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GB/T 16886.15-2022
Biological Evaluation of Medical Devices-Part 15: Qualitative and Quantitative Degradation Products of Metals and Alloys
医疗器械生物学评价 第15部分:金属与合金降解产物的定性与定量 - 英文版
GB/T 16886.9-2022
Biological evaluation of medical devices - Part 9: Qualitative and quantitative framework for potential degradation products
医疗器械生物学评价 第9部分:潜在降解产物的定性和定量框架 - 英文版
GB/Z 42217-2022
Medical devices for the validation of Medical device quality system software
医疗器械 用于医疗器械质量体系软件的确认 - 英文版
GB/T 42218-2022
Laboratory medicine - In vitro diagnostic medical devices - Manufacturer's confirmation of quality control procedures provided to users
检验医学 体外诊断医疗器械 制造商对提供给用户的质量控制程序的确认 - 英文版
GB/T 42061-2022
Medical device quality management system for regulatory requirements
医疗器械 质量管理体系 用于法规的要求 - 英文版

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