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CEI - UNI EN/ISO 15225

Medical devices - Quality management - Medical device nomenclature data structure

active, Most Current
Organization: CEI
Publication Date: 1 June 2016
Status: active
Page Count: 26
ICS Code (Information technology (Vocabularies)): 01.040.35
ICS Code (Health care technology (Vocabularies)): 01.040.11
ICS Code (IT applications in health care technology): 35.240.80
ICS Code (Medical equipment in general): 11.040.01
scope:

This International Standard 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.

This International Standard 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.

This International Standard does not include the nomenclature itself, which is provided as a separate data file.

Document History

UNI EN/ISO 15225
June 1, 2016
Medical devices - Quality management - Medical device nomenclature data structure
This International Standard 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...
March 1, 2011
Medical devices - Quality management - Medical device nomenclature data structure (ISO/FDIS 15225:2009)
La presente Norma fornisce i requisiti e le linee guida per la struttura dei dati per la nomenclatura per i dispositivi medici, al fine di facilitare la cooperazione e lo scambio di dati utilizzati...

References

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