ASTM-F648 Historical Revision Information
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

ASTM-F648 - 2007 EDITION - SUPERSEDED
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Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
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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 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.<>

Keywords

fabricated forms; powdered form; ultra-high molecular weight polyethylene; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics); 83.080.20 (Thermoplastic materials)

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

83.080.20 (Thermoplastic materials)

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Document Number

ASTM-F648-07

Revision Level

2007 EDITION

Status

Superseded

Modification Type

Revision

Publication Date

Feb. 1, 2007

Document Type

Specification

Page Count

8 pages

Committee Number

F04.11