Standard Code | Standard Title | Standard Class | Order |
---|---|---|---|
GB/Z 42217-2022 |
Medical devices for the validation of Medical device quality system software {译} 医疗器械 用于医疗器械质量体系软件的确认 |
China National Standards Medical device quality |
English PDF |
GB/T 42218-2022 |
Laboratory medicine - In vitro diagnostic medical devices - Manufacturer's confirmation of quality control procedures provided to users {译} 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 |
China National Standards Medical device quality |
English PDF |
GB/T 42061-2022 |
Medical device quality management system for regulatory requirements {译} 医疗器械 质量管理体系 用于法规的要求 |
China National Standards Medical device quality |
English PDF |
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