SIST EN ISO/IEEE 11073-10404:2023
(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)
ISO/IEEE 11073-10404:2010 establishes a normative definition of communication between personal telehealth pulse oximeter devices and computer engines (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play (PnP) 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 behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability.
ISO/IEEE 11073-10404:2010 defines a common core of communication functionality for personal telehealth pulse oximeters and addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and computer engines.
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)
L'ISO/IEEE 11073-10404:2010 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 du 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. Elle définit un noyau commun de fonctionnalités de communication pour les oxymètres de pouls personnels de télésanté.
L'ISO/IEEE 11073-10404:2010 répond au besoin d'une norme indépendante définie de manière ouverte portant sur la commande de l'échange d'informations entre des dispositifs personnels de santé et des moteurs informatiques.
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
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO/IEEE 11073-10404:2023
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
SIST EN ISO/IEEE 11073-10404:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO/IEEE 11073-10404:2023
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SIST EN ISO/IEEE 11073-10404:2023
EN ISO/IEEE 11073-
EUROPEAN STANDARD
10404
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.
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SIST EN ISO/IEEE 11073-10404:2023
EN ISO/IEEE 11073-10404:2022 (E)
Contents Page
European foreword . 3
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SIST EN ISO/IEEE 11073-10404:2023
EN ISO/IEEE 11073-10404:2022 (E)
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.
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SIST EN ISO/IEEE 11073-10404:2023
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SIST EN ISO/IEEE 11073-10404:2023
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
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SIST EN ISO/IEEE 11073-10404:2023
ISO/IEEE 11073-10404:2022(E)
COPYRIGHT PROTECTED DOCUMENT
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Website: www.ieee.org
Published in Switzerland
ii
© IEEE 2021 – All rights reserved
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SIST EN ISO/IEEE 11073-10404:2023
ISO/IEEE 11073-10404:2022(E)
Foreword
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© IEEE 2021 – All rights reserved iii
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SIST EN ISO/IEEE 11073-10404:2023
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SIST EN ISO/IEEE 11073-10404:2023
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
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SIST EN ISO/IEEE 11073-10404:2023
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
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SIST EN ISO/IEEE 11073-10404:2023
ISO/IEEE 11073-10404:2022(E)
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SIST EN ISO/IEEE 11073-10404:2023
ISO/IEEE 11073-10404:2022(E)
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SIST EN ISO/IEEE 11073-10404:2023
ISO/IEEE 11073-10404:2022(E)
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SIST EN ISO/IEEE 11073-10404:2023
ISO/IEEE 11073-10404:2022(E)
Participants
At the time this standard was completed, the Personal Health Devices Working Group had the following
membership:
Daidi Zhong, Co-Chair
Michael J. Kirwan, Co-Chair
Karsten Aalders
Chia-Chin Chong Amit Gupta
Charles R. Abbruscato Saeed A. Choudhary Jeff Guttmacher
Nabil Abujbara Jinhan Chung Rasmus Haahr
Maher Abuzaid John A. Cogan Christian Habermann
James Agnew John T. Collins Michael Hagerty
Manfred Aigner Cory Condek Jerry Hahn
Jorge Alberola Todd H. Cooper Robert Hall
