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SRPS EN ISO 15225:2017

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

Jan 31, 2017

General information

60.60     Jan 31, 2017

ISS

Z076

European Norm

01.040.11     01.040.35     35.240.80     11.040.01  

English  

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN ISO 15225:2012

NOW

PUBLISHED
SRPS EN ISO 15225:2017
60.60 Standard published
Jan 31, 2017

Related project

Adopted from EN ISO 15225:2016

Adopted from ISO 15225:2016