SIST EN ISO/IEEE 11073-10701:2025

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,
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
© 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
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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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ISO/IEEE 11073-10701:2024(en)
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ISO/IEEE 11073-10701:2024(en)
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vii
ISO/IEEE 11073-10701:2024(en)
Participants
At the time this IEEE standard was completed, the Point of Care Devices Working Group had the following membership:
Stefan Schlichting, Chair
Martin Kasparick, Subgroup Chair
Björn Andersen Christian Haye Erik Moll
Fabian Baumeister Werner Hoelzl Karen Moniz
Jin-Woo Choi Martin Hurrell Jody Paul
Malcolm Clarke Andy Iverson Craig Reister
Paul Close Jennifer Jacobs John Rhoads
Todd Cooper Sven Kämmer Sean Rocke
Sandra Costanzo Anton Keller Martin Rosner
Steven Dain Tobias Klotz Enrico Rudorf
Kurt Elliason Satoshi Kobayashi Gilani Sadeghi
Javier Espina Anil Kochhar Paul Schluter
Michael Faughn Peter Kranich Elliot Silver
Ken Fuchs Ray Krasinski Tulasi Sivanesan
John Garguilo Jithin Krishnan Isabel Tejero
Frank Golatowski Sungkee Lee James Vollmer
David Gregoczyk Konstantinos Makrodimitris Brian Witkowski
Steve Griffiths Koichiro Matsumoto Ravi Sekhar Yarrabothu
Peter Gunter Jörg-Uwe Meyer Greg Zeller
Bob Harbort Madhu Mohan
Daidi Zhong
The following members of the individual Standards Association balloting group voted on this standard. Balloters may have
voted for approval, disapproval, or abstention.
Robert Aiello David Gregorczyk Rajesh Murthy
Björn Andersen Kai Hassing Bansi Patel
Pradeep Balachandran Werner Hoelzl Scott Robertson
Fabian Baumeister Piotr Karocki Stefan Schlichting
Lyle Bullock Martin Kasparick Harry Solomon
Juan Carreon Stuart Kerry Eugene Stoudenmire
Pin Chang Yongbum Kim Walter Struppler
Todd Cooper Marcus Koeny John Vergis
Javier Espina Javier Luiso Lisa Ward
Kenneth Fuchs Konstantinos Makrodimitris Yu Yuan
David Fuschi H. Moll Oren Yuen
When the IEEE SA Standards Board approved this standard on 3 December 2022, it had the following membership:
David J. Law, Chair
Ted Burse, Vice Chair
Gary Hoffman, Past Chair
Konstantinos Karachalios, Secretary
Edward A. Addy Johnny Daozhuang Lin Mark Siira
Ramy Ahmed Fathy Kevin Lu Dorothy V. Stanley
J. Travis Griffith Daleep C. Mohla Lei Wang
Guido R. Hiertz Andrew Myles F. Keith Waters
Yousef Kimiagar Damir Novosel Karl Weber
Joseph L. Koepfinger* Annette D. Reilly Sha Wei
Thomas Koshy Robby Robson Philip B. Winston
John D. Kulick Jon Walter Rosdahl Daidi Zhong
*Member Emeritus
© IEEE 2024 – All rights reserved
viii
ISO/IEEE 11073-10701:2024(en)
Introduction
This introduction is not part of IEEE Std 11073-10701-2022, Health Informatics—Device Interoperability—Part 10701: Point-of-Care Medical
Device Communication—Metric Provisioning by Participants in a Service-Oriented Device Connectivity (SDC) System.
The IEEE 11073 Point-of-Care Medical Device Communication Standards enable communication between health IT elements
in a HEALTH IT SYSTEM including MEDICAL DEVICEs. They provide automatic and detailed electronic data capture of
patient vital signs information and device operational data. The primary goals are to:
⎯ Provide real-time plug-and-play interoperability for MEDICAL DEVICEs. “Real-time” means that data from multiple
MEDICAL DEVICEs can be retrieved, temporally correlated, displayed, and processed in fractions of a second. “Plug-
and-play” means that there are no recurring configuration steps necessary to enable data exchange between MEDICAL
DEVICEs.
⎯ Facilitate the efficient and effective exchange of vital signs and MEDICAL DEVICE data acquired at the PoC in all
health care environments. “Efficient and effective exchange of MEDICAL DEVICE data” means that data captured at
the PoC, e.g., patient vital signs, can be received, parsed, and interpreted by different types of applications without the
loss of safety-critical information.
