iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
ASTM

ASTM F452-76(2022)

(Specification)

Standard Specification for Preformed Cranioplasty Plates

Standard Specification for Preformed Cranioplasty Plates

ABSTRACT
This specification covers compositional, physical performance, and packaging requirements of preformed cranioplasty plates for covering skull defects. This specification does not cover toxicity nor biocompatibility of the material. Cranioplasty shall be fabricated in a variety of dimensions to accommodate various sized skull defects and shall contain multiple perforations. Cranioplasty plates shall conform to materials, manufacturing, packaging, and labeling requirements of this specification.
SCOPE
1.1 This specification covers preformed cranioplasty plates which do not require further alteration for covering skull defects. This specification covers compositional and physical performance and packaging requirements, but does not cover toxicity nor biocompatibility of the materials.  
1.2 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.

General Information

Status
Published
Publication Date
31-Oct-2022
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.31 - Neurosurgical Standards
Current Stage
Ref Project

Relations

Refers
ASTM F139-19 - Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
Effective Date
01-Dec-2019
Refers
ASTM F86-12a - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
Effective Date
01-Dec-2012
Refers
ASTM F139-12 - Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
Effective Date
01-Oct-2012
Refers
ASTM F86-12 - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
Effective Date
15-May-2012
Refers
ASTM F75-12 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
Effective Date
15-May-2012
Refers
ASTM F86-04(2009) - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
Effective Date
01-Dec-2009
Refers
ASTM F139-08 - Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
Effective Date
01-Feb-2008
Refers
ASTM F75-07 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
Effective Date
01-Jan-2007
Refers
ASTM F86-04 - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
Effective Date
01-Oct-2004
Refers
ASTM F139-03 - Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
Effective Date
10-Jun-2003
Refers
ASTM F75-98 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
Effective Date
10-Dec-2001
Refers
ASTM F75-01 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
Effective Date
10-Dec-2001
Refers
ASTM F86-01 - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
Effective Date
10-Jan-2001
Refers
ASTM F86-00 - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
Effective Date
10-Jan-2001
Refers
ASTM F139-00 - Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
Effective Date
10-Jun-2000

Buy Standard

ASTM F452-76(2022) - Standard Specification for Preformed Cranioplasty PlatesASTM F452-76(2022) - Standard Specification for Preformed Cranioplasty Plates
PreviousNext
Technical specification
ASTM F452-76(2022) - Standard Specification for Preformed Cranioplasty Plates
English language
2 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (Sample)


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.
Designation: F452 −76 (Reapproved 2022)
Standard Specification for
Preformed Cranioplasty Plates
ThisstandardisissuedunderthefixeddesignationF452;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope of Specification F56, Grade 2, F75,or F139, Grade 2. The
condition of the material (such as annealed, cold finished, and
1.1 This specification covers preformed cranioplasty plates
so forth) should be specified in the purchase order.
which do not require further alteration for covering skull
defects. This specification covers compositional and physical
4. Dimensions and Tolerances
performance and packaging requirements, but does not cover
toxicity nor biocompatibility of the materials. 4.1 Cranioplasty plates conforming to this specification
shall be fabricated in a variety of dimensions to accommodate,
1.2 This international standard was developed in accor-
without further alteration, various-sized skull defects.
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
4.2 Shape shall be contoured so as to re-establish the normal
Development of International Standards, Guides and Recom-
configuration and symmetry of the skull at various anticipated
mendations issued by the World Trade Organization Technical
sites of defect such as the parietal bosses, the inion, the brow,
Barriers to Trade (TBT) Committee.
the linea temporalis, and so forth.
2. Referenced Documents 4.3 Plates shall contain multiple perforations (see Fig. 1).
2.1 ASTM Standards: 4.4 Thicknesses and individual shapes shall vary with need.
F56 Specification for Stainless Steel Sheet and Strip for
Thickness tolerances shall be as follows:
Surgical Implants (Withdrawn 1989)
Thickness Tolerances,
Specified Thickness, in. (mm)
in. (mm)
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
Alloy Castings and Casting Alloy for Surgical Implants
0.005 (0.13) to 0.010 (0.25), incl ±10 %
(UNS R30075)
0.010 (0.25) to 0.020 (0.51), incl ±0.0015 (0.04)
F86 Practice for Surface Preparation and Marking of Metal- 0.020 (0.51) to 0.035 (0.89), incl ±0.002 (0.05)
0.035 (0.89) to 0.050 (1.27), incl ±0.0025 (0.06)
lic Surgical Implants
0.050 (1.27) to 0.100 (2.54), incl ±0.003 (0.08)
F139 Specification for Wrought 18Chromium-14Nickel-
2.5Molybdenum Stainless Steel Sheet and Strip for Sur-
5. Finish and Identification
gical Implants (UNS S31673)
5.1 Cranioplasty plates conforming to this specification
2.2 American Society for Quality (ASQ) Standard:
shall have their surfaces prepared in accordance with the latest
ASQ C1 Specifications of General Requirements for a Qual-
issueofPracticeF86.Specificrequirementsofsurfacefinish(if
ity Program
any) shall be stated in the purchase order.
3. Materials
5.2 The method of marking the plates shall be one of those
3.1 Cranioplasty plates conforming to this specification
specified in Practice F86.
shall be fabricated from materials described in the latest issue
6. Precautions
This specification is under the jurisdiction of ASTM Committee F04 on
6.1 Cranioplasty plates covered by this specification shall
Medi
...

