ASTM International - ASTM F648-00e1

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

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Organization: ASTM International
Publication Date: 10 May 2000
Status: historical
Page Count: 8
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
ICS Code (Thermoplastic materials): 83.080.20
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).

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.

Document History

March 1, 2014
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
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...
July 1, 2013
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
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...
December 1, 2010
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
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...
September 15, 2010
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
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...
February 1, 2007
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
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...
February 1, 2007
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
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...
October 1, 2004
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
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...
ASTM F648-00e1
May 10, 2000
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
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...
May 10, 2000
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
1.1 This specification covers ultra-high-molecular-weight polyethylene powder (UHMWPE) intended for use in surgical implants. 1.2 The requirements of this specification apply to UHMWPE in two forms....
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