Health informatics — Identification of medicinal products (IDMP) — Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances

This document is used in the implementation of ISO 11238. This document defines substances based on their scientific identity (i.e. what they are) rather than on their use or method of production. ISO 11238 provides the conceptual framework for defining Substances and Specified Substances and for assigning unique identifiers in the context of the ISO IDMP standards. ISO 11238 describes general concepts for defining and distinguishing substances and a high-level model for the structuring of information for substances. This document provides detailed explanations of each type or grouping of substance information, an element-by-element description for implementation of ISO 11238, and examples for a variety of Substances and Specified Substances. This third edition of the document addresses Substances Groups 1 to 3 of the Specified Substances as defined in ISO 11238 and Annexes A, B, C, D, E, F, G, H, I, J and K. It is anticipated that Specified Substances Group 4, as defined in ISO 11238, will be addressed in a subsequent edition of this document. Some information that would typically fall under Specified Substances Group 4 is covered in the Annexes of this document. This information, although not defining of either a Substance or a Specified Substance Group 1, might be essential to distinguishing substances. This document addresses the following: - data elements necessary for defining Substances and Specified Substances Groups 1 to 3; - the logical use of data elements as defined in ISO 11238; - Substances and Specified Substances Groups 1 to 3 business rules for: - determining necessary data elements, - distinguishing and defining materials according to ISO 11238, - triggering the assignment of identifiers. This document does not address the following: - business processes for data management; - implementation of a specific data information system (e.g. a relational database schema); - normative messaging standards for substances; - the maintenance of controlled vocabularies; - the specific global identifier system that should be used; - nomenclature standards for substances.

Informatique de santé — Identification des médicaments — Lignes directrices pour·la·mise·en·oeuvre de l'ISO 11238 relative aux éléments de données et structures pour l'identification unique et l'échange d'informations réglementées sur les substances

General Information

Status
Published
Publication Date
01-Jul-2018
Current Stage
9092 - International Standard to be revised
Completion Date
29-Nov-2023
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ISO/TS 19844:2018 - Health informatics -- Identification of medicinal products (IDMP) -- Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances
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REDLINE ISO/TS 19844:2018 - Health informatics — Identification of medicinal products (IDMP) — Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances Released:7/2/2018
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TECHNICAL ISO/TS
SPECIFICATION 19844
Third edition
2018-07
Health informatics — Identification
of medicinal products (IDMP) —
Implementation guidelines for
ISO 11238 for data elements
and structures for the unique
identification and exchange of
regulated information on substances
Informatique de santé — Identification des médicaments — Lignes
directrices pour·la·mise·en·oeuvre de l'ISO 11238 relative aux
éléments de données et structures pour l'identification unique et
l'échange d'informations réglementées sur les substances
Reference number
ISO/TS 19844:2018(E)
©
ISO 2018

---------------------- Page: 1 ----------------------
ISO/TS 19844:2018(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/TS 19844:2018(E)
Contents
Foreword . viii
Introduction . ix
1 Scope . 1
2 Normative references . 2
3 Symbols and abbreviated terms . 2
4 General background and history . 5
5 Substance (Mandatory) . 7
5.1 General . 7
5.2 Defining substances . 9
5.2.1 Substance type (Mandatory) . 10
5.2.2 Substance ID (Mandatory) . 14
5.3 Substance names (Mandatory) . 15
5.3.1 Substance name (Mandatory) . 16
5.3.2 Substance name type (Mandatory) . 17
5.3.3 Language (Mandatory) . 17
5.3.4 Substance name domain (Conditional) . 18
5.3.5 Jurisdiction (Conditional) . 18
5.3.6 Official name (Conditional) . 19
5.4 Reference source (Conditional). 20
5.4.1 Public domain (Conditional) . 20
5.4.2 Reference source type (Mandatory) . 21
5.4.3 Reference source class (Optional) . 21
5.4.4 Reference source ID (Conditional) . 22
5.4.5 Reference source citation (Conditional) .
...

ISOISO /TS 19844:2018
ISO TC 215
Date: 2018-xx07
ISO TC 215/WG 6
Secretariat: ANSI
Health informatics — Identification of medicinal products (IDMP) — Implementation
guidelines for ISO 11238 for data elements and structures for the unique identification
and exchange of regulated information on substances
Informatique de santé — Identification des médicaments — Lignes directrices pour ·la ·mise ·en
·oeuvre desde l'ISO 11238 relative aux éléments de données et structures pour l'identification
unique et l'échange d'informations réglementées sur les substances

---------------------- Page: 1 ----------------------
ISO/TS 19844:2018(E)
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as
permitted under the applicable laws of the user's country, neither this ISO draft nor any extract
from it may be reproduced, stored in a retrieval system or transmitted in any form or by any means,
electronic, photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
© ISO 2018 – All rights reserved
ii

---------------------- Page: 2 ----------------------
ISO/TS 19844:2018(E)
Contents
Foreword . viii
Introduction . ix
1 Scope . 1
2 Normative references . 2
3 Symbols and abbreviated terms . 2
4 General background and history . 5
5 Substance (Mandatory) . 7
5.1 General . 7
5.2 Defining substances . 9
5.2.1 Substance type (Mandatory) . 10
5.2.2 Substance ID (Mandatory) . 14
5.3 Substance names (Mandatory) . 15
5.3.1 Substance name (Mandatory) . 16
5.3.2 Substance name type (Mandatory) . 17
5.3.3 Language (Mandatory) . 17
5.3.4 Substance name domain (Conditional) . 18
5.3.5 Jurisdiction (Conditional) . 18
5.3.6 Official name (Conditional) . 19
5.4 Reference source (Conditional). 20
5.4.1 Public domain (Conditional) . 20
5.4.2 Reference source type (Mandatory) . 21
5.4.3 Reference source class (Optional) . 21
5.4.4 Reference source ID (Conditional) . 22
5.4.5 R
...

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