CEN - EN ISO 15225
Medical devices - Quality management - Medical device nomenclature data structure
|Publication Date:||1 April 2016|
|ICS Code (Information technology (Vocabularies)):||01.040.35|
|ICS Code (Health care technology (Vocabularies)):||01.040.11|
|ICS Code (IT applications in health care technology):||35.240.80|
|ICS Code (Medical equipment in general):||11.040.01|
This International Standard 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.