EN ISO/IEEE 11073-10404:2022
(Main)Health informatics - Device interoperability - Part 10404: Personal health device communication - Device specialization - Pulse oximeter (ISO/IEEE 11073-10404:2022)
Health informatics - Device interoperability - Part 10404: Personal health device communication - Device specialization - Pulse oximeter (ISO/IEEE 11073-10404:2022)
Within the context of the ISO/IEEE 11073 family of standards for device communication, this document establishes a normative definition of communication between personal telehealth pulse oximetry devices and compute engines (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This document defines a common core of communication functionality for personal telehealth pulse oximeters.
Medizinische Informatik - Geräteinteroperabilität - Teil 10404: Kommunikation von Geräten für die persönliche Gesundheit - Gerätespezifikation - Pulsoximeter (ISO/IEEE 11073-10404:2022)
Informatique de santé - Interopérabilité des dispositifs - Partie 10404: Communication entre dispositifs de santé personnels - Spécialisation des dispositifs - Oxymètre de pouls (ISO/IEEE 11073-10404:2022)
Dans le contexte de la famille de normes ISO/IEEE 11073 relatives à la communication entre des dispositifs, le présent document établit une définition normative de la communication entre des dispositifs d’oxymètres de pouls personnels de télésanté et des moteurs informatiques (par exemple des téléphones cellulaires, des ordinateurs personnels, des équipements personnels de santé et des boîtiers décodeurs) d’une manière qui permet une interopérabilité de type prêt à l’emploi. Elle s’appuie sur les parties appropriées de normes existantes, y compris la terminologie, des modèles d’informations, des normes de profils d’applications et des normes de transport de l’ISO/IEEE 11073. Elle spécifie l’utilisation de codes, de formats et de comportements en termes spécifiques dans les environnements de télésanté, en limitant les choix à des cadres de travail de base en faveur de l’interopérabilité. Le présent document définit un noyau commun de fonctionnalités de communication pour les oxymètres de pouls personnels de télésanté
Zdravstvena informatika - Interoperabilnost naprav - 10404. del: Komunikacija osebnih medicinskih naprav - Specialne naprave - Pulzni oksimeter (ISO/IEEE 11073-10404:2022)
Standard ISO/IEEE 11073-10404:2010 določa normativno opredelitev komunikacije med osebnimi telemedicinskimi pulznimi oksimetri in upravljalnimi napravami (npr. mobilnimi telefoni, osebnimi računalniki, osebnimi medicinskimi napravami in digitalnimi sprejemniki) na način, ki omogoča interoperabilnost Plug and Play. Standard temelji na ustreznih delih obstoječih standardov, vključno s terminologijo iz standarda ISO/IEEE 11073, informacijskimi modeli, standardi za profile aplikacij in transportnimi standardi. Določa uporabo posebnih kod izrazov, formatov in vedenj v telemedicinskih okoljih, kjer v korist interoperabilnosti omejuje izbirnost osnovnih okvirov.
Standard ISO/IEEE 11073-10404:2010 določa skupno jedro komunikacijske funkcionalnosti za osebne telemedicinske pulzne oksimetre in obravnava potrebo po jasno opredeljenem, neodvisnem standardu za nadzor izmenjave informacij med osebnimi medicinskimi napravami in upravljalnimi napravami.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2023
Nadomešča:
SIST EN ISO 11073-10404:2011
Zdravstvena informatika - Interoperabilnost naprav - 10404. del: Komunikacija
osebnih medicinskih naprav - Specialne naprave - Pulzni oksimeter (ISO/IEEE
11073-10404:2022)
Health informatics - Device interoperability - Part 10404: Personal health device
communication - Device specialization - Pulse oximeter (ISO/IEEE 11073-10404:2022)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10404: Gerätespezifikation - Pulsoximeter (ISO/IEEE 11073-10404:2022)
Informatique de santé - Interopérabilité des dispositifs - Partie 10404: Spécialisation des
dispositifs - Oxymètre de pouls (ISO/IEEE 11073-10404:2022)
Ta slovenski standard je istoveten z: EN ISO/IEEE 11073-10404:2022
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
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/IEEE 11073-
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2022
ICS 35.240.80 Supersedes EN ISO 11073-10404:2011
English Version
Health informatics - Device interoperability - Part 10404:
Personal health device communication - Device
specialization - Pulse oximeter (ISO/IEEE 11073-
10404:2022)
Informatique de santé - Interopérabilité des dispositifs Medizinische Informatik - Kommunikation von Geräten
- Partie 10404: Communication entre dispositifs de für die persönliche Gesundheit - Teil 10404:
santé personnels - Spécialisation des dispositifs - Gerätespezifikation - Pulsoximeter (ISO/IEEE 11073-
Oxymètre de pouls (ISO/IEEE 11073-10404:2022) 10404:2022)
This European Standard was approved by CEN on 4 December 2022.
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, 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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO/IEEE 11073-10404:2022 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO/IEEE 11073-10404:2022) 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 June 2023, and conflicting national standards shall be
withdrawn at the latest by June 2023.
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 EN ISO 11073-10404:2011.
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 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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO/IEEE 11073-10404:2022 has been approved by CEN as EN ISO/IEEE 11073-
10404:2022 without any modification.
