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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
Buying
Published
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
WITHDRAWN
ISO/IEC Guide 63:2012
NOW
PUBLISHED
ISO/IEC Guide 63:2019
60.60
Standard published
Aug 12, 2019