ISO/IEEE 11073-10101:2020/FDAmd 1

FINAL DRAFT
Amendment
ISO/IEEE
11073-10101:2020/
FDAM 1
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
2026-02-13
Part 10101:
Point-of-care medical device
Voting terminates on:
2026-07-03
communication — Nomenclature
Second edition
AMENDMENT 1: Additional definitions
2020-08
Informatique de santé — Interopérabilité des dispositifs —
AMENDMENT 1
Partie 10101: Communication entre dispositifs médicaux sur le
site des soins — Nomenclature
AMENDEMENT 1
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Reference number
ISO/IEEE FDIS 11073­10101:2020/FDAM
1:2026(en) © IEEE 2026
FINAL DRAFT
ISO/IEEE FDIS 11073-10101:2020/FDAM 1:2026(en)
Amendment
ISO/IEEE
11073-10101:2020/
FDAM 1
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
Part 10101:
Point-of-care medical device
Voting terminates on:
communication — Nomenclature
Second edition
AMENDMENT 1: Additional definitions
2020-08
Informatique de santé — Interopérabilité des dispositifs —
AMENDMENT 1
Partie 10101: Communication entre dispositifs médicaux sur le
site des soins — Nomenclature
AMENDEMENT 1
This document is circulated as received from the committee secretariat.
FAST TRACK PROCEDURE
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 SUPPORTING D OCUMENTATION.
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© IEEE 2026
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING
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Published in Switzerland ISO/IEEE FDIS 11073­10101:2020/FDAM
1:2026(en)
© IEEE 2024
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ISO/IEEE FDIS 11073-10101:2020/FDAM 1:2026(en)
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© IEEE 2024 – All rights reserved
iii
IEEE Std 11073-10101b™-2023
(Amendment to IEEE Std 11073-10101-2019)
Health informatics—Device Interoperability
Part 10101: Foundational—Nomenclature
Amendment 1: Additional definitions

Developed by the
IEEE 11073™ Standards Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 8 November 2023
IEEE SA Standards Board
ISO/IEEE FDIS 11073-10101:2020/FDAM 1:2026(en)

Abstract: The scope of this standard is to define a nomenclature for communication of information from point-of-
care medical devices. Primary emphasis is placed on acute care medical devices and patient vital signs
information. The nomenclature also supports concepts in an object oriented information model that is for medical
device communications. This amendment extends IEEE Std 11073-10101-2019 to include additional terms
primarily related to infusion pumps, ventilators, dialysis and other key medical devices as well as event and alert
identifiers for devices and systems used in acute care.

Keywords: alarm, alarm inactivation, alarms, alert communication, anesthesia, device containment model, device
model, dialysis, diaphragm, ECG, EDI, electrocardiography, events, fluid chemistry, hemodialysis, hemodynamic
monitoring, HFV, high flow therapy, high frequency ventilation, IEEE 11073-10101b™, IHE PCD, information
model, infusion pump, ISO 19223, ISO/IEEE 11073-10101, medical device alarms, medical device alerts, medical
device communication, medical device types, NAVA, network communication controller, neurally adjusted
ventilatory assist, neuromuscular blockade, neuromuscular stimulation, neuromuscular transmission, NMT,
nomenclature, observation set identifier, ontology, patient, patient controlled analgesia, PCA, POC, point-of-care,
pulse oximetry, pump library, query identifier, regional cerebral oximetry, rSO2, semantics, service-oriented device
connectivity, signal quality index, SQI, target controlled infusion, TCI, terminology, UCUM, units of measure,
ventilation, ventilation mode
•
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Participants
At the time this standard was completed, the Point-of-Care Devices Working Group had the following membership:
Stefan Schlichting, Working Group Chair
Paul Schluter, Working Subgroup Chair
Björn Andersen Martin Hurrell Roland Persson
Piyush Bhageriya Anders Häggström Mikael Petrini
Manfred Bier
Per Johansson Jan-Alrik Philipsen
Kimberly Brauer Norman Jones Dalibor Pokrajac
Malcolm Clarke Martin Kasparick John Rhoads
Todd Cooper Tobias Klotz Jeff Rinda
Steven Dain Tom Kowalczyk Mathieu Roullet
Lisa Diggett Mike Krajnak Daniel Rubery
Kurt Elliason Thomas Kreuger Neil Seidl
Al Engelbert Konstantinos Makrodimitris Naveen Sharma
Javier Espina Duane Martz Michael Tietz
Michael Faughn Eldon Metz Peter Verständig
Kenneth Fuchs Steve Myers John Walsh
John Garguilo Teri Neal Rob Wilder
David Gregorczyk Steven Nichols Brian Witkowski
Bill Haralson Monroe Pattillo 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.
Björn Andersen David Gregorczyk Stefan Schlichting
Pradeep Balachandran Charles Gropper Paul Schluter
Malcolm Clarke Werner Hoelzl Harry Solomon
Kurt Elliason Piotr Karocki Walter Struppler
Javier Espina Martin Kasparick Lisa Ward
Michael Faughn Raymond Krasinski Yu Yuan
Kenneth Fuchs H. Moll Oren Yuen
John Garguilo Rajesh Murthy Janusz Zalewski
Frank Golatowski John Rhoads Daidi Zhong
Scott Robertson
When the IEEE SA Standards Board approved this standard on 8 November 2023, it had the following membership:
David J. Law, Chair
Ted Burse, Vice Chair
Gary Hoffman, Past Chair
Konstantinos Karachalios, Secretary
Sara R. Biyabani Joseph S. Levy Paul Nikolich
Doug Edwards Howard Li Annette D. Reilly
Ramy Ahmed Fathy Johnny Daozhuang Lin Robby Robson
Guido R. Hiertz Gui Lin Lei Wang
Yousef Kimiagar Xiaohui Liu F. Keith Waters
Joseph L. Koepfinger* Kevin W. Lu Karl Weber
Thomas Koshy Daleep C. Mohla
Philip B. Winston
John D. Kulick Andrew Myles Don Wright

