Publication details
| Publication CODE |
Title |
| NBN EN ISO 15225:2016 (2017-12) |
MEDICAL DEVICES - QUALITY MANAGEMENT - MEDICAL DEVICE NOMENCLATURE DATA STRUCTURE (ISO 15225:2016) |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
60.00 €
|
3 P.. |
Description
ISO 15225:2016 specifies 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, healthcare providers and end users.
ISO 15225:2016 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.
ISO 15225:2016 does not include the nomenclature itself, which is provided as a separate data file.
|
| 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.
Very important notice: 98% of the text of the NBN EN 55XXX,
NBN EN 6XXXX comes from the IEC text which is NOT included.
This text can be ordered electronically on our website, but isn't available
via this link. Please contact the BEC if you want to buy this text and we'll
give you the appropriate link.
|
|
|
Status
| Status |
Registered trilingual Belgian standard EN or FR or DE |
| Situation |
Currently active
Replaces
NBN EN ISO 15225:2010
|
|
Origin
| Committee |
CEN/CLC JTC 3
QUALITY MANAGEMENT AND CORRESPONDING GENERAL ASPECTS FOR MEDICAL DEVICES
|
Approval
| NBN Approval |
2016-05-27 |
| Registration |
167024 |
| ICS-Code (International Standards Classification) |
11.040.01
, 35.240.80
, 01.040.11
, 01.040.35
|
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2017-12-20 |
| Date of availability (d.a.v.) |
2017-12-20 |
| Date of announcement (d.o.a.) |
2016-07-31 |
| Date of publication (d.o.p.) |
2016-10-31 |
| Date of withdrawal former edition (d.o.w.) |
2016-10-31 |
|
Correspondences with international standards
| Relation |
International standard |
Date |
| is identical to |
EN ISO 15225:2016
|
2016-04-06 |
| is identical to |
ISO 15225:2016/ed. 3.0
|
2016-03-05 |
|
