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)

ISO/TS 19844:2016 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 second 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 and H. 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 may be covered in the Annexes of this document. This information, although not defining of either a Substance or a Specified Substance Group 1, may 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.
ISO/TS 19844:2016 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.

Medizinische Informatik - Identifikation von Arzneimitteln - Implementierungsleitfaden für Datenelemente und Strukturen zur eindeutigen Identifikation und zum Austausch von vorgeschriebenen Informationen von Substanzen (ISO/TS 19844:2016)

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 19844:2016)

Zdravstvena informatika - Identifikacija zdravil - Vodilo za uporabo podatkovnih elementov in struktur za enotno identifikacijo in izmenjavo predpisanih informacij o substancah (ISO/TS 19844:2016)

ISO/TS 19844:2016 se uporablja v okviru uvedbe standarda ISO 11238. Ta dokument 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 dokument podaja podrobne razlage informacij o posameznih vrstah ali skupinah substanc, opise na ravni posameznih elementov za uvedbo standarda ISO 11238 ter primere za številne substance in specificirane substance.
Druga izdaja dokumenta obravnava substance skupin 1–3 specificiranih substanc, kot je določeno v standardu ISO 11238 ter dodatkih A, B, C, D, E, F, G in H. Specificirane substance skupine 4 bodo po pričakovanjih obravnavane v naslednji izdaji tega dokumenta, kot je določeno v standardu ISO 11238. Nekatere informacije, ki bi običajno sodile v okvir specificiranih substanc skupine 4, so morda obravnavane v dodatkih tega dokumenta. Te informacije so lahko bistvene za razlikovanje substanc, čeprav ne določajo substance ali specificirane substance skupine 1. Ta dokument 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.
ISO/TS 19844:2016 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;
• nomenklaturne standarde za substance.

General Information

Status
Published
Publication Date
07-Nov-2017
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
08-Sep-2017
Due Date
13-Nov-2017
Completion Date
08-Nov-2017

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SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 19844:2017
01-december-2017
1DGRPHãþD
SIST-TS CEN ISO/TS 19844:2016
Zdravstvena informatika - Identifikacija zdravil - Vodilo za uporabo podatkovnih

elementov in struktur za enotno identifikacijo in izmenjavo predpisanih informacij

o substancah (ISO/TS 19844:2016)

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)

Medizinische Informatik - Identifikation von Arzneimitteln - Implementierungsleitfaden für

Datenelemente und Strukturen zur eindeutigen Identifikation und zum Austausch von

vorgeschriebenen Informationen von Substanzen (ISO/TS 19844:2016)

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 19844:2016)
Ta slovenski standard je istoveten z: CEN ISO/TS 19844:2017
ICS:
11.120.10 Zdravila Medicaments
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST-TS CEN ISO/TS 19844:2017 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TS CEN ISO/TS 19844:2017
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SIST-TS CEN ISO/TS 19844:2017
CEN ISO/TS 19844
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
August 2017
TECHNISCHE SPEZIFIKATION
ICS 35.240.80 Supersedes CEN ISO/TS 19844:2015
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 19844:2016)

Informatique de santé - Identification des médicaments Medizinische Informatik - Identifikation von

- Lignes directrices pour la mise en oeuvre des Arzneimitteln - Implementierungsleitfaden für

éléments de données et structures pour l'identification Datenelemente und Strukturen zur eindeutigen

unique et l'échange d'informations réglementées sur Identifikation und zum Austausch von

les substances (ISO/TS 19844:2016) vorgeschriebenen Informationen von Substanzen
(ISO/TS 19844:2016)

This Technical Specification (CEN/TS) was approved by CEN on 26 July 2017 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, Serbia, 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

© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 19844:2017 E

worldwide for CEN national Members.
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SIST-TS CEN ISO/TS 19844:2017
CEN ISO/TS 19844:2017 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST-TS CEN ISO/TS 19844:2017
CEN ISO/TS 19844:2017 (E)
European foreword

The text of ISO/TS 19844:2016 has been prepared by Technical Committee ISO/TC 215 “Health

informatics” of the International Organization for Standardization (ISO) and has been taken over as

CEN ISO/TS 19844:2017 by 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 shall not be held responsible for identifying any or all such patent rights.

This document supersedes CEN ISO/TS 19844:2015.

