BS EN 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.

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 separate data file.


Cross References:
ISO/IEC 8859-1:1998
ISO 1087-1:2000
ISO 1942
ISO/IEC 2382:2015
ISO 25964-1:2011
ISO 25964-2:2013
ISO 4135
ISO 9999
ISO 10241-1
IEC 60601
90/385/EEC
93/42/EEC
98/79/EC
ENV 12611


All current amendments available at time of purchase are included with the purchase of this document.