ISO 15225:2010

Medical devices — Quality management — Medical device nomenclature data structure

Publication date:   Apr 19, 2010

95.99   Withdrawal of Standard   Mar 18, 2016

General information

95.99   Withdrawal of Standard   Mar 18, 2016

ISO

ISO/TC 210 Quality management and corresponding general aspects for medical devices

International Standard

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

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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WITHDRAWN
ISO 15225:2000

WITHDRAWN
ISO 15225:2000/Amd 1:2004

NOW

WITHDRAWN
ISO 15225:2010
95.99 Withdrawal of Standard
Mar 18, 2016

REVISED BY

WITHDRAWN
ISO 15225:2016