ASTM F648-21
(Specification)Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
ABSTRACT
This specification covers ultra-high-molecular-weight polyethylene (UHMWPE) powder and fabricated forms for use in surgical implants. UHMWPE powder shall be of virgin polymer manufactured from a homopolymer of ethylene, while the fabricated forms shall be manufactured from the same UHMWPE powder without any stabilizers or processing aids. Tests for viscosity number, elongation stress, ash content, extraneous matter, and trace elements shall be performed for UHMWPE powders, while tests for density, ash content, tensile strength, yield strength, elongation, and impact strength shall be performed for fabricated forms. All tests shall conform to the requirements specified.
SCOPE
1.1 This specification covers ultra-high molecular weight polyethylene powder (UHMWPE) and fabricated forms intended for use in surgical implants.
1.2 The requirements of this specification apply to UHMWPE in two forms. One is virgin polymer powder (Section 4). The second is any form fabricated from this powder from which a finished product is subsequently produced (Section 5). This specification addresses material characteristics and does not apply to the packaged and sterilized finished implant.
1.3 The requirements of this specification do not apply to UHMWPE virgin powder or fabricated forms intentionally crosslinked or blended with other additives, for example, antioxidants.
1.4 The biological response to polyethylene in soft tissue and bone has been well characterized by a history of clinical use (1-3)2 and by laboratory studies (4-6).
1.5 The values stated in SI units are to be regarded as standard.
1.6 The following precautionary caveat pertains only to the test method portion, Section 7, of this specification: 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.
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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:F648 −21
Standard Specification for
Ultra-High-Molecular-Weight Polyethylene Powder and
1
Fabricated Form for Surgical Implants
ThisstandardisissuedunderthefixeddesignationF648;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
3
1.1 This specification covers ultra-high molecular weight
2.1 ASTM Standards:
polyethylene powder (UHMWPE) and fabricated forms in-
D256Test Methods for Determining the Izod Pendulum
tended for use in surgical implants.
Impact Resistance of Plastics
D638Test Method for Tensile Properties of Plastics
1.2 The requirements of this specification apply to UHM-
D648Test Method for Deflection Temperature of Plastics
WPE in two forms. One is virgin polymer powder (Section 4).
The second is any form fabricated from this powder from Under Flexural Load in the Edgewise Position
whichafinishedproductissubsequentlyproduced(Section5). D790Test Methods for Flexural Properties of Unreinforced
This specification addresses material characteristics and does
and Reinforced Plastics and Electrical Insulating Materi-
not apply to the packaged and sterilized finished implant.
als
D792Test Methods for Density and Specific Gravity (Rela-
1.3 The requirements of this specification do not apply to
tive Density) of Plastics by Displacement
UHMWPE virgin powder or fabricated forms intentionally
D1505Test Method for Density of Plastics by the Density-
crosslinked or blended with other additives, for example,
Gradient Technique
antioxidants.
4
D1898Practice for Sampling of Plastics (Withdrawn 1998)
1.4 The biological response to polyethylene in soft tissue
D4020SpecificationforUltra-High-Molecular-WeightPoly-
and bone has been well characterized by a history of clinical
2 ethylene Molding and Extrusion Materials
use (1-3) and by laboratory studies (4-6).
F619Practice for Extraction of Materials Used in Medical
1.5 The values stated in SI units are to be regarded as
Devices
standard.
F748PracticeforSelectingGenericBiologicalTestMethods
1.6 The following precautionary caveat pertains only to the
for Materials and Devices
test method portion, Section 7, of this specification: This
F749Practice for Evaluating Material Extracts by Intracuta-
standard does not purport to address all of the safety concerns,
neous Injection in the Rabbit
if any, associated with its use. It is the responsibility of the user
F756Practice for Assessment of Hemolytic Properties of
of this standard to establish appropriate safety, health, and
Materials
environmental practices and determine the applicability of
F763Practice for Short-Term Screening of Implant Materi-
regulatory limitations prior to use.
als
1.7 This international standard was developed in accor-
F813Practice for Direct Contact Cell Culture Evaluation of
dance with internationally recognized principles on standard-
Materials for Medical Devices
ization established in the Decision on Principles for the
F895TestMethodforAgarDiffusionCellCultureScreening
Development of International Standards, Guides and Recom-
for Cytotoxicity
mendations issued by the World Trade Organization Technical
F981Practice for Assessment of Compatibility of Biomate-
Barriers to Trade (TBT) Committee.
rials for Surgical Implants with Respect to Effect of
Materials on Muscle and Insertion into Bone
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
3
Subcommittee F04.11 on Polymeric Materials. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved April 1, 2021. Published April 2021. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1980. Last previous edition approved in 2014 as F648–14. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F0648-21. the ASTM website.
2 4
Theboldfacenumbersinparenthesesrefertothelistofreferencesattheendof The last approved version of this historical standard is referenced on
this specification. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F648−21
TABLE 1 Requirements for UHMWPE Powders
F2759Guide for Assessment of the Ultra-High Molecular
WeightPolyethylene(UHMWPE)UsedinOrthopedicand Property Test Method Requirement
Resin Type Type 1 Type 2 Type
...
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: F648 − 14 F648 − 21
Standard Specification for
Ultra-High-Molecular-Weight Polyethylene Powder and
1
Fabricated Form for Surgical Implants
This standard is issued under the fixed designation F648; 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 specification covers ultra-high molecular weight polyethylene powder (UHMWPE) and fabricated forms intended for use
in surgical implants.
1.2 The requirements of this specification apply to UHMWPE in two forms. One is virgin polymer powder (Section 4). The second
is any form fabricated from this powder from which a finished product is subsequently produced (Section 5). This specification
addresses material characteristics and does not apply to the packaged and sterilized finished implant.
1.3 The requirements of this specification do not apply to UHMWPE virgin powder or fabricated forms intentionally crosslinked
or blended with other additives, for example, antioxidants.
1.4 The biological response to polyethylene in soft tissue and bone has been well characterized by a history of clinical use (11-3,
2
2, 3) and by laboratory studies (44-6, 5, 6).
1.5 The values stated in SI units are to be regarded as standard.
1.6 The following precautionary caveat pertains only to the test method portion, Section 7, of this specification: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.
1.7 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.
2. Referenced Documents
3
2.1 ASTM Standards:
D256 Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics
D638 Test Method for Tensile Properties of Plastics
D648 Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position
1
This specification 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 March 1, 2014April 1, 2021. Published April 2014April 2021. Originally approved in 1980. Last previous edition approved in 20132014 as
F648 – 13.F648 – 14. DOI: 10.1520/F0648-14. 10.1520/F0648-21.
2
The boldface numbers in parentheses refer to the list of references at the end of this specification.
3
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 ----------------------
F648 − 21
D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
D792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
D1505 Test Method for Density of Plastics by the Density-Gradient Technique
4
D1898 Practice for Sampling of Plastics (Withdrawn 1998)
D4020 Specification for Ultra-High-Molecular-Weight Polyethylene Molding and Extrusion Materials
F619 Practice for Extraction of Materials Used in Medical Devices
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 Bon
...
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