BS ISO 16142-1:2016
医疗设备 公认的医疗器械安全和性能的基本原则 所有非 IVD 医疗器械的一般基本原则和附加具体基本原则以及选择指南
Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of s...