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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO/TS 19844:2016 has been approved by CEN as CEN ISO/TS 19844:2017 without any

modification.
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SIST-TS CEN ISO/TS 19844:2017
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SIST-TS CEN ISO/TS 19844:2017
TECHNICAL ISO/TS
SPECIFICATION 19844
Second edition
2016-12-15
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 19844:2016(E)
ISO 2016
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SIST-TS CEN ISO/TS 19844:2017
ISO/TS 19844:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, 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.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
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SIST-TS CEN ISO/TS 19844:2017
ISO/TS 19844:2016
Contents

1 Scope ....................................................................................................................................................................1

2 Normative references ....................................................................................................................................2

3 General background and history ...............................................................................................................2

4 Substance (Mandatory) .................................................................................................................................3

4.1 General ................................................................................................................................................................3

4.2 Defining substances ........................................................................................................................................5

4.2.1 Substance type (Mandatory) .......................................................................................................................7

4.2.2 Substance ID (Mandatory) ......................................................................................................................... 10

4.3 Substance names (Mandatory) ................................................................................................................ 11

4.3.1 Substance name ............................................................................................................................................. 12

4.3.2 Substance name type ................................................................................................................................... 13

4.3.3 Language .......................................................................................................................................................... 14

4.3.4 Official name (Conditional......................................................................................................................... 14

4.4 Reference source (Conditional) ............................................................................................................... 17

4.4.1 Public domain ................................................................................................................................................ 17

4.4.2 Reference source type ................................................................................................................................. 18

4.4.3 Reference source class ................................................................................................................................ 18

4.4.4 Reference source ID ..................................................................................................................................... 19

4.4.5 Reference source citation .......................................................................................................................... 19

4.5 Reference source document (Conditional) ......................................................................................... 19

4.5.1 Public domain ................................................................................................................................................ 19

4.5.2 Reference source document ..................................................................................................................... 20

4.5.3 Reference source document type ........................................................................................................... 20

4.5.4 Reference source document ID ................................................................................................................ 21

4.5.5 Reference source document classification .......................................................................................... 21

4.5.6 Reference source document URL ............................................................................................................ 21

4.6 Substance code (Conditional) .................................................................................................................. 21

4.6.1 Code ................................................................................................................................................................... 22

4.6.2 Code system .................................................................................................................................................... 22

4.6.3 Code system ID ............................................................................................................................................... 23

4.6.4 Code system status ....................................................................................................................................... 23

4.6.5 Code change date .......................................................................................................................................... 24

4.6.6 Comment .......................................................................................................................................................... 24

4.6.7 Reference source .......................................................................................................................................... 24

4.7 Reference information (Conditional) .................................................................................................... 24

4.7.1 Comment .......................................................................................................................................................... 25

4.7.2 Substance classification (Conditional).................................................................................................. 25

4.7.3 Substance relationship (Conditional) ................................................................................................... 28

4.7.4 Target (Conditional) .................................................................................................................................... 30

4.7.5 Gene (Conditional) ....................................................................................................................................... 33

4.7.6 Gene element (Conditional) ...................................................................................................................... 35

4.8 Structure .......................................................................................................................................................... 36

4.8.1 Structural Representation (Conditional) ............................................................................................. 36

4.8.2 Stereochemistry ............................................................................................................................................ 42

4.8.3 Optical activity ............................................................................................................................................... 43

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4.8.4 Molecular Formula ...................................................................................................................................... 44

4.8.5 Molecular Formula by Moiety .................................................................................................................. 44

4.8.6 Molecular weight (Mandatory) ............................................................................................................... 44

4.8.7 Isotope (Conditional) .................................................................................................................................. 44

4.9 Amount (Conditional) ................................................................................................................................. 46

4.9.1 Average ............................................................................................................................................................ 46

4.9.2 Low limit .......................................................................................................................................................... 47

4.9.3 High limit ......................................................................................................................................................... 47

4.9.4 Unit .................................................................................................................................................................... 47

4.9.5 Non-numeric Value ...................................................................................................................................... 48

4.9.6 Reference Source (Conditional) .............................................................................................................. 48

4.9.7 Reference source document (Conditional) ......................................................................................... 48

4.10 Source material (Conditional) ................................................................................................................. 48

4.10.1 Source material class .................................................................................................................................. 49

4.10.2 Source material type ................................................................................................................................... 50

4.10.3 Source material state .................................................................................................................................. 50

4.10.4 Organism ID.................................................................................................................................................... 50

4.10.5 Organism name ............................................................................................................................................. 51

4.10.6 Parent substance ID .................................................................................................................................... 51

4.10.7 Parent substance name .............................................................................................................................. 51

4.10.8 Development stage ...................................................................................................................................... 52

4.10.9 Part Description (CONDITIONAL) .......................................................................................................... 52

4.10.10 Fraction (Conditional) .............................................................................................................................. 54

4.10.11 Organism (Conditional) ............................................................................................................................ 57

4.11 Modification (Conditional) ....................................................................................................................... 64

4.11.1 Modification type ......................................................................................................................................... 66

4.11.2 Residue modified ......................................................................................................................................... 66