INTERNATIONAL ISO/IEEE
STANDARD 11073-10404
Second edition
2022-12
Health informatics — Device
interoperability —
Part 10404:
Personal health device communication
— Device specialization — Pulse
oximeter
Informatique de santé — Interopérabilité des dispositifs —
Partie 10404: Communication entre dispositifs de santé personnels —
Spécialisation des dispositifs — Oxymètre de pouls
Reference number
ISO/IEEE 11073-10404:2022(E)
© IEEE 2021
ISO/IEEE 11073-10404:2022(E)
© IEEE 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 IEEE at the address below.
Institute of Electrical and Electronics Engineers, Inc
3 Park Avenue, New York
NY 10016-5997, USA
Email: stds.ipr@ieee.org
Website: www.ieee.org
Published in Switzerland
ii
© IEEE 2021 – All rights reserved
ISO/IEEE 11073-10404:2022(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 (see www.iso.org/directives).
IEEE Standards documents are developed within the IEEE Societies and the Standards Coordinating
Committees of the IEEE Standards Association (IEEE-SA) Standards Board. The IEEE develops its
standards through a consensus development process, approved by the American National Standards
Institute, which brings together volunteers representing varied viewpoints and interests to achieve the
final product. Volunteers are not necessarily members of the Institute and serve without compensation.
While the IEEE administers the process and establishes rules to promote fairness in the consensus
development process, the IEEE does not independently evaluate, test, or verify the accuracy of any of the
information contained in its standards.
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.
ISO/IEEE 11073-10404 was prepared by the IEEE 11073 Standards Committee of the IEEE Engineering in
Medicine and Biology Society (as IEEE Std 11073-10404-2020) and drafted in accordance with its editorial
rules. It was adopted, under the “fast-track procedure” defined in the Partner Standards Development
Organization cooperation agreement between ISO and IEEE, by Technical Committee ISO/TC 215, Health
informatics.
This second edition cancels and replaces the first edition (ISO/IEEE 11073-10404:2010), which has been
technically revised.
A list of all parts in the ISO/IEEE 11073 series can be found on the ISO website.
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.
© IEEE 2021 – All rights reserved iii
IEEE Std 11073-10404™-2020
(Revision of IEEE Std 11073-10404-2008)
Health informatics—Personal health device communication
Part 10404: Device specialization—
Pulse oximeter
Developed by the
IEEE 11073™ Standards Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 30 January 2020
IEEE SA Standards Board
ISO/IEEE 11073-10404:2022(E)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device
communication, this standard establishes a normative definition of communication between
personal telehealth pulse oximetry devices and compute engines (e.g., cell phones, personal
computers, personal health appliances, set top boxes) in a manner that enables plug-and-play
interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073
terminology, information models, application profile standards, and transport standards. It
specifies the use of specific term codes, formats, and behaviors in telehealth environments
restricting optionality in base frameworks in favor of interoperability. This standard defines a
common core of communication functionality for personal telehealth pulse oximeters.
Keywords: IEEE 11073-10404™, medical device communication, personal health devices, PHD,
pulse oximeter
The Institute of Electrical and Electronics Engineers, Inc.
3 Park Avenue, New York, NY 10016-5997, USA
All rights reserved. Published 7 January 2021. Printed in the United States of America.
IEEE is a registered trademark in the U.S. Patent & Trademark Office, owned by The Institute of Electrical and Electronics Engineers,
Incorporated.
PDF: ISBN 978-1-5044-6458-1 STD24061
Print: ISBN 978-1-5044-6459-8 STDPD24061
IEEE prohibits discrimination, harassment, and bullying.
For more information, visit https://www.ieee.org/about/corporate/governance/p9-26.html.
No part of this publication may be reproduced in any form, in an electronic retrieval system or otherwise, without the prior written permission
of the publisher.
ISO/IEEE 11073-10404:2022(E)
Important Notices and Disclaimers Concerning IEEE Standards Documents
IEEE Standards documents are made available for use subject to important notices and legal disclaimers.
These notices and disclaimers, or a reference to this page (https://standards.ieee.org/ipr/disclaimers.html),
appear in all standards and may be found under the heading “Important Notices and Disclaimers
Concerning IEEE Standards Documents.”
Notice and Disclaimer of Liability Concerning the Use of IEEE Standards
Documents
IEEE Standards documents are developed within the IEEE Societies and the Standards Coordinating
Committees of the IEEE Standards Association (IEEE SA) Standards Board. IEEE develops its standards
through an accredited consensus development process, which brings together volunteers representing
varied viewpoints and interests to achieve the final product. IEEE Standards are documents developed by
volunteers with scientific, academic, and industry-based expertise in technical working groups. Volunteers
are not necessarily members of IEEE or IEEE SA, and participate without compensation from IEEE. While
IEEE administers the process and establishes rules to promote fairness in the consensus development
process, IEEE does not independently evaluate, test, or verify the accuracy of any of the information or the
soundness of any judgments contained in its standards.
IEEE makes no warranties or representations concerning its standards, and expressly disclaims all
warranties, express or implied, concerning this standard, including but not limited to the warranties of
merchantability, fitness for a particular purpose and non-infringement. In addition, IEEE does not warrant
or represent that the use of the material contained in its standards is free from patent infringement. IEEE
standards documents are supplied “AS IS” and “WITH ALL FAULTS.”
Use of an IEEE standard is wholly voluntary. The existence of an IEEE Standard does not imply that there
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.