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New Specification for Standard Specification for Polyphenylsulfone Resin for Medical Applications
1. Scope
1.1 This specification covers polyphenylsulfone resin (oxybiphenyl-4,4'-diyloxy-1,4-phenylenesulfonyl-
1,4-phenylene) as defined in ISO 25137–1, supplied by a vendor in virgin form (pellets, powder, fabricated forms and so forth) for medical applications. This specification provides requirements and associated test methods for this thermoplastic when it is intended for use in manufacturing medical devices or components of medical devices.
1.3 The standard allows for designation of polyphenylsulfone resin for all medical applications. The actual extent of performance and suitability for a specific application must be evaluated by the vendor, purchaser, and regulating bodies.
1.4 The properties included in this specification are those applicable for unfilled polyphenylsulfone (PPSU) polymers with the addition of colorants and processing aids. Indicated properties are for injection molded forms. Forms containing fillers or other additives, as well as polymer blends which contain PPSU, or reclaimed materials, are not covered by this specification.
Polyphenylsulfone has been used in medical applications for many years and the need for a unified designation and description of the material for use in medical applications has been requested by many of the manufacturers of medical devices. The primary users of the proposed specifications will be the device designers, manufacturers, molders and convertors of the PPSU material in finished or semi-finished products. The method has been modeled after the F702 Polysulfone standard to keep as much definition in line with the sulfone family of polymers.
