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    ASTM F702-18

    Standard Specification for Polysulfone Resin for Medical Applications
    • 발행일 : 2018-12-01
    • 발행기관 : ASTM
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분야 13.01 : 의료기, 외과용 도구 및 장비
적용범위

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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

국제분류(ICS)코드 11.100.99 : 약실험과 관련한 다른 표준
83.080.20 : 열가소성 수지재
페이지수 4
Edition 18

이력정보

No. 표준번호 표준명 발행일 상태
1 ASTM F702-18상세보기 Standard Specification for Polysulfone Resin for Medical Applications 2018-12-01 표준
2 ASTM F702-18 REDLINE상세보기 Standard Specification for Polysulfone Resin for Medical Applications 2018-12-01 표준
3 ASTM F702-10 REDLINE상세보기 Standard Specification for Polysulfone Resin for Medical Applications 2010-09-01 구판
4 ASTM F702-10상세보기 Standard Specification for Polysulfone Resin for Medical Applications 2010-09-01 구판
5 ASTM F702-98a(2003)상세보기 Standard Specification for Polysulfone Resin for Medical Applications 2003-04-10 구판
6 ASTM F702-98a상세보기 Standard Specification for Polysulfone Resin for Medical Applications 1998-10-10 구판
7 ASTM F702-98ae1상세보기 Standard Specification for Polysulfone Resin for Medical Applications 1998-10-10 구판

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