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ASTM F1855-00(2019)
Standard Specification for Polyoxymethylene (Acetal) for Medical Applications- 발행일 : 2019-12-01
- 발행기관 : ASTM
상세정보
| 분야 | 13.01 : 의료기, 외과용 도구 및 장비 |
|---|---|
| 적용범위 | 1.1 This specification covers polyoxymethylene (acetal) resin for medical applications. This specification provides requirements and associated test methods for a form of this thermoplastic which is intended for use in manufacturing medical devices, instrumentation or components thereof. 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 Although this resin has been used for specific implant applications in the United States, the use of this resin in medical devices should be restricted to non-implant applications until biocompatibility evaluations appropriate for the intended applications are successfully completed. 1.4 The biocompatibility of plastic compounds made up of polyoxymethylene (acetal) resin containing colorants, fillers, processing aids, or other additives as well as polymer blends which contain polyacetal should not be assumed on the basis of resin biocompatibility alone. Their biocompatibility must be established by testing the final (end-use) compositions using evaluation methods appropriate for the intended applications. It should be noted that the types, test 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 The values stated in inch-pound units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 This standard does not purport to address all of the safety 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 standard does not purport to address all of the safety 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. 1.8 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 |
83.080.20 : 열가소성 수지재
11.040.30 : 외과장비 |
| 페이지수 | 3 |
| Edition | 00(2019) |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ASTM F1855-00(2019)상세보기 | Standard Specification for Polyoxymethylene (Acetal) for Medical Applications | 2019-12-01 | 표준 |
| 2 | ASTM F1855-00(2011)상세보기 | Standard Specification for Polyoxymethylene (Acetal) for Medical Applications | 2011-12-01 | 구판 |
| 3 | ASTM F1855-00(2005)상세보기 | Standard Specification for Polyoxymethylene (Acetal) for Medical Applications | 2005-03-01 | 구판 |
| 4 | ASTM F1855-00상세보기 | Standard Specification for Polyoxymethylene (Acetal) for Medical Applications | 2000-05-10 | 구판 |
관련상품
- 관련상품이 존재하지 않습니다.
다른 사람이 함께 구입한 상품
- ASTM F2313-18 - Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide
- ISO 14322:2018 - Plastics — Epoxy resins — Determination of degree of crosslinking of crosslinked epoxy resins by differential scanning calorimetry (DSC)
- ISO 5833:2002 - Implants for surgery — Acrylic resin cements
- ASTM F2820-12 - Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
- ASTM F1925-17 - Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
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