SIST-TS CEN ISO/TS 19844:2016
(Main)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)
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)
This Technical Specification is used in the implementation of ISO 11238. This Technical Specification 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 Technical
Specification provides detailed explanations of each type or grouping of substance information, an element-byelement
description for implementation of ISO 11238, and examples for a variety of substances and specified
substances.
This first edition of the Technical Specification will only address substances, and Groups 1 to 3 of the specified
substances as defined in ISO 11238 and Annexes A, B, C, and D. It is anticipated that specified substances Group 4,
as defined in ISO 11238, will be addressed in a subsequent edition of this Technical Specification. Some
information that would typically fall under specified substances Group 4 may be covered in the Annexes of this
Technical Specification. This information, although not defining of either a substance or a specified substance
Group 1, may be essential to distinguishing substances.
This Technical Specification 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.
This Technical Specification 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 - 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)
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)
Ta tehnična specifikacija se uporablja v okviru uvajanja standarda ISO 11238. Ta tehnična specifikacija 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 tehnična specifikacija podaja podrobne razlage informacij o posameznih vrstah ali skupinah substanc, opise na ravni posameznih elementov za uvajanje standarda ISO 11238 ter primere za številne substance in specificirane substance.
Prva izdaja te tehnične specifikacije obravnava samo substance in skupine 1–3 specificiranih substanc, kot je določeno v standardu ISO 11238 ter dodatkih A, B, C in D. Specificirane substance skupine 4 bodo po pričakovanjih obravnavane v naslednji izdaji te tehnične specifikacije, kot je določeno v standardu ISO 11238. Nekatere informacije, ki bi običajno sodile v okvir specificiranih substanc skupine 4, so morda obravnavane v dodatkih te tehnične specifikacije. Te informacije so lahko bistvene za razlikovanje substanc, čeprav ne določajo substance ali specificirane substance skupine 1.
Ta tehnična specifikacija 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.
Ta tehnična specifikacija 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;
• nomenklaturni standardi za substance.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 19844:2016
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
SIST-TS CEN ISO/TS 19844:2016 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST-TS CEN ISO/TS 19844:2016
---------------------- Page: 2 ----------------------
SIST-TS CEN ISO/TS 19844:2016
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.
---------------------- Page: 3 ----------------------
SIST-TS CEN ISO/TS 19844:2016
CEN ISO/TS 19844:2015 (E)
Contents Page
European foreword . 3
2
---------------------- Page: 4 ----------------------
SIST-TS CEN ISO/TS 19844:2016
CEN ISO/TS 19844:2015 (E)
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.
3
---------------------- Page: 5 ----------------------
SIST-TS CEN ISO/TS 19844:2016
---------------------- Page: 6 ----------------------
SIST-TS CEN ISO/TS 19844:2016
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
---------------------- Page: 7 ----------------------
SIST-TS CEN ISO/TS 19844:2016
ISO/TS 19844:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
---------------------- Page: 8 ----------------------
SIST-TS CEN ISO/TS 19844:2016
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 2015 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST-TS CEN ISO/TS 19844:2016
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
---------------------- Page: 10 ----------------------
SIST-TS CEN ISO/TS 19844:2016
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 .
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.