INTERNATIONAL ISO/IEEE

STANDARD 11073-10101

Second edition
2020-08

Health informatics — Device

interoperability —
Part 10101:
Point-of-care medical device
communication — Nomenclature
Informatique de santé
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Foreword
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Committee ISO/TC 215, Health informatics.
This second edition cancels and replaces the first edition (ISO/IEEE 11073-10101:2004), which has been
technically revised. It also incorporates the Amendment ISO/IEEE 11073-10101:2004/Amd 1:2017.
A list of all parts in the ISO/IEEE 11073 series can be found on the ISO website.
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 IEEE Std 11073-10101™-2019
(Revision of
ISO/IEEE 11073-10101:2004)

Health informatics—Point-of-care medical device communication

Part 10101: Nomenclature

Developed by the

IEEE 11073™ Standards Committee

of the
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IEEE Engineering in Medicine and Biology Society

(standards.iteh.ai)
Approved 13 June 2019
ISO/IEEE 11073-10101:2020
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ISO/IEEE 11073-10101:2020(E)

Abstract: Within the context of the ISO/IEEE 11073 family of standards for point-of-care (POC)
and personal health devices (PHD) medical device communication (MDC), this standard provides
the nomenclature that supports both the domain information model and service model
components of the standards family, as well as the semantic content exchanged with medical
devices. The nomenclature is specialized for patient vital signs information representation and
medical device informatics, with major areas including concepts for electrocardiograph (ECG),
haemodynamics, respiration, blood gas, urine, fluid-related metrics, and neurology, as well as
specialized units of measurement, general device events, alarms, and body sites. The standard
defines both the architecture and major components of the nomenclature, along with extensive
definitions for each conceptual area.

Keywords: codes, IEEE 11073-10101™, IHE PCD-01, independent living, information model,
medical device communication, nomenclature, ontology, patient, personal health devices, PHD,
POC, point-of-care, semantics, service model, terminology

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Participants
At the time this draft standard was approved by the IEEE SA Standards Board, the Point-of-Care Devices
Working Group had the following membership:

Malcolm Clarke, Chair

Paul Schluter, Vice Chair

Spencer Crosswy Kai Hassing Mathieu Roullet

Steven Dain Stefan Karl Stefan Schlichting
Michael Faughn Brian Reinhold Richard Tayrien
Kenneth Fuchs Melvin Reynolds Michi Tietz
Marcus Garbe John Rhoads Jan Wittenber
John Garguilo Daidi Zhong

The following members of the individual balloting committee voted on this standard. Balloters may have
voted for approval, disapproval, or abstention.

Bjoern Andersen Noriyuki Ikeuchi Paul Schluter

Keith Chow Atsushi Ito Walter Struppler
Malcolm Clarke Stefan Karl Ganesh Subramanian
David Fuschi Piotr Karocki Lisa Ward
Randall Groves Martin Kasparick Jan Wittenber
Kai Hassing H. Moll Oren Yuen
Werner Hoelzl iTeh STANDARD PREVIEW
Beth Pumo Daidi Zhong
Stefan Schlichting
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When the IEEE SA Standards Board approved this standard on 13 June 2019, it had the following
membership: ISO/IEEE 11073-10101:2020
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Gary Hoffman, Chair
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Ted Burse, Vice Chair
Jean-Philippe Faure, Past Chair
Konstantinos Karachalios, Secretary

Masayuki Ariyoshi Thomas Koshy Annette D. Reilly

Ted Burse John D. Kulick Dorothy Stanley
Stephen D. Dukes David J. Law Sha Wei
J. Travis Griffith Joseph Levy Phil Wennblom
Guido Hiertz Howard Li Philip Winston
Christel Hunter Xiaohui Liu Howard Wolfman
Thomas Koshy Kevin Lu Feng Wu
Joseph L. Koepfinger* Daleep Mohla Jingyi Zhou
Andrew Myles

*Member Emeritus

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Introduction

This introduction is not part of IEEE Std 11073-10101-2019, Health informatics—Point-of-Care Medical Device
Communication—Nomenclature.

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.

“Real-time” means that data from multiple devices can be retrieved, time correlated, and displayed or
processed in fractions of a second. “Plug-and-play” means that all the clinician has to do is make the
connection — the systems automatically detect, configure, and communicate without any other human
interaction.

