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ISO/IEC Guide 63:2019

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

General information
Valid from 12.08.2019
Directives or regulations
None

Standard history

Status
Date
Type
Name
12.08.2019
Main
10.01.2012
Main
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.
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