CEN ISO/TS 19844:2015

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.
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 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 . 36
4.8.7 Molecular Formula by Moieties (new class to be included in the second edition of ISO 11238) . 37
4.8.8 Isotope (repeat as necessary) . 37
ISO/TS 19844:2015
4.9 Amount (Conditional) . 38
4.9.1 Average . 38
4.9.2 Low Limit. 38
4.9.3 High Limit . 39
4.9.4 Unit . 39
4.9.5 Non-numeric Value . 39
4.10 Source Material (Conditional) . 39
4.10.1 Source Material Class. 40
4.10.2 Source Material Type . 41
4.10.3 Source Material state . 41
4.10.4 Organism ID . 41
4.10.5 Organism Name . 41
4.10.6 Development Stage . 42
4.10.7 Part Description (repeat as necessary) . 42
4.10.8 Fraction (repeat as necessary) . 42
4.10.9 Organism . 43
4.11 Modification (repeat as necessary) (Conditional) . 49
4.11.1 Modification Type . 50
4.11.2 Residue Modified . 51
4.11.3 Residue Site . 51
4.11.4 Structural Modification . 51
4.12 Property (Conditional) . 55
4.12.1 Property Type . 56
4.12.2 Property Name . 56
4.12.3 Property Parameters (new class to be included in the second edition of ISO 11238) . 56
4.12.4 Substance Name . 57
4.12.5 Substance ID. 57
4.12.6 Amount type . 57
4.13 Version (repeat as necessary) (Mandatory) . 57
4.13.1 Version Number . 57
4.13.2 Effective date . 58
4.13.3 Change Made . 58
5 Substance definitions . 58
5.1 Chemical Substance . 58
5.1.1 Structure . 59
5.1.2 Stoichiometric . 59
5.1.3 Stoichiometric Chemicals. 59
5.1.4 Comment . 62
5.1.5 Non- Stoichiometric Chemicals . 62
5.2 Proteins/ Peptides . 64
5.2.1 Microheterogeneity . 65
5.2.2 Sequence Type . 66
5.2.3 Number of subunits . 66
5.2.4 Disulfide Linkage . 66
5.2.5 Comment . 67
5.2.6 Protein Subunit (repeat as necessary) . 67
5.2.7 Molecular Weight (repeat as necessary) . 69
5.2.8 Glycosylation . 69
5.2.9 Structure . 71
5.2.10 Modification . 71
5.2.11 Property . 71
5.2.12 Molecular Weight . 71
5.3 Nucleic Acids . 72
5.3.1 Structure . 73
5.3.2 Sequence Type . 73
5.3.3 Number of Subunits. 73
5.3.4 Area of hybridisation . 74
iv © ISO 2015 – All rights reserved

