NF EN ISO 11239
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.
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.
<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>
- Avant-proposiv
- Introductionv
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1 Domaine d'application1
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2 Références normatives1
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3 Termes, définitions et abréviations1
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3.1 Termes et définitions1
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3.2 Abréviations6
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4 Exigences7
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4.1 Exigences générales relatives aux vocabulaires contrôlés7
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4.2 Exigences liées à l'utilisation dans l'ensemble de normes IDMP7
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5 Schéma7
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5.1 Généralités7
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5.2 Modèles conceptuels - Concepts sous-jacents8
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5.3 Modèles conceptuels - Concepts de haut niveau11
- Annexe A (informative) Exemples de vocabulaires contrôlés18
- Annexe B (informative) Exemples de vocabulaires contrôlés pour décrire les médicaments24
- Bibliographie29
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