CEN ISO/TS 19844:2015

Health informatics - Identification of medicinal products - Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances (ISO/TS 19844:2015)

ISO/TS 19844:2015 is used in the implementation of ISO 11238. ISO/TS 19844:2015 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. ISO/TS 19844:2015 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 first edition of ISO/TS 19844:2015 will only address substances, and Groups 1 to 3 of the specified substances as defined in ISO 11238 and Annexes A, B, C, and D. It is anticipated that specified substances Group 4, as defined in ISO 11238, will be addressed in a subsequent edition of ISO/TS 19844:2015. Some information that would typically fall under specified substances Group 4 may be covered in the Annexes of ISO/TS 19844:2015. This information, although not defining of either a substance or a specified substance Group 1, may be essential to distinguishing substances.
ISO/TS 19844:2015 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.

Medizinische Informatik - Identifikation von Arzneimitteln - Anwendungsleitfaden für EN ISO 11238, Struktur und kontrollierten Vokabularien zur Identifikation und Beschreibung von Substanzen und Inhaltsstoffen (ISO/TS 19844:2015)

Informatique de santé - Identification des médicaments - Lignes directrices pour la mise en oeuvre des éléments de données et structures pour l'identification unique et l'échange d'informations réglementées sur les substances (ISO/TS 19844:2015)

Zdravstvena informatika - Identifikacija medicinskih izdelkov - Vodilo za uporabo podatkovnih elementov in struktur za enotno identifikacijo in izmenjavo predpisanih informacij o substancah (ISO/TS 19844:2015)

Ta tehnična specifikacija se uporablja v okviru uvajanja standarda ISO 11238. Ta tehnična specifikacija določa substance na podlagi njihove znanstvene identitete (tj. to, kar so) namesto njihove uporabe ali načina izdelave. ISO 11238 ponuja konceptualni okvir za določanje substanc in specificiranih substanc ter za dodeljevanje enoličnih identifikatorjev v kontekstu standardov ISO IDMP. ISO 11238 opisuje splošne koncepte za določanje in razlikovanje substanc ter model za strukturiranje informacij za substance na visoki ravni. Ta tehnična specifikacija podaja podrobne razlage informacij o posameznih vrstah ali skupinah substanc, opise na ravni posameznih elementov za uvajanje standarda ISO 11238 ter primere za številne substance in specificirane substance.
Prva izdaja te tehnične specifikacije obravnava samo substance in skupine 1–3 specificiranih substanc, kot je določeno v standardu ISO 11238 ter dodatkih A, B, C in D. Specificirane substance skupine 4 bodo po pričakovanjih obravnavane v naslednji izdaji te tehnične specifikacije, kot je določeno v standardu ISO 11238. Nekatere informacije, ki bi običajno sodile v okvir specificiranih substanc skupine 4, so morda obravnavane v dodatkih te tehnične specifikacije. Te informacije so lahko bistvene za razlikovanje substanc, čeprav ne določajo substance ali specificirane substance skupine 1.
Ta tehnična specifikacija obravnava:
• podatkovne elemente, potrebne za določitev substanc in specificiranih substanc skupin 1–3;
• logično uporabo podatkovnih elementov, kot je določeno v standardu ISO 11238;
• poslovna pravila za substance in specificirane substance skupin 1–3 glede:
– določanja potrebnih podatkovnih elementov,
– razlikovanja in določanja materialov v skladu s standardom ISO 11238,
– sprožanja dodelitve identifikatorjev.
Ta tehnična specifikacija ne obravnava:
• poslovnih procesov za upravljanje podatkov;
• uvedbe posebnega informacijskega sistema za obdelavo podatkov, kot je na primer relacijska zbirka podatkov;
• normativnih standardov o sporočanju za substance;
• vzdrževanja nadzorovanih slovarjev;
• posebnega globalnega sistema identifikatorjev;
• nomenklaturni standardi za substance.

