and metallurgical general requirements for metal injection molded (MIM) cobalt-28chromium-6molybddenum components to be used in manufacturing surgical implants. In this specification, the MIM components covered may have been densified beyond their as-sintered density by post-sinter processing. For the chemical requirements, the components supplied in this specification must conform in accordance to the chemical requirements specified herein in Table 1. The product analysis tolerances must also conform to the product tolerances presented in Table 2. The specification also enumerates the mechanical requirements for MIM components wherein the tensile properties of the MIM must conform to the mechanical properties in Table 3. The microstructural requirements and specimen preparation shall be in accordance with Guide E3 and Practice E407.
SCOPE
1.1 This specification covers chemical, mechanical, and metallurgical requirements for metal injection molded (MIM) cobalt-28chromium-6molybdenum components to be used in the manufacture of surgical implants  
1.2 The MIM components covered by this specification may have been densified beyond their as-sintered density by post-sinter processing.  
1.3 Units—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.  
1.4 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.

  • Technical specification
    5 pages
    English language
    sale 15% off
ASTM
ASTM F3140-23(Test Method)
Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements

SIGNIFICANCE AND USE
4.1 This test method can be used to describe the effects of materials, manufacturing, and design variables on the fatigue performance of metallic tibial trays subject to cyclic loading for relatively large numbers of cycles.  
4.2 The loading of tibial tray designs in vivo will, in general, differ from the loading defined in this practice. The results obtained here cannot be used to directly predict in vivo performance. However, this practice is designed to allow for comparisons between the fatigue performance of different metallic tibial tray designs, when tested under similar conditions.  
4.3 In order for fatigue data on tibial trays to be comparable, reproducible, and capable of being correlated among laboratories, it is essential that uniform procedures be established.
SCOPE
1.1 This test method covers a procedure for the fatigue testing of metallic tibial trays used in partial knee joint replacements.  
1.2 This test method covers the procedures for the performance of fatigue tests on metallic tibial components using a cyclic, constant-amplitude force. It applies to tibial trays which cover either the medial or the lateral plateau of the tibia.  
1.3 This test method may require modifications to accommodate other tibial tray designs.  
1.4 This test method is intended to provide useful, consistent, and reproducible information about the fatigue performance of metallic tibial trays with unsupported mid-section of the condyle.  
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.

  • Standard
    6 pages
    English language
    sale 15% off
  • Standard
    6 pages
    English language
    sale 15% off
ASTM
ASTM F981-23(Practice)
Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices

SIGNIFICANCE AND USE
4.1 This practice is a guideline for short-term and long-term assessment of skeletal muscle and bone tissue responses to long-term implant materials. For testing of final finished medical devices, the test article for implantation shall be as for intended use, including packaging and sterilization. The tissue responses to the test article are compared to the skeletal muscle and/or bone tissue response(s) elicited by control materials. The controls consistently demonstrate known cellular reaction and wound healing.
SCOPE
1.1 This practice provides guidelines for biological assessment of tissue responses to nonabsorbable for medical device implants. It assesses the effects of the material that is implanted intramuscularly or intraosseously. The experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, immune response, carcinogenicity, or mutagenicity of the material since other standards address these issues. It applies only to materials with projected applications in humans where the materials will reside in bone or skeletal muscle tissue in excess of 30 days. Applications in other organ systems or tissues may be inappropriate and are therefore excluded. Control materials are well recognized with a well-characterized long-term response and can include metals and any one of the metal alloys in Specification F67, F75, F90, F136, F138, or F562, high purity dense aluminum oxide as described in Specification F603, ultra high molecular weight polyethylene as stated in Specification F648, or USP polyethylene negative control.  
1.2 The values stated in SI units, including units officially accepted for use with SI, are to be regarded as standard. No other systems 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.

  • Standard
    5 pages
    English language
    sale 15% off
  • Standard
    5 pages
    English language
    sale 15% off
ASTM
ASTM F601-23(Practice)
Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants

SIGNIFICANCE AND USE
3.1 This practice is intended to confirm the method of obtaining and evaluating the fluorescent penetrant indications on metallic surgical implants.
SCOPE
1.1 This practice is intended as a standard for fluorescent penetrant inspection of metallic surgical implants.  
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.

  • Standard
    2 pages
    English language
    sale 15% off
  • Standard
    2 pages
    English language
    sale 15% off
ASTM
ASTM F3495-23(Test Method)
Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components

SIGNIFICANCE AND USE
5.1 These test methods are intended to determine the ultimate failure load of a ceramic femoral knee component. This information can be used for evaluation of different ceramic component designs or different ceramic materials, or for series production control.  
5.2 Although the test methodology described attempts to identify physiologically relevant intraoperative and in vivo loading conditions, the interpretation of results is limited to an in vitro comparison between ceramic femoral component designs and materials regarding their static ultimate failure load under the stated test conditions.
SCOPE
1.1 The test methods included in this standard cover two procedures for static burst testing of a ceramic femoral component used in total knee replacement (TKR). The two procedures are used to determine the static ultimate failure load of a ceramic femoral knee component. Both procedures are simulating in vivo loading conditions. One of the procedures additionally simulates intraoperative loading conditions. The standard applies to cruciate retaining (CR) femoral components which cover both the medial and lateral condyles and the patellar surface of the femur. These test methods may require modifications to accommodate other femoral component designs.  
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.

