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 , PDF 3 Users , PDF 5 Users , PDF 9 Users
English
12-08-2019
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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.
| Committee |
ISO/TMBG
|
| DocumentType |
Guide
|
| Pages |
26
|
| ProductNote |
THIS STAMNDARD REFERS:ISO/TR 80002-1,IEC 60417,GHTF/SG1/N055,GHTF/SG1/N071
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| PD ISO/IEC GUIDE 63:2019 | Identical |
| JIS T 0063:2020 | Identical |
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