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ASTM F648-10

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 requirements of this specification do not apply to UHMWPE virgin powder or fabricated forms intentionally crosslinked or blended with other additives, for example, antioxidents.

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 values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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 and health practices and determine the applicability of regulatory limitations prior to use.

This specification covers ultra-high-molecular-weight polyethylene (UHMWPE) powder and fabricated forms for use in surgical implants. UHMWPE powder shall be of virgin polymer manufactured from a homopolymer of ethylene, while the fabricated forms shall be manufactured from the same UHMWPE powder without any stabilizers or processing aids. Tests for viscosity number, elongation stress, ash content, extraneous matter, and trace elements shall be performed for UHMWPE powders, while tests for density, ash content, tensile strength, yield strength, elongation, and impact strength shall be performed for fabricated forms. All tests shall conform to the requirements specified.


SDO ASTM: ASTM International
Document Number F648
Publication Date Sept. 15, 2010
Language en - English
Page Count 9
Revision Level 10
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