“Efficient exchange of medical device data” means that information that is captured at the point-of-care
(e.g., patient vital signs data) can be archived, retrieved, and processed by many different types of
applications without extensive software and equipment support, and without needless loss of information.
The standards focus on acute care devices, such as patient monitors, ventilators, infusion pumps, ECG
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devices, etc, and personal health devices and systems. They comprise a family of standards that can be
layered together to provide connectivity optimized for the specific devices being interfaced.
(standards.iteh.ai)
IEEE Std 11073-10101 was originally published in 2004 in conjunction with the International Organization
for Standardization (ISO). In 2015, IEEE published
ISO/IEEE an amendment that expanded the nomenclature and
11073-10101:2020
definitions coveredhttps://standards.iteh.ai/catalog/standards/sist/f60b7e23-9ec8-4520-864c-
in the standard to reflect the continued innovation in medical device and system design.
This 2019 revision integrates the amendment into the original text and further updates and expands the
6876486bf213/iso-ieee-11073-10101-2020
nomenclature and definitions.

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Contents

1. Scope ........................................................................................................................................................ 20

2. Normative references................................................................................................................................ 20

3. Terms, definitions, symbols, and abbreviated terms................................................................................. 22

3.1 Terms and definitions ........................................................................................................................ 22
3.2 Symbols and abbreviated terms ......................................................................................................... 22

4. Conformance ............................................................................................................................................ 25

5. Introduction to the standard ...................................................................................................................... 25

6. Application ............................................................................................................................................... 25

7. Semantics.................................................................................................................................................. 26
7.1 Attribution ......................................................................................................................................... 26
7.2 Coding ............................................................................................................................................... 27
7.2.1 Context-sensitivity ..................................................................................................................... 27
7.2.2 Grouping .................................................................................................................................... 28
7.3 Synonyms .......................................................................................................................................... 29
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7.4 Deprecated terms ............................................................................................................................... 29
7.5 Withdrawn terms ............................................................................................................................... 29
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8. Syntax ....................................................................................................................................................... 29
8.1 Transfer..............................................................................................................................................
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8.1.1 Types..........................................................................................................................................
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8.1.2 Notation .....................................................................................................................................
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8.2 Programmatic form ............................................................................................................................ 32
8.2.1 Attribution .................................................................................................................................. 32
8.2.2 Notation ..................................................................................................................................... 32

9. Extensibility.............................................................................................................................................. 33

10. Version exporting ................................................................................................................................... 33

Annex A (normative) Nomenclature semantics........................................................................................... 34

A.1 Overview of nomenclature for vital signs—Semantics .................................................................... 34
A.2 Code assignment to the MDIB elements........................................................................................... 35
A.2.1 Overview ................................................................................................................................... 35
A.2.2 Relationship to other standards ................................................................................................. 35
A.2.3 Basic rules ................................................................................................................................. 35
A.2.4 Coding spaces ........................................................................................................................... 36
A.3 Data dictionary and codes for object-oriented modeling elements (Partition 1) ............................... 45
A.3.1 Introduction ............................................................................................................................... 45
A.3.2 Object-oriented modeling elements: inventory tables ............................................................... 46
A.4 Data dictionary and codes for communication infrastructure (Partition 8) ....................................... 79
A.4.1 Introduction ............................................................................................................................... 79
A.4.2 Communication infrastructure: inventory tables ....................................................................... 79
A.5 Nomenclature, data dictionary, and codes for vital signs devices (Partition 1) ................................ 84
A.5.1 Introduction ............................................................................................................................... 84
A.5.2 Base concepts ............................................................................................................................ 85

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A.5.3 First set of differentiating criteria.............................................................................................. 85

A.5.4 Second set of differentiating criteria ......................................................................................... 86
A.5.5 Third set of differentiating criteria ............................................................................................ 86
A.5.6 Attributes................................................................................................................................... 87
A.5.7 Device class discriminator ........................................................................................................ 87
A.5.8 Code table ................................................................................................................................. 87
A.6 Terminology and codes for units of measurement (Partition 4)........................................................ 98
A.6.1 Introduction ............................................................................................................................... 98
A.6.2 Orders of magnitude discriminator ........................................................................................... 98
A.6.3 Units outside of SI..................................................................................................................... 99
A.6.4 Units of measurement ..............................................................................................................100
A.6.5 Withdrawn terms for vital signs units of measurement ............................................................122
A.6.6 Deprecated terms for vital signs units of measurement ............................................................123
A.6.7 Deprecated RefIds for Vital Signs Units of Measurement .......................................................124
A.7 Nomenclature, data dictionary, and codes for metrics (measurements and enumerations)
(Partition 2) .............................................................................................................................................125
A.7.1 Nomenclature for ECG measurements .....................................................................................125
A.7.2 Nomenclature for ECG enumerations ......................................................................................157
A.7.3 Nomenclature, data dictionary, and codes for haemodynamic monitoring measurements ......173
A.7.4 Nomenclature and codes for respiratory, ventilator, and anesthesia measurements.................192
A.7.5 Nomenclature, data dictionary, and codes for common blood-gas, blood, urine, and other
fluid chemistry measurements ...........................................................................................................273
A.7.6 Nomenclature, data dictionary, and codes for fluid output measurements...............................288
A.7.7 Nomenclature, data dictionary, and codes for pumps ..............................................................292
A.7.8 Nomenclature, data dictionary, and codes for neurological monitoring measurements ...........309
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A.7.9 Nomenclature, data dictionary, and codes for neurophysiologic enumerations .......................322
A.7.10 Nomenclature, data dictionary, and codes for stimulation modes ..........................................346
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A.7.11 Nomenclature, data dictionary, and codes for miscellaneous measurements .........................353
A.7.12 Nomenclature and code extensions for infant incubator and warmer microenvironments.....360
A.7.13 Nomenclature, data dictionary, ISO/IEEE 11073-10101:2020
and codes for spirometry ......................................................362
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A.7.14 Nomenclature and code extensions for personal health devices ............................................372
A.8 Nomenclature, data dictionary, and codes for body sites (Partition 7) ............................................377
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A.8.1 Introduction ..............................................................................................................................377
A.8.2 Sites for neurophysiological signal monitoring: locations near peripheral nerves ...................378
A.8.3 Sites for neurophysiological signal monitoring: locations near muscles..................................392
A.8.4 Sites for EEG-electrode placement on the head .......................................................................430
A.8.5 Sites for EOG signal monitoring ..............................................................................................438
A.8.6 Sites for general neurological monitoring measurements and drainage ...................................443
A.8.7 Sites for cardiovascular measurements ....................................................................................445
A.8.8 Miscellaneous sites used in vital signs monitoring and measurement .....................................451
A.8.9 Equipment sites used in vital signs monitoring and measurement ...........................................466
A.8.10 Qualifiers of body site locations.............................................................................................468
A.9 Nomenclature, data dictionary, and codes for events and alerts (Partition 3) ..................................472
A.9.1 Introduction ..............................................................................................................................472
A.9.2 Diagnostic pattern events .........................................................................................................472
A.9.3 Device-related and environment-related events .......................................................................483
A.10 Systematic derivations of terms and codes for infrastructure (Partition 8) ....................................519
A.10.1 Introduction ............................................................................................................................519
A.10.2 Base concepts, device specialization ......................................................................................519
A.10.3 Base concepts, device sub-specialization ...............................................................................523
A.10.4 Base concepts, time synchronization profiles ........................................................................526
A.11 Systematic derivations of terms and codes for personal health devices disease management
(Partition 128) .........................................................................................................................................527
A.11.1 Introduction ............................................................................................................................527
A.11.2 Base concepts, general device properties ...............................................................................527
A.11.3 Base concepts, Basic ECG sensors and status ........................................................................528

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ISO/IEEE 11073-10101:2020(E)

A.11.4 Base concepts, Basic ECG event context ...............................................................................528

A.11.5 Base concepts, SABTE sensors and settings ..........................................................................529
A.11.6 Base concepts, SABTE modes ...............................................................................................540
A.11.7 Base concepts, Glucose Monitoring, carbohydrate source .....................................................542
A.11.8 Base concepts, Glucose Monitoring, carbohydrate source .....................................................543
A.11.9 Base concepts, Glucose Monitoring, carbohydrate sources ...................................................543
A.11.10 Base concepts, Glucose Monitoring, insulin type ................................................................545
A.11.11 Base concepts, Glucose Monitoring, insulin types ...............................................................546
A.11.12 Base concepts, Glucose Monitoring, general health.............................................................547
A.11.13 Base concepts, Glucose Monitoring, general health.............................................................548
A.11.14 Base concepts, Glucose Monitoring, sample location ..........................................................549
A.11.15 Base concepts, Glucose Monitoring, sample locations ........................................................549
A.11.16 Base concepts, Glucose Monitoring, meal ...........................................................................551
A.11.17 Base concepts, Glucose Monitoring, meal type ...................................................................552
A.11.18 Base concepts, Glucose Monitoring, tester ..........................................................................553
A.11.19 Base concepts, Glucose Monitoring, tester type ..................................................................554
A.11.20 INR Status and Context ........................................................................................................554
A.11.21 Base concepts, Continuous Glucose Monitoring..................................................................556
A.11.22 Base concepts, Continuous Glucose Monitoring, status.......................................................558
A.11.23 Base concepts, Continuous Glucose Monitoring, device .....................................................559
A.11.24 Base concepts, Insulin Pump, sensors ..................................................................................560
A.11.25 Base concepts, Power StatusMonitor, sensors .....................................................................563
A.11.26 Base concepts, Power Status Monitor, battery .....................................................................564
A.11.27 Base concepts, Peak Expiratory Flow ..................................................................................565
A.12 Systematic derivations of terms and codes for health and fitness (Partition 129)..........................566
iTeh STANDARD PREVIEW
A.12.1 Introduction ............................................................................................................................566
A.12.2 Base concepts .........................................................................................................................566
(standards.iteh.ai)
A.12.3 First set of differentiating criteria, sensors .............................................................................566
A.12.4 Second set of differentiating criteria, activity ........................................................................570
A.12.5 First set of differentiating ISO/IEEE 11073-10101:2020
criteria, exercise ............................................................................572
https://standards.iteh.ai/catalog/standards/sist/f60b7e23-9ec8-4520-864c-
A.12.6 Second set of differentiating criteria, exercise .......................................................................572
A.13 Systematic derivations of terms and codes for independent living monitoring measurements
6876486bf213/iso-ieee-11073-10101-2020
(Partition 130) .........................................................................................................................................575
A.13.1 Introduction ............................................................................................................................575
A.13.2 Base concepts .........................................................................................................................575
A.13.3 First set of differentiating criteria, sensor ..............................................................................575
A.13.4 Second set of differentiating criteria, location, general ..........................................................579
A.13.5 Second set of differentiating criteria, location, room .............................................................581
A.13.6 Second set of differentiating criteria, location, medical room ...............................................584
A.13.7 Second set of differentiating criteria, location, doors and windows.......................................586
A.13.8 Second set of differentiating criteria, location, furniture........................................................587
A.13.9 Second set of differentiating criteria, location, appliance ......................................................588
A.13.10 Third set of differentiating criteria, AI events ......................................................................590
A.13.11 First set of differentiating criteria, sensors, medication dispenser .......................................593
A.14 Nomenclature for error return codes (Partition 255)......................................................................595
A.14.1 Base concepts .........................................................................................................................595
A.14.2 First set of differentiating criteria...........................................................................................595
A.14.3 Code table ..............................................................................................................................595
A.14.4 Withdrawn terms for error return codes .................................................................................596
A.15 Nomenclature, data dictionary, and codes for external nomenclatures and messaging standards
(Partition 256) .........................................................................................................................................597
A.15.1 Introduction ............................................................................................................................597
A.15.2 Base concepts .........................................................................................................................597
A.15.3 First set of differentiating criteria...........................................................................................597
A.15.4 Second set of differentiating criteria ......................................................................................598
A.15.5 Third set of differentiating criteria .........................................................................................598

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Copyright © 2019 IEEE. All rights reserved.
 ISO/IEEE 11073-10101:2020(E)

A.15.6 Discriminator .........................................................................................................................598

A.15.7 Code table ..............................................................................................................................598
A.16 Information attributes to support IHE PCD DEC and PCHA/Continua Services Interface
(Partition 1 and Partition 8) ....................................................................................................................602
A.16.1 Information attributes to support IHE PCD Alert Communication Management ..................602
A.16.2 Notification attributes to support IHE PCD Alert Communication Management ..................602
A.16.3 Infrastructure attributes to support PCHA/Continua Services Interface and
IHE PCD DEC ...................................................................................................................................602
A.16.4 Information attributes to support PCHA/Continua Services Interface ...................................604
A.16.5 Information attributes to support IHE PCD DEC and PCHA/Continua Services Interface
timekeeping ........................................................................................................................................604
A.16.6 Information attributes to support semantics defined by this standard ....................................607
A.16.7 Information attributes to support ECG semantics defined by this standard ...........................607

Annex B (normative) Nomenclature syntax ...............................................................................................608

B.1 General .............................................................................................................................................608
B.1.1 Notation ....................................................................................................................................608
B.1.2 Partition codes ..........................................................................................................................608
B.2 Object infrastructure and device nomenclature – Partition 1 ...........................................................609
B.2.1 Object infrastructure .................................................................................................................609
B.2.2 Device nomenclature ................................................................................................................630
B.3 Medical supervisory control and data acquisition (SCADA) – Partition 2 ......................................650
B.3.1 Discriminator ranges ................................................................................................................650
B.3.2 SCADA Term Codes ................................................................................................................651
iTeh STANDARD PREVIEW
B.4 Events – Partition 3 ..........................................................................................................................722
B.5 Dimensions – Partition 4 ..................................................................................................................741
(standards.iteh.ai)
B.6 Virtual attributes – Partition 5 ..........................................................................................................761
B.7 Parameter groups – Partition 6 .........................................................................................................761
B.8 Body Sites – Partition 7 ...................................................................................................................761
B.9 Communication infrastructure – ISO/IEEE Partition 811073-10101:2020
.....................................................................................802
https://standards.iteh.ai/catalog/standards/sist/f60b7e23-9ec8-4520-864c-
B.10 File Exchange Format – Partition 9 ...............................................................................................810
B