ISO/TS 19844:2015

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

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ISO/TS 19844:2015(E)

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ii © ISO 2015 – All rights reserved

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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
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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
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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
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ISO/TS 19844:2015
6.4 specified substance Group 2 for herbal preparations .
...