ASTM-F648 › Historical Revision Information
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
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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.
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 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.
Keywords
fabricated forms; powdered form; ultra-high molecular weight polyethylene; Plastic surgical devices/applications--specifications; Polyethylene (PE) surgical implant applications--specifications; Powder coatings--specifications; UHMWPE (ultra-high molecular weight polyethylene); ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics); 83.080.20 (Thermoplastic materials)
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-F648-10a
Revision Level
2010A EDITION
Status
Superseded
Modification Type
Revision
Publication Date
Dec. 1, 2010
Document Type
Specification
Page Count
8 pages
Committee Number
F04.11