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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
Translate name
STANDARD published on 21.8.2017
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The information about the standard:
Designation standards: ISO 16142-2:2017
Publication date standards: 21.8.2017
SKU: NS-693596
The number of pages: 42
Approximate weight : 126 g (0.28 lbs)
Country: International technical standard
The category - similar standards:
Annotation of standard text ISO 16142-2:2017 :
Description / Abstract: ISO 16142-2:2017, 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. This document identifies and describes the six general essential principles of safety and performance (see Table B.1) that apply to all medical devices, including IVD medical devices (in vitro diagnostic). ISO 16142-2:2017 also identifies and describes the additional essential principles of safety and performance which need to be considered during the design and manufacturing process, which are relevant to IVD medical devices. NOTE During the design process, the manufacturer selects which of the listed design and manufacturing principles apply to the particular medical device and documents the reasons for excluding others. ISO 16142-2:2017 is intended for use as guidance by medical device manufacturers, standards development organizations, authorities having jurisdiction, and conformity assessment bodies.
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