内容提示: Biological evaluation of medical devices —Part 1: Requirements and general principles for the evaluation of biological safety within a risk management processICS: 11.100; 11.100.20DRAFT International StandardISO/DIS 10993-1ISO/TC 194Secretariat: DINVoting begins on: 2024-06-24Voting ...
Reference numberISO 10993-1:2009(E)© ISO 2009 INTERNATIONAL STANDARD ISO10993-1Fourth edition2009-10-15Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process Évaluation biologique des dispositifs médicaux — Partie 1: Évaluation et essais ...
© ISO 2018Biological evaluation of medical devices —Part 1: Evaluation and testing within a risk management processÉvaluation biologique des dispositifs médicaux —Partie 1: Évaluation et essais au sein d'un processus de gestion du risqueINTERNATIONAL STANDARDISO10993-1Fifth edition2018-08Refe...
内容提示: © ISO 2018Biological evaluation of medical devices —Part 1: Evaluation and testing within a risk management processÉvaluation biologique des dispositifs médicaux —Partie 1: Évaluation et essais au sein d'un processus de gestion du risqueINTERNATIONAL STANDARDISO10993-1Fifth edition...
BS EN ISO10993-1:2009ICS 11.100.20NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDBiological evaluationof medical devicesPart 1: Evaluation and testing (ISO10993-1:2003)Licensed copy: Vocational Trading Council, Vocational Training Council, Version correct as of ...
内容提示: ISO 10993-1 简介 此部分的基本目标是保护人类不受医疗器械生物学潜在风险的危害。它是由众多国际、国家的有关医疗器械生物学评价标准和指导规范编译出来的。它将作为一个用于医疗器械生物学评价的指导文件,作为整个评价和每种器械发展的一部分,此指导文件还带有一个风险管理过程。这种方法整合了各种资源...
内容提示: EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN ISO 10993-1:2009/AC June 2010 Juin 2010 Juni 2010 ICS 11.100.20 English version Version Française Deutsche Fassung Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - ...
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内容提示: ISO 10993-1:2009(E) 7 c) Breached or compromised surfaces ⎯ devices that contact breached or otherwise compromised body surfaces. EXAMPLES Dressings or healing devices and occlusive patches, for ulcers, burns and granulation tissue. 5.2.2 External communicating devices External ...
简介:ISO 10993《医疗器械生物学评价》, 由 下列部分组成: —第 1 部分: 风险管理过程中的评价与试验; —第 2 部分: 动物福利要求; —第 3 部分: 遗传毒性、致癌性和生殖毒性试验; —第 4 部分: 与血液相互作用试验选择; —第 5 部分: 体外细胞毒性试验; —第 6 部分: 植入后局部反应试验; —第 7...