General Information

• Status: Withdrawn
• Publication Date: 22-Dec-2015
• Withdrawal Date: 29-Aug-2017
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: CEN/TC 251 - Medical informatics
• Drafting Committee: CEN/TC 251/WG 1 - Information models
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 30-Aug-2017
• Ref Project: SIST-TS CEN ISO/TS 19844:2016 - Health informatics - Identification of medicinal products - Implementation guide for data elements and structures for the unique identification and exchange of regulated information on substances (ISO/TS 19844:2015)

Relations

• Replaced By: CEN ISO/TS 19844:2017 - Health informatics - Identification of medicinal products - Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances (ISO/TS 19844:2016)
• Effective Date: 06-Sep-2017

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2016
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Vodilo za uporabo
podatkovnih elementov in struktur za enotno identifikacijo in izmenjavo
predpisanih informacij o substancah (ISO/TS 19844:2015)
Health informatics - Identification of medicinal products - Implementation guide for data
elements and structures for the unique identification and exchange of regulated
information on substances (ISO/TS 19844:2015)
Medizinische Informatik - Identifikation von Arzneimitteln - Anwendungsleitfaden für die
Struktur und kontrollierten Vokabularien zur Identifikation und Beschreibung von
Substanzen und Inhaltsstoffen (ISO/TS 19844:2015)
Informatique de santé - Identification des médicaments - Guide pour la mise en oeuvre
des éléments de données et structures pour l'identification unique et l'échange
d'informations réglementées sur les substances (ISO/TS 19844:2015)
Ta slovenski standard je istoveten z: CEN ISO/TS 19844:2015
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

CEN ISO/TS 19844
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
December 2015
TECHNISCHE SPEZIFIKATION
ICS 35.240.80
English Version
Health informatics - Identification of medicinal products -
Implementation guidelines for data elements and
structures for the unique identification and exchange of
regulated information on substances (ISO/TS 19844:2015)
Informatique de santé - Identification des médicaments Medizinische Informatik - Identifikation von
- Lignes directrices pour la mise en oeuvre des Arzneimitteln - Anwendungsleitfaden für die Struktur
éléments de données et structures pour l'identification und kontrollierten Vokabularien zur Identifikation und
unique et l'échange d'informations réglementées sur Beschreibung von Substanzen und Inhaltsstoffen
les substances (ISO/TS 19844:2015) (ISO/TS 19844:2015)
This Technical Specification (CEN/TS) was approved by CEN on 4 April 2016 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 19844:2015 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (CEN ISO/TS 19844:2015) has been prepared by Technical Committee ISO/TC 215
"Health informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO/TS 19844:2015 has been approved by CEN as CEN ISO/TS 19844:2015 without any
modification.
TECHNICAL ISO/TS
SPECIFICATION 19844
First edition
2015-12-15
Health informatics — Identification
of medicinal products —
Implementation guidelines 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 des éléments de données et
structures pour l’identification unique et l’échange d’informations
réglementées sur les substances
Reference number
ISO/TS 19844:2015(E)
©
ISO 2015
ISO/TS 19844:2015(E)
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, 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.
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ii © ISO 2015 – All rights reserved

ISO/TS 19844:2015
Contents Page
Foreword . viii
Introduction . ix
1 Scope . 1
2 Normative references . 2
3 General background and history . 2
4 Substance (Mandatory) . 3
4.1 Introduction . 3
4.2 Defining Substances . 5
4.3 Substance Types (Mandatory). 7
4.4 Substance ID (Mandatory) . 10
4.5 Substance Names (Mandatory) . 11
4.5.1 Substance Name . 12
4.5.2 Substance Name Type . 12
4.5.3 Language . 13
4.5.4 Official Name (repeat as necessary) . 13
4.6 Reference Sources (Mandatory) . 15
4.6.1 Public Domain . 16
4.6.2 Reference Source Type. 16
4.6.3 Reference Source Class . 16
4.6.4 Reference Source ID . 17
4.6.5 Reference Source Citation . 17
4.6.6 Reference Source Document (new class to be included in the second edition of ISO 11238) . 17
4.6.7 Reference Source Document Type (new class to be included in the second edition of ISO
11238) . 18
4.6.8 Reference Source Document Classification (new class to be included in the second edition of
ISO 11238) . 18
4.6.9 Reference Source URL (new class to be included in the second edition of ISO 11238) . 18
4.7 Substance Code (Conditional) . 18
4.7.1 Code . 19
4.7.2 Code System . 19
4.7.3 Code System ID . 20
4.7.4 Code System Status . 20
4.7.5 Code System Status Change Date . 20
4.7.6 Comment . 20
4.7.7 Reference Source . 21
4.7.8 Substance Classification (repeat as necessary) . 21
4.7.9 Target . 23
4.7.10 Gene. 25
4.7.11 Gene Elements . 26
4.7.12 Substance Relationship . 27
4.8 Structure (repeat as necessary) (Conditional) . 29
4.8.1 Structural Representation Type . 34
4.8.2 Structural Representation . 35
4.8.3 Structural Representation Attachment . 35
4.8.4 Stereochemistry . 35
4.8.5 Optical Activity . 36
4.8.6 Molecular Formula .
...