David Aparisi David Cornejo Shu Han
Lawrence Arne Douglas Coup Nathaniel Hamming
Diego B. Arquillo Nigel Cox Rickey L. Hampton
Serafin Arroyo Hans Crommenacker Sten Hanke
Muhammad Asim Tomio Crosley Aki Harma
Kit August Allen Curtis Jordan Hartmann
Doug Baird Jesús Daniel Trigo Kai Hassing
David Baker David Davenport Avi Hauser
Anindya Bakshi Wolfgang Heck
Russell Davis
Abira Balanadarasan
Sushil K. Deka Nathaniel Heintzman
Ananth Balasubramanian Ciro de la Vega Charles Henderson
Sunlee Bang Pedro de-las-Heras-Quiros Jun-Ho Her
M. Jonathan Barkley Jim Dello Stritto Helen B. Hernandez
Gilberto Barrón Kent Dicks Timothy L. Hirou
David Bean Hyoungho Do Allen Hobbs
John Bell Jonathan Dougherty Alex Holland
Olivia Bellamou-Huet Xiaolian Duan Arto Holopainen
Rudy Belliardi Sourav Dutta Kris Holtzclaw
Kathryn M. Bennett Jakob Ehrensvard Xinyi Hong
Daniel Bernstein Fredrik Einberg Robert Hoy
George A. Bertos Javier Escayola Calvo Di Hu
Chris Biernacki Mark Estes Anne Huang
Ola Björsne Leonardo Estevez Zhiqiang Huang
Thomas Blackadar Hailing Feng Zhiyong Huang
Marc Blanchet Bosco T. Fernandes Ron Huby
Thomas Bluethner Christoph Fischer
David Hughes
Morten Flintrup
Douglas P. Bogia Robert D. Hughes
Joseph W. Forler
Xavier Boniface Jiyoung Huh
Shannon Boucousis Russell Foster Hugh Hunter
Julius Broma Eric Freudenthal Philip O. Isaacson
Lyle G. Bullock, Jr. Matthias Frohner Atsushi Ito
Bernard Burg Ken Fuchs Michael Jaffe
Chris Burns Jing Gao Praduman Jain
Jeremy Byford-Rew Qi Gao Danny Jochelson
Satya Calloji Marcus Garbe Akiyoshi Kabe
Xiaoying Cao John Garguilo Steve Kahle
Carole C. Carey Rick Geimer Tomio Kamioka
Craig Carlson Igor Gejdos James J. Kang
Santiago Carot-Nemesio Ferenc Gerbovics Kei Kariya
Randy W. Carroll Alan Godfrey Andy Kaschl
Simon Carter Nicolae Goga Junzo Kashihara
Seungchul Chae Julian Goldman Colin Kennedy
Raul Gonzalez Gomez
Rahul Chauhan Ralph Kent
Chris Gough
Peggy Chien Laurie M. Kermes
David Chiu Channa Gowda Ahmad Kheirandish
Jinyong Choi Charles M. Gropper Junhyung Kim
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SIST EN ISO/IEEE 11073-10404:2023
ISO/IEEE 11073-10404:2022(E)
Minho Kim Yoshiteru Nozoe Nicholas Steblay
Min-Joon Kim Lars Steubesand
Abraham Ofek
Taekon Kim John (Ivo) Stivoric
Brett Olive
Tetsuya Kimura BegonyaOtal Raymond A. Strickland
Michael J. Kirwan Marco Paleari ChandrasekaranSubramaniam
Alfred Kloos Bud Panjwani Hermanni Suominen
Jeongmee Koh Carl Pantiskas Lee Surprenant
Jean-Marc Koller Harry P. Pappas Ravi Swami
John Koon Hanna Park Ray Sweidan
Patty Krantz Jong-Tae Park Na Tang
Raymond Krasinski Myungeun Park Yi Tang
Alexander Kraus Soojun Park Haruyuyki Tatsumi
Ramesh Krishna Phillip E. Pash Isabel Tejero
Geoffrey Kruse TongBi Pei Tom Thompson
Falko Kuester Soren Petersen Jonas Tirén
Rafael Lajara James Petisce Janet Traub
Pierre Landau Peter Piction Gary Tschautscher
Jaechul Lee Masato Tsuchid
Michael Pliskin
JongMuk Lee Ken Tubman
Varshney Prabodh
Kyong Ho Lee
Jeff Price Akib Uddin
Rami Lee Harald Prinzhorn Sunil Unadkat
Sungkee Lee Harry Qiu Fabio Urbani
Woojae Lee Tanzilur Rahman Philipp Urbauer
Qiong Li Phillip Raymond Laura Vanzago
Xiangchen Li Terrie Reed Alpo Värri
Yingsong Li Barry Reinhold Andrei Vasilateanu
Zhuofang Li Brian Reinhold Dalimar Velez
Patrick Lichter Melvin I. Reynolds Martha Velezis
Lin Lin John G. Rhoads Rudi Voon
Jisoon Lim Jeffrey S. Robbins Barry Vornbrock
Joon-Ho Lim Chris Roberts Isobel Walker
Liang Liu Moskowitz Robert David Wang
Xiaoming Liu Stefan Robert Linling Wang
Wei-Jung Lo Scott M. Robertson Jerry P. Wang
Charles Lowe Timothy Robertson Yao Wang
Don Ludolph Patricia Roder
Yi Wang
David Rosales
Christian Luszick Steve Warren
Bill Saltzstein
Bob MacWilliams Fujio Watanabe
Srikkanth Madhurbootheswaran Giovanna Sannino Toru Watsuji
Miriam L. Makhlouf Jose A. Santos-Cadenas David Weissman
Romain Marmot Stefan Sauermann Kathleen Wible
Sandra Martinez John Sawyer Paul Williamson
Miguel Martínez de AloisSchloegl Jan Wittenber
