| Publication CODE |
Title |
| ISO/IEC GUIDE 63:2019 (2019-08) |
GUIDE TO THE DEVELOPMENT AND INCLUSION OF ASPECTS OF SAFETY in INTERNATIONAL STANDARDS FOR MEDICAL DEVICES |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
137.00 €
|
26. |
Description
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.
|
| Class |
C990
(IEC PUBLICATIONS IEC PUBLICATIONS)
|
| Committee |
IEC unknown
This Committee is presently unknown
|
| BEC Approval |
2019-08-12 |
| ICS-Code (International Standards Classification) |
01.120
, 11.040.01
|
| NBN Status |
New |
|
| IEC publication date |
2019-08-12 |
| IEC file modification date |
2019-08-15 |
| IEC last modification date |
2019-08-15 |
|
