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About This Item

 

Full Description

This European Standard specifies requirements and 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.

The requirements contained in this standard are applicable to the development and maintenance of a European nomenclature for medical device identification.

 

Document History

  1. ISO 15225:2016


    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

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

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. ISO 15225/Amd1:2004


    Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange - Amendment 1