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 (ε) 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 UHM-WPE 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 (1-3)2 and by laboratory studies (4-6).

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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.7

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

2. Referenced Documents

2.1 ASTM Standards:3

2.2 ISO Standards:5

3. Terminology

4. Virgin UHMWPE Powder Requirements

4.1 Generic Properties:

4.2 Nongeneric Properties:

4.3 Quality System Requirements:

5. UHMWPE Fabricated Form Requirements

5.1 Compositional Requirements:

5.2 Physical Requirements:

5.3 Mechanical Requirements:

5.4 Quality System Requirements:

6. Sampling

6.1

7. Test Methods

7.1 UHMWPE Powder:

7.2 UHMWPE Fabricated Form:

8. Biocompatibility

8.1

9. Keywords

9.1

REFERENCES

ASTM F648 - 21

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

Current

Published:

1 Apr 2021