EsproncedaCámara Paul S. Schluter Jia-Rong Wu
Peter Mayhew Mark G. Schnell Will Wykeham
Jim McCain Richard A. Schrenker Ariton Xhafa
LászlóMeleg Antonio Scorpiniti Ricky Yang
Alexander Mense KwangSeok Seo Shaoqin Ye
Behnaz Minaei Riccardo Serafin Melanie S. Yeung
Jins
...
SLOVENSKI STANDARD
oSIST prEN ISO/IEEE 11073-10404:2022
01-september-2022
Zdravstvena informatika - Interoperabilnost naprav - 10404. del: Komunikacija
osebnih medicinskih naprav - Specialne naprave - Pulzni oksimeter
(ISO/IEEE/FDIS 11073-10404:2022)
Health informatics - Device interoperability - Part 10404: Personal health device
communication - Device specialization - Pulse oximeter (ISO/IEEE/FDIS 11073-
10404:2022)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10404: Gerätespezifikation - Pulsoximeter (ISO/IEEE/FDIS 11073-10404:2022)
Informatique de santé - Interopérabilité des dispositifs - Partie 10404: Spécialisation des
dispositifs - Oxymètre de pouls (ISO/IEEE/FDIS 11073-10404:2022)
Ta slovenski standard je istoveten z: prEN ISO/IEEE 11073-10404
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
oSIST prEN ISO/IEEE 11073-10404:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO/IEEE 11073-10404:2022
---------------------- Page: 2 ----------------------
oSIST prEN ISO/IEEE 11073-10404:2022
FINAL
INTERNATIONAL ISO/IEEE
DRAFT
STANDARD FDIS
11073-10404
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
2022-06-16
Part 10404:
Voting terminates on:
Personal health device communication
2022-11-03
— Device specialization — Pulse
oximeter
Informatique de santé — Interopérabilité des dispositifs —
Partie 10404: Spécialisation des dispositifs — Oxymètre de pouls
ISO/CEN PARALLEL PROCESSING
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/IEEE FDIS 11073-10404:2022(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © IEEE 2022
---------------------- Page: 3 ----------------------
oSIST prEN ISO/IEEE 11073-10404:2022
ISO/IEEE FDIS 11073-10404:2022(E)
FINAL
INTERNATIONAL ISO/IEEE
DRAFT
STANDARD FDIS
11073-10404
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
2022-06-16
Part 10404:
Voting terminates on:
Personal health device communication
2022-11-03
— Device specialization — Pulse
oximeter
Informatique de santé — Interopérabilité des dispositifs —
Partie 10404: Spécialisation des dispositifs — Oxymètre de pouls
COPYRIGHT PROTECTED DOCUMENT
ISO/CEN PARALLEL PROCESSING
© IEEE 2022
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.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
Institute of Electrical and Electronics Engineers, Inc
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
3 Park Avenue, New York
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
NY 10016-5997, USA
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: stds.ipr@ieee.org
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/IEEE FDIS 11073-10404:2022(E)
Website: www.ieee.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
© IEEE 2022 – All rights reserved
NATIONAL REGULATIONS. © IEEE 2022
---------------------- Page: 4 ----------------------
oSIST prEN ISO/IEEE 11073-10404:2022
ISO/IEEE FDIS 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
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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
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Any trade name used in this document is information given for the convenience of users and does not
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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
---------------------- Page: 5 ----------------------
oSIST prEN ISO/IEEE 11073-10404:2022
---------------------- Page: 6 ----------------------
oSIST prEN ISO/IEEE 11073-10404:2022
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
---------------------- Page: 7 ----------------------
oSIST prEN ISO/IEEE 11073-10404:2022
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
Copyright © 2021 by The Institute of Electrical and Electronics Engineers, Inc.
