EN ISO 18530:2021
(Main)Health Informatics - Automatic identification and data capture marking and labelling - Subject of care and individual provider identification (ISO 18530:2021)
Health Informatics - Automatic identification and data capture marking and labelling - Subject of care and individual provider identification (ISO 18530:2021)
This document outlines the standards needed to identify and label the Subject of Care (SoC) and the Individual Provider on objects such as identification (wrist) bands, identification tags or other objects, to enable automatic data capture using data carriers in the care delivery process.
It provides for a unique SoC identification that can be used for other purposes, such as recording the identity of the SoC in individual health records.
This document serves as a reference for any organization which plans to implement or improve Automatic Identification and Data Capture (AIDC) in their delivery of care process. It is based on the use of the GS1® system of standards. Other solutions, such as using other identification systems (for example, systems based on ISBT 128), are possible but not addressed by this document.
This document describes good practices to reduce/avoid variation and workarounds which challenge the efficiency of AIDC at the point of care and compromise patient safety[5][6].
This document specifies how to manage identifiers in the AIDC process, and completes the information found in ISO/TS 22220 and ISO/TS 27527.
Medizinische Informatik - Automatische Identifikation und Datenerfassungskennzeichnung und -beschriftung - Identifikation von Behandelten und individuellen Anbietern (ISO 18530:2021)
Informatique de santé - Marquage et étiquetage à l’aide de l’identification et de la saisie automatiques des données - Identification du sujet des soins et du prestataire considéré (ISO 18530:2021)
Le présent document décrit les normes nécessaires pour identifier et étiqueter le sujet des soins (SdS) et le prestataire considéré sur des objets tels que des bracelets d'identification, des étiquettes d'identification ou autres, afin de permettre la saisie automatique de données à l'aide de porteuses de données dans le cadre du processus de prestation de soins.
Il présente le processus d'identification unique des SdS qui peut être utilisé à d'autres fins, par exemple l'enregistrement de l'identité des SdS dans les dossiers individuels de santé.
Le présent document sert de référence pour toutes les organisations qui prévoient de mettre en œuvre ou d'améliorer l'identification et la saisie automatiques des données (AIDC) dans leur processus de prestation de soins. Il s'appuie sur l'utilisation du système de normes GS1®. D'autres solutions, telles que l'utilisation d'autres systèmes d'identification (par exemple, des systèmes basés sur l'ISBT 128), sont possibles, mais elles ne sont pas traitées dans le présent document.
Le présent document décrit les bonnes pratiques qui permettent de réduire/éviter les variations et les solutions de contournement qui affectent l'efficacité de l'AIDC sur le site des soins et qui compromettent la sécurité du patient[5][6].
Le présent document explique comment gérer les identificateurs au sein du processus AIDC et complète les informations disponibles dans l'ISO/TS 22220 et l'ISO/TS 27527.
Zdravstvena informatika - Samodejna identifikacija ter zajem podatkov za označevanje in etiketiranje - Predmet varstva in posamezna identifikacija (ISO 18530:2021)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2021
Nadomešča:
SIST-TS CEN ISO/TS 18530:2016
Zdravstvena informatika - Samodejna identifikacija ter zajem podatkov za
označevanje in etiketiranje - Predmet varstva in posamezna identifikacija (ISO
18530:2021)
Health Informatics - Automatic identification and data capture marking and labelling -
Subject of care and individual provider identification (ISO 18530:2021)
Medizinische Informatik - Automatische Identifikation und
Datenerfassungskennzeichnung und -beschriftung - Identifikation von Behandelten und
individuellen Anbietern (ISO 18530:2021)
Informatique de santé - identification lisible par capture automatique et marquage -
identification des sujets de soins de santé et des professionnels de la santé (ISO
18530:2021)
Ta slovenski standard je istoveten z: EN ISO 18530:2021
ICS:
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.
EN ISO 18530
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2021
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes CEN ISO/TS 18530:2015
English Version
Health Informatics - Automatic identification and data
capture marking and labelling - Subject of care and
individual provider identification (ISO 18530:2021)
Informatique de santé - Marquage et étiquetage à l'aide Medizinische Informatik - Automatische Identifikation
de l'identification et de la saisie automatiques des und Datenerfassungskennzeichnung und -beschriftung
données - Identification du sujet des soins et du - Identifikation von Behandelten und individuellen
prestataire considéré (ISO 18530:2021) Anbietern (ISO 18530:2021)
This European Standard was approved by CEN on 11 June 2020.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
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, Turkey 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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18530:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 18530:2021) 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.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by August 2021, and conflicting national standards shall
be withdrawn at the latest by August 2021.
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 18530:2015.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: 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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 18530:2021 has been approved by CEN as EN ISO 18530:2021 without any modification.
INTERNATIONAL ISO
STANDARD 18530
First edition
2021-01
Health informatics — Automatic
identification and data capture
marking and labelling — Subject
of care and individual provider
identification
Informatique de santé — Marquage et étiquetage à l’aide de
l’identification et de la saisie automatiques des données —
Identification du sujet des soins et du prestataire considéré
Reference number
ISO 18530:2021(E)
©
ISO 2021
ISO 18530:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
ISO 18530:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 GS1® specifications and ISO deliverables. 3
5 Data structures and semantics . 3
5.1 Application identifiers . 3
5.2 Global service relation number (GSRN) . 4
5.3 Service relation instance number (SRIN) . 4
6 SoC and Individual Provider identification as a recognized priority .4
6.1 General . 4
6.2 Supported processes . 5
7 The purpose of globally unique identification . 6
7.1 SoC identification and data processing . 6
7.2 Implementation challenges . 6
7.3 Symbol placement on identification bands . 6
7.4 Individual Provider identification . 7
Annex A (informative) Examples of use cases (UC) . 8
Bibliography .51
ISO 18530:2021(E)
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
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration
with the European Committee for Standardization (CEN) Technical Committee CEN/TC 251, Health
informatics, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement).
This first edition cancels and replaces ISO/TS 18530:2014, which has been technically revised.
The main changes compared to the previous edition are as follows:
— new definitions added;
— use case and UML diagrams updated;
— bibliography expanded.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved
ISO 18530:2021(E)
Introduction
The delivery of healthcare relies heavily on the ability to uniquely and accurately identify people when
they attend for care, i.e. the Subject of Care (SoC), as well as, when they provide care, i.e. the Individual
Provider.
Health informatics, supporting healthcare delivery, requires a clear specification to identify the SoC
and the Individual Provider so that they are correctly associated with the health information contained
within a healthcare application. This has led to the need to capture and share information across
different systems and healthcare applications.
Data carriers, such as barcodes and Radio Frequency Identification (RFID), commonly referred to
as Automatic Identification and Data Capture (AIDC), have amplified the importance of defining the
identifier data structures for the SoC and Individual Provider to prevent ambiguity when information
is being captured. AIDC provides a wide spectrum of solutions, in particular, regarding optical carriers
(such as barcodes). Furthermore, the semantics of data carried is defined by a number of organizations
(also named “issuing agencies”), some of them having commercial activities, others nation-wide
missions, as well as, standard development organizations. This document focuses on the use of the
® 1)
GS1 System of Standards since a considerable majority of supplies in healthcare around the world
are identified in accordance to this multisectorial and global system of standards. Interoperability is
easier
...
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