ASTM F648-10a

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, antioxidents.
1.4 The biological response to polyethylene in soft tissue and bone has been well characterized by a history of clinical use (1, 2, 3) and by laboratory studies (4, 5, 6).
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 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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 30-Nov-2010
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• ICS: 83.080.20 - Thermoplastic materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.11 - Polymeric Materials

Relations

• Replaces: ASTM F648-10 - Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• Effective Date: 01-Dec-2010
• Replaced By: ASTM F648-13 - Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• Effective Date: 01-Jul-2013
• Referred By: ASTM F1408-20a - Standard Practice for Subcutaneous Screening Test for Implant Materials
• Effective Date: 01-Dec-2010
• Referred By: ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
• Effective Date: 01-Dec-2010
• Referred By: ASTM F1714-96(2018) - Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
• Effective Date: 01-Dec-2010
• Referred By: ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
• Effective Date: 01-Dec-2010
• Referred By: ASTM F1357-23 - Standard Specification for Articulating Total Wrist Implants
• Effective Date: 01-Dec-2010
• Referred By: ASTM F1378-18e1 - Standard Specification for Shoulder Prostheses
• Effective Date: 01-Dec-2010
• Referred By: ASTM F2848-21 - Standard Specification for Medical-Grade Ultra-High-Molecular-Weight Polyethylene Yarns
• Effective Date: 01-Dec-2010
• Referred By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 01-Dec-2010
• Referred By: ASTM F2003-02(2022) - Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene After Gamma Irradiation in Air
• Effective Date: 01-Dec-2010
• Referred By: ASTM F3336-22 - Standard Practice for Lipid Preconditioning of Ultra-High-Molecular-Weight Polyethylene for Accelerated Aging
• Effective Date: 01-Dec-2010
• Referred By: ASTM F763-22 - Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
• Effective Date: 01-Dec-2010
• Referred By: ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
• Effective Date: 01-Dec-2010
• Referred By: ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
• Effective Date: 01-Dec-2010

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:F648 −10a
StandardSpecification 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
2.1 ASTM Standards:
1.1 This specification covers ultra-high molecular weight
D256Test Methods for Determining the Izod Pendulum
polyethylene powder (UHMWPE) and fabricated forms in-
Impact Resistance of Plastics
tended for use in surgical implants.
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).
Under Flexural Load in the Edgewise Position
The second is any form fabricated from this powder from
D790Test Methods for Flexural Properties of Unreinforced
whichafinishedproductissubsequentlyproduced(Section5).
and Reinforced Plastics and Electrical Insulating Materi-
This specification addresses material characteristics and does
als
not apply to the packaged and sterilized finished implant.
D792Test Methods for Density and Specific Gravity (Rela-
tive Density) of Plastics by Displacement
1.3 The requirements of this specification do not apply to
UHMWPE virgin powder or fabricated forms intentionally D1505Test Method for Density of Plastics by the Density-
Gradient Technique
crosslinked or blended with other additives, for example,
4
antioxidents. D1898Practice for Sampling of Plastics (Withdrawn 1998)
D4020SpecificationforUltra-High-Molecular-WeightPoly-
1.4 The biological response to polyethylene in soft tissue
ethylene Molding and Extrusion Materials
and bone has been well characterized by a history of clinical
F619Practice for Extraction of Medical Plastics
2
use (1, 2, 3) and by laboratory studies (4, 5, 6).
F748PracticeforSelectingGenericBiologicalTestMethods
1.5 The values stated in SI units are to be regarded as for Materials and Devices
F749Practice for Evaluating Material Extracts by Intracuta-
standard. No other units of measurement are included in this
standard. neous Injection in the Rabbit
F756Practice for Assessment of Hemolytic Properties of
1.6 The following precautionary caveat pertains only to the
Materials
test method portion, Section 7, of this specification: This
F763Practice for Short-Term Screening of Implant Materi-
standard does not purport to address all of the safety concerns,
als
if any, associated with its use. It is the responsibility of the user
F813Practice for Direct Contact Cell Culture Evaluation of
of this standard to establish appropriate safety and health
Materials for Medical Devices
practices and determine the applicability of regulatory limita-
F895TestMethodforAgarDiffusionCellCultureScreening
tions prior to use.
for Cytotoxicity
F981Practice for Assessment of Compatibility of Biomate-
rials for Surgical Implants with Respect to Effect of
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 Dec. 1, 2010. Published December 2010. Originally contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
approved in 1980. Last previous edition approved in 2010 as F648–10. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F0648-10a. 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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F648−10a
TABLE 1 Requirements for UHMWPE Powders
Materials on Muscle and Bone
Property Test Method Requirement
2.2 ISO Standards
Resin Type Type 1 Type 2 Type 3
5
ISO 527Plastics: Determination of Tensile Properties
Viscosity Number, mL/g, ASTM D4020 (0.02 %) 2000-3200 >3200 >3200
Elongation Stress, (Mini- ASTM D4020 0.20 0.42 0.42
ISO3451-1Plastics—DeterminationofAsh,Part1:General
5 mum)†
Methods
Ash, mg/kg, (Maximum) ISO 3451-1 125 125 300
ISO 11542/2Plastics—Ultra-High Molecular Weight Poly-
Extraneous Matter, No. 4.2.1 33 25
Particles, (Maximum)
ethylene (UHMWPE) Moulding and Extrusion
Titanium, mg/kg, (Maximum) 7.1.3.1 40 40 150
Materials—Part 2: Preparation of Test Specimens and
Alumin
...

This document is not anASTM standard and is intended only to provide the user of anASTM 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:F648–10 Designation: F648 – 10a
Standard Specification for
Ultra-High-Molecular-Weight Polyethylene Powder and
1
Fabricated Form for Surgical Implants
ThisstandardisissuedunderthefixeddesignationF648;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
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 TherequirementsofthisspecificationdonotapplytoUHMWPEvirginpowderorfabricatedformsintentionallycrosslinked
or blended with other additives, for example, antioxidents.
1.4 The biological response to polyethylene in soft tissue and bone has been well characterized by a history of clinical use (1,
2
2, 3) and by laboratory studies (4, 5, 6).
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 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 and health practices and determine the applicability of regulatory limitations prior to use.
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
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
D4020 Specification for Ultra-High-Molecular-Weight Polyethylene Molding and Extrusion Materials
F619 Practice for Extraction of Medical Plastics
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 Bone
2.2 ISO Standards
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.
´1
Current edition approved Sept. 15, 2010. Published October 2010. Originally approved in 1980. Last previous edition approved in 2007 as F648–07 . DOI:
10.1520/F0648-10.
Current edition approved Dec. 1, 2010. Published December 2010. Originally approved in 1980. Last previous edition approved in 2010 as F648 – 10. DOI:
10.1520/F0648-10a.
2
The boldface numbers in parentheses refer to the list of references at the end of this specification.
3
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
4
Withdrawn.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

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F648 – 10a
5
ISO 527 Plastics: Determination of Tensile Properties
5
ISO 3451-1 Plastics—Determination of Ash, Part 1: General Methods
ISO 11542/2, Plastics—Ultra-High Molecular Weight Polyethylene (UHMWPE) Moulding and Extrusion Mate
...