*Member Emeritus
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Introduction
This introduction is not part of IEEE Std 11073-10101b-2023, Health informatics—Device interoperability—
Part 10101: Foundational—Nomenclature—Amendment 1: Additional definitions.
ISO/IEEE 11073 standards enable communication between medical devices and external computer systems. 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 patient-connected medical devices
 Facilitate the efficient exchange of vital signs and medical device data, acquired at the point-of-care, in all health care
environments
This amendment extends the nomenclature defined in IEEE Std 11073-10101-2019. It reflects the continued innovation in
medical device and is based on a highly successful collaboration with the following organizations:
 Integrating the Healthcare Enterprise Devices (IHE DEV) domain, which includes the Patient Care Devices (PCD),
Personal Connected Health (PCH) and Device Point-of-Care Interoperability (DPi) Programs
 ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee 4, Terminology and semantics
In addition, other vendors and standards development and profiling organizations have contributed to and have recognized the
value of this work and the benefit it provides to the user and provider communities and to the patients that we ultimately serve.
This nomenclature amendment includes significant extensions to support:
 Haemodynamic monitoring, pulse oximetry and regional cerebral oxygen monitoring
 Respiratory, ventilation and anesthesia: high-frequency ventilation, high-flow therapy, neurally adjusted ventilatory
assist (NAVA) and ventilation mode based on ISO 19223
 Infusion pumps, target-controlled infusion (TCI), patient-controlled analgesia (PCA) and other capabilities based on
the work of the IHE DEV PCD domain program
 Hemodialysis for chronic and acute care, including fluid chemistry and other fluid related metrics
 Neuromuscular transmission monitoring (NMT) and stimulation modes
 Signal quality index (SQI) and mapping to a unified vendor- and device-independent representation
 Major extension of medical device event and alert nomenclature and grouping with existing terms
 Alarm inactivation and additional attributes related to alert management and communication
 New units of measurement
 New medical device types and monitoring parameters

This amendment also includes:
 Units of measure associated with individual numeric observations and attributes
 Enumerated values with descriptions associated with individual observations and attributes

NOTES as used in this amendment (preceding editorial instructions) are not meant to be included in the rollup or part of the
editorial instructions. They are used solely to provide informative guidance and background to the reader as to why certain
changes were made.
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Acknowledgments
Permissions have been granted as follows:
Hemodialysis Overview reprinted with permission from the Dialysis Interoperability Consortium © 2022.

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Contents
1. Overview . 1
1.1 Scope . 1
1.2 Word usage . 1

2. Normative references . 2

3. Terms, definitions, acronyms, and abbreviations . 2
3.1 Terms and definitions . 2
3.2 Symbols and abbreviated terms . 2

