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ASTM F 639 : 2009 : R2024

ASTM F 639 : 2009 : R2024

Current

Current

The latest, up-to-date edition.

Standard Specification for Polyethylene Plastics for Medical Applications

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

13-05-2024

Publisher

American Society for Testing and Materials

Committee
F 04
DocumentType
Standard
Pages
4
PublisherName
American Society for Testing and Materials
Status
Current
Supersedes

1.1This specification covers polyethylene plastics (as defined in Terminology D883) 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.

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

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

1.4This 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.5This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ASTM F 2027 : 2016 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products

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Hardcopy - English
PDF - English
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