SIST EN ISO/IEEE 11073-10701:2025
(Main)Health informatics - Device interoperability - Part 10701: Point-of-care medical device communication - Metric provisioning by participants in a Service-oriented Device Connectivity (SDC) system (ISO/IEEE 11073-10701:2024)
Health informatics - Device interoperability - Part 10701: Point-of-care medical device communication - Metric provisioning by participants in a Service-oriented Device Connectivity (SDC) system (ISO/IEEE 11073-10701:2024)
This standard specifies a set of Participant Key Purposes (PKPs) pertaining to metric data exchange for the Service-oriented Device Connectivity (SDC) series of standards. PKPs are role-based sets of requirements for products in order to support safe, effective, and secure interoperability in medical IT networks at point-of-care environments such as the intensive care unit (ICU), operating room (OR) or other acute care settings. This standard specifies both product development process and technical requirements.
Medizinische Informatik - Interoperabilität von Geräten - Teil 10701: Kommunikation von Geräten für die persönliche Gesundheit - Bereitstellung von Metriken durch Teilnehmer in einem serviceorientierten Gerätekonnektivitätssystem (SDC) (ISO/IEEE 11073-10701:2024)
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) (ISO/IEEE 11073-10701:2024)
La présente norme spécifie un ensemble d’objectifs clés des participants (PKP) relatifs à l’échange de données de métriques pour la série de normes sur la connectivité des dispositifs orientée services (SDC). Les PKP sont des ensembles d’exigences applicables aux produits établis sur la base des rôles visant à soutenir une interopérabilité sûre, efficace et sécurisée dans les réseaux de TI médicaux dans les environnements de sites de soins tels que l’unité de soins intensifs (USI), le bloc opératoire (BO) ou d’autres centres de soins intensifs. La présente norme spécifie à la fois le processus de développement du produit et les exigences techniques.
Zdravstvena informatika - Interoperabilnost naprav - 10701. del: Komunikacija medicinskih naprav na mestu oskrbe - Zagotavljanje metrike s strani udeležencev v storitveno usmerjenem sistemu povezovanja naprav (SDC) (ISO/IEEE 11073-10701:2024)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2025
Zdravstvena informatika - Interoperabilnost naprav - 10701. del: Komunikacija
medicinskih naprav na mestu oskrbe - Zagotavljanje metrike s strani udeležencev
v storitveno usmerjenem sistemu povezovanja naprav (SDC) (ISO/IEEE 11073-
10701:2024)
Health informatics - Device interoperability - Part 10701: Point-of-care medical device
communication - Metric provisioning by participants in a Service-oriented Device
Connectivity (SDC) system (ISO/IEEE 11073-10701:2024)
Medizinische Informatik - Interoperabilität von Geräten - Teil 10701: Kommunikation von
Geräten für die persönliche Gesundheit - Bereitstellung von Metriken durch Teilnehmer
in einem serviceorientierten Gerätekonnektivitätssystem (SDC) (ISO/IEEE 11073-
10701:2024)
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)
(ISO/IEEE 11073-10701:2024)
Ta slovenski standard je istoveten z: EN ISO/IEEE 11073-10701:2025
ICS:
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
English Version
Health informatics - Device interoperability - Part 10701:
Point-of-care medical device communication - Metric
provisioning by participants in a Service-oriented Device
Connectivity (SDC) system (ISO/IEEE 11073-10701:2024)
Informatique de santé - Interopérabilité des dispositifs Medizinische Informatik - Interoperabilität von
- Partie 10701: Communication entre dispositifs Geräten - Teil 10701: Kommunikation von Geräten für
médicaux sur le site de soins - Fourniture de métriques die persönliche Gesundheit - Bereitstellung von
par les participants à un système de connectivité des Metriken durch Teilnehmer in einem
dispositifs orientée services (SDC) (ISO/IEEE 11073- serviceorientierten Gerätekonnektivitätssystem (SDC)
10701:2024) (ISO/IEEE 11073-10701:2024)
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
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,
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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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO/IEEE 11073-10701:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO/IEEE 11073-10701:2025) 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.
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 11073-10701:2024 has been approved by CEN as EN ISO/IEEE 11073-
10701:2025 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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© IEEE 2024 – All rights reserved
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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