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 F2267-24(Test Method)
Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

SIGNIFICANCE AND USE
5.1 Intervertebral body fusion devices are generally simple geometric-shaped devices, which are often porous or hollow in nature. Their function is to support the anterior column of the spine to facilitate arthrodesis of the motion segment.  
5.2 This test method is designed to quantify the subsidence characteristics of different designs of intervertebral body fusion devices since this is a potential clinical failure mode. These tests are conducted in vitro in order to simplify the comparison of simulated vertebral body subsidence induced by the intervertebral body fusion devices.  
5.3 The static axial compressive loads that will be applied to the intervertebral body fusion devices and test blocks will differ from the complex loading seen in vivo, and therefore, the results from this test method may not be used to directly predict in vivo performance. The results, however, can be used to compare the varying degrees of subsidence between different intervertebral body fusion device designs for a given density of simulated bone.  
5.4 The location within the simulated vertebral bodies and position of the intervertebral body fusion device with respect to the loading axis will be dependent upon the design and manufacturer's recommendation for implant placement.
SCOPE
1.1 This test method specifies the materials and methods for the axial compressive subsidence testing of non-biologic intervertebral body fusion devices, spinal implants designed to promote arthrodesis at a given spinal motion segment.  
1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future non-biologic intervertebral body fusion devices. This test method is intended to enable the user to mechanically compare intervertebral body fusion devices and does not purport to provide performance standards for intervertebral body fusion devices.  
1.3 This test method describes a static test method by specifying a load type and a specific method of applying this load. This test method is designed to allow for the comparative evaluation of intervertebral body fusion devices.  
1.4 Guidelines are established for measuring test block deformation and determining the subsidence of intervertebral body fusion devices.  
1.5 Since some intervertebral body fusion devices require the use of additional implants for stabilization, the testing of these types of implants may not be in accordance with the manufacturer's recommended usage.  
1.6 Units—The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in terms of either degrees or radians.  
1.7 The use of this standard may involve the operation of potentially hazardous 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.

  • Standard
    8 pages
    English language
    sale 15% off
  • Standard
    8 pages
    English language
    sale 15% off
ASTM
ASTM F1295-24(Specification)
Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed, cold worked, or hot rolled titanium-6aluminum-7niobium alloy (UNS R56700) bar and wire to be used in the manufacture of surgical implants. Titanium mill products covered in this specification shall be formed with the conventional forging and rolling equipment found in primary ferrous and nonferrous plants, and may be furnished as descaled or pickled, sandblasted, chemically milled, ground, machined, peeled, polished, or cold drawn. The alloy shall be multiple melted in arc furnaces (including furnaces such as plasma arc and electron beam) of a type conventionally used for reactive metals. Heat analysis shall conform to the chemical composition requirements prescribed for aluminum, niobium, tantalum, iron, oxygen, carbon, nitrogen, hydrogen, and titanium. The material shall conform to the specified requirements for mechanical properties such as ultimate tensile strength, yield strength, and elongation. A minimum of two tension tests from each lot shall be performed. Special requirements for the microstructure are detailed as well.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed, cold-worked, or hot-worked titanium-6aluminum-7niobium alloy bar, wire, sheet, strip, and plate to be used in the manufacture of surgical implants (1-7).2  
1.2 The SI units in this standard are the primary units. The values stated in either primary SI units or secondary 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.  
1.3 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.

