Abstract

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, which is provided as a data file.


General information 

  • Status
     : Withdrawn
    Publication date
     : 2010-05
  • Edition
     : 2
    Number of pages
     : 20
  • Technical Committee
     : ISO/TC 210 Quality management and corresponding general aspects for products with a health purpose including medical devices
  • ICS
     :
    11.040.01 Medical equipment in general
    35.240.80 IT applications in health care technology

Life cycle

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