2903198

ASTM F639-09(2024)

Standard Specification for Polyethylene Plastics for Medical Applications

standard by ASTM International , 05/01/2024

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Full Description

1.1 This 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.
1.2 This specification is not applicable to ultra-high molecular weight polyethylene (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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This 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.
 

Product Details

Published:
05/01/2024
Number of Pages:
4
File Size:
1 file , 260 KB
Note:
This product is unavailable in Russia, Ukraine, Belarus
 

Document History

  1. ASTM F639-09(2024)

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    Standard Specification for Polyethylene Plastics for Medical Applications

    • Most Recent

  2. ASTM F639-09(2015)


    Standard Specification for Polyethylene Plastics for Medical Applications

    • Historical Version

  3. ASTM F639-09


    Standard Specification for Polyethylene Plastics for Medical Applications

    • Historical Version

  4. ASTM F639-98a(2003)


    Standard Specification for Polyethylene Plastics for Medical Applications

    • Historical Version

  5. ASTM F639-98a


    Standard Specification for Polyethylene Plastics for Medical Applications

    • Historical Version