Standard Specification for Polyethylene Plastics for Medical Applications

Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Language(s)

English

Published date

08-01-2009

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 13.01, 2015 Defines polyethylene plastics (as defined in Terminology D 883) intended for use in medical Device applications involving human tissue contact devices, short-term indwellings of 30 days or less, and fluid transfer devices.

1.1 This specification covers polyethylene plastics (as defined in Terminology D 883) intended for use in medical device applications involving human tissue contact devices, short-term indwellings of 30 days or less, and fluid transfer devices. The biocompatibility of these materials as a class has not been established. Biocompatibility tests must be conducted on the final product.

1.2 This specification is not applicable to ultra-high molecular weight polyethylenes (UHMWPE) plastics, such as those used in joint implants, and so forth.

1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.4 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.

Committee	F 04
DocumentType	Standard
Pages	3
ProductNote	Reconfirmed 2009
PublisherName	American Society for Testing and Materials
Status	Superseded
Supersedes	ASTM F 639 : 1998 : REV A : R2003

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