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
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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.
2
Copyright © 2021 IEEE. All rights reserved.
---------------------- Page: 8 ----------------------
oSIST prEN ISO/IEEE 11073-10404:2022
ISO/IEEE 11073-10404:2022(E)
Important Notices and Disclaimers Concerning IEEE Standards Documents
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3
Copyright © 2021 IEEE. All rights reserved.
---------------------- Page: 9 ----------------------
oSIST prEN ISO/IEEE 11073-10404:2022
ISO/IEEE 11073-10404:2022(E)
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4
Copyright © 2021 IEEE. All rights reserved.
---------------------- Page: 10 ----------------------
oSIST prEN ISO/IEEE 11073-10404:2022
ISO/IEEE 11073-10404:2022(E)
Updating of IEEE Standards documents
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5
Copyright © 2021 IEEE. All rights reserved.
---------------------- Page: 11 ----------------------
oSIST prEN ISO/IEEE 11073-10404:2022
ISO/IEEE 11073-10404:2022(E)
Participants
At the time this standard was completed, the Personal Health Devices Working Group had the following
membership:
Daidi Zhong, Co-Chair
Michael J. Kirwan, Co-Chair
Karsten Aalders
Chia-Chin Chong Amit Gupta
Charles R. Abbruscato Saeed A. Choudhary Jeff Guttmacher
Nabil Abujbara Jinhan Chung Rasmus Haahr
Maher Abuzaid John A. Cogan Christian Habermann
James Agnew John T. Collins Michael Hagerty
Manfred Aigner Cory Condek Jerry Hahn
Jorge Alberola Todd H. Cooper Robert Hall
David Aparisi David Cornejo Shu Han
Lawrence Arne Douglas Coup Nathaniel Hamming
Diego B. Arquillo Nigel Cox Rickey L. Hampton
Serafin Arroyo Hans Crommenacker Sten Hanke
Muhammad Asim Tomio Crosley Aki Harma
Kit August Allen Curtis Jordan Hartmann
Doug Baird Jesús Daniel Trigo Kai Hassing
David Baker David Davenport Avi Hauser
Anindya Bakshi Wolfgang Heck
Russell Davis
Abira Balanadarasan
Sushil K. Deka Nathaniel Heintzman
Ananth Balasubramanian Ciro de la Vega Charles Henderson
Sunlee Bang Pedro de-las-Heras-Quiros Jun-Ho Her
M. Jonathan Barkley Jim Dello Stritto Helen B. Hernandez
Gilberto Barrón Kent Dicks Timothy L. Hirou
David Bean Hyoungho Do Allen Hobbs
John Bell Jonathan Dougherty Alex Holland
Olivia Bellamou-Huet Xiaolian Duan Arto Holopainen
Rudy Belliardi Sourav Dutta Kris Holtzclaw
Kathryn M. Bennett Jakob Ehrensvard Xinyi Hong
Daniel Bernstein Fredrik Einberg Robert Hoy
George A. Bertos Javier Escayola Calvo Di Hu
Chris Biernacki Mark Estes Anne Huang
Ola Björsne Leonardo Estevez Zhiqiang Huang
Thomas Blackadar Hailing Feng Zhiyong Huang
Marc Blanchet Bosco T. Fernandes Ron Huby
Thomas Bluethner Christoph Fischer
David Hughes
Morten Flintrup
Douglas P. Bogia Robert D. Hughes
Joseph W. Forler
Xavier Boniface Jiyoung Huh
Shannon Boucousis Russell Foster Hugh Hunter
Julius Broma Eric Freudenthal Philip O. Isaacson
