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.
BS EN ISO 15225:2010 history
2016BS EN ISO 15225:2016 Medical devices. Quality management. Medical device nomenclature data structure
2010BS EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure