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sklademVydáno: 2019-08-21
PD 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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| Označení normy: | PD ISO/IEC GUIDE 63:2019 |
| Počet stran: | 38 |
| Vydáno: | 2019-08-21 |
| ISBN: | 978 0 539 03709 8 |
| Status: | Standard |
DESCRIPTION
PD ISO/IEC GUIDE 63:2019
This standard PD ISO/IEC GUIDE 63:2019 Guide to the development and inclusion of aspects of safety in International Standards for medical devices is classified in these ICS categories:
- 01.120 Standardization. General rules
- 11.040.01 Medical equipment in general
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.