ASTM F 648 : 2014 : REDLINE
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
Available format(s)
PDF
Superseded date
05-03-2021
Superseded by
Language(s)
English
Published date
03-01-2014
Important note : All end users must be registered with an Account prior to user licenses being assigned.CONTAINED IN VOL. 13.01, 2015 Specifies Ultra-High Molecular Weight Polyethylene powder (UHMWPE) and fabricated forms intended for use in surgical implants.
| Committee |
F 04
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| DocumentType |
Redline
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| Pages |
11
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| PublisherName |
American Society for Testing and Materials
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| Status |
Superseded
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| SupersededBy |
1.1This specification covers ultra-high molecular weight polyethylene powder (UHMWPE) and fabricated forms intended for use in surgical implants.
1.2The 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.
1.3The requirements of this specification do not apply to UHMWPE virgin powder or fabricated forms intentionally crosslinked or blended with other additives, for example, antioxidants.
1.4The 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).
1.5The values stated in SI units are to be regarded as standard.
1.6The 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.
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| 04/30031040 DC : 0 | ISO 5834-3 - IMPLANTS FOR SURGERY - ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE - PART 3: ACCELERATED AGEING METHODS |
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| 04/30099319 DC : DRAFT APR 2004 | ISO 5834-5 - IMPLANTS FOR SURGERY - ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE - PART 5: MORPHOLOGY ASSESSMENT METHOD |
| 17/30360581 DC : 0 | BS ISO 5834-2 - IMPLANTS FOR SURGERY - ULTRA-HIGH-MOLECULAR-WEIGHT POLYETHYLENE - PART 2: MOULDED FORMS |
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