ASTM F2565-21
(Guide)Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
ABSTRACT
This guide covers extensively irradiation-crosslinked ultra-high molecular weight polyethylene (UHMWPE) fabricated forms for surgical implant applications. Only gamma and electron beam irradiated extensively crosslinked materials are covered by this guide. Chemical composition and physical properties of extensively crosslinked UHMWPE fabricated form shall conform to the requirements of this guide which include ultimate tensile strength, yield strength, elongation, Izod impact strength, ultimate load, fatigue crack propagation, compressive modulus, percent crystallinity, melting temperature, residual free radicals, swell ratio, oxidation index, and t-vinylene content. Biocompatibility of the material shall also be considered when new applications of the material, or modification to the material or physical forms of the materials are being contemplated.
SCOPE
1.1 This guide covers extensively crosslinked ultra-high molecular weight polyethylene (UHMWPE) materials (fabricated forms) that are produced starting with virgin resin powders and consolidated forms meeting all the requirements of Specification F648.
1.2 This guide does not cover fabricated forms of ultra-high molecular weight polyethylene which have received only gas plasma, ethylene oxide, or less than 40 kGy ionizing radiation treatments, that is, materials treated only by historical sterilization methods.
1.3 This guide pertains only to UHMWPE materials extensively crosslinked by gamma and electron beam sources of ionizing radiation.
1.4 The specific relationships between these mechanical properties and the in vivo performance of a fabricated form have not been determined. While trends are apparent, specific property-polymer structure and polymer-design relationships are not well understood. These mechanical tests are frequently used to evaluate the reproducibility of a fabrication procedure and are applicable for comparative studies of different materials.
1.5 The following precautionary caveat pertains only to the test method portion, Section 5, of this guide: 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.
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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: F2565 − 21
Standard Guide for
Extensively Irradiation-Crosslinked Ultra-High Molecular
Weight Polyethylene Fabricated Forms for Surgical Implant
1
Applications
This standard is issued under the fixed designation F2565; 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 mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
1.1 This guide covers extensively crosslinked ultra-high
molecular weight polyethylene (UHMWPE) materials (fabri-
2. Referenced Documents
cated forms) that are produced starting with virgin resin
2
2.1 ASTM Standards:
powders and consolidated forms meeting all the requirements
D695 Test Method for Compressive Properties of Rigid
of Specification F648.
Plastics
1.2 This guide does not cover fabricated forms of ultra-high 3
D1898 Practice for Sampling of Plastics (Withdrawn 1998)
molecular weight polyethylene which have received only gas
D2765 Test Methods for Determination of Gel Content and
plasma, ethylene oxide, or less than 40 kGy ionizing radiation
Swell Ratio of Crosslinked Ethylene Plastics
treatments, that is, materials treated only by historical steril-
E647 Test Method for Measurement of Fatigue Crack
ization methods.
Growth Rates
1.3 This guide pertains only to UHMWPE materials exten-
F619 Practice for Extraction of Materials Used in Medical
sively crosslinked by gamma and electron beam sources of Devices
ionizing radiation.
F648 Specification for Ultra-High-Molecular-Weight Poly-
ethylene Powder and Fabricated Form for Surgical Im-
1.4 The specific relationships between these mechanical
plants
properties and the in vivo performance of a fabricated form
F748 PracticeforSelectingGenericBiologicalTestMethods
have not been determined. While trends are apparent, specific
for Materials and Devices
property-polymer structure and polymer-design relationships
F749 Practice for Evaluating Material Extracts by Intracuta-
are not well understood. These mechanical tests are frequently
neous Injection in the Rabbit
used to evaluate the reproducibility of a fabrication procedure
F756 Practice for Assessment of Hemolytic Properties of
and are applicable for comparative studies of different materi-
Materials
als.
