ASTM F648-04

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 requirements of this specification do not apply to UHMWPE virgin powder or fabricated forms intentionally crosslinked.
1.4 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.
1.5 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).
1.6 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-Sep-2004
• 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 F648-00e1 - Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• Effective Date: 01-Oct-2004
• Replaced By: ASTM F648-07 - Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• Effective Date: 01-Feb-2007
• Referred By: ASTM F2193-20 - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
• Effective Date: 01-Oct-2004
• 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-Oct-2004
• Referred By: ASTM F763-22 - Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
• Effective Date: 01-Oct-2004
• Referred By: ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
• Effective Date: 01-Oct-2004
• 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: 01-Oct-2004
• Referred By: ASTM F1714-96(2018) - Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
• Effective Date: 01-Oct-2004
• 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-Oct-2004
• Referred By: ASTM F2224-09(2020) - Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
• Effective Date: 01-Oct-2004
• Referred By: ASTM F732-17 - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
• Effective Date: 01-Oct-2004
• Referred By: ASTM F755-19 - Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
• Effective Date: 01-Oct-2004
• Referred By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 01-Oct-2004
• 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-Oct-2004
• Referred By: ASTM F1357-23 - Standard Specification for Articulating Total Wrist Implants
• Effective Date: 01-Oct-2004

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: F 648 – 04
Standard Specification for
Ultra-High-Molecular Weight Polyethylene Powder and
1
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.
1. Scope D 638 Test Method for Tensile Properties of Plastics
D 648 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-
D 790 Test Methods for Flexural Properties of Plastics and
tended for use in surgical implants.
Electrical Insulating Materials
1.2 The requirements of this specification apply to UHM-
D 792 Test Methods for Specific Gravity (Relative Density)
WPE in two forms. One is virgin polymer powder (Section 4).
and Density of Plastics by Displacement
The second is any form fabricated from this powder from
D 1505 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
D 1898 Practice for Sampling of Plastics
not apply to the packaged and sterilized finished implant.
D 4020 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
E 691 Practice for Conducting an Interlaboratory Study to
crosslinked.
Determine the Precision of a Test Method
1.4 The provisions of Specification D 4020 apply. Special
F 619 Practice for Extraction of Medical Plastics
requirementsdetailedinthisspecificationareaddedtodescribe
F 748 Practice for Selecting Generic Biological Test Meth-
material which will be used in surgical implants.
ods for Materials and Devices
1.5 The biological response to polyethylene in soft tissue
F 749 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).
F 756 Practice 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
F 763 Practice for Short-Term Screening of Implant Mate-
standard does not purport to address all of the safety concerns,
rials
if any, associated with its use. It is the responsibility of the user
F 813 PracticeforDirectContactCellCultureEvaluationof
of this standard to establish appropriate safety and health
Materials for Medical Devices
practices and determine the applicability of regulatory limita-
F 895 Test Method forAgar Diffusion Cell Culture Screen-
tions prior to use.
ing for Cytotoxicity
2. Referenced Documents
F 981 Practice for Assessment of Compatibility of Bioma-
3
terials for Surgical Implants with Respect to Effect of
2.1 ASTM Standards:
Materials on Muscle and Bone
D 256 Test Methods for Determining the Izod Pendulum
5
2.2 ISO Standards:
Impact Resistance of Plastics
ISO 527 Plastics: Determination of Tensile Properties
ISO 3451-1 Plastics—Determination of Ash, Part 1: Gen-
1
eral Methods
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of ISO 11542–2 Plastics—Ultra-High Molecular Weight Poly-
Subcommittee F04.11 on Polymeric Materials.
ethylene (UHMWPE) Moulding and Extrusion
Current edition approved Oct. 1, 2004. Published October 2004. Originally
Materials—Part 2: Preparation of Test Specimens and
e1
approved in 1996. Last previous edition approved in 2000 as F 648 – 00 .
2
Determination
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F648–04
TABLE 1 Requirements for UHMWPE Powders
3. Terminology
Property Test Method Requirement
3.1 Definitions of Terms Specific to This Standard:
Resin Type Type 1 Type 2 Type 3
3.1.1 fabricated form—any bulk s
...