4.11.3 Residue sites .................................................................................................................................................. 66

4.11.4 Structural modification (Conditional) .................................................................................................. 67

4.11.5 Agent modification (Conditional) .......................................................................................................... 69

4.11.6 Physical Modification (Conditional) ...................................................................................................... 70

4.12 Property (Conditional) ............................................................................................................................... 72

4.12.1 Property type ................................................................................................................................................. 72

4.12.2 Property name .............................................................................................................................................. 73

4.12.3 Property parameters .................................................................................................................................. 73

4.12.4 Substance ID ................................................................................................................................................... 73

4.12.5 Substance name ............................................................................................................................................ 74

4.12.6 Amount type (Mandatory) ........................................................................................................................ 74

4.13 Version (Mandatory) .................................................................................................................................. 74

4.13.1 Version number ............................................................................................................................................ 74

4.13.2 Effective date ................................................................................................................................................. 75

4.13.3 Change made .................................................................................................................................................. 75

5 Substance definitions ................................................................................................................................. 75

5.1 Chemical substance ..................................................................................................................................... 75

5.1.1 Comment ......................................................................................................................................................... 76

5.1.2 Structure .......................................................................................................................................................... 77

5.1.3 Stoichiometric/Non-stoichiometric chemicals ................................................................................. 77

5.1.4 Stoichiometric chemicals .......................................................................................................................... 78

5.1.5 Non-stoichiometric chemicals (Conditional) ..................................................................................... 81

5.1.6 Substance Name (Mandatory) ................................................................................................................. 83

5.1.7 Substance Code (Conditional).................................................................................................................. 83

5.1.8 Version (Mandatory) .................................................................................................................................. 83

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ISO/TS 19844:2016

5.1.9 Reference information ................................................................................................................................ 83

5.1.10 Reference source (Conditional) ............................................................................................................... 83

5.1.11 Reference source document (Conditional) ......................................................................................... 83

5.2 Proteins/peptides ........................................................................................................................................ 83

5.2.1 Microheterogeneity ..................................................................................................................................... 84

5.2.2 Sequence type ................................................................................................................................................ 86

5.2.3 Number of subunits...................................................................................................................................... 86

5.2.4 Disulfide linkage ........................................................................................................................................... 86

5.2.5 Comment .......................................................................................................................................................... 87

5.2.6 Protein subunit (Mandatory) ................................................................................................................... 87

5.2.7 Molecular weight (Conditional) .............................................................................................................. 90

5.2.8 Glycosylation (Conditional) ...................................................................................................................... 91

5.2.9 Property (Conditional) ............................................................................................................................... 92

5.2.10 Structure (Mandatory) ................................................................................................................................ 93

5.2.11 Substance name (Mandatory) .................................................................................................................. 93

5.2.12 Modification (Conditional) ........................................................................................................................ 93

5.2.13 Substance code (Conditional) .................................................................................................................. 93

5.2.14 Source material (Conditional) ................................................................................................................. 93

5.2.15 Version (Mandatory) ................................................................................................................................... 93

5.2.16 Reference information (Conditional) .................................................................................................... 93

5.2.17 Reference source (Conditional) ............................................................................................................... 93

5.2.18 Reference source document (Conditional) ......................................................................................... 93

5.3 Nucleic acids ................................................................................................................................................... 93

5.3.1 Structure (Conditional) .............................................................................................................................. 94

5.3.2 Sequence type ................................................................................................................................................ 95

5.3.3 Number of subunits...................................................................................................................................... 95

5.3.4 Area of hybridisation................................................................................................................................... 96

5.3.5 Comment .......................................................................................................................................................... 96

5.3.6 Nucleic acid subunit (Mandatory) .......................................................................................................... 96

5.3.7 Modification (Conditional) ..................................................................................................................... 100

5.3.8 Property (Conditional) ............................................................................................................................ 100

5.3.9 Molecular weight (Conditional) ........................................................................................................... 101

5.3.10 Substance Name (Mandatory) ............................................................................................................... 101

5.3.11 Substance Code (Conditional) ............................................................................................................... 101

5.3.12 Version (Mandatory) ................................................................................................................................ 101

5.3.13 Reference information (Conditional) ................................................................................................. 101

5.3.14 Reference source (Conditional) ............................................................................................................ 101

5.3.15 Reference source document (Conditional) ...................................................................................... 101

5.4 Polymers ....................................................................................................................................................... 101

5.4.1 Polymer class .............................................................................................................................................. 103

5.4.2 Polymer geometry ..................................................................................................................................... 103

5.4.3 Copolymer sequence type ....................................................................................................................... 103

5.4.4 Comment ....................................................................................................................................................... 103

5.4.5 Substance name (Mandatory) ..............................................................

...

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