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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

Aug 12, 2019

General information

60.60     Aug 12, 2019

ISO/IEC

ISO/TMBG

Guide

01.120     11.040.01  

English  

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Scope

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.

Life cycle

PREVIOUSLY

Revises
ISO/IEC Guide 63:2012

NOW

PUBLISHED
ISO/IEC Guide 63:2019
60.60 Standard published
Aug 12, 2019