Publication details
| Publication CODE |
Title |
| ISO/IEC GUIDE 63:2012 (2012-01) |
GUIDE TO THE DEVELOPMENT AND INCLUSION OF SAFETY ASPECTS in INTERNATIONAL STANDARDS FOR MEDICAL DEVICES |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
0.00 €
|
21 P. |
Description
ISO/IEC Guide 63:2012 provides guidance to standards writers on how to include safety aspects in the development of medical device safety standards intended to be used within the risk management framework established in ISO 14971. It expands on the concepts developed in ISO/IEC Guide 51 to include safety-related performance and usability.
ISO/IEC Guide 63:2012 is intended to be read in conjunction with ISO/IEC Guide 51 and ISO 14971.
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| Class |
C990
(IEC PUBLICATIONS IEC PUBLICATIONS)
|
Available files
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ATTENTION: With some browsers, you may experience problems if you open the downloaded file directly. If you experience this problem, please first save the file locally and then open it |
Status
Origin
| Committee |
ISO/TC 210
Quality management and corresponding general aspects for medical devices
|
Approval
| BEC Approval |
2012-01-10 |
| ICS-Code (International Standards Classification) |
01.120
, 11.020
|
| NBN Status |
New |
|
| IEC publication date |
2012-01-10 |
| IEC last modification date |
2019-01-30 |
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