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ISO 16142-1:2016现行

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

出版：International Organization for Standardization

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基本信息

标准编号： ISO 16142-1:2016

发布时间：2016/3/9 0:00:00

标准类别：Standard

出版单位：International Organization for Standardization

标准页数：47

标准简介

This part of ISO 16142, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical device to the recognized essential principles that when met, indicate a medical device is safe and performs as intended.

本标准替代的旧标准

ISO TR 16142 : 2006

ISO/DIS 16142-1 : 60.00 (2016)

ISO/TR 16142:2006

ISO/FDIS 16142-1

等同采用的国际标准

NEN ISO 16142-1 : 2016 - Identical

SS-ISO 16142-1 : 2017 - Identical

DS ISO 16142-1 : 2016 - Identical

AAMI ISO 16142-1 : 2016 - Identical