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...
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...
ISO 1099317:2023 EN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:ISO 10993系列标准是一组针对医疗器械及其相关材料在人体内植入或使用的生物评价标准。这些标准旨在确保医疗器械的安全性和有效
ENISO10993-17
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...
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...
内容提示: EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 10993-17April 2009ICS 11.100.20 Supersedes EN ISO 10993-17:2002 English VersionBiological evaluation of medical devices - Part 17: Establishmentof allowable limits for leachable substances (ISO 10993-17:2002)Évaluation biologique des...
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...
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