Lyle G. Bullock, Jr. Matthias Frohner Atsushi Ito
Bernard Burg Ken Fuchs Michael Jaffe
Chris Burns Jing Gao Praduman Jain
Jeremy Byford-Rew Qi Gao Danny Jochelson
Satya Calloji Marcus Garbe Akiyoshi Kabe
Xiaoying Cao John Garguilo Steve Kahle
Carole C. Carey Rick Geimer Tomio Kamioka
Craig Carlson Igor Gejdos James J. Kang
Santiago Carot-Nemesio Ferenc Gerbovics Kei Kariya
Randy W. Carroll Alan Godfrey Andy Kaschl
Simon Carter Nicolae Goga Junzo Kashihara
Seungchul Chae Julian Goldman Colin Kennedy
Raul Gonzalez Gomez
Rahul Chauhan Ralph Kent
Chris Gough
Peggy Chien Laurie M. Kermes
David Chiu Channa Gowda Ahmad Kheirandish
Jinyong Choi Charles M. Gropper Junhyung Kim
6
Copyright © 2021 IEEE. All rights reserved.
---------------------- Page: 12 ----------------------
oSIST prEN ISO/IEEE 11073-10404:2022
ISO/IEEE 11073-10404:2022(E)
Minho Kim Yoshiteru Nozoe Nicholas Steblay
Min-Joon Kim Lars Steubesand
Abraham Ofek
Taekon Kim John (Ivo) Stivoric
Brett Olive
Tetsuya Kimura BegonyaOtal Raymond A. Strickland
Michael J. Kirwan Marco Paleari ChandrasekaranSubramaniam
Alfred Kloos Bud Panjwani Hermanni Suominen
Jeongmee Koh Carl Pantiskas Lee Surprenant
Jean-Marc Koller Harry P. Pappas Ravi Swami
John Koon Hanna Park Ray Sweidan
Patty Krantz Jong-Tae Park Na Tang
Raymond Krasinski Myungeun Park Yi Tang
Alexander Kraus Soojun Park Haruyuyki Tatsumi
Ramesh Krishna Phillip E. Pash Isabel Tejero
Geoffrey Kruse TongBi Pei Tom Thompson
Falko Kuester Soren Petersen Jonas Tirén
Rafael Lajara James Petisce Janet Traub
Pierre Landau Peter Piction Gary Tschautscher
Jaechul Lee Masato Tsuchid
Michael Pliskin
JongMuk Lee Ken Tubman
Varshney Prabodh
Kyong Ho Lee
Jeff Price Akib Uddin
Rami Lee Harald Prinzhorn Sunil Unadkat
Sungkee Lee Harry Qiu Fabio Urbani
Woojae Lee Tanzilur Rahman Philipp Urbauer
Qiong Li Phillip Raymond Laura Vanzago
Xiangchen Li Terrie Reed Alpo Värri
Yingsong Li Barry Reinhold Andrei Vasilateanu
Zhuofang Li Brian Reinhold Dalimar Velez
Patrick Lichter Melvin I. Reynolds Martha Velezis
Lin Lin John G. Rhoads Rudi Voon
Jisoon Lim Jeffrey S. Robbins Barry Vornbrock
Joon-Ho Lim Chris Roberts Isobel Walker
Liang Liu Moskowitz Robert David Wang
Xiaoming Liu Stefan Robert Linling Wang
Wei-Jung Lo Scott M. Robertson Jerry P. Wang
Charles Lowe Timothy Robertson Yao Wang
Don Ludolph Patricia Roder
Yi Wang
David Rosales
Christian Luszick Steve Warren
Bill Saltzstein
Bob MacWilliams Fujio Watanabe
Srikkanth Madhurbootheswaran Giovanna Sannino Toru Watsuji
Miriam L. Makhlouf Jose A. Santos-Cadenas David Weissman
Romain Marmot Stefan Sauermann Kathleen Wible
Sandra Martinez John Sawyer Paul Williamson
Miguel Martínez de AloisSchloegl Jan Wittenber
EsproncedaCámara Paul S. Schluter Jia-Rong Wu
Peter Mayhew Mark G. Schnell Will Wykeham
Jim McCain Richard A. Schrenker Ariton Xhafa
LászlóMeleg Antonio Scorpiniti Ricky Yang
Alexander Mense KwangSeok Seo Shaoqin Ye
