ASTM F639-09(2024)

Annotation of standard text ASTM F639-09(2024) :

This specification covers the properties for polyethylene plastics for use in medical device applications involving human tissue contact devices, short term indwellings, and fluid transfer devices. Biocompatibility tests must be conducted on the final products as the biocompatibility of these materials as a class has not been established. Plyethylene plastics should consist of basic polymers with ethylene as essentially the sole monomer. The compound may contain optional adjuvant substances required in polymer production or fabrication. The final compound should yield a consistent absorption spectrum characteristic of the established formulation. The polyethylene plastics should be tested using the specified physical test procedures for density, melt flow, tensile properties, compressive properties, stiffness, flexural fatigue, and other flexural properties.


Keywords:
plastic surgical devices/applications, polyethylene (PE) plastics—surgical implant applications, polymers—surgical applications,, ICS Number Code 11.100.99 (Other standards related to laboratory medicine),83.080.20 (Thermoplastic materials)