ISO 11737-2:2019 医疗保健产品灭菌微生物学方法 第2部分:用于灭菌过程定义、确认和维护中的无菌试验标准(中文,20页) Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in th...
GB/T 16886.12-2023/ISO 10993-12:2021 医疗器械生物学评价 第12部分:样品制备与参照材料标准 采标情况:ISO 10993-12:2021 发布日期:2023-11-27 实施日期:2024-12-01 标准简介 本文件规定了医疗器械在主要按照ISO 10993(所有部分)的一个或多个部分规定的生物学系统进行试验时所...
ISO 18562-3:2024 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 3: Tests for emissions of volatile organic substances ISO 18562-3:2024 医疗应用中呼吸气体通路的生物相容性评价...
ISO 18562-4:2024 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 4: Tests for leachables in condensate ISO 18562-4:2024 医疗保健应用中呼吸气体通路的生物相容性评估 第4部分:冷凝水中可浸出物...
ISO 11138-5:2017医疗保健产品的灭菌——生物指示剂第5部分:低温蒸汽和甲醛灭菌过程的生物指示剂 ISO 11138-5:2017Sterilization of health care products — Biological indicatorsPart 5: Biological indicators for low-tempe...
ISO 10993-10:2021/ GB/T 16886.10-2024 医疗器械生物学评价 第10部分:皮肤致敏试验 ISO 10993-10:2021 Biological evaluation of medical devices—Part 10:Tests for skin sensitization 标准简介 采标情况:ISO 109...
GB/T 16886.10-2024医疗器械生物学评价 第10部分:皮肤致敏试验(48页) 标准简介 采标情况:ISO 10993-10:2021 IDT 发布日期:2024-08-23 实施日期:2025-09-01 本文件规定了医疗器械及其组成材料诱导潜在皮肤致敏反应的评估步骤。 本文件适用于: ——详细的体内皮肤致敏试验步骤; ...
ISO 18113-3:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) Part 3: In vitro diagnostic instruments for professional use ISO 18113-3:...
ISO 18113-4:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) Part 4: In vitro diagnostic reagents for self-testing ISO 18113-4:2022体外诊断医疗器械&...
ISO 18113-5:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) Part 5: In vitro diagnostic instruments for self-testing ISO 18113-5:2022体外诊断医疗...