NEN EN ISO 15225 : 2016

Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Principle of structure
5 Requirements
6 Data file dictionary
Annex A (normative) Device categories description
Annex B (informative) Examples for generation of generic
                      device group terms and synonyms
Annex C (informative) Examples of generic device group records
Annex ZA (informative) Relationship of this document with EC
                       Directives
Annex ZB (informative) Clauses of this European Standard
                       addressing essential requirements or
                       other provisions of Council Directive
                       90/385/EEC relating to active
                       implantable medical devices
Bibliography

Defines 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.