ASTM F648-10

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: 14-Sep-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 F648-07e1 - Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• Effective Date: 15-Sep-2010
• Replaced By: ASTM F648-10a - Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• Effective Date: 01-Dec-2010
• Referred By: ASTM F763-22 - Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
• Effective Date: 15-Sep-2010
• Referred By: ASTM F2848-21 - Standard Specification for Medical-Grade Ultra-High-Molecular-Weight Polyethylene Yarns
• Effective Date: 15-Sep-2010
• Referred By: ASTM F2224-09(2020) - Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
• Effective Date: 15-Sep-2010
• Referred By: ASTM F2565-21 - Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
• Effective Date: 15-Sep-2010
• Referred By: ASTM F732-17 - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
• Effective Date: 15-Sep-2010
• Referred By: ASTM F2759-19 - Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
• Effective Date: 15-Sep-2010
• Referred By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 15-Sep-2010
• Referred By: ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
• Effective Date: 15-Sep-2010
• Referred By: ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
• Effective Date: 15-Sep-2010
• Referred By: ASTM F2695-12(2020) - Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
• Effective Date: 15-Sep-2010
• Referred By: ASTM F2193-20 - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
• Effective Date: 15-Sep-2010
• Referred By: ASTM F1357-23 - Standard Specification for Articulating Total Wrist Implants
• Effective Date: 15-Sep-2010
• Referred By: ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
• Effective Date: 15-Sep-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 – 10
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 D638 Test Method for Tensile Properties of Plastics
D648 Test Method for Deflection Temperature of Plastics
1.1 This specification covers ultra-high molecular weight
Under Flexural Load in the Edgewise Position
polyethylene powder (UHMWPE) and fabricated forms in-
D790 Test Methods for Flexural Properties of Unreinforced
tended for use in surgical implants.
and Reinforced Plastics and Electrical Insulating Materials
1.2 The requirements of this specification apply to UHM-
D792 Test Methods for Density and Specific Gravity (Rela-
WPE in two forms. One is virgin polymer powder (Section 4).
tive Density) of Plastics by Displacement
The second is any form fabricated from this powder from
D1505 Test Method for Density of Plastics by the Density-
which a finished product is subsequently produced (Section 5).
Gradient Technique
This specification addresses material characteristics and does
4
D1898 Practice for Sampling of Plastics
not apply to the packaged and sterilized finished implant.
D4020 Specification for Ultra-High-Molecular-Weight
1.3 The requirements of this specification do not apply to
Polyethylene Molding and Extrusion Materials
UHMWPE virgin powder or fabricated forms intentionally
F619 Practice for Extraction of Medical Plastics
crosslinked or blended with other additives, for example,
F748 Practice for Selecting Generic Biological Test Meth-
antioxidents.
ods for Materials and Devices
1.4 The biological response to polyethylene in soft tissue
F749 Practice for Evaluating Material Extracts by Intracu-
and bone has been well characterized by a history of clinical
2
taneous Injection in the Rabbit
use (1, 2, 3) and by laboratory studies (4, 5, 6).
F756 Practice for Assessment of Hemolytic Properties of
1.5 The values stated in SI units are to be regarded as
Materials
standard. No other units of measurement are included in this
F763 Practice for Short-Term Screening of Implant Materi-
standard.
als
1.6 The following precautionary caveat pertains only to the
F813 Practice for Direct Contact Cell Culture Evaluation of
test method portion, Section 7, of this specification: This
Materials for Medical Devices
standard does not purport to address all of the safety concerns,
F895 Test Method for Agar Diffusion Cell Culture Screen-
if any, associated with its use. It is the responsibility of the user
ing for Cytotoxicity
of this standard to establish appropriate safety and health
F981 Practice forAssessment of Compatibility of Biomate-
practices and determine the applicability of regulatory limita-
rials for Surgical Implants with Respect to Effect of
tions prior to use.
Materials on Muscle and Bone
2. Referenced Documents 2.2 ISO Standards
5
3
ISO 527 Plastics: Determination of Tensile Properties
2.1 ASTM Standards:
ISO 3451-1 Plastics—Determination of Ash, Part 1: Gen-
D256 Test Methods for Determining the Izod Pendulum
5
eral Methods
Impact Resistance of Plastics
ISO 11542/2, Plastics—Ultra-High Molecular Weight Poly-
ethylene (UHMWPE) Moulding and Extrusion
1
This specification is under the jurisdiction of ASTM Committee F04 on Materials—Part 2: Preparation of Test Specimens and
5
Medical and Surgical Materials and Devices and is the direct responsibility of
Determination
Subcommittee F04.11 on Polymeric Materials.
Current edition approved Sept. 15, 2010. Published October 2010. Originally
3. Terminology
´1
approved in 1980. Last previous edition approved in 2007 as F648 – 07 . DOI:
10.1520/F0648-10.
3.1 Definitions of Terms Specific to This Standard:
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
4
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Withdrawn.
5
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

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F648 – 10
3.1.1 fabricated form, n—any bulk shape of UHMWPE, 4.2.3 When determined as described in ISO 3451-1, the
fabricated from the virgin polymer powder and used during the
...

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.
´1
Designation:F648–07 Designation: F648 – 10
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
´ NOTE—Table1 was editorially corrected in June 2007.
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.
1.3The provisions of Specification D4020 apply. Special requirements detailed in this specification are added to describe
material which will be used in surgical implants.
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
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
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 Feb. 1, 2007. Published February 2007. Originally approved in 1980. Last previous edition approved in 2004 as F648–04. DOI:
10.1520/F0648-07E01.
´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.
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

---------------------- Page: 1 ----------------------
F648 – 10
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
...