ASTM F639-09(2015),Standard Specification for Polyethylene Plastics for Medical Applications.
ASTM F639-09(2015) 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.
4. Classification
4.1 Types of polyethylene plastics molding and extrusion material are described in Specification D4976.
5. General Requirements
5.1 Polyethylene plastics consist of basic polymers made with ethylene as essentially the sole monomer(as defined in Terminology D883).
5.2 Polyethylene for use in medical applications shall have a maximum extractable fraction, expressed as weight percent in polymer, in n-hexane of 5.5 at 50°C.
5.3 The formulated compound may contain optional adjuvant substances required in the production of the polymer or in the fabrication or intended use of the end product. The biocompatibility of these adjuvant substances shall be established on the finished compound (see Section 9).
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