  • Technical specification
    6 pages
    English language
    sale 15% off
  • Technical specification
    6 pages
    English language
    sale 15% off
ASTM
ASTM F1538-24(Specification)
Standard Specification for Glass and Glass-Ceramic Biomaterials for Implantation

ABSTRACT
This specification covers the material requirements and characterization techniques for glass and glass-ceramic biomaterials intended for use as bulk porous or powdered surgical implants, or as coatings on surgical devices, but not including drug delivery systems. Glass and glass-ceramic biomaterials should be evaluated thoroughly for biocompatibility before human use. Tests shall be performed to determine the properties of the biomaterials, in accordance with the following test methods: bulk composition; density; flexural strength; Young's modulus; hardness; surface area; bond strength of glass or glass ceramic coating; crystallinity; thermal expansion; and particle size.
SCOPE
1.1 This specification covers the material requirements and characterization techniques for glass and glass-ceramic biomaterials intended for use as bulk porous or powdered surgical implants, or as coatings on surgical devices, but not including drug delivery systems.  
1.2 The biological response to glass and glass-ceramic biomaterials in bone and soft tissue has been demonstrated in clinical use (1-12)2 and laboratory studies (13-17).  
1.3 This specification excludes synthetic hydroxylapatite, hydroxylapatite coatings, aluminum oxide ceramics, alpha- and beta-tricalcium phosphate, and whitlockite.  
1.4 Warning—Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law.  
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.

  • Technical specification
    4 pages
    English language
    sale 15% off
  • Technical specification
    4 pages
    English language
    sale 15% off
ASTM
ASTM F1350-24(Specification)
Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)

ABSTRACT
This specification covers UNS S31673 chromium-nickel-molybdenum wrought annealed stainless steel surgical fixation wires. The wires should conform to the required values of tensile strength and elongation. Wire surfaces should be processed to minimize tool marks, nicks, scratches, cracks, cavities, spurs, and other imperfections that would impair wire serviceability.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for the manufacture of wrought 18chromium-14nickel-2.5molybdenum stainless steel in the form of surgical fixation wire.  
1.2 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 are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.  
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.

  • Technical specification
    4 pages
    English language
    sale 15% off
  • Technical specification
    4 pages
    English language
    sale 15% off
ASTM
ASTM F2914-12(2024)(Guide)
Standard Guide for Identification of Shelf-Life Test Attributes for Endovascular Devices

SIGNIFICANCE AND USE
3.1 The purpose of this guide is to provide a procedure for determining the appropriate attributes to evaluate in a shelf-life study for an endovascular device.
SCOPE
1.1 This guide addresses the determination of appropriate device attributes for testing as part of a shelf-life study for endovascular devices. Combination and biodegradable devices (for example, drug devices, biologic devices, or drug biologics) may require additional considerations, depending on their nature.  
1.2 This guide does not directly provide any test methods for conducting shelf-life testing.  
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.

  • Guide
    6 pages
    English language
    sale 15% off
ASTM
ASTM F2527-24(Specification)
Standard Specification for Wrought Seamless and Welded and Drawn Cobalt Alloy Small Diameter Tubing for Surgical Implants (UNS R30003, UNS R30008, UNS R30035, UNS R30605, and UNS R31537)

ABSTRACT
This specification covers the requirements for wrought seamless and welded and drawn cobalt alloy small diameter tubing used for the manufacture of surgical implants. Product variables that differentiate small diameter medical tubing from the bar, wire, sheet, and strip product forms are addressed. This specification applies to straight length tubing of specified diameters and thickness. Seamless tubing shall be made from bar, hollow bar, rod, or hollow rod raw material forms through a prescribed process. Welded and drawn tubing shall be made from strip or sheet raw material forms that meet the specified chemical requirements. The tubing shall be subject to tensile testing.
SCOPE
1.1 This specification covers the requirements for wrought seamless and welded and drawn cobalt alloy small diameter tubing used for the manufacture of surgical implants. Material shall conform to the applicable requirements of Specifications F90, F562, F688, F1058 or F1537, Alloy 1. This specification addresses those product variables that differentiate small diameter medical tubing from the bar, wire, sheet, and strip product forms covered in these specifications.  
1.2 This specification applies to straight length tubing with 6.3 mm [0.250 in.] and smaller nominal outside diameter (OD) and 0.76 mm [0.030 in.] and thinner nominal wall thickness.  
1.3 The specifications in 2.1 are referred to as the ASTM material standard(s) in this specification.  
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 are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.  
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.

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