【国外标准】 Standard Specification for Polysulfone Resin for Medical Applications
本网站 发布时间:
2024-02-28
开通会员免费在线看70000余条国内标准,赠送文本下载次数,单本最低仅合13.3元!还可享标准出版进度查询、定制跟踪推送、标准查新等超多特权!  
查看详情>>
标准简介
适用范围:
This specification covers polysulfone resin (poly(oxy-p-phenylenesulfonyl-p-phenyleneoxy-p-phenyleneisopropylidene-p-phenylene)) for medical applications. Requirements and associated test methods for a form of this thermoplastic intended for use in manufacturing medical devices or components of medical devices are provided. The use of this resin in medical devices should be restricted to nonimplant applications until biocompatibility evaluations appropriate for the intended applications are successfully completed. The molecular weight of the resin shall be determined by osmotic pressure in monochlorobenzene. The polysulfone resin shall yield an infrared transmittance spectrum that exhibits major transmittance bands only at the same wavelengths as that of a reference spectrum. Medical devices made of polysulfone may be repeatedly sterilized through steam, ethylene oxide, irradiation, and dry heat sterilization, among others. The polysulfone resin shall be tested for nonvolatile content and melt flow, and shall conform to the specified electrical, physical and mechanical, and thermal properties.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.
标准号:
ASTM F702-18
标准名称:
Standard Specification for Polysulfone Resin for Medical Applications
英文名称:
Standard Specification for Polysulfone Resin for Medical Applications标准状态:
Active-
发布日期:
-
实施日期:
出版语种:
- 推荐标准
- 国家标准计划
- BS EN IEC 61753-071-02:2020+A1:2024 Fibre optic interconnecting devices and passive components. Performance standard
- 24/30492859 DC BS EN IEC 61753-1 Fibre optic interconnecting devices and passive components - Performance standard
- 24/30491443 DC standard
- 24/30489392 DC BS EN IEC 62358 Ferrite cores. Standard inductance factor for gapped cores and its tolerance
- BS ISO 19848:2024 - TC Tracked Changes. Ships and marine technology. Standard data for shipboard machinery and equipment
- BS ISO 19848:2024 Ships and marine technology. Standard data for shipboard machinery and equipment
- BS IEC 61360-7:2024 Standard data element types with associated classification scheme
- 24/30487130 DC BS EN 50566:2017/A2:2024 Product standard to demonstrate the compliance of wireless communication
- 24/30486472 DC - Product standard
- KS M ISO 4259-4 석유 및 관련 제품 — 측정 방법과 결과의 정밀도 — 제4부: 개별 실험실에서 표준 시험방법의 실행에 대한 ‘통계적 관리’ 상태를 확인하기 위한 통계적 관리도의 사용
- KS C IEC 61340-4-6 정전기학 — 제4-6부: 구체적 적용 분야에 대한 표준 시험방법 — 손목접지대
- KS C IEC 61340-4-7 정전기학 — 제4-7부: 구체적 적용 분야에 대한 표준 시험방법 — 이온화
- KS C IEC 61340-4-8 정전기학 — 제4-8부: 구체적 적용 분야에 대한 표준 시험방법 — ESD 차폐성 — 봉투
- 24/30485973 DC standard
- BS EN 14662-1:2023 - TC Tracked Changes. Ambient air quality. Standard method for measurement of benzene concentrations