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Scope

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.

Keywords

Plastic surgical devices/applications; Polyethylene (PE)-surgical implant applications; Polymers-surgical applications; polyethylene (PE) plastics for medical applications, spec

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

11.100.99 (Other standards related to laboratory medicine)

11.120.01 (Pharmaceutics in general)

83.080.20 (Thermoplastic materials)

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