BS EN ISO 10993-5:2009 适用范围 ISO 10993 的这一部分描述了评估医疗器械体外细胞毒性的测试方法。这些方法指定直接或通过扩散 a) 与装置提取物和/或 b) 与装置接触来孵育培养细胞。这些方法旨在使用适当的生物参数确定哺乳动物细胞体外的生物反应。 购买 正式版专题...
BS EN ISO 10993-5:2009 医疗器械生物学评价.第5部分:细胞毒性体外试验法(ISO 10993-5-2009) Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) 预览BS EN ISO 10993-5:2009前三页 标准号 ...
BS EN ISO 10993-5:2009
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...
BSIStandardsPublicationBiologicalevaluationofmedicaldevicesPart10:TestsforskinsensitizationBSENISO10993-10:03
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)...
BS EN ISO10993-1:2009ICS 11.100.20NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDBiological evaluationof medical devicesPart 1: Evaluation and testing (ISO10993-1:2003)Licensed copy: Vocational Trading Council, Vocational Training Council, Version correct as of ...
BS EN ISO 10993-4-2002医疗器械的生物评定.与血液相互作用试验选择(Biological evaluation of medical devices - Selection of tests for interactions with blood) BS EN ISO 10993-5-1999医疗器械的生物评定.在试管内的细胞毒性试验(Biological evaluation of medical devices - Tests for in vitro cytotoxicity) ...
BS EN ISO 10993-18-2009 中文名称:医疗器械生物学评价 材料的化学特性 英文名称:Biological evaluation of medical devices. Chemical characterization of materials 中国标准分类(CCS):C30 国际标准分类(ICS):11.120 发布日期:2009-6-30 实施日期: 页数:28...
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...