Publication details
| Publication CODE |
Title |
| NBN EN ISO 15225:2010 (2016-04) |
MEDICAL DEVICES - QUALITY MANAGEMENT - MEDICAL DEVICE NOMENCLATURE DATA STRUCTURE |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
60.00 €
|
19 P. |
Description
This International Standard provides rules and guidelines for a medical device nomenclature data structure, in order to facilitate cooperation and exchange of data used by regulatory bodies on an international level between interested parties, e.g. regulatory authorities, manufacturers, suppliers, health care providers and end users. This International Standard includes guidelines for a minimum data set and its structure. These guidelines are provided for system designers setting up databases that utilize the nomenclature system described herein. The requirements contained in this International Standard are applicable to the development and maintenance of an international nomenclature for medical device identification. This International Standard does not include the nomenclature itself, which is provided as a data file.
|
| Class |
C
|
Available files
Not available under electronic format.
The publication in paper format can be ordered << here >>.
|
Status
| Status |
Registered trilingual Belgian standard EN or FR or DE |
| Situation |
Withdrawn
Replaced by
NBN EN ISO 15225:2016
|
|
Origin
| Committee |
CEN/CLC JTC 3
QUALITY MANAGEMENT AND CORRESPONDING GENERAL ASPECTS FOR MEDICAL DEVICES
|
Approval
| BEC Approval |
2010-02-27 |
| NBN Approval |
2010-06-11 |
| Belgian Official Journal |
2010-07-16 |
| Registration |
156124 |
| ICS-Code (International Standards Classification) |
11.040.01
, 35.240.80
|
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2016-04-06 |
| Date of availability (d.a.v.) |
2016-04-06 |
| Date of announcement (d.o.a.) |
2010-08-31 |
| Date of publication (d.o.p.) |
2010-11-30 |
| Date of withdrawal former edition (d.o.w.) |
2010-11-30 |
|
Correspondences with international standards
| Relation |
International standard |
Date |
| is identical to |
15225/ed. 2.0
|
2010-05-01 |
| is identical to |
EN ISO 15225:2010
|
|
|
