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ISO/IEC/GUIDE 63:2019-ed.3.0

Guide to the development and inclusion of aspects of safety in International Standards for medical devices

STANDARD published on 12.8.2019

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The information about the standard:

Designation standards: ISO/IEC/GUIDE 63:2019-ed.3.0
Publication date standards: 12.8.2019
The number of pages: 26
Approximate weight : 78 g (0.17 lbs)
Country: International technical standard
Category: Technical standards ISO

Annotation of standard text ISO/IEC/GUIDE 63:2019-ed.3.0 :

Description / Abstract: This document provides requirements and recommendations to writers of medical device standards on the inclusion of aspects related to safety in International Standards, based on well-established risk management concepts and methodology. This document is applicable to any aspect related to the safety of people, property, the environment, or a combination of these. In this document, the term "product" includes a medical device or a system consisting of one or more medical devices, possibly combined with non-medical devices.