| Publication CODE |
Title |
| ISO TR 24971:2013 (2013-06) |
MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 14971 |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
67.00 €
|
12 P. |
Description
This Technical Report provides guidance in addressing specific areas of ISO 14971 when implementing
risk management. The guidance is intended to assist manufacturers and other users of the standard to:
- understand the role of international product safety and process standards in risk management;
- develop the policy for determining the criteria for risk acceptability;
- incorporate production and post-production feedback loop into risk management;
- differentiate between information for safety and disclosure of residual risk; and
- evaluate overall residual risk.
|
| Class |
C990
(IEC PUBLICATIONS IEC PUBLICATIONS)
|
| Committee |
TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
|
| Responsible |
De heer VAN HECKE Luk
|
| BEC Approval |
2013-06-19 |
| Registration |
136742 |
| ICS-Code (International Standards Classification) |
11.040.01
|
| NBN Status |
New |
|
| IEC publication date |
2013-06-19 |
|
