NF EN ISO 11239

NF EN ISO 11239

January 2013
Standard Cancelled

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging

ISO 11239:2012 specifies: · the structures and relationships between the data elements required for the exchange of information, which uniquely and with certainty identify pharmaceutical dose forms, units of presentation, routes of administration and packaging items related to medicinal products; · a mechanism for the association of translations of a single concept into different languages; · a mechanism for the versioning of the concepts in order to track their evolution; · rules to allow regional authorities to map existing regional terms to the terms created using ISO 11239:2012 in a harmonized and meaningful way.

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Main informations

Collections

National standards and national normative documents

Publication date

January 2013

Number of pages

39 p.

Reference

NF EN ISO 11239

ICS Codes

35.240.80   IT applications in health care technology

Classification index

S95-239

Print number

1 - 09/01/2013

International kinship

ISO 11239:2012

European kinship

EN ISO 11239:2012
Sumary
Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging

ISO 11239:2012 specifies:

· the structures and relationships between the data elements required for the exchange of information, which uniquely and with certainty identify pharmaceutical dose forms, units of presentation, routes of administration and packaging items related to medicinal products;

· a mechanism for the association of translations of a single concept into different languages;

· a mechanism for the versioning of the concepts in order to track their evolution;

· rules to allow regional authorities to map existing regional terms to the terms created using ISO 11239:2012 in a harmonized and meaningful way.

Standard replaced by (1)
NF EN ISO 11239
June 2023
Standard Current
Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging

<p class="MsoBodyText"><span lang="EN-GB">This document specifies:</span></p> <p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">the data elements, structures and relationships between the data elements required for the exchange of information, which uniquely and with certainty identify pharmaceutical dose forms, units of presentation, routes of administration and packaging items (containers, closures and administration devices) related to medicinal products;</span></p> <p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">a mechanism for the association of translations of a single concept into different languages, which is an integral part of the information exchange;</span></p> <p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">a mechanism for the versioning of the concepts in order to track their evolution;</span></p> <p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">rules to help regional authorities to map existing regional terms to the terms created using this document, in a harmonized and meaningful way.</span></p>

Table of contents
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  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes, définitions et abréviations
    1
  • 3.1 Termes et définitions
    1
  • 3.2 Abréviations
    6
  • 4 Exigences
    7
  • 4.1 Exigences générales relatives aux vocabulaires contrôlés
    7
  • 4.2 Exigences liées à l'utilisation dans l'ensemble de normes IDMP
    7
  • 5 Schéma
    7
  • 5.1 Généralités
    7
  • 5.2 Modèles conceptuels - Concepts sous-jacents
    8
  • 5.3 Modèles conceptuels - Concepts de haut niveau
    11
  • Annexe A (informative) Exemples de vocabulaires contrôlés
    18
  • Annexe B (informative) Exemples de vocabulaires contrôlés pour décrire les médicaments
    24
  • Bibliographie
    29
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