| Publication CODE |
Title |
| ISO 14971:2007 (2007-03) |
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
229.00 €
|
98 P.. |
Description
ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.
|
| 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 |
2007-03-31 |
| Registration |
175580 |
| NBN Status |
New |
|
| IEC publication date |
2007-03-31 |
| IEC file modification date |
2017-02-16 |
|
