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)

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 Stoffen (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: 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: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 30-Aug-2017
• Due Date: 16-Oct-2017
• Completion Date: 30-Aug-2017
• Ref Project: SIST-TS 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)

Relations

• Replaces: 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)
• Effective Date: 06-Sep-2017

Overview

CEN ISO/TS 19844:2017 (ISO/TS 19844:2016) provides implementation guidelines for the identification of medicinal-product substances. It supports the ISO IDMP (Identification of Medicinal Products) family by detailing the data elements and structures needed for unique identification and exchange of regulated information on substances. The technical specification defines substances by their scientific identity (what they are), not by use or production method, and is intended to be used together with ISO 11238 (the conceptual model for Substance definitions and identifiers).

Key topics and requirements

• Data elements for Substances and Specified Substances Groups 1–3: element‑by‑element descriptions and examples to implement ISO 11238.
• Logical use of data elements: guidance on how to apply ISO 11238 attributes when building substance records.
• Business rules: rules for determining required data elements, distinguishing and defining materials, and triggering assignment of unique identifiers.
• Structural and reference information: examples of structural representations, substance names, codes, reference sources, amounts, source material and modifications.
• Annexes A–H: detailed examples and supplementary material; Group 4 of Specified Substances is noted for a future edition (some Group 4–relevant details may appear in annexes).
• Scope exclusions: the specification does not cover business process design for data management, specific database schemas, normative messaging standards, maintenance of controlled vocabularies, choice of a global identifier system, or nomenclature standards.

Practical applications

This technical specification is practical for organizations implementing ISO 11238 and IDMP-compliant substance registries:

• Regulatory authorities: to standardize substance definitions and exchange regulated substance information across jurisdictions.
• Pharmaceutical companies: for harmonized substance identification, cleansed master data, and regulatory submissions.
• Health informatics teams & data architects: to design data models, map data elements, and implement validation/business rules for substance records.
• Terminologists and chemoinformatics specialists: to specify structural representation, molecular attributes, and reference metadata.
• Vendors of regulatory and safety systems: to align product databases with IDMP guidelines for interoperability.

Related standards

• ISO 11238 - Conceptual framework and high‑level model for defining Substances and Specified Substances (core dependency).
• ISO IDMP family - broader set of standards for the identification of medicinal products and regulated data exchange.

This specification is essential for anyone building IDMP‑aligned substance data exchange solutions, ensuring consistent, scientific identification of substances across regulatory and commercial systems. Keywords: ISO/TS 19844:2016, CEN ISO/TS 19844:2017, ISO 11238, IDMP, health informatics, substance identification, unique identifiers, data elements.

Standards Content (Sample)

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

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.

Contents Page
European foreword . 3

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
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.
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
ISO/TS 19844:2016(E)
© 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. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2016 – All rights reserved

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) . 117
5.6.5 Substance name (Mandatory) . 117
5.6.6 Substance code (Conditional) . 117
5.6.7 Reference information (Conditional) . 118
5.6.8 Version (Mandatory) . 118
6 Specified substance (Optional) . 118
6.1 Specified Substance Group 1 (repeat as necessary) . 118
6.1.1 Specified substance Group 1 ID . 119
6.1.2 Specified substance Group1 Name . 120
6.1.3 Substance Name (Mandatory) . 120
6.1.4 Substance Code (Conditional). 120
6.1.5 Version (Mandatory) . 120
6.1.6 Reference source (Conditional) . 120
6.1.7 Reference source document (Conditional) . 120
6.1.8 Property (Conditional) . 120
6.1.9 Fraction (Conditional) . 121
6.1.10 Modification (Conditional) . 125
6.1.11 Reference Information (Conditional) . 125
6.1.12 Constituent (Mandatory) . 125

6.1.13 Physical form (Conditional) . 127
6.1.14 Specified substance particulars . 128
6.2 Specified substance Group 2 . 133
6.2.1 Specified Substance Group2 ID . 135
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ISO/TS 19844:2016
6.2.2 Specified Substance Group2 Name . 136
6.2.3 Parent Substance ID . 136
6.2.4 Reference source (Conditional) . 136
6.2.5 Reference source document (Conditional) . 136
6.2.6 Manufacturing (Mandatory) . 136
6.3 Specified Substance Group 2 for Herbal preparations . 142
6.3.1 Specified Substance Group2 ID . 142
6.3.2 Specified substance Group2 Name . 142
6.3.3 Parent Substance ID . 142
6.3.4 Manufacturing . 143
6.3.5 Version. 144
6.4 Specified Substance Group 3 . 144
6.4.1 Specified Substance Group 3 ID . 145
6.4.2 Specified Substance Group3 Name . 145
6.4.3 Parent Substance ID . 145
6.4.4 Grade (Mandatory). 145
6.4.5 Version (Mandatory) . 146
6.4.6 Reference source (Conditional) . 146
6.4.7 Reference source document (Conditional) . 147
6.4.8 Substance name (Mandatory) . 147
6.4.9 Substance code (Conditional) . 147
6.4.10 Version (Mandatory) . 147
7 Description of the information modelling principles and practices . 147
Annex A (normative) Choosing a Substance ID . 148
Annex B (normative) Chemical substance . 150
Annex C (normative) Protein substance . 270
Annex D (normative) Nucleic acid substance . 329
Annex E (normative) Structurally Diverse Substance – Herbal Substance/Herbal Specified
Substance . 348
Annex F (normative) Structurally Diverse Substance, Homeopathic substance . 466
Annex G (normative) Structurally Diverse Substance – Plasma-derived substances . 509
Annex H (normative) Polymer Substance . 581
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ISO/TS 19844:2016
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national
standards bodies (ISO member bodies). The work of preparing International Standards is normally
carried out through ISO technical committees. Each member body interested in a subject for which a
technical committee has been established has the right to be represented on that committee.
International organizations, governmental and non-governmental, in liaison with ISO, also take part in
the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all
matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
...