NF EN ISO 15225

NF EN ISO 15225

August 2010
Standard Cancelled

Medical devices - Quality management - Medical device nomenclature data structure

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.

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Main informations

Collections

National standards and national normative documents

Publication date

August 2010

Number of pages

29 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 - 23/08/2010

International kinship

ISO 15225:2010

European kinship

EN ISO 15225:2010
Sumary
Medical devices - Quality management - Medical device nomenclature data structure

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.

Replaced standards (2)
NF EN ISO 15225
August 2000
Standard Cancelled
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange

Le présent document spécifie les exigences et les recommandations destinées à l'élaboration d'un système de nomenclature des dispositifs médicaux pour faciliter les échanges de données réglementaires à un niveau international/européen. Il donne des lignes directrices destinées aux concepteurs de systèmes de bases de données utilisant le système de nomenclature.

NF EN ISO 15225/A1
September 2004
Standard Cancelled
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange

Le présent document modifie les paragraphes 5.2.2, 5.2.3, 6.1.6.3 et l'annexe B.

Standard replaced by (1)
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.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Principe de structure
    5
  • 4.1 Généralités
    5
  • 4.2 Catégorie de dispositifs
    5
  • 4.3 Terme collectif
    5
  • 4.4 Groupe de dispositifs génériques
    5
  • 4.5 Type de dispositif
    6
  • 4.6 Exemple de structure de nomenclature
    7
  • 5 Exigences
    7
  • 5.1 Catégorie de dispositifs
    7
  • 5.2 Groupe de dispositifs génériques
    8
  • 5.3 Type de dispositif
    9
  • 5.4 Terme collectif
    10
  • 6 Dictionnaire de fichier de données
    10
  • 6.1 Généralités
    10
  • 6.2 Fichier de données de catégories de dispositifs
    10
  • 6.3 Fichier de données de groupe de dispositifs génériques
    10
  • 6.4 Fichier de données de type de dispositif
    11
  • 6.5 Fichier de données de terme collectif
    12
  • Annexe A (informative) Catégories de dispositifs
    13
  • Annexe B (informative) Exemples de génération de termes de groupe de dispositifs génériques et de synonymes
    16
  • Annexe C (informative) Exemples d'enregistrements de groupe de dispositifs génériques
    19
  • Annexe D (informative) Exemples de termes collectifs
    20
  • Bibliographie
    21
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