This standard specifies requirements and guidance on the composition of medical device nomenclature in order to facilitate the management of information on an international scale among interested parties such as competent authorities, manufacturers, suppliers, health care providers and end users. exchange and cooperation. NOTE: This standard includes guidance on minimum data sets and their composition. This guide is provided to enable system designers to build databases using the naming system described hereafter. This standard contains requirements for establishing and maintaining nomenclature used to identify medical devices. Note 2: This standard does not include the name compilation itself. The compilation of names is provided in a separate file. Note 3: In the original international standard, in order to supplement the specific requirements of the European Medical Device Directive. Specifies a method for achieving common identification between agencies that exchange information as required by the Directive.
YY/T 0468-2003 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