ISO/IEC GUIDE 63:2019 

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


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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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Additional information

Publication typeGuide
Publication date2019-08-12
Available language(s)English
TC/SCISO/TC 210 - Quality management and corresponding general aspects for medical devicesrss
ICS11.040.01 - Medical equipment in general
01.120 - Standardization. General rules
File size1366 KB

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