EN ISO 15225:2010

Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010)

Publication date:   Aug 20, 2010

General information

99.60 Withdrawal effective   Apr 6, 2016

CEN/CENELEC

CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices

European Norm

11.040.01   Medical equipment in general | 35.240.80   IT applications in health care technology

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 15225:2000

WITHDRAWN
EN ISO 15225:2000/A1:2004

WITHDRAWN
EN ISO 15225:2000/A2:2005

NOW

WITHDRAWN
EN ISO 15225:2010
99.60 Withdrawal effective
Apr 6, 2016

REVISED BY

WITHDRAWN
EN ISO 15225:2016