scope:

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 such as: 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 utilizing the nomenclature system described herein. The requirements contained in this standard are applicable to the development and maintenance of an international nomenclature for medical device identification. This International Standard will not include the nomenclature itself. The nomenclature will be supplied as a data file.