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 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.

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

General Information

• Status: Withdrawn
• Publication Date: 11-Dec-2016
• Withdrawal Date: 11-Dec-2016
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215/WG 6 - Pharmacy and medicines business
• Current Stage: 9599 - Withdrawal of International Standard
• Completion Date: 25-Jun-2018

Relations

• Revised: 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
• Effective Date: 28-Apr-2018
• Revises: 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
• Effective Date: 16-Jan-2016

Standards Content (Sample)

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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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
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ii © ISO 2016 – All rights reserved

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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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ISO/TS 19844:2016
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) . 103
5.4.6 Structure (Mandatory) . 104
5.4.7 Monomer description (Conditional) . 104
5.4.8 Structural repeat (Conditional) . 105
5.4.9 Molecular weight (Mandatory) . 108
5.4.10 Property (Conditional) . 108
5.4.11 Substance code (Conditional) . 108
5.4.12 Version (Mandatory) . 108
5.4.13 Reference information (Conditional) . 108
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ISO/TS 19844:2016
5.4.14 Modification (Conditional) . 108
5.4.15 Source material (Conditional) . 109
5.4.16 Reference source (Conditional) . 109
5.4.17 Reference source document (Conditional) . 109
5.5 Structurally diverse substances. 109
5.5.1 Comment . 110
5.5.2 Substance name (Mandatory) . 110
5.5.3 Structure (Mandatory) . 110
5.5.4 Property (Conditional) . 110
5.5.5 Molecular weight . 111
5.5.6 Glycosylation (Conditional) . 111
5.5.7 Modification (Conditional) . 111
5.5.8 Source material (Conditional) . 111
5.5.9 Substance code (Conditional) . 111
5.5.10 Reference information (Conditional) . 111
5.5.11 Version (Mandatory) . 111
5.5.12 Reference source (Conditional) . 111
5.5.13 Reference source document (Conditional) . 111
5.5.14 Herbals and substances used in the preparation of plant-based allergenic extracts . 111
5.5.15 Vaccines . 114
5.5.16 Plasma-derived substance for human blood products and polyclonal antibodies . 114
5.5.17 Allergens. 114
5.5.18 Advance Therapies and Advanced Vaccines (Genes, Modified Viruses, Cells and
Tissues as Substances) . 115
5.5.19 Minerals . 115
5.6 Mixture substance . 116
5.6.1 Mixture type . 116
5.6.2 Mixture constituent (Mandatory) . 116
5.6.3 Modification (Conditional) . 117
5.6.4 Source material (Conditional) .
...