ASTM F639 : 98a

Standard Specification for Polyethylene Plastics for Medical Applications

Standard Details

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 polyethylenes (UHMWPE) plastics, such as those used in joint implants, etc.