F763 Practice for Short-Term Screening of Implant Materi-
1.5 The following precautionary caveat pertains only to the
als
test method portion, Section 5, of this guide: This standard
F813 Practice for Direct Contact Cell Culture Evaluation of
does not purport to address all of the safety concerns, if any,
Materials for Medical Devices
associated with its use. It is the responsibility of the user of this
F895 TestMethodforAgarDiffusionCellCultureScreening
standard to establish appropriate safety, health, and environ-
for Cytotoxicity
mental practices and determine the applicability of regulatory
F981 Practice for Assessment of Compatibility of Biomate-
limitations prior to use.
rials for Surgical Implants with Respect to Effect of
1.6 This international standard was developed in accor-
Materials on Muscle and Insertion into Bone
dance with internationally recognized principles on standard-
F2003 Practice for Accelerated Aging of Ultra-High Mo-
ization established in the Decision on Principles for the
lecular Weight Polyethylene after Gamma Irradiation in
Development of International Standards, Guides and Recom-
Air
1 2
This guide is under the jurisdiction of ASTM Committee F04 on Medical and For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Surgical Materials and Devices and is the direct responsibility of Subcommittee contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
F04.11 on Polymeric Materials. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved May 15, 2021. Published May 2021. Originally the ASTM website.
3
approved in 2006. Last previous edition approved in 2013 as F2565 – 13. DOI: The last approved version of this historical standard is referenced on
10.1520/F2565-21. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2565 − 21
TABLE 1 UHMWPE Mechanical and Physical Assessments, Part 1
F2102 Guide for Evaluating the Extent of Oxidation in
Polyethylene Fabricated Forms Intended for Surgical Test Description Method
Tensile Streng
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2565 − 13 F2565 − 21
Standard Guide for
Extensively Irradiation-Crosslinked Ultra-High Molecular
Weight Polyethylene Fabricated Forms for Surgical Implant
1
Applications
This standard is issued under the fixed designation F2565; 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
1.1 This guide covers extensively crosslinked ultra-high molecular weight polyethylene (UHMWPE) materials (fabricated forms)
that are produced starting with virgin resin powders and consolidated forms meeting all the requirements of Test Method
Specification F648.
1.2 This guide does not cover fabricated forms of ultra-high molecular weight polyethylene which have received only gas plasma,
ethylene oxide, or less than 40 kGy ionizing radiation treatments, that is, materials treated only by historical sterilization methods.
1.3 This guide pertains only to UHMWPE materials extensively crosslinked by gamma and electron beam sources of ionizing
radiation.
1.4 The specific relationships between these mechanical properties and the in vivo performance of a fabricated form have not been
determined. While trends are apparent, specific property-polymer structure and polymer-design relationships are not well
understood. These mechanical tests are frequently used to evaluate the reproducibility of a fabrication procedure and are applicable
for comparative studies of different materials.
1.5 The following precautionary caveat pertains only to the test method portion, Section 5, of this guide.guide: 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 safety, health, and healthenvironmental 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.
2. Referenced Documents
2
2.1 ASTM Standards:
D638 Test Method for Tensile Properties of Plastics
D695 Test Method for Compressive Properties of Rigid Plastics
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.11
on Polymeric Materials.
Current edition approved July 15, 2013May 15, 2021. Published August 2013May 2021. Originally approved in 2006. Last previous edition approved in 20062013 as
F2565F2565 – 13.-06. DOI: 10.1520/F2565-13.10.1520/F2565-21.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 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 the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2565 − 21
3
D1898 Practice for Sampling of Plastics (Withdrawn 1998)
D2765 Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene Plastics
E647 Test Method for Measurement of Fatigue Crack Growth Rates
F619 Practice for Extraction of Materials Used in Medical Devices
F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F749 Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
F756 Practice for Assessment of Hemolytic Properties of Materials
F763 Practice for Short-Term Screening of Implant Materials
F813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
F895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Insertion into Bone
F2003 Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
F2102 Guide for Evaluating the Exte
...
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