The IEEE 11073 Point-of-Care Medical Device Communication Standards are targeted at surgical as well as acute and
continuous care devices, such as patient monitors, ventilators, infusion pumps, ECG devices, endoscopic camera systems,
insufflators, dissectors, etc. They build a family of standards that can be bound to one another to provide optimized connectivity
for devices at the PoC.
Within the context of the ISO/IEEE 11073 family of standards for Point-of-Care Medical Device Communication, this standard
defines the 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.
Examples of such SYSTEM FUNCTIONs are remote display, calculation of derived parameters based on METRIC information,
and partial automation of diagnosis and therapy, such as changing settings based on received METRIC information.
Acknowledgments
The author thanks the International Electrotechnical Commission (IEC) for permission to reproduce Information from its
International Standards. All such extracts are copyright of IEC, Geneva, Switzerland. All rights reserved. Further information on
the IEC is available from www.iec.ch. IEC has no responsibility for the placement and context in which the extracts and
contents are reproduced by the author, nor is IEC in any way responsible for the other content or accuracy therein.
IEC 60601-1 ed.3.2 Copyright © 2020 IEC Geneva, Switzerland. www.iec.ch
IEC 62366-1 ed.1.0 Copyright © 2020 IEC Geneva, Switzerland. www.iec.ch
The following material is reproduced from the International Organization for Standardization (ISO) with permission of the
American National Standards Institute (ANSI) on behalf of ISO All rights reserved.
ISO 20417:2021, Sections 3.2 and 3.11
ISO 81001-1:2021, Sections 3.2, 3.14, 3.1.12, 3.3.8, and 3.3.11
ISO 14971:2019, Section 3.18
© IEEE 2024 – All rights reserved
ix
ISO/IEEE 11073-10701:2024(en)
Contents
1. Overview . 1
1.1 Scope . 1
1.2 Word usage . 1
1.3 Service-oriented Device Connectivity standards . 1
1.4 Participant key purposes. 1
2. Normative references . 2
3. Definitions, acronyms, and abbreviations . 2
3.1 Definitions . 2
3.2 Acronyms and abbreviations . 7
4. Notational conventions . 8
4.1 Requirement categories and numbering . 8
4.2 References to IEEE 11073-10207 model elements . 8
4.3 XML Schema namespaces. 9
4.4 Notation of IEEE 11073 Nomenclature codes . 9
5. Responsibilities . 9
5.1 General responsibilities . 9
5.2 Intended interoperability . 10
5.3 System use . 11
6. Technical design . 15
6.1 METRICs . 15
6.2 Device components . 20
7. Conformity . 22
7.1 Implementation conformity statements . 22
Annex A (normative) Object Identifiers . 25
A.1 OID assignments . 25
A.2 Participant Key Purpose concept definitions . 25
A.3 Additional capabilities concept definitions . 26
Annex B (normative) Extension XML Schema . 27
Annex C (informative) Utilized IEEE 11073 Nomenclature . 29
Annex D (informative) Determining metric categories . 30
Annex E (informative) Composing metric labels . 32
E.1 Sources of information . 32
E.2 Suggested composition approach . 32
Annex F (informative) Bibliography . 33
© IEEE 2024 – All rights reserved
x
ISO/IEEE 11073-10701:2024(en)
Health Informatics—Device Interoperability

Part 10701: Point-of-Care Medical Device Communication—
Metric Provisioning by Participants in a Service-Oriented
Device Connectivity (SDC) System
1. Overview
1.1 Scope
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.
1.2 Word usage
The word shall indicates mandatory requirements strictly to be followed in order to conform to the standard and from which no
,
1 2
deviation is permitted (shall equals is required to).
The word should indicates that among several possibilities one is recommended as particularly suitable, without mentioning or
excluding others; or that a certain course of action is preferred but not necessarily required (should equals is recommended that).
The word may is used to indicate a course of action permissible within the limits of the standard (may equals is permitted to).
The word can is used for statements of possibility and capability, whether material, physical, or causal (can equals is able to).
1.3 Service-oriented Device Connectivity standards
The SDC STANDARDs are a subset of the IEEE 11073 standards and define requirements for MEDICAL DEVICEs and other
participants that exchange physiological or technical information or enable external control while being operated in an IT
NETWORK.
The SDC STANDARDs comprise the specification of a domain and message model (IEEE Std 11073-10207) and transport
technology (IEEE Std 11073-20702) that form a service-oriented MEDICAL DEVICE architecture (IEEE Std 11073-20701).
