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About This Item

 

Full Description

ISO 15225:2010 provides 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, health care providers and end users.

ISO 15225:2010 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 ISO 15225:2010 are applicable to the development and maintenance of an international nomenclature for medical device identification.

ISO 15225:2010 does not include the nomenclature itself.
 

Document History

  1. ISO 15225:2010

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    Medical devices - Quality management - Medical device nomenclature data structure

    • Most Recent
  2. ISO 15225:2000


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

    • Historical Version