ISO/IEC-GUIDE 63 › Guide to the development and inclusion of aspects of safety in International Standards for medical devices

ISO/IEC-GUIDE 63 - 3RD EDITION - CURRENT
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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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Document Number

ISO/IEC Guide 63:2019

Revision Level

3RD EDITION

Status

Current

Publication Date

Aug. 1, 2019

Committee Number

ISO/TMBG