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ISO/IEC GUIDE 63 (2019-08)
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ISO/IEC GUIDE 63 (2019-08)
ISO/IEC GUIDE 63:2019 Guide to the development and inclusion of aspects of safety in International Standards for medical devicesMore info
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 |