ASTM-F648 › Historical Revision Information
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) 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 D4020 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:
Keywords
fabricated forms; powdered form; ultra-high molecular weight polyethylene
To find similar documents by ASTM Volume:
13.01 (Medical and Surgical Materials and Devices)
To find similar documents by classification:
83.080.20 (Thermoplastic materials)
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Document Number
ASTM-F648-00
Revision Level
2000 EDITION
Status
Superseded
Modification Type
Revision
Publication Date
May 10, 2000
Document Type
Specification
Page Count
8 pages
Committee Number
F04.11