  • Standard
    11 pages
    English language
    sale 15% off
ASTM
ASTM F1609-23(Specification)
Standard Specification for Calcium Phosphate Coatings for Implantable Materials

ABSTRACT
This specification covers the material requirements for calcium phosphate coatings for surgical implant applications. In particulate and monolithic form, the calcium phosphate materials system has been well-characterized regarding biological response and laboratory characterization. This specification includes hydroxylapatite coatings, tricalcium phosphate coatings, or combinations thereof, with or without intentional minor additions of other ceramic or metallic, and applied by methods including, but not limited to, the following: mechanical capture, plasma spray deposition, dipping/sintering, electrophoretic deposition, porcelainizing, and sputtering. Substrates may include smooth, porous, textured, and other implantable topographical forms. This specification excludes organic coatings that may contain calcium and phosphate ionic species. Materials shall be tested and the individual grades shall conform to chemical requirements such as elemental analysis for calcium and phosphates, and intentional additions, trace element analysis for hydroxylapatite and beta tricalcium phosphate; crystallographic characterization such as Fourier Transform infrared spectroscopy, and environmental stability; physical characterization such as coverage of substrate, thickness, porosity, color, surface topography, and density; and mechanical characterization such as tensile bond strength, shear strength, and fatigue strength. The test specimen fabrication and contact with calcium phosphate coatings are also detailed.
SCOPE
1.1 This specification covers the material requirements for calcium phosphate coatings for surgical implant applications.  
1.2 In particulate and monolithic form, the calcium phosphate materials system has been well characterized regarding biological response (1, 2)2 and laboratory characterization (2-4). Several publications (5-10) have documented the in vitro and in vivo properties of selected calcium phosphate coating systems.  
1.3 This specification covers hydroxylapatite coatings, other calcium phosphate (for example, octacalcium calcium phosphate, amorphous calcium phosphate, dicalcium phosphate dihydrate) coatings, or a coating containing a combination of two or more calcium phosphate phases, with or without intentional minor additions of other elements or compounds (for example, fluorine, manganese, magnesium, carbonate),3 and applied by methods including, but not limited to, the following: (1) plasma spray deposition, (2) solution precipitation, (3) dipping/sintering, (4) electrophoretic deposition, and (5) sputtering.  
1.4 For a coating containing two or more calcium phosphate phases, one or more of which will be a major phase or major phases in the coating, while the other phase(s) may occur as a second or minor phases, the phase composition(s) of the coating should be determined against each corresponding crystalline phase, respectively. See X1.2.  
1.5 Substrates may include smooth, porous, textured, and other implantable topographical forms.  
1.6 This specification excludes organic coatings that may contain calcium and phosphate ionic species.  
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.

  • Technical specification
    5 pages
    English language
    sale 15% off
  • Technical specification
    5 pages
    English language
    sale 15% off
ASTM
ASTM F3141-23(Guide)
Standard Guide for Total Knee Replacement Loading Profiles

SIGNIFICANCE AND USE
4.1 The purpose of this test guide is to provide load profile information on how one could test a total knee replacement in order to evaluate in vitro its function and wear during several types of knee motions as described in 4.2 and 4.3.  
4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms.  
4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually.  
4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.
SCOPE
1.1 Motion path, load history, and loading modalities all contribute to the wear, degradation, and damage of implanted prosthetics. Simulating a variety of functional activities promises more realistic testing for wear and damage mode evaluation. Such activities are often called activities of daily living (ADLs). ADLs identified in the literature include walking, stair ascent and descent, sit-to-stand, stand-to-sit, squatting, kneeling, cross-legged sitting, into bath, out of bath, turning, and cutting motions (1-7).2 Activities other than walking gait often involve an extended range of motion and higher imposed loading conditions, which have the ability to cause damage and modes of failure other than normal wear (8-10).  
1.2 This document provides guidance for functional simulation that could be used to evaluate in vitro the durability of knee prosthetic devices under force control.  
1.3 Function simulation is defined as the reproduction of loads and motions that might be encountered in activities of daily living, but it does not necessarily cover every possible type of loading. Functional simulation differs from typical wear testing in that it attempts to exercise the prosthetic device through a variety of loading and motion conditions such as might be encountered in situ in the human body in order to reveal various damage modes and damage mechanisms that might be encountered throughout the life of the prosthetic device.  
1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control.  
1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking, turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation, and the active musculature acting across the knee.  
1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.  
1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

  • Guide
    34 pages
    English language
    sale 15% off
  • Guide
    34 pages
    English language
    sale 15% off
ASTM
ASTM F3047M-23(Guide)
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

SIGNIFICANCE AND USE
5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations.  
5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
SCOPE
1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6).  
1.5 The values stated in SI units are to be regarded as 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.

  • Guide
    8 pages
    English language
    sale 15% off
  • Guide
    8 pages
    English language
    sale 15% off
ASTM
ASTM F543-23(Specification)
Standard Specification and Test Methods for Metallic Medical Bone Screws

ABSTRACT
This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
SIGNIFICANCE AND USE
A1.1 Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
SCOPE
1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
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 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of 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.

  • Technical specification
    22 pages
    English language
    sale 15% off
  • Technical specification
    22 pages
    English language
    sale 15% off