BS EN ISO 10993-18:2020+A1:2023 适用范围 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,允许使用一般逐步的化学表征方法来识别生物危害并估计和控制材料成分的生物风险。其中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)的识别和定量来表征建筑材料; —...
BS EN ISO 10993-18:2020+A1:2023 购买 正式版其他标准ISO 8669-1:1988 尿收集袋 第1部分:词汇 两种语言版 BS EN 1644-1:1997 医用非纺织的压敷布的检验方法.第1部分:生产压敷布料用的非纺织物 ISO 10993-14:2001 医疗器械的生物学评价 第14部分:陶瓷降解产物的识别和量化 ISO 8536-5:2004 医用输液...
107 p. Handbook of Validation in Pharmaceutical Processes 13 p. s12248-024-00909-7 37 p. 工艺验证检查指南(征求意见稿)2024版 7 p. F 838 - 20 113 p. ECA 确认与验证指南2024 12 p. 出口中药材辐照中药材鉴定方法 热释光法 SNT4061-2014dz 74 p. 6.IEC 60601-1 A2-2020 医用电...
BS EN ISO 10993-1:2020 Biological evaluation of medical devices —Part 1:Evaluation and testing within a risk management process 本文件规定: ——在风险管理过程中管理医疗器械生物学评价的一般原则; ——医疗器械根据其与身体接触的性质和持续时间的一般分类; ...
(small and larger blisters) or a combination of these. To reduce the likelihood of adverse reactions and ultimately to make medical devices safer,BS EN ISO 10993-10:2023Biological evaluation of medical devices — Part 10: Tests for skin sensitizationspecifies procedures for assessing devices and ...
BS EN ISO 10993-1:October 2009
So EO has unique and useful properties, but it’s also very volatile and dangerous stuff. Hence the care that needs to be exercised when EO is used to sterilize medical devices, and the existence ofBS EN ISO 10993-7:2008+A1:2022 Biological evaluation of medical devices -- Part 7: Ethyle...
N ISO 10993-12:2012 BS EN ISO 10993-12:2012BS EN ISO 10993-12:2012
BS EN ISO10993-15:2009ICS 11.100.20NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDBiological evaluationof medical devicesPart 15: Identification andquantification of degradationproducts from metals and alloys (ISO10993-15:2000)...
28 p. ISO 4437-1_2024 42 p. ISO 4437-3_2024 22 p. ISO 4437-5_2024 28 p. ISO 5060_2024 30 p. ISO 8655-10_2024 64 p. ISO 17546_2024 46 p. ISO 23217_2024 68 p. ISO 24511_2024 42 p. ISO 24596_2024 16 p. ISO 27996_2024 关于...