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...
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...
ISO-10993-17-2023医疗器械的生物学评价 第17部分:医疗器械成分的毒理学风险评估.pdf,INTERNATIONAL ISO STANDARD 10993-17 Second edition 2023-09 Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
FDA指南2023版本的下载地址: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and FDA指南2020版本的下载地址: https://www.fda.gov/media/85865/download ...
ISO 10993-17-2023 下载积分: 5000 内容提示: Biological evaluation of medical devices —Part 17: Toxicological risk assessment of medical device constituentsÉvaluation biologique des dispositifs médicaux —Partie 17: Appréciation du risque toxicologique des constituants des dispositifs médicaux...
Biological evaluation of medical devices-Part 17: Toxicological risk assessment of medical device constituents Evaluation biologique des dispositifs medicaux-Partie 17: Appreciation du risque toxicologique des constituants des dispositi f s medicaux Reference number ISO 10993-17:2023(E) ©ISO 2023 ...
ISO10993-17:2023(E)中英文版 目录 Foreword前言4 Introduction介绍7 1.Scope范围9 2.Normativereferences规范性引用文件10 3.Termsanddefinitions术语及定义10 4Abbreviatedtermsandsymbols缩写术语和符号21 5Toxicologicalriskassessmentwithinthebiologicalevaluationprocess 生物评价过程中的毒理学风险评估21 5.1General概述22 ...
由于ISO 10993-1:2018 新版标准之内容大幅更新,FDA于 2020 年 10 月公布新版生物相容性评估指南草案,又于 2023 年 9 月发布最终指南,取代了1995 的 G95-1 蓝皮书备忘录。 FDA新版生物相容性评价指南,在原则上虽同样参采 ISO 10993-1 标准,以风险管理流程进行生物评估,但对于风险管理流程的实施,以至于医疗器械...
标准号:ISO 10993-17:2023 EN 标准名称:医疗器械的生物学评价 第17部分:医疗器械成分的毒理学风险评估 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 ...