ASTM F702-10
Standard Specification for Polysulfone Resin for Medical Applications
- Standard No.
- ASTM F702-10
- Release Date
- 2010
- Published By
- American Society for Testing and Materials (ASTM)
- Status
- Replace By
- ASTM F702-18
- Latest
- ASTM F702-18
- Scope
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.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 When evaluating material in accordance with this specification, hazardous materials, operations, and equipment may be involved. 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.
ASTM F702-10 Referenced Document
- ASTM D256 Standard Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics
- ASTM D638 Standard Test Method for Tensile Properties of Plastics
- ASTM D6394 Standard Specification for Sulfone Plastics (SP)
- ASTM D648 Standard Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position*， 2024-04-19 Update
- ASTM D792 Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
- ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
- ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
- ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories [Standard in French]
ASTM F702-10 history
- 2018 ASTM F702-18 Standard Specification for Polysulfone Resin for Medical Applications
- 2010 ASTM F702-10 Standard Specification for Polysulfone Resin for Medical Applications
- 1998 ASTM F702-98a(2003) Standard Specification for Polysulfone Resin for Medical Applications
- 1998 ASTM F702-98ae1 Standard Specification for Polysulfone Resin for Medical Applications
- 1998 ASTM F702-98a Standard Specification for Polysulfone Resin for Medical Applications
