BS EN ISO 10993-16-2010 医疗器械的生物学评定.降解产物和可滤取物的毒物动力学研究设计

标准号：BS EN ISO 10993-16-2010
中文标准名称：医疗器械的生物学评定.降解产物和可滤取物的毒物动力学研究设计
英文标准名称：Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables
标准类型：C37
发布日期：2010/3/31 12:00:00
实施日期：2010/3/31 12:00:00
中国标准分类号：C37
国际标准分类号：11.100.20
引用标准：ISO 10993-1;ISO 10993-2;ISO 10993-12;ISO 10993-17;ISO 10993-18;ISO 14971
适用范围：This part of ISO 10993 gives principles on how toxicokinetic studies relevant to medical devices should bedesigned and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in thebiological evaluation of medical devices.