| Publication CODE |
Title |
| NBN EN ISO 13485:2012 (2016-03) |
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
128.00 €
|
29 P. |
Description
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of this International Standard is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001 (see Annex B).
|
| 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.
|
|
|
| Status |
Registered trilingual Belgian standard EN or FR or DE |
| Situation |
Withdrawn
Replaced by
NBN EN ISO 13485:2016
|
|
| Committee |
CEN/CLC JTC 3
QUALITY MANAGEMENT AND CORRESPONDING GENERAL ASPECTS FOR MEDICAL DEVICES
|
| BEC Approval |
2012-01-02 |
| NBN Approval |
2012-04-20 |
| Belgian Official Journal |
2012-05-23 |
| Registration |
156120 |
| 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
, 03.100.70
, 03.100.70
, 11.040.01
|
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2016-03-02 |
| Date of availability (d.a.v.) |
2016-03-02 |
| Date of announcement (d.o.a.) |
2012-05-31 |
| Date of publication (d.o.p.) |
2012-08-31 |
| Date of withdrawal former edition (d.o.w.) |
2012-08-31 |
|
