Standard: AAMI 15225

MEDICAL DEVICES-QUALITY MANAGEMENT-MEDICAL DEVICE NOMENCLATURE DATA STRUCTURE

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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.

 

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami 15225
Publish Date: 2016-01-01
Page Count: 23
Change Type: COMPLETE REVISION
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: YES
Status: Active
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