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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 |