CAN/CSA-ISO 15225-01

Scope

This European Standard specifies requirements and guidance for the guidance for the construction of a nomenclature for medical devices in order to facilitate co-operation and exchange of regulatory data on an international level between interested parties such as: Regulatory Authorities Manufacturers, Suppliers, Health Care Providers, and End Users.

Note 1:
This European 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 a European nomenclature for medical device identification.

Note 2:
This European Standard will not include the nomenclature itself. The nomenclature will be supplied as a separate document.

Note 3:
It is intended to complement the specific requirements of the IC Directives on medical devices in the context of specifying means by which common identification can be achieved between bodies required to exchange data in conformity with the requirements of the Directives.