ASTM F648-07e1

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 provisions of Specification D 4020 apply. Special requirements detailed in this specification are added to describe material which will be used in surgical implants.
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).
The following precautionary caveat pertains only to the test method portion, Section , 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: 31-Jan-2007
• 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 F648-07 - Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• Effective Date: 01-Feb-2007
• Replaced By: ASTM F648-10 - Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• Effective Date: 15-Sep-2010
• Referred By: ASTM F981-23 - Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
• Effective Date: 01-Feb-2007
• Referred By: ASTM F1408-20a - Standard Practice for Subcutaneous Screening Test for Implant Materials
• Effective Date: 01-Feb-2007
• Referred By: ASTM F2565-21 - Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
• Effective Date: 01-Feb-2007
• 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: 01-Feb-2007
• Referred By: ASTM F1714-96(2018) - Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
• Effective Date: 01-Feb-2007
• Referred By: ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
• Effective Date: 01-Feb-2007
• Referred By: ASTM F1672-14(2019) - Standard Specification for Resurfacing Patellar Prosthesis (Withdrawn 2023)
• Effective Date: 01-Feb-2007
• Referred By: ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
• Effective Date: 01-Feb-2007
• Referred By: ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
• Effective Date: 01-Feb-2007
• Referred By: ASTM F755-19 - Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
• Effective Date: 01-Feb-2007
• Referred By: ASTM F763-22 - Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
• Effective Date: 01-Feb-2007
• Referred By: ASTM F3336-22 - Standard Practice for Lipid Preconditioning of Ultra-High-Molecular-Weight Polyethylene for Accelerated Aging
• Effective Date: 01-Feb-2007
• Referred By: ASTM F1814-22 - Standard Guide for Evaluating Modular Hip and Knee Joint Components
• Effective Date: 01-Feb-2007

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
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Designation: F648 – 07
Standard Specification for
Ultra-High-Molecular-Weight Polyethylene Powder and
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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—Table 1 was editorially corrected in June 2007.
1. Scope Under Flexural Load in the Edgewise Position
D790 Test Methods for Flexural Properties of Unreinforced
1.1 This specification covers ultra-high molecular weight
and Reinforced Plastics and Electrical Insulating Materials
polyethylene powder (UHMWPE) and fabricated forms in-
D792 Test Methods for Density and Specific Gravity (Rela-
tended for use in surgical implants.
tive Density) of Plastics by Displacement
1.2 The requirements of this specification apply to UHM-
D1505 Test Method for Density of Plastics by the Density-
WPE in two forms. One is virgin polymer powder (Section 4).
Gradient Technique
The second is any form fabricated from this powder from
4
D1898 Practice for Sampling of Plastics
which a finished product is subsequently produced (Section 5).
D4020 Specification for Ultra-High-Molecular-Weight
This specification addresses material characteristics and does
Polyethylene Molding and Extrusion Materials
not apply to the packaged and sterilized finished implant.
F619 Practice for Extraction of Medical Plastics
1.3 The provisions of Specification D4020 apply. Special
F748 Practice for Selecting Generic Biological Test Meth-
requirementsdetailedinthisspecificationareaddedtodescribe
ods for Materials and Devices
material which will be used in surgical implants.
F749 Practice for Evaluating Material Extracts by Intracu-
1.4 The biological response to polyethylene in soft tissue
taneous Injection in the Rabbit
and bone has been well characterized by a history of clinical
2
F756 Practice for Assessment of Hemolytic Properties of
use (1, 2, 3) and by laboratory studies (4, 5, 6).
Materials
1.5 The following precautionary caveat pertains only to the
F763 Practice for Short-Term Screening of Implant Materi-
test method portion, Section 7, of this specification: This
als
standard does not purport to address all of the safety concerns,
F813 Practice for Direct Contact Cell Culture Evaluation of
if any, associated with its use. It is the responsibility of the user
Materials for Medical Devices
of this standard to establish appropriate safety and health
F895 Test Method for Agar Diffusion Cell Culture Screen-
practices and determine the applicability of regulatory limita-
ing for Cytotoxicity
tions prior to use.
F981 Practice forAssessment 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:
2.2 ISO Standards
D256 Test Methods for Determining the Izod Pendulum
5
ISO 527 Plastics: Determination of Tensile Properties
Impact Resistance of Plastics
ISO 3451-1 Plastics—Determination of Ash, Part 1: Gen-
D638 Test Method for Tensile Properties of Plastics
5
eral Methods
D648 Test Method for Deflection Temperature of Plastics
ISO 11542/2, Plastics—Ultra-High Molecular Weight Poly-
ethylene (UHMWPE) Moulding and Extrusion
1
Materials—Part 2: Preparation of Test Specimens and
This specification is under the jurisdiction of ASTM Committee F04 on
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Medical and Surgical Materials and Devices and is the direct responsibility of
Determination
Subcommittee F04.11 on Polymeric Materials.
Current edition approved Feb. 1, 2007. Published February 2007. Originally
3. Terminology
approved in 1980. Last previous edition approved in 2004 as F648 – 04. DOI:
3.1 Definitions of Terms Specific to This Standard:
10.1520/F0648-07E01.
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.
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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.
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F648 – 07
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 mean ash of duplicate samples shall not exceed the limits
process of fabricating surgica
...