The electronic version of this Guide can be downloaded from the ISO/IEC Guides web page.
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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ISO/IEC Guide 63:2012
ISO/IEC Guide 63:2019Stage: 60.60
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