BSI Standards PublicationBiological evaluation of medical devicesPart 23: Tests for irritationBS EN ISO 10993‑23:2021
BS EN ISO 10993-10 - 皮肤过敏测试是什么?这是关于如何进行医疗器械生物学评价的国际系列标准中的第十个标准。与医疗材料和设备的安全相关,BS EN ISO 10993-10:2023 涵盖了评估皮肤致敏反应的测试的选择和实施。 BS EN ISO 10993-10 – 皮肤过敏测试适合谁?医疗器械制造商和供应商 医疗实验室 监管机构 公....
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; ...
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...
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...
BS EN ISO 10993-17:2023的标准全文信息,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 IS
BSENISO10993-1:009ICS11.100.0NOCOPYINGWITHOUTBSIPERMISSIONEXCEPTASPERMITTEDBYCOPYRIGHTLAWBRITISHSTANDARDBiologicalevaluationofmedicaldevicesPart1:SamplepreparationandreferencematerialsISO10993-1:007
BSIStandardsPublicationBiologicalevaluationofmedicaldevicesPart1:EvaluationandtestingwithinariskmanagementprocessBSENISO10993‑1:00
BS EN ISO 10993-13:2010
BS EN ISO10993-12:2009ICS 11.100.20NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDBiological evaluationof medical devicesPart 12: Sample preparation andreference materials (ISO 10993-12:2007)