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ISO 16142-2:2017现行

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

出版:International Organization for Standardization

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基本信息
标准编号: ISO 16142-2:2017
发布时间:2017/8/21 0:00:00
标准类别:Standard
出版单位:International Organization for Standardization
标准页数:42
标准简介

This document, 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.

等同采用的国际标准

BS ISO 16142-2 : 2017 - Identical

NEN ISO 16142-2 : 2017 - Identical

DS ISO 16142-2 : 2017 - Identical

AAMI ISO 16142-2 : 2017 - Identical

DS ISO 16142-2 : 2017 - Identical

BS ISO 16142-2 : 2017 - Identical

AAMI ISO 16142-2 : 2017 - Identical

NEN ISO 16142-2 : 2017 - Identical