ASTM F648 - 14 - Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

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ASTM F648 - 14

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

Status : Current   Published : January 2014

Format
PDF

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HARDCOPY



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, antioxidants.

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)2 and by laboratory studies (4, 5, 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 and health practices and determine the applicability of regulatory limitations prior to use.




Standard NumberASTM F648 - 14
TitleStandard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
StatusCurrent
Publication Date03 January 2014
Descriptors Fabricated forms, Powdered form, Ultra-high molecular weight polyethylene
ICS11.040.40
PublisherASTM
FormatA4
DeliveryYes
Pages8
File Size0 KB
Price£39.00


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