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CEN - EN ISO 15225

Medical devices - Quality management - Medical device nomenclature data structure

inactive
Organization: CEN
Publication Date: 1 May 2010
Status: inactive
Page Count: 30
ICS Code (IT applications in health care technology): 35.240.80
ICS Code (Medical equipment in general): 11.040.01
scope:

This International Standard 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.

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 data file.

Document History

April 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...
EN ISO 15225
May 1, 2010
Medical devices - Quality management - Medical device nomenclature data structure
This International Standard 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...
February 1, 2000
Nomenclature - Specification for a Nomenclature System for Medical Devices for the Purpose of Regulatory Data Exchange
A description is not available for this item.
February 1, 2000
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange
A description is not available for this item.
February 1, 2000
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange
A description is not available for this item.

References

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