SIST EN ISO/IEEE 11073-10471:2025
(Main)Health informatics - Device interoperability - Part 10471: Personal Health Device Communication - Device Specialization - Independent Living Activity Hub (ISO/IEEE 11073-10471:2024)
Health informatics - Device interoperability - Part 10471: Personal Health Device Communication - Device Specialization - Independent Living Activity Hub (ISO/IEEE 11073-10471:2024)
Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between independent living activity hubs and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards, including ISO/IEEE 11073 terminology and information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting ambiguity in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for independent living activity hubs. In this context, independent living activity hubs are defined as devices that communicate with simple situation monitors (binary sensors), normalize information received from the simple environmental monitors, and provide this normalized information to one or more managers. This information can be examined, for example, to determine when a person’s activities/behaviors have deviated significantly from what is normal for them such that relevant parties can be notified. Independent living activity hubs will normalize information from the following simple situation monitors (binary sensors) for the initial release of the proposed standard: fall sensor, motion sensor, door sensor, bed/chair occupancy sensor, light switch sensor, smoke sensor, (ambient) temperature threshold sensor, personal emergency response system (PERS), and enuresis sensor (bed-wetting).
Medizinische Informatik - Interoperabilität von Geräten - Teil 10471: Kommunikation von Geräten für die persönliche Gesundheit - Gerätespezifikation - Schnittstellenkonzentrator und - umsetzer für assistierende Systeme (ISO/IEEE 11073-10471:2024)
Informatique de santé - Interopérabilité des dispositifs - Partie 10471: Communication entre dispositifs de santé personnels - Spécialisation des dispositifs - Concentrateur d’activités pour une vie autonome (ISO/IEEE 11073-10471:2024)
Dans le contexte de la famille de normes ISO/IEEE 11073 relatives à la communication entre des dispositifs, la présente norme établit une définition normative de la communication entre des concentrateurs d’activités pour une vie autonome et des gestionnaires (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 et des modèles d’informations 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 l’ambiguïté dans les cadres de travail de base en faveur de l’interopérabilité. La présente norme définit un noyau commun de fonctionnalités de communication pour les concentrateurs d’activités pour une vie autonome. Dans ce contexte, des concentrateurs d’activités pour une vie autonome sont définis comme des dispositifs qui communiquent avec de simples dispositifs de surveillance de situation (capteurs binaires), normalisent des informations reçues des simples dispositifs de surveillance d’environnement et fournissent ces informations normalisées à un ou plusieurs gestionnaires. Ces informations peuvent être examinées (par exemple) pour déterminer le moment où les activités ou les comportements d’une personne se sont particulièrement écartés de ce qui constitue la normale pour eux de telle sorte que des tiers concernés puissent en être informés. Les concentrateurs d’activités pour une vie autonome normaliseront des informations provenant des simples dispositifs de surveillance suivants (capteurs binaires) dans le cadre de l’édition initiale de la norme proposée : capteur de chute, capteur de mouvement, capteur de porte, capteur d’occupation de lit/chaise, capteur d’interrupteur de lumière, détecteur de fumée, sonde de température (ambiante) à seuil, système de réponse d’urgence personnel (PERS) et capteur d’énurésie (lit mouillé).
