ISO 16142-1:2016
医疗器械. 医疗器械安全性和性能的公认基本原则. 第1部分: 所有非IVD医疗器械的通用基本原则和额外具体基本原则和标准选择指南
Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards