ISO10993-18:2020ENBiologicalevaluationofmedicaldevices—Part18:Chemicalcharacterizationofmedicaldevicematerialswithinariskmanagementprocess是一个非常重要的标准,对于医疗器械制造商来说是不可或缺的。他们必须采用这个标准以确保他们生产的安全和有效的医疗器械。当前...
英文名称:Biological evaluation of medical devices — Part 18: Chemical characterization of materials 标准状态:废止 发布日期:2005-06-30 文档简介 ISO10993系列标准是一组用于评估医疗器械生物相容性的国际标准。其中,ISO10993-18是关于医疗器械材料化学特性的部分。这部分主要关注医疗器械材料在植入或与生物体接触后...
本部分代替 GB/T 16886.18-2011 《医疗器械生物学评价第 18 部分:材料化学表征》,与 GB/T16886.18—2011 相比,主要技术变化如下: ——进一步整合和协调了ISO 10993-1、ISO 10993-12 与ISO 10993-17; ——修订和扩展了化学表征流程图; ——进一步解释了不一定需要进行分析测试; ——增加了许多定义(例如,医疗...
INTERNATIONAL STANDARD ISO 10993-18 Second edition 2020-01 Biological evaluation of medical devices 一Part 18: Chemical characterization of medical device materials within a risk management process Evaluation biologique des dispositifs medicaux 一Partie 18: Caracterisation chimique des materiaux des dispositif...
Caractérisation chimique des matériaux des dispositifs médicaux au sein d'un processus de gestion du risqueAMENDEMENT 1: Détermination du coefficient d'incertitudeINTERNATIONAL STANDARDISO 10993-18Second edition 2020-01AMENDMENT 1 2022-05Reference number ISO 10993-18:2020/Amd.1:2022(E)© ISO ...
ISO 10993-1-2018中文,医疗器械的生物评价.第1部分.pdf,ISO 10993-1:2018(E) 中英文版 INTERNATIONAL Fifth edition 第5版 STANDARD 2018-08 国际标准 Biological evaluation of medical devices —Part 1:Evaluation and testing within a risk management process 医疗器
【英语版】国际标准 ISO 10993-18:2020/AMD 1:2022 EN Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process — Amendment 1: Determination of the uncertainty factor 医疗器
part of the risk assessment process and are outside the scope of this part of ISO 10993 They are given for information to indicate the important interaction between chemical characterization and risk assessment NOTE 2 The supplier can be a useful source of appropriate analytical methods In the ...
materials within a risk management processÉvaluation biologique des dispositifs médicaux —Partie 18: Caractérisation chimique des matériaux des dispositifs médicaux au sein d'un processus de gestion du risqueINTERNATIONAL STANDARDISO10993-18Second edition2020-01Reference numberISO 10993-18:2020(E)...
If the data needed to conduct this analysis are not readily available, ISO 10993 Part 18 outlines a framework for the programme of tests required to chemically characterise the materials and generate the information. Companies involved in the specification of materials for new medical devices should ...