Zdravstvena informatika - Interoperabilnost naprav - 10471. del: Komunikacija osebnih medicinskih naprav - Specialne naprave - Sistem hišnih naprav za samostojno življenje starejših in bolnih (ISO/IEEE 11073-10471:2024)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2025
Nadomešča:
SIST EN ISO 11073-10471:2011
Zdravstvena informatika - Interoperabilnost naprav - 10471. del: Komunikacija
osebnih medicinskih naprav - Specialne naprave - Sistem hišnih naprav za
samostojno življenje starejših in bolnih (ISO/IEEE 11073-10471:2024)
Health informatics - Device interoperability - Part 10471: Personal Health Device
Communication - Device Specialization - Independent Living Activity Hub (ISO/IEEE
11073-10471:2024)
Medizinische Informatik - Interoperabilität von Geräten - Teil 10471: Kommunikation von
Geräten für die persönliche Gesundheit - Gerätespezifikation - Schnittstellenkonzentrator
und - umsetzer für assistierende Systeme (ISO/IEEE 11073-10471:2024)
Informatique de santé - Interopérabilité des dispositifs - Partie 10471: Communication
entre dispositifs de santé personnels - Spécialisation des dispositifs - Concentrateur
d’activités pour une vie autonome (ISO/IEEE 11073-10471:2024)
Ta slovenski standard je istoveten z: EN ISO/IEEE 11073-10471:2025
ICS:
11.180.99 Drugi standardi v zvezi s Other standards related to
pripomočki za invalide aids for disabled and
handicapped people
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
October 2025
ICS 35.240.80 Supersedes EN ISO 11073-10471:2011
English Version
Health informatics - Device interoperability - Part 10471:
Personal Health Device Communication - Device
Specialization - Independent Living Activity Hub
(ISO/IEEE 11073-10471:2024)
Informatique de santé - Interopérabilité des dispositifs Medizinische Informatik - Interoperabilität von
- Partie 10471: Communication entre dispositifs de Geräten - Teil 10471: Kommunikation von Geräten für
santé personnels - Spécialisation des dispositifs - die persönliche Gesundheit - Gerätespezifikation -
Concentrateur d'activités pour une vie autonome Schnittstellenkonzentrator und - umsetzer für
(ISO/IEEE 11073-10471:2024) assistierende Systeme (ISO/IEEE 11073-10471:2024)
This European Standard was approved by CEN on 30 September 2024.
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
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member.
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COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
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© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO/IEEE 11073-10471:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO/IEEE 11073-10471:2025) 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 April 2026, and conflicting national standards shall be
withdrawn at the latest by April 2026.
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 11073-10471:2011.
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 11073-10471:2024 has been approved by CEN as EN ISO/IEEE 11073-
10471:2025 without any modification.
International
Standard
ISO/IEEE
11073-10701
First edition
Health informatics — Device
2024-09
interoperability —
Part 10701:
Point-of-care medical device
communication — Metric
provisioning by participants
in a Service-oriented Device
Connectivity (SDC) system
Informatique de santé — Interopérabilité des dispositifs —
Partie 10701: Communication entre dispositifs médicaux sur le
site de soins – Fourniture de métriques par les participants à un
système de connectivité des dispositifs orientée services (SDC)
Reference number
ISO/IEEE 11073-10701:2024(en) © IEEE 2024
ISO/IEEE 11073-10701:2024(en)
© IEEE 2024
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ii
ISO/IEEE 11073-10701:2024(en)
Foreword
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© IEEE 2024 – All rights reserved
iii
ISO/IEEE 11073-10701:2024(en)
Abstract: Medical devices that offer a communication interface as specified by the IEEE 11073 Service-oriented
Device Connectivity (SDC) standards can be integrated into a health IT system to jointly execute system functions.
However, implementing the IEEE 11073 SDC communication protocol is not sufficient to demonstrate safety,
effectiveness, and security of system functions resulting from the combination of system function contributions from
two or more medical devices. SDC participant key purposes (PKPs) are sets of requirements that allow for
manufacturers to have certain expectations about BICEPS participants from other manufacturers. This common
understanding enables the manufacturers to perform risk management, verification, validation, and usability
engineering for the safe use of system functions. This standard defines requirements for SDC metric participants in
an SDC system that comprises an IT network of medical devices to enable safe and secure contribution to system
functions based on the exchange of metric information.
Keywords: base PKP; BICEPS; communication protocol specification; device component; documentation and
process responsibilities; dynamic medical device interoperability; IEEE 11073-10701™; integrated clinical
environment; medical device communication; metric; metric PKP; participant key purpose; point-of-care service-
oriented device connectivity; risk management; safety, effectiveness, and security; SDC; system function; system
function contribution; usability engineering
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ISO/IEEE 11073-10701:2024(en)
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