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DS ISO/IEC Udhëzues 63:2019

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

Mar 5, 2021

General information

60.60     Jan 20, 2021

DPS

DPS/KT 1

Pure national standard

11.040.01     01.120  

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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.

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PUBLISHED
DS ISO/IEC Udhëzues 63:2019
60.60 Standard published
Jan 20, 2021