SIST EN ISO/IEEE 11073-10404:2023

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.

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oSIST prEN ISO/IEEE 11073-10404:2022

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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

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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

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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
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The procedures used to develop this document and those intended for its further maintenance are
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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
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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

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oSIST prEN ISO/IEEE 11073-10404:2022

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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

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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.
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oSIST prEN ISO/IEEE 11073-10404:2022
ISO/IEEE 11073-10404:2022(E)
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oSIST prEN ISO/IEEE 11073-10404:2022
ISO/IEEE 11073-10404:2022(E)
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oSIST prEN ISO/IEEE 11073-10404:2022
ISO/IEEE 11073-10404:2022(E)
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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
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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

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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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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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oSIST prEN ISO/IEEE 11073-10404:2022
ISO/IEEE 11073-10404:2022(E)

Contents
1. Overview .
...