Behnaz Minaei Riccardo Serafin Melanie S. Yeung
Jinsei Miyazaki Sid Shaw Qiang Yin
Erik Moll Frank Shen Done-Sik Yoo
Darr Moore Min Shih
Zhi Yu
Mazen Shihabi
Carsten Mueglitz Jianchao Zeng
Redmond Shouldice
Soundharya Nagasubramanian Jason Zhang
Alex Neefus Sternly K. Simon Jie Zhao
Trong-Nghia Nguyen-Dobinsky Marjorie Skubic Thomas Zhao
Michael E. Nidd Robert Smith Daidi Zhong
Jim Niswander Ivan Soh Hongyuan Zhong
Hongliang Niu Motoki Sone Yuanhong Zhong
Hiroaki Niwamoto Emily Sopensky Miha Zoubek
Thomas Norgall Rajagopalan Srinivasan Szymon Zyskoter
7
Copyright © 2021 IEEE. All rights reserved.
---------------------- Page: 13 ----------------------
oSIST prEN ISO/IEEE 11073-10404:2022
ISO/IEEE 11073-10404:2022(E)
The following members of the individual balloting committee voted on this standard. Balloters may have
voted for approval, disapproval, or abstention.
Bjoern Andersen Werner Hoelzl Iulian Profir
Lyle Bullock Noriyuki Ikeuchi
Beth Pumo
Keith Chow Atsushi Ito Stefan Schlichting
Malcolm Clarke Raj Jain Janek Schumann
Kenneth Fuchs Piotr Karocki Walter Struppler
David Fuschi Martin Kasparick Oren Yuen
Randall Groves Raymond Krasinski Janusz Zalewski
Robert Heile H. Moll Daidi Zhong
When the IEEE SA Standards Board approved this standard on 30 January 2020, it had the following
membership:
Gary Hoffman, Chair
Vacant Position, Vice Chair
Jean-Philippe Faure, Past Chair
Konstantinos Karachalios, Secretary
Ted Burse David J. Law Dorothy Stanley
Doug Edwards Howard Li Mehmet Ulema
J. Travis Griffith Dong Liu Lei Wang
Grace Gu Kevin Lu Sha Wei
Guido R. Hiertz Paul Nikolich Philip B. Winston
Joseph L. Koepfinger* Damir Novosel Daidi Zhong
John D. Kulick Jon Walter Rosdahl Jingyi Zhou
*Member Emeritus
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Copyright © 2021 IEEE. All rights reserved.
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oSIST prEN ISO/IEEE 11073-10404:2022
ISO/IEEE 11073-10404:2022(E)
Introduction
This introduction is not part of IEEE Std 11073-10404-2020, Health informatics—Personal health device communication—
Part 10404: Device specialization—Pulse oximeter.
ISO/IEEE 11073 standards enable communication between medical devices and external computer systems.
This document uses the optimized framework created in IEEE Std 11073-20601-2019™ and describes a
1
specific, interoperable communication approach for the pulse oximeter. These standards align with, and
draw on, the existing clinically focused standards to provide support for communication of data from
clinical or personal health devices.
1
Information on references can be found in Clause 2.
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Copyright © 2021 IEEE. All rights reserved.
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oSIST prEN ISO/IEEE 11073-10404:2022
ISO/IEEE 11073-10404:2022(E)
Contents
1. Overview .
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.