【国外标准】 Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical 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:
4.1 This guide is intended to aid device fabricators in the selection of proper commercially available polyurethane solids and solutions for their application.4.2 The polyurethanes covered by this guide may be thermoformed or solution cast into biomedical devices for use as surgical aids or for implantation as determined to be appropriate, based on supporting biocompatibility and physical test data.1.1 This guide covers the evaluation of thermoplastic polyurethanes in both solid and solution form for biomedical applications. The polymers have been reacted to completion and require no further chemical processing.1.2 The tests and methods listed in this guide may be referenced in specifications containing minimum required values and tolerances for specific end-use products.1.3 Standard tests for biocompatibility are included to aid in the assessment of safe utilization in biomedical applications. Compliance with these criteria shall not be construed as an endorsement of implantability. Since many compositions, formulations, and forms of thermoplastic polyurethanes in solid and solution forms are within this material class, the formulator or fabricator must evaluate the biocompatibility of the specific composition or form in the intended use and after completion of all manufacturing processes including sterilization.1.4 Purchase specifications may be prepared by agreement between the buyer and seller by selection of appropriate tests and methods from those listed applicable to the specific biomedical end use.1.5 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.
标准号:
ASTM F624-09(2015)e1
标准名称:
Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
英文名称:
Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical 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 ISO 24138:2024 Information and documentation. International Standard Content Code (ISCC)
- 24/30492859 DC BS EN IEC 61753-1 Fibre optic interconnecting devices and passive components - Performance standard
- BS EN IEC 61753-071-02:2020+A1:2024 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 61340-4-7 정전기학 — 제4-7부: 구체적 적용 분야에 대한 표준 시험방법 — 이온화
- KS C IEC 61340-4-6 정전기학 — 제4-6부: 구체적 적용 분야에 대한 표준 시험방법 — 손목접지대
- KS C IEC 61340-4-8 정전기학 — 제4-8부: 구체적 적용 분야에 대한 표준 시험방법 — ESD 차폐성 — 봉투
- 24/30485973 DC standard