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ASTM F639-09(2015)
- Standard Specification for Polyethylene Plastics for Medical Applications
- standard by ASTM International, 03/01/2015
- Publisher: ASTM
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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.