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医疗器械 保障医疗器械安全和性能公认基本原则的标准选用指南 Medical devices—Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
发布日期: 2016-01-26
实施日期: 2017-01-01
废止日期: 2025-08-26
本标准规定了评定医疗器械安全和性能的公认基本原则,提供了有关重要标准和指南。本标准适用于医疗器械安全和性能的符合性评定
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现行
AAMI/ISO TIR16142-2005
Medical devices- Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
医疗器械.支持医疗器械安全和性能公认基本原则的标准选择指南
2005-10-19
现行
BS ISO 16142-2-2017
Medical devices. Recognized essential principles of safety and performance of medical devices-General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
医疗设备 公认的医疗器械安全和性能基本原则
2017-09-20
现行
BS ISO 16142-1-2016
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 standards
医疗设备 医疗器械安全和性能的公认基本原则第1部分:所有非IVD医疗器械的一般基本原则和附加特定基本原则及标准选择指南
2016-03-31
现行
AAMI/ISO 16142-2-2017
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
医疗器械.医疗器械安全和性能的公认基本原则.第2部分:所有IVD医疗器械的一般基本原则和附加特定基本原则及标准选择指南
2017-07-31
现行
AAMI/ISO 16142-1-2016
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
医疗器械.医疗器械安全和性能的公认基本原则.第1部分:所有非IVD医疗器械的一般基本原则和附加特定基本原则及标准选择指南
2016-08-10