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About This Item


Full Description

ISO 15225:2016 specifies 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, e.g. regulatory authorities, manufacturers, suppliers, healthcare providers and end users.

ISO 15225:2016 includes guidelines for a minimum data set and its structure. These guidelines are provided for system designers setting up databases that utilize the nomenclature system described herein.

The requirements contained in this International Standard are applicable to the development and maintenance of an international nomenclature for medical device identification.

ISO 15225:2016 does not include the nomenclature itself, which is provided as a separate data file.


Document History

  1. ISO 15225:2016

    👀 currently

    Medical devices - Quality management - Medical device nomenclature data structure

    • Most Recent
  2. ISO 15225:2010

    Medical devices - Quality management - Medical device nomenclature data structure

    • Historical Version
  3. ISO 15225:2000

    Nomenclature -- Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange

    • Historical Version