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...
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...
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...
EN ISO 10993-18:2020/A1:2023 适用范围 本文件规定了医疗器械成分识别和(如有必要)量化的框架,允许识别生物危害并估计和控制材料成分的生物风险,使用一般逐步的化学表征方法,该方法可以包括以下一项或多项: ——其构造材料的标识(医疗器械配置);——通过化学成分(材料成分)的识别和量化来表征结构材料; ——医疗...
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)...
DIN EN ISO 10993-18:2023-11的发布历史信息,医疗器械的生物学评估 第 18 部分:风险管理流程中医疗器械材料的化学特性 (ISO 10993-18:2020 + Amd 1:2022), Biological evaluation of medical devices - Part 18: C
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 ...
【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 ...
<1> ISO10993-18:2020 Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process 这是我们上一期的内容: ISO10993-18:2020风险管理过程中的医疗器械材...