EN ISO 10993-17:2023/prA1 是欧洲标准化委员会(CEN)发布的一项关于医疗器械生物学评价的标准修正案。该修正案基于国际标准ISO 10993-17:2023,专门针对医疗器械成分的毒理风险评估进行了更新和补充。 本标准修正案的主要目的是为医疗器械制造商和相关监管机构提供更为详细和科学的指导,以确保医疗器械在使用过程中对...
BS EN ISO 10993-17:2023 适用范围 本文件规定了医疗器械成分毒理学风险评估的流程和要求。还规定了用于评估接触某种成分是否不会造成明显危害的方法和标准。毒理学风险评估可以作为最终产品生物学评估的一部分,如 ISO 10993-1 所述。本文件中描述的过程适用于根据 ISO 10993-18 获得的化学特性信息。当需要对成分...
英文名称:Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents 标准状态:现行 发布日期:2023-09-13 文档简介 ISO10993-17:2023EN生物评价的医疗器械-第17部分:医疗器械组分的毒理学风险评估详细解释如下: ISO10993系列标准是一组针对医疗器械及其相关材料...
DEUTSCHE NORM August 2009 DIN EN ISO 10993-17 DIN ICS 11.100.20 Supersedes DIN EN ISO 10993- 17:2003-06 See start of va lidity Bi。l。gical evaluation of medical devices - Part 17: Establishment 。f all。wable limits for leachable substances (ISO 10993-17:2002) English versi。n 。f ...
To reduce the likelihood of adverse reactions and ultimately to make medical devices safer, BS EN ISO 10993-10:2023 Biological evaluation of medical devices — Part 10: Tests for skin sensitization specifies procedures for assessing devices and their constituent materials for their potential to induce...
DIN EN ISO 10993-10-2023 中文版翻译 实施日期:2023-04-01 英文名:Biological evaluation of medical devices- Part10: Tests for skin sensitization (ISO10993-10:2021); German version ENISO10993-10:202...
EN ISO 10993-1-2020 yichuangjian 2021-12-9 02813 yichuangjian 2021-12-9 EN ISO 15223-1-2021 yichuangjian 2021-12-9 02036 yichuangjian 2021-12-9 EN ISO 15223-1-2021 yichuangjian 2021-12-9 01837 yichuangjian 2023-11-5
In fact,BS EN ISO 10993-10:2023is the fourth edition of this standard, which is in itself the tenth in an extensive international series on the biological evaluation of medical devices. Other standards in the series cover e.g.: animal welfare requirements, sample preparation, and good clinical...
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DIN EN ISO 10993-7-2022 Biological evaluation of medical devices - Part 7:Ethylene oxide sterilization residuals 医疗器械的生物评定. 第7部分: 环氧乙烷灭菌残留物.pdf,DEUTSCHE NORM September 2022 DIN EN ISO 10993-7 DIN JCS 11.100.20 Ersatz fiir 。IN EN IS