These SDC core standards constitute the technical building blocks for foundational, structural, and semantic MEDICAL
DEVICE interoperability over secure data transmission. The SDC PKP STANDARDs (see 1.4) and particular SDC Device
Specializations address additional levels.
1.4 Participant key purposes
MEDICAL DEVICEs that offer a communication interface as specified by the SDC STANDARDs can be integrated into a
HEALTH IT SYSTEM on behalf of the SYSTEM OWNER, establishing an SDC SYSTEM to be used by the HEALTHCARE
DELIVERY ORGANIZATION.
The use of the word must is deprecated and cannot be used when stating mandatory requirements; must is used only to describe unavoidable situations.
The use of will is deprecated and cannot be used when stating mandatory requirements; will is only used in statements of fact.
Information on references can be found in Clause Error! Reference source not found.
© IEEE 2024 – All rights reserved
ISO/IEEE 11073-10701:2024(en)
The SYSTEM FUNCTIONs made available in an SDC SYSTEM depend on the individual SYSTEM FUNCTION
CONTRIBUTIONs of its BICEPS PARTICIPANTs. Accordingly, the MANUFACTURER of a BICEPS SERVICE
PROVIDER can only specify its intended SYSTEM FUNCTION CONTRIBUTIONs, whereas the MANUFACTURER of a
BICEPS SERVICE CONSUMER can specify the intended SYSTEM FUNCTIONs as well as the SYSTEM FUNCTION
CONTRIBUTIONs required from BICEPS SERVICE PROVIDERs in the SDC SYSTEM.
But to verify the safety, effectiveness, and security of these SYSTEM FUNCTIONs, only implementing the communication
protocol based on the SDC STANDARDs is not sufficient. The safety, effectiveness, and security of the SDC SYSTEM is based
on allocating responsibilities to the individual BICEPS PARTICIPANTs according to the requirements of the SDC
PARTICIPANT KEY PURPOSEs (PKPs) they assume.
The responsibility for the individual products as BICEPS PARTICIPANTs in an SDC SYSTEM remains with the
MANUFACTURERs whereas the SYSTEM OWNER is responsible for integration of the products into a HEALTH IT
SYSTEM and the ADMINISTRATOR is responsible for operation and maintenance of the HEALTH IT SYSTEM (see ISO
81001-1:2021, Clause 4.5 [B11]). In addition, the SYSTEM OWNER and ADMINISTRATOR take the responsibilities placed
on them by declarations in the ACCOMPANYING INFORMATION of the individual products that are to be integrated, e.g.,
pertaining to configuration, IT NETWORK bandwidth, etc.
The SDC PKP Standards specify the allocation of responsibilities and allow for MANUFACTURERs to have certain
expectations about BICEPS PARTICIPANTs from other MANUFACTURERs. Conformity to SDC PKP Standards and
indication of this conformity creates confidence in these expectations and enables MANUFACTURERs to take the
responsibilities for SYSTEM FUNCTION CONTRIBUTIONs of their BICEPS PARTICIPANTs in an SDC SYSTEM. These
responsibilities pertain to technical design, implementation, verification, validation, RISK MANAGEMENT, USABILITY
ENGINEERING, and labeling of BICEPS PARTICIPANTs.
This standard defines the SDC METRIC PROVIDER and SDC METRIC CONSUMER PKPs, which comprise requirements
regarding METRICs and device components, i.e., CHANNELs, VMDs, and MDSs. Conformity to these PKPs supports safe,
effective, and secure exchange of METRIC data between SDC METRIC PARTICIPANTs in an SDC SYSTEM.
2. Normative references
The following referenced documents are indispensable for the application of this document (i.e., they must be understood and
used, so each referenced document is cited in text and its relationship to this document is explained). For dated references, only
the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments or
corrigenda) applies.
,
5 6
IEEE Std 11073-10101™, Health informatics—Point-of-care medical device communication—Part 10101: Nomenclature.
IEEE Std 11073-10207™, Health informatics—Point-of-care medical device communication—Part 10207: Domain Information
and Service Model for Service-Oriented Point-of-Care Medical Device Communication.
IEEE Std 11073-10700™, Health Informatics—Device Interoperability—Part 10700: Point-of-Care Medical Device
Communication—Standard for Base Requirements for Participants in a Service-Oriented Device Connectivity (SDC) System.
3. Definitions, acronyms, and abbreviations
3.1 Definitions
For the purposes of this document, the following terms and definitions apply. The IEEE Standards Dictionary Online should be
consulted for terms n
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