ASTM F648-00e1

Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

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).
1.5 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: 09-May-2000
• 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 F648-00 - Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• Effective Date: 10-May-2000
• Replaced By: ASTM F648-04 - Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• Effective Date: 01-Oct-2004
• Referred By: ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
• Effective Date: 10-May-2000
• Referred By: ASTM F2224-09(2020) - Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
• Effective Date: 10-May-2000
• 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: 10-May-2000
• Referred By: ASTM F2003-02(2022) - Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene After Gamma Irradiation in Air
• Effective Date: 10-May-2000
• Referred By: ASTM F1378-18e1 - Standard Specification for Shoulder Prostheses
• Effective Date: 10-May-2000
• Referred By: ASTM F2193-20 - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
• Effective Date: 10-May-2000
• Referred By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 10-May-2000
• Referred By: ASTM F2848-21 - Standard Specification for Medical-Grade Ultra-High-Molecular-Weight Polyethylene Yarns
• Effective Date: 10-May-2000
• Referred By: ASTM F1714-96(2018) - Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
• Effective Date: 10-May-2000
• 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: 10-May-2000
• Referred By: ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
• Effective Date: 10-May-2000
• Referred By: ASTM F1814-22 - Standard Guide for Evaluating Modular Hip and Knee Joint Components
• Effective Date: 10-May-2000
• Referred By: ASTM F732-17 - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
• Effective Date: 10-May-2000

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: F 648 – 00
Standard Specification for
Ultra-High-Molecular-Weight Polyethylene Powder and
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Fabricated Form for Surgical Implants
This standard is issued under the fixed designation F 648; 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 (e) indicates an editorial change since the last revision or reapproval.
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e NOTE—Editorial changes were made throughout in June 2003.
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1. Scope Under Flexural Load
D 790 Test Methods for Flexural Properties of Plastics and
1.1 This specification covers Ultra-High Molecular Weight
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Electrical Insulating Materials
Polyethylene powder (UHMWPE) and fabricated forms in-
D 792 Test Methods for Specific Gravity (Relative Density)
tended for use in surgical implants.
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and Density by Displacement
1.2 The requirements of this specification apply to UHM-
D 1505 Test Method for Density of Plastics by the Density-
WPE in two forms. One is virgin polymer powder (Section 4).
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Gradient Technique
The second is any form fabricated from this powder from
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D 1898 Practice for Sampling of Plastics
which a finished product is subsequently produced (Section 5).
D 4020 Specification for Ultra-High Molecular Weight
This specification addresses material characteristics and does
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Polyethylene Molding and Extrusion Materials
not apply to the packaged and sterilized finished implant.
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F 619 Practice for Extraction of Medical Plastics
1.3 The provisions of Specification D 4020 apply. Special
F 748 Practice for Selecting Generic Biological Test Meth-
requirements detailed in this specification are added to describe
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ods for Materials and Devices
material which will be used in surgical implants.
F 749 Practice for Evaluating Material Extracts by Intracu-
1.4 The biological response to polyethylene in soft tissue
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taneous Injection in the Rabbit
and bone has been well characterized by a history of clinical
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F 756 Practice for Assessment of Hemolytic Properties of
use (1, 2, 3) and by laboratory studies (4, 5, 6).
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Materials
1.5 The following precautionary caveat pertains only to the
F 763 Practice for Short-Term Screening of Implant Mate-
test method portion, Section 7, of this specification: This
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rials
standard does not purport to address all of the safety concerns,
F 813 Practice for Direct Contact Cell Culture Evaluation of
if any, associated with its use. It is the responsibility of the user
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Materials for Medical Devices
of this standard to establish appropriate safety and health
F 895 Test Method for Agar Diffusion Cell Culture Screen-
practices and determine the applicability of regulatory limita-
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ing for Cytotoxicity
tions prior to use.
F 981 Practice for Assessment of Compatibility of Bioma-
2. Referenced Documents terials (Nonporous) for Surgical Implants with Respect to
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Effect of Materials on Muscle and Bone
2.1 ASTM Standards:
2.2 ISO Standards
D 256 Test for Impact Resistance of Plastics and Electrical
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3
ISO 527 Plastics: Determination of Tensile Properties
Insulating Materials
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ISO 3451-1 Plastics—Determination of Ash, Part 1: Gen-
D 638 Test Method for Tensile Properties of Plastics
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eral Methods
D 648 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 material.
Current edition approved May 10, 2000. Published August 2000. Originally
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published as F 648 – 96. Last previous edition F 648 – 98. Annual Book of ASTM Standards, Vol 08.02.
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The boldface numbers in parentheses refer to the list of references at the end of Annual Book of ASTM Standards, Vol 13.01.
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this specification. Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
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Annual Book of ASTM Standards, Vol 08.01. 4th Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F648–00
3. Terminology 4.2.3 When determined as described in ISO 3451-1, the
mean ash of duplicate samples shall not exceed the limits
3.1 Definitions of Terms Specific to This Standard:
established in Table 1.
3.1.1 fabricated form—any bulk shape of UHMWPE, fab-
ricated from the virgin polymer powder, used during the
5. UHMWPE Fabricated Form Requirements
process of fabricating surgical implants prior to packaging and
5.1 Compositional Requirements:
sterilization.
5.1.1 No stabilizers or
...