ASTM-F2695 2007

$35.75

F2695-07 Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications

Published By	Publication Date	Number of Pages
ASTM	2007	4

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, ASTM

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Description

1.1 This specification covers ultra-high molecular weight polyethylene (UHMWPE) powder blended with alpha-tocopherol (vitamin E) intended for use in surgical implants.

1.2 The requirements of this specification apply to alpha-tocopherol-containing UHMWPE in two forms. One is virgin polymer powder blended with alpha-tocopherol prior to consolidation (Section 4). The second is any form fabricated from this blended, alpha-tocopherol-containing powder from which a finished product is subsequently produced (Section 5). This specification does not apply to finished or semi-finished products that are doped with vitamin E after consolidation.

1.3 Aside from blending with alpha-tocopherol, the provisions of Specifications F 648 and D 4020 apply. Special requirements detailed in this specification are added to describe powders containing alpha-tocopherol that will be used in surgical implants. This specification addresses material characteristics and does not apply to the packaged and sterilized finished implant. This specification also does not apply to UHMWPE materials extensively crosslinked by gamma and electron beam sources of ionizing radiation.

1.4 The following precautionary caveat pertains only to the fabricated forms portion, Section 5, 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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PDF Pages	PDF Title
1	Scope Referenced Documents Terminology
2	Alpha-Tocopherol-Blended UHMWPE Powder Requirements Alpha-Tocopherol-Blended UHMWPE Fabricated Form Requirements Sampling Biocompatibility Keywords
3	X1. RATIONALE X1.1 X1.2 X1.3 X1.4 REFERENCES

Additional information

Standard Title	F2695-07 Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
Published Code	ASTM
Publication Date	2007
Pages Count	4
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics

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ASTM-F2695 2007

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