Standard Specification for Polysulfone Resin for Medical Applications
NORMA vydaná dňa 1.12.2018
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Označenie normy: ASTM F702-18
Dátum vydania normy: 1.12.2018
Počet strán: 4
Približná hmotnosť: 12 g (0.03 libier)
Krajina: Americká technická norma
Kategória: Technické normy ASTM
This specification covers polysulfone resin (poly(oxy-p-phenylenesulfonyl-p-phenyleneoxy-p-phenyleneisopropylidene-p-phenylene)) for medical applications. Requirements and associated test methods for a form of this thermoplastic intended for use in manufacturing medical devices or components of medical devices are provided. The use of this resin in medical devices should be restricted to nonimplant applications until biocompatibility evaluations appropriate for the intended applications are successfully completed. The molecular weight of the resin shall be determined by osmotic pressure in monochlorobenzene. The polysulfone resin shall yield an infrared transmittance spectrum that exhibits major transmittance bands only at the same wavelengths as that of a reference spectrum. Medical devices made of polysulfone may be repeatedly sterilized through steam, ethylene oxide, irradiation, and dry heat sterilization, among others. The polysulfone resin shall be tested for nonvolatile content and melt flow, and shall conform to the specified electrical, physical and mechanical, and thermal properties.
Keywords:
plastic surgical devices/applications, polymers´surgical applications, polysulfone resins, unfilled polysulfone (PSU),, ICS Number Code 11.100.99 (Other standards related to laboratory medicine),83.080.20 (Thermoplastic materials)