
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

专家解读视频
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.
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