| Publication CODE |
Title |
| EN ISO 13485:2016/AC:2018 (2018-03) |
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES (ISO 13485:2016) |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
0.00 €
|
9. |
Description
[Text at this stage is not available in English]
|
| Class |
C
|
| Status |
Registered trilingual Belgian standard EN or FR or DE |
| Situation |
In preparation phase
|
|
| Committee |
CEN/CLC JTC 3
QUALITY MANAGEMENT AND CORRESPONDING GENERAL ASPECTS FOR MEDICAL DEVICES
|
| 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.) |
2018-03-28 |
|
