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ASTM F648-00e1

Historical Revision

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

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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.


SDO ASTM: ASTM International
Document Number F648
Publication Date May 10, 2000
Language en - English
Page Count 8
Revision Level 00e1
Supercedes
Committee F04.11
Publish Date Document Id Type View
April 1, 2021 F0648-21 Revision
March 1, 2014 F0648-14 Revision
July 1, 2013 F0648-13 Revision
Dec. 1, 2010 F0648-10A Revision
Sept. 15, 2010 F0648-10 Revision
Feb. 1, 2007 F0648-07E01 Revision
Feb. 1, 2007 F0648-07 Revision
Oct. 1, 2004 F0648-04 Revision
May 10, 2000 F0648-00E01 Revision
May 10, 2000 F0648-00 Revision