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CEN ISO/TS 17251:2023

(Main)

Health informatics - Business requirements for a syntax to exchange structured dose information for medicinal products (ISO/TS 17251:2023)

Health informatics - Business requirements for a syntax to exchange structured dose information for medicinal products (ISO/TS 17251:2023)

This document specifies the business requirements for the structured content of structured or semi-
structured dose instructions for recording dose instructions in the electronic health record (EHR),
supporting clinical decision support, and in exchanging medication orders, as applicable to primary,
secondary and tertiary care.
This document is focused on the dose instructions as will be presented to the individual subject of care
or caregiver. Comprehension of dose instructions by the subject of care or caregiver is an overarching
consideration for subject of care safety and the best outcomes. Related factors are discussed but are not
part of the primary scope.
This document does not define an information model, except to the extent that those information model
concepts are necessary to define business requirements.
Outside the scope of this document are:
— The implementation of dose instructions, i.e. assembling the structured elements into a form
appropriate for the patient or caregiver;
— The content of a medication order (see ISO 17523) beyond content related to dose instructions;
— The content of a record of dispense of a medicinal product (see ISO/TS 19293);
— The functionality of health, clinical and/or pharmacy systems;
— Other kinds of content of health, clinical or pharmacy systems that are needed to support the whole
process of health care providers, such as:
— A drug knowledge database (see ISO/TS 22756);
— A decision support system (see ISO/TS 22756 and ISO/TS 22703);
— A complete medical record (EHR);
— A medicinal product dictionary (see ISO/TS 19256);
— Verification of the medicinal product and dose being administered.
— Some concepts from Identification of Medicinal Products are referenced, but not defined, in this
document. See Clause 4 for discussion of the relationship of this document with IDMP.

Medizinische Informatik - Geschäftsanforderungen an eine Syntax zum Austausch von Dosierungsinformationen für Arzneimittel (ISO/TS 17251:2023)

Informatique de santé - Exigences d'affaire pour une syntaxe d'échange d'informations de dose structurée pour les produits médicaux (ISO/TS 17251:2023)

Zdravstvena informatika - Poslovne zahteve za sintakso za izmenjavo strukturiranih podatkov o odmerkih za zdravila (ISO/TS 17251:2023)

Ta dokument določa poslovne zahteve za strukturirano vsebino strukturiranih ali polstrukturiranih navodil za odmerke za shranjevanje navodil za odmerke v elektronski zdravstveni zapis (EHR), zagotavljanje podpore za klinično odločanje ter uporabo v izmenjavi naročil zdravil, kot se uporabljajo v primarni, sekundarni in terciarni oskrbi.
Ta dokument se osredotoča na navodila za odmerke in bo predstavljen posameznemu oskrbovancu ali negovalcu. Oskrbovančevo oziroma negovalčevo razumevanje navodil za odmerke je najpomembnejši vidik za zagotavljanje oskrbovančeve varnosti in najboljših rezultatov zdravljenja. Obravnavani so povezani dejavniki, ki pa niso del primarnega področja uporabe.
Ta dokument ne določa informacijskega modela, razen v obsegu, v katerem so ti koncepti informacijskega modela potrebni za opredelitev poslovnih zahtev.
Področje uporabe tega dokumenta ne vključuje:
– Izvajanje navodil za odmerke, tj. sestavljanje strukturiranih elementov v obliki, ki ustreza bolniku ali negovalcu;
– Vsebina naročila zdravila (glej standard ISO 17523) zunaj vsebine v zvezi z navodili za odmerke;
– Vsebina zapisov o izdaji zdravila (glej standard ISO/TS 19293);
– Funkcionalnost zdravstvenih, kliničnih in/ali lekarniških sistemov;
– Druge vrste vsebin zdravstvenih, kliničnih ali lekarniških sistemov, ki so potrebne za zagotavljanje podpore za celoten postopek ponudnikov zdravstvenih storitev, kot so:
– Podatkovna zbirka znanja o zdravilih (glej standard ISO/TS 22756);
– Sistem za zagotavljanje podpore za sprejemanje odločitev (glej standarda ISO/TS 22756 in ISO/TS 22703);
– Celovit elektronski zdravstveni zapis;
– Slovar zdravil (glej ISO/TS 19256);
– Preverjanje količine uporabljenega zdravila in odmerka.
– V tem dokumentu so referenčno navedeni nekateri koncepti iz identifikacije medicinskih izdelkov, vendar niso opredeljeni. Glej točko 4 za obravnavo razmerja med tem dokumentom in standardom za identifikacijo medicinskih izdelkov.

General Information

Status
Published
Publication Date
14-Mar-2023
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
15-Mar-2023
Completion Date
15-Mar-2023
Ref Project
SIST-TS CEN ISO/TS 17251:2023 - Health informatics - Business requirements for a syntax to exchange structured dose information for medicinal products (ISO/TS 17251:2023)

Relations

Replaces
CEN ISO/TS 17251:2016 - Health Informatics - Business requirements for a syntax to exchange structured dose information for medicinal products (ISO/TS 17251:2016)
Effective Date
04-Dec-2019

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SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 17251:2023
01-maj-2023
Nadomešča:
SIST-TS CEN ISO/TS 17251:2017
Zdravstvena informatika - Poslovne zahteve za sintakso za izmenjavo
strukturiranih podatkov o odmerkih za zdravila (ISO/TS 17251:2023)
Health informatics - Business requirements for a syntax to exchange structured dose
information for medicinal products (ISO/TS 17251:2023)
Medizinische Informatik - Geschäftsanforderungen an eine Syntax zum Austausch von
Dosierungsinformationen für Arzneimittel (ISO/TS 17251:2023)
Informatique de santé - Exigences d'affaire pour une syntaxe d'échange d'informations
de dose structurée pour les produits médicaux (ISO/TS 17251:2023)
Ta slovenski standard je istoveten z: CEN ISO/TS 17251:2023
ICS:
11.120.10 Zdravila Medicaments
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST-TS CEN ISO/TS 17251:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TS CEN ISO/TS 17251:2023

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SIST-TS CEN ISO/TS 17251:2023


CEN ISO/TS 17251
TECHNICAL SPECIFICATION

SPÉCIFICATION TECHNIQUE

March 2023
TECHNISCHE SPEZIFIKATION
ICS 35.240.80 Supersedes CEN ISO/TS 17251:2016
English Version

Health informatics - Business requirements for a syntax to
exchange structured dose information for medicinal
products (ISO/TS 17251:2023)
Informatique de santé - Exigences d'affaire pour une Medizinische Informatik - Geschäftsanforderungen an
syntaxe d'échange d'informations de dose structurée eine Syntax zum Austausch von
pour les produits médicaux (ISO/TS 17251:2023) Dosierungsinformationen für Arzneimittel (ISO/TS
17251:2023)
This Technical Specification (CEN/TS) was approved by CEN on 24 February 2023 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 17251:2023 E
worldwide for CEN national Members.

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SIST-TS CEN ISO/TS 17251:2023
CEN ISO/TS 17251:2023 (E)
Contents Page
European foreword . 3

2

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SIST-TS CEN ISO/TS 17251:2023
CEN ISO/TS 17251:2023 (E)
European foreword
This document (CEN ISO/TS 17251:2023) 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 shall not be held responsible for identifying any or all such patent rights.
This document supersedes CEN ISO/TS 17251:2016.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO/TS 17251:2023 has been approved by CE
...

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