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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 052 Date of Entry 07/15/2019 
FR Recognition Number 8-509
Standard
ASTM  F702-18
Standard Specification for Polysulfone Resin for Medical Applications
Scope/Abstract
1.1 This specification covers polysulfone resin (poly(oxy-1,4-phenylenesulfonyl-1,4-phenylene (dimethylmethylene)-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.


1.2 As with any material, some characteristics may be altered by the processing techniques (such as molding, extrusion, machining, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated using test methods which are appropriate to ensure safety and efficacy as agreed upon by the vendor, purchaser, and regulating bodies.


1.3 The standard allows for designation of polysulfone 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 polysulfone (PSU) 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 PSU, or reclaimed materials, are not covered by this specification.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Jinrong (Jinny) Liu
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIC/
  240-402-3160
  jinrong.liu@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
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