This standard provides rules and guidance for the structure of medical device terminology system data to facilitate the international communication of data used by regulatory agencies between interested parties (e.g. regulatory agencies, manufacturers, suppliers, health care organizations and end users). exchange and cooperation. This standard includes guidance on minimum data groups and their structure. These guidelines are provided to enable system designers to build databases using the terminology described here. This standard contains requirements that may be used to establish and maintain an international terminology system for the identification of medical devices. This standard does not cover the terminology system itself, which is provided as a data file.
YY/T 0468-2015 history
2015YY/T 0468-2015 Medical devices.Quality management.Medical device nomenclature data structure
2003YY/T 0468-2003 Nomenclature-Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange