BH GSO ISO 16142-2:2022 医疗器械 公认的医疗器械安全和性能基本原则 第2部分:所有 IVD 医疗器械的一般基本原则和附加具体基本原则以及标准选择指南
Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards