| Publication CODE |
Title |
| NBN EN ISO 13485:2016/AC:2017 (2016-12) |
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES (ISO 13485:2016) |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
0.00 €
|
4 P.. |
Description
[Text at this stage is not available in English]
|
| 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
|
NL version
|
FR version
|
|
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 |
Registered trilingual Belgian standard EN or FR or DE |
| Situation |
Currently active
|
|
| Committee |
CEN/CLC JTC 3
QUALITY MANAGEMENT AND CORRESPONDING GENERAL ASPECTS FOR MEDICAL DEVICES
|
| NBN Approval |
2017-01-27 |
| Registration |
175340 |
| 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) |
03.100.70
, 11.040.01
|
| NBN Status |
New |
|
| Date of availability (d.a.v.) |
2016-12-21 |
|
