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EVS-EN ISO 15225:2016

Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)

General information
Withdrawn from 15.02.2018
Base Documents
ISO 15225:2016; EN ISO 15225:2016
Directives or regulations
None
Standard history
Status
Date
Type
Name
03.05.2016
Main
07.06.2010
Main
EVS-EN ISO 15225:2010
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.
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