PD ISO/IEC GUIDE 63:2019
Current
The latest, up-to-date edition.
Guide to the development and inclusion of aspects of safety in International Standards for medical devices
Hardcopy , PDF
English
21-08-2019
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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.
| Committee |
CH/210/4
|
| DocumentType |
Standard
|
| ISBN |
9780539037098
|
| Pages |
38
|
| ProductNote |
This standard also refers to IEC 60417,ISO 10993,ISO/TR 80002-1.
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
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.
| Standards | Relationship |
| ISO/IEC Guide 63:2019 | Identical |
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