Publication details
| Publication CODE |
Title |
| NBN EN ISO 14971:2012 (2012-07) |
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
142.00 €
|
25 P. |
Description
This International Standard 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 this International Standard are applicable to all stages of the life-cycle of a medical device. This International Standard does not apply to clinical decision making. This International Standard does not specify acceptable risk levels. This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.
|
| Class |
C
|
Available files
ATTENTION: Belgian registered standards (NBN EN or NBN HD) are generally
only available in English or French. Only the cover page is translated
and the document itself is in English or in French.
|
EN version
|
DE version
|
FR version
|
|
Status
| Status |
Registered trilingual Belgian standard EN or FR or DE |
| Situation |
Withdrawn
Replaced by
EN ISO 14971:2019
|
|
Origin
| Committee |
CEN/CLC JTC 3
QUALITY MANAGEMENT AND CORRESPONDING GENERAL ASPECTS FOR MEDICAL DEVICES
|
Approval
| BEC Approval |
2012-05-16 |
| NBN Approval |
2012-08-31 |
| Belgian Official Journal |
2012-10-26 |
| Registration |
156122 |
| Numbers identifying the european directives |
90/385/EEC
(Active implantable medical devices)
93/42/EEC
(Medical devices)
98/79/EC
(In vitro diagnostic medical devices)
|
| ICS-Code (International Standards Classification) |
11.040.01
|
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2012-05-16 |
| Date of availability (d.a.v.) |
2012-07-04 |
| Date of announcement (d.o.a.) |
2012-10-31 |
| Date of publication (d.o.p.) |
2013-01-31 |
| Date of withdrawal former edition (d.o.w.) |
2013-01-31 |
|
Correspondences with international standards
| Relation |
International standard |
Date |
| is identical to |
14971 (Corrected version)/ed. 2.0
|
2007-10-01 |
| is identical to |
EN ISO 14971:2012
|
|
|
