YY/T 0468-2015 Medical devices—Quality management—Medical device nomenclature data structure

Scope

This standard provides rules and guidelines for the data structure of medical device terminology systems, with the aim of facilitating communication and cooperation among various parties (such as regulatory authorities, manufacturers, suppliers, healthcare institutions, and end users) worldwide regarding the data used by regulatory authorities.
This standard includes guidelines for the minimum data set and its structure. These guidelines are provided to enable system designers to establish databases using the terminology systems described herein.
The requirements contained in this standard can be used to establish and maintain an international terminology system for the identification of medical devices.
This standard does not include the terminology system itself, which is provided as a data file.

Development Information

Replace the following standards

Referenced Standards

Adopt standards

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