Standard Specification for Polysulfone Resin for Medical Applications

1.1 This specification covers polysulfone resin (poly(oxy-p-phenylenesulfonyl-p-phenyleneoxy-p-phenyleneisopropylidene-p-phenylene)) for medical applications (as defined in Terminology D883). This specification provides requirements and associated test methods for a form of this thermoplastic which is intended for use in manufacturing medical devices or components of medical devices.

1.2 As with any material, some characteristics may be altered by the processing techniques (such as molding, extrusion, machining, sterilization, and so forth) required for a specific application. Therefore, properties of fabricated forms of this resin should be evaluated using appropriate test methods to assure safety and efficacy.

1.3 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.

1.4 The biocompatibility of plastic compounds made up of polysulfone resin containing colorants, fillers, processing aids, or other additives as well as polymer blends which contain polysulfone should not be assumed on the basis of resin compatibility alone. Their biocompatibility must be established by testing the final (end-use) compositions using evaluation methods appropriate for the intended applications. Note that the types, levels, and biological effects of extractives yielded by the additives contained in a compound or blend may also have to be evaluated for some end-use applications.

1.5 All values in this standard are in SI units with the equivalent values in inch-pound units given in parentheses where applicable.

1.6 This standard does not purport to address all of the concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.