ISO/TS 19844:2015
5.3.5 Comment . 74
5.3.6 Nucleic Acid Subunit (repeat as necessary) . 74
5.3.7 Modification . 77
5.3.8 Property . 77
5.3.9 Molecular Weight . 77
5.4 Polymers –To be addressed in more detail in the next edition of this Technical Specification . 78
5.4.1 Substance Name . 79
5.4.2 Structure . 79
5.4.3 Polymer Class . 79
5.4.4 Polymer Geometry . 80
5.4.5 Copolymer Sequence type . 80
5.4.6 Comment . 80
5.4.7 Monomer Description (repeat as necessary) . 80
5.4.8 Structural Repeat (repeat as necessary) . 81
5.4.9 Molecular Weight (repeat as necessary) . 83
5.4.10 Property (repeat as necessary) . 83
5.4.11 Reference Source (repeat as necessary) . 83
5.5 Structurally-Diverse Substances . 83
5.5.1 herbals and Substances Used in the Preparation of Plant-Based Allergenic Extracts . 84
5.5.2 Vaccines — Annex addressing this will be included in the next edition of this Technical
Specification . 93
5.5.3 Purified Blood Products and Polyclonal Antibodies — Annex addressing this will be included
in the next edition of this Technical Specification . 93
5.5.4 Cells and Tissues — Annex addressing this will be included in the next edition of this
Technical Specification . 93
5.5.5 Minerals — Annex addressing this will be included in the next edition of this Technical
Specification . 93
5.6 Mixture Substance (repeat as necessary) . 94
5.6.1 Mixture Type . 94
5.6.2 Mixture Constituent (repeat as necessary) . 94
6 specified substance (Optional) . 95
6.1 specified substance Group 1 (repeat as necessary) . 96
6.1.1 specified substance Group 1 ID . 97
6.1.2 specified substance Group1 Name . 97
6.1.3 Substance Name (repeat as necessary). 97
6.1.4 Substance Code . 97
6.1.5 Version (repeat as necessary) . 97
6.1.6 Reference Sources . 97
6.1.7 Property (repeat as necessary) . 97
6.1.8 Fraction (new class to be included in the second edition of ISO 11238) . 98
6.1.9 Modification . 98
6.1.10 Reference Information (repeat as necessary) . 98
6.1.11 Constituent (repeat as necessary) . 98
6.1.12 Physical Form (repeat as necessary) . 99
6.2 specified substance Group 1 intended for herbal Substance and herbal Preparation . 100
6.2.1 specified substance Group 1 ID . 101
6.2.2 specified substance Group1 Name . 101
6.2.3 Reference Sources . 101
6.2.4 Fraction (new class to be included in the second edition of ISO 11238) . 101
6.2.5 Modification (new classes to be included in the second edition of ISO 11238) . 102
6.2.6 Constituent (repeat as necessary) . 102
6.2.7 Physical Form (repeat as necessary) . 103
6.3 specified substance Group 2 (repeat as necessary) . 104
6.3.1 specified substance Group2 ID . 107
6.3.2 specified substance Group2 Name . 107
6.3.3 Parent Substance ID . 107
6.3.4 Manufacturing . 107
ISO/TS 19844:2015
6.4 specified substance Group 2 for herbal preparations . 111
6.4.1 specified substance Group2 ID . 111
6.4.2 specified substance Group2 Name . 111
6.4.3 Parent Substance ID . 111
6.4.4 Manufacturing . 112
6.4.5 Version (repeat as necessary) . 113
6.5 specified substance Group 3 (repeat as necessary) . 113
6.5.1 specified substance Group3 ID . 114
6.5.2 specified substance Group3 Name . 114
6.5.3 Parent Substance ID . 114
6.5.4 Grade . 115
6.5.5 Reference Source (repeat as necessary) . 115
6.5.6 Version (repeat as necessary) . 115
6.5.7 Reference Source (repeat as necessary) . 116
6.5.8 Version (repeat as necessary) . 116
Annex A (normative) Choosing a Substance ID . 117
A.1 Requesting a Substance ID and providing information . 117
Annex B (normative) Chemical Substance . 119
B.0 Introduction . 119
B.0.1 Proposal for the update of the ISO 11238 Substance standard . 120
B.0.2 Outline of Annex B . 122
B.1 Scope . 123
B.2 Terms and definitions . 123
B.3 Chemical Substance subtypes and Mixture Substance . 132
B.3.1 Substance type, Chemical substance . 132
B.3.2 Solid state forms of the Substance . 132
B.3.3 Need to substantiate the chemical structure, molecular formula and molecular weight . 135
B.3.4 Polymorphism . 136
B.3.5 Non-Stoichiometric chemical substances . 137
B.3.6 Mixture substance . 138
B.3.7 Multi substance material . 139
B.4 Discussion of the key elements of a chemical substance . 142
B.4.1 Identity of material . 142
B.4.2 Nomenclature . 142
B.4.3 Molecular formula . 142
B.4.4 Molecular weight . 143
B.4.5 Substance Structure . 143
B.4.6 Geometric Isomerism . 146
B.4.7 Stereo-descriptors in systematic nomenclature: Substance with one centre of Asymmetry . 147
B.4.8 Substance with two centres of Asymmetry, Epimers, Diastereomers . 148
B.4.9 Anomers . 148
B.4.10 Substance with more than two centres of Asymmetry (Mixture of stereoisomers) . 151
B.4.11 Conclusion for the Key elements . 152
B.4.12 Decision tree for a new Substance ID . 152
B.5 Discussing other elements of importance regarding the characteristics of a substance . 153
B.5.1 Introduction . 153
B.5.2 Naming Vegetable Oils . 153
B.5.3 Castor Oil and related products . 169
B.5.4 Properties to be captured, related to liquids (Gas), Nitrous oxide . 172
B.6 Examples . 177
B.6.1 Example 1: Amlodipine besilate . 178
B.6.2 Example 2: Ponatinib hydrochloride . 185
B.6.3 Example 3: Benzathine Benzylpenicillin tetrahydrate, sterilised. . 201
B.6.4 specified substance Group 2 information level . 206
B.6.5 specified substance Group 3 information level . 207
B.7 Radiopharmaceutical substance . 207
B.7.1 Introduction . 207
vi © ISO 2015 – All rights reserved

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