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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
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Website: www.ieee.org
Published in Switzerland
ii
© IEEE 2021 – All rights reserved
ISO/IEEE 11073-10404:2022(E)
Foreword
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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).
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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
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
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ISO/IEEE 11073-10404:2022(E)
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