Norm

NEN-EN-ISO 15225:2016 en

Medische hulpmiddelen - Kwaliteitsmanagement - Gegevensstructuur voor medisch hulpmiddel nomenclatuur

79,70

Over deze norm

Status Definitief
Aantal pagina's 13
Commissie Medische hulpmiddelen - horizontale onderwerpen
Gepubliceerd op 01-04-2016
Taal Engels
NEN-EN- ISO 15225 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.

Details

ICS-code 01.040.11
01.040.35
11.040.01
35.240.80
Nederlandse titel Medische hulpmiddelen - Kwaliteitsmanagement - Gegevensstructuur voor medisch hulpmiddel nomenclatuur
Engelse titel Medical devices - Quality management - Medical device nomenclature data structure
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