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ISO/IEC GUIDE 63 (2019-08)

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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

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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.

Author ISO/IEC
Editor ISO/IEC
Document type Standard
Format File
Edition 3.0
ICS 01.120 : Standardization. General rules
11.040.01 : Medical equipment in general
Number of pages 26
Replace ISO/IEC GUIDE 63 (2012-01)

Year 2019
Document history ISO/IEC GUIDE 63 (2012-01)
Country International
Keyword IEC63;ISO/IEC GUIDE 63:2019