ASTM-F648 › Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
Show Complete Document History
The following bibliographic material is provided to assist you with your purchasing decision:
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.
Changes from the previous issue
A redline edition is available for this document, with all changes visible. Ask Document Center Inc. for more information.
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.
fabricated forms; powdered form; 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:
To find similar documents by classification:
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
April 15, 2014