ASTM F648-14

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, 2, 3)2 and by laboratory studies (4, 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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 28-Feb-2014
• 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

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 −14
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 D256Test Methods for Determining the Izod Pendulum
Impact Resistance of Plastics
1.1 This specification covers ultra-high molecular weight
D638Test Method for Tensile Properties of Plastics
polyethylene powder (UHMWPE) and fabricated forms in-
D648Test Method for Deflection Temperature of Plastics
tended for use in surgical implants.
Under Flexural Load in the Edgewise Position
1.2 The requirements of this specification apply to UHM-
D790Test Methods for Flexural Properties of Unreinforced
WPE in two forms. One is virgin polymer powder (Section 4).
and Reinforced Plastics and Electrical Insulating Materi-
The second is any form fabricated from this powder from
als
whichafinishedproductissubsequentlyproduced(Section5).
D792Test Methods for Density and Specific Gravity (Rela-
This specification addresses material characteristics and does
tive Density) of Plastics by Displacement
not apply to the packaged and sterilized finished implant.
D1505Test Method for Density of Plastics by the Density-
Gradient Technique
1.3 The requirements of this specification do not apply to
4
UHMWPE virgin powder or fabricated forms intentionally D1898Practice for Sampling of Plastics (Withdrawn 1998)
D4020SpecificationforUltra-High-Molecular-WeightPoly-
crosslinked or blended with other additives, for example,
antioxidants. ethylene Molding and Extrusion Materials
F619Practice for Extraction of Medical Plastics
1.4 The biological response to polyethylene in soft tissue
F748PracticeforSelectingGenericBiologicalTestMethods
and bone has been well characterized by a history of clinical
2 for Materials and Devices
use (1, 2, 3) and by laboratory studies (4, 5, 6).
F749Practice for Evaluating Material Extracts by Intracuta-
1.5 The values stated in SI units are to be regarded as
neous Injection in the Rabbit
standard.
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-
2. Referenced Documents
rials for Surgical Implants with Respect to Effect of
3
Materials on Muscle and Bone
2.1 ASTM Standards:
5
2.2 ISO Standards:
ISO3451-1Plastics—DeterminationofAsh,Part1:General
Methods
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of ISO 11542/2Plastics—Ultra-High Molecular Weight Poly-
Subcommittee F04.11 on Polymeric Materials.
ethylene (UHMWPE) Moulding and Extrusion
Current edition approved March 1, 2014. Published April 2014. Originally
Materials—Part 2: Preparation of Test Specimens and
approved in 1980. Last previous edition approved in 2013 as F648–13. DOI:
Determination
10.1520/F0648-14.
2
Theboldfacenumbersinparenthesesrefertothelistofreferencesattheendof
this specification.
3 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or The last approved version of this historical standard is referenced on
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM www.astm.org.
5
Standards volume information, refer to the standard’s Document Summary page on Available from International Organization for Standardization (ISO), 1, ch. de
the ASTM website. la Voie-Creuse, CP 56, CH-1211 Geneva 20, Switzerland, http://www.iso.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F648−14
ISO 9001Quality Management Systems - Requirements 4.2.1 When a 300 g sample is prepared and viewed in
ISO13485MedicalDevices–QualityManagementSystems accordance with 7.1.2, there shall be no more particles of
– Requirements for Regulatory Purposes extraneous matter than that specified in Table 1.
4.2.2 To promote uniformity betwe
...

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 − 13 F648 − 14
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 (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.
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 (Withdrawn 1998)
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
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 July 1, 2013March 1, 2014. Published August 2013April 2014. Originally approved in 1980. Last previous edition approved in 20102013 as
F648 – 10a.F648 – 13. DOI: 10.1520/F0648-13.10.1520/F0648-14.
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 [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
4
The last approved version of this historical standard is referenced on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F648 − 14
5
2.2 ISO Standards:
ISO 3451-1 Plastics—Determination of Ash, Part 1: General Methods
ISO 11542/2 Plastics—Ultra-High Molecular Weight Polyethylene (UHMWPE) Moulding and Extrusion Materials—Part 2:
Preparation of Test Specimens and Determination
ISO 9001 Quality Management Systems - Requirements
IS
...