Annex A (normative) Nomenclature semantics . 4
A.1 Overview of nomenclature for vital signs—Semantics . 4
A.3 Data dictionary and codes for object-oriented modeling elements (Partition 1) . 5
A.3.2 Object-oriented modeling elements: inventory tables . 5
A.5 Nomenclature, data dictionary, and codes for vital signs, diagnostic and therapeutic devices (Partition 1) . 16
A.6 Terminology and codes for units of measurement (Partition 4) . 23
A.6.4 Units of measurement . 23
A.7 Nomenclature, data dictionary, and codes for metrics (measurements and enumerations)
(Partition 2) . 25
A.7.1 Nomenclature for ECG measurements . 25
A.7.3 Nomenclature, data dictionary, and codes for haemodynamic monitoring measurements . 26
A.7.4 Nomenclature and codes for respiratory, ventilator, and anesthesia measurements . 28
A.7.5 Nomenclature, data dictionary, and codes for common blood-gas, blood, urine, and
other fluid chemistry measurements . 38
A.7.7 Nomenclature, data dictionary, and codes for pumps . 40
A.7.10 Nomenclature, data dictionary, and codes for stimulation modes . 53
A.7.11 Nomenclature, data dictionary, and codes for miscellaneous measurements . 58
A.7.15 Nomenclature and codes for hemodialysis measurements . 63
A.8 Nomenclature, data dictionary, and codes for body sites and enumerated values (Partition 7) . 87
A.8.11 Nomenclature and codes for ventilator mode based on ISO 19223 . 87
A.9 Nomenclature, data dictionary, and codes for events and alerts (Partition 3) . 99
A.9.1 Introduction . 99
A.9.2 Diagnostic pattern events . 100
A.9.3 Device-related and environment-related events and alerts . 109
A.9.4 Alarm Inactivation State (AIS) events . 179
A.16 Information attributes to support IHE PCD DEC and PCHA/Continua Services Interface
(Partition 1 and Partition 8) . 185
A.17 Nomenclature to support the Service-oriented Device Connectivity (SDC) series of standards (Partition 8) . 187
A.17.1 IEEE P11073-10700 Ensemble nomenclature . 187
A.17.2 IEEE P11073-10700 Context validator nomenclature . 187
A.17.3 IEEE P11073-10700 Enumerated value set for medical device operational mode . 188

Annex C (normative) Terms, discriminators, and numeric codes . 189
C.3.18 Alarm Inactivation State [AIS] discriminator set . 189

Annex I (informative) Mapping vendor ventilation modes to ISO 19223 and IEEE 11073 . 235
I.1 Recommended process . 235
I.2 XSLT for converting ISO 19223 ventilator mode to IEEE 11073 Reference IDs . 252

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Annex J (normative) Units of measure and _UOM_GROUPS . 257
J.1 Specifying individual UOM_MDC and UOM_UCUM units of measure in Annex A . 257
J.2 Specifying _UOM_GROUPS . 258
J.3 Mapping UOM_MDC to UOM_UCUM units of measure . 259
J.4 List of UOM_MDC to UOM_UCUM units of measure . 259

Annex K (normative) MDC_ENUMGV enumeration groups and values. 284
K.3 Enum_Groups . 284
K.4 Enum_Values . 284
K.5 Creating Reference ID(s) from Enum_Group and Enum_Value . 285
K.6 Referencing enumerated value sets and/or PEGjs validation expressions . 285
K.7 Referencing enumerated value sets and/or PEGjs validation expressions . 286

Annex L (informative) Bibliography . 287

Annex M (informative) Revision history . 288

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Tables
Table A.3.2.2.2—Object-oriented modeling elements—Medical Package—attributes . 5
Table A.3.2.2.2.1—Enumerated values for [_MDC_ATTR_PT_BODY_POSN] (multipage table) . 5
Table A.3.2.2.2.1—Enumerated values for [_MDC_ATTR_PT_BODY_POSN] (multipage table) . 6
Table A.3.2.4.1—Object-oriented modeling elements—System Package—object class items . 7
Table A.3.2.4.2—Object-oriented modeling elements—System Package—attributes . 8
Table A.3.2.4.2.1—Enumerated values for [_MDC_ATTR_BATT_CONFIG] . 8
Table A.3.2.4.2.2—Enumerated values for [_MDC_ATTR_PILLAR_ASSEMBLY] . 9
Table A.3.2.4.2.3—PEGjs for [_MDC_ATTR_PILLAR_ASSEMBLY] . 9
Table A.3.2.4.2.4—PEGjs for [_MDC_ATTR_PUMP_PILLAR_DETAILS] . 9
Table A.3.2.4.6—Object-oriented modeling elements—System Package—additional object class items . 10
Table A.3.2.13.1—Object-oriented modeling elements—MEM-DMC NCC-Wired—attributes . 11
Table A.3.2.13.1.1—Enumerated values for [_BOOL] . 11
Table A.3.2.13.1.2—Enumerated values for [_MDC_NCC_WIRED_STATE] . 12
Table A.3.2.13.2—Object-oriented modeling elements—MEM-DMC NCC-Wireless—attributes (multipage table). 12
Table A.3.2.13.2.1—Enumerated values for [_MDC_NCC_WIRELESS_STATE] . 13
Table A.3.2.13.2.2—Enumerated values for [_MDC_NCC_WIRELESS_AUTH] . 13
Table A.3.2.13.2.3—Enumerated values for [_MDC_NCC_WIRELESS_ENCRYPT] . 14
Table A.3.2.13.2.4—Enumerated values for [_MDC_NCC_WIRELESS_BAND] . 14
Table A.3.2.14.2—Object-oriented modeling elements—USI—attributes . 15
Table A.3.2.15.1—Object-oriented modeling elements—QPD—message query name identifiers . 15
Table A.5.1—Nomenclature and codes for vital signs, diagnostic and therapeutic devices (multipage table) . 16
Table A.5.1—Nomenclature and codes for vital signs, diagnostic and therapeutic devices (multipage table) . 17
Table A.5.1—Nomenclature and codes for vital signs, diagnostic and therapeutic devices (multipage table) . 18
Table A.5.1—Nomenclature and codes for vital signs, diagnostic and therapeutic devices (multipage table) . 19
Table A.5.1—Nomenclature and codes for vital signs, diagnostic and therapeutic devices (multipage table) . 20
Table A.5.1—Nomenclature and codes for vital signs, diagnostic and therapeutic devices (multipage table) . 21
Table A.5.2—Device Type placeholder . 22
Table A.6.4.1—Vital signs units of measurement (multipage table) . 23
Table A.6.4.1—Vital signs units of measurement (multipage table) . 24
Table A.7.1.6.2—Nomenclature and codes for ECG measurements with lead origin (multipage table) . 25
Table A.7.3.6.1—Nomenclature and codes for haemodynamic monitoring measurements (multipage table) . 26
Table A.7.3.6.1—Nomenclature and codes for haemodynamic monitoring measurements (multipage table) . 27
Table A.7.4.11.3—Ventilator modes nomenclature and codes . 28
Table A.7.4.11.3.1—Enumerated values for [_MDC_VENT_MODE_SEL_ADJUNCTS_ISO_19223] . 29
Table A.7.4.11.3.2—Enumerated values for [_MDC_VENT_MODE_TRIGGER_TYPE] . 29
Table A.7.4.11.3.3—Enumerated values for [_MDC_VENT_OPERATIONAL_STATE] . 30
Table A.7.4.19.2—Nomenclature and codes for respiratory, ventilator, and anesthesia measurements (multipage table). 32
Table A.7.5.6.1—Nomenclature and codes for common blood-gas, blood, urine, and other fluid chemistry measurements
(multipage table) . 38
Table A.7.5.6.1—Nomenclature and codes for common blood-gas, blood, urine, and other fluid chemistry measurements
(multipage table) . 39
Table A.7.5.6.2—Regional brain oxygen saturation (rSO2) (multipage table) . 39
Table A.7.5.6.2—Regional brain oxygen saturation (rSO2) (multipage table) . 40
Table A.7.7.20.1—Nomenclature and codes for pump data (multipage table) . 41
Table A.7.7.20.1—Nomenclature and codes for pump data (multipage table) . 42
Table A.7.7.20.1—Nomenclature and codes for pump data (multipage table) . 43
Table A.7.7.20.1—Nomenclature and codes for pump data (multipage table) . 44
Table A.7.7.20.1—Nomenclature and codes for pump data (multipage table) . 45
Table A.7.7.20.1—Nomenclature and codes for pump data (multipage table) . 46
Table A.7.7.20.1—Nomenclature and codes for pump data (multipage table) . 47
Table A.7.7.20.1—Nomenclature and codes for pump data (multipage table) . 48
Table A.7.7.20.1.1—Enumerated values for [_MDC_PUMP_INFUSING_STATUS] . 48
Table A.7.7.20.1.2—Enumerated values for [_PUMP_SOURCE_INFO] . 49
Table A.7.7.20.1.3—Enumerated values for [_MDC_PUMP_CURRENT_DELIVERY_STATUS] . 49
Table A.7.7.20.1.4—Enumerated values for [_MDC_PUMP_NOT_DELIVERING_REASON]. 50
Table A.7.7.20.1.5—Enumerated values for [_MDC_PUMP_PROGRAM_COMPLETION_MODE] . 50
Table A.7.7.20.1.6—Enumerated values for [_MDC_PUMP_PROGRAM_DELIVERY_MODE] . 50
Table A.7.7.20.1.7—Enumerated values for [_MDC_PUMP_
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