EN ISO 15225:2016

European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principle of structure
5 Data file dictionary
Annex A (informative) - Examples for generation of
        generic device group terms and synonyms
Annex B (informative) - Example of term record
Annex C (informative) - Examples of collective terms
Annex D (informative) - Examples of top-level collective
        term nodes
Bibliography

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.