International Standard
ISO/IEC Guide 63:2019
Guide to the development and inclusion of aspects of safety in International Standards for medical devices
Reference number
ISO/IEC Guide 63:2019
ISO/IEC Guide 63:2019
Edition 3
2019-08
2019-08
© ISO 2024
International Standard
ISO/IEC Guide 63:2019
ISO/IEC Guide 63:2019
67944
CHF
129
Convert Swiss francs (CHF) to your currency
The electronic version of this Guide can be downloaded from the ISO/IEC Guides web page.
Abstract
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
WithdrawnISO/IEC Guide 63:2012
-
Now
Got a question?
Check out our FAQs
Customer care
+41 22 749 08 88
Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)