NF EN ISO 15225

NF EN ISO 15225

May 2017
Standard Cancelled

Medical devices - Quality management - Medical device nomenclature data structure

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.

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Main informations

Collections

National standards and national normative documents

Publication date

May 2017

Number of pages

21 p.

Reference

NF EN ISO 15225

ICS Codes

01.040.11   Health care technology (Vocabularies)
11.020.01   Quality and environmental management in health care
11.040.01   Medical equipment in general
35.240.80   IT applications in health care technology

Classification index

S99-012

Print number

1

International kinship

ISO 15225:2016

European kinship

EN ISO 15225:2016
Sumary
Medical devices - Quality management - Medical device nomenclature data structure

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.

Replaced standards (1)
NF EN ISO 15225
August 2010
Standard Cancelled
Medical devices - Quality management - Medical device nomenclature data structure

Le présent document propose des règles et des lignes directrices de structuration des données d'une nomenclature des dispositifs médicaux pour faciliter les échanges de données réglementaires à un niveau international entre les parties intéressées. Il comprend les lignes directrices destinées aux concepteurs de systèmes de bases de données utilisant le système de nomenclature. Il n'inclut pas la nomenclature en elle-même qui est fournie sous forme d'un fichier de données.

Table of contents
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  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Principe de structure
  • 5 Dictionnaire de fichier de données
  • Annexe A (informative) Exemples de génération de termes de groupe de dispositifs génériques et de synonymes
  • Annexe B (informative) Exemple d'enregistrement de terme
  • Annexe C (informative) Exemples de termes collectifs
  • Annexe D (informative) Exemples de noeuds de termes collectifs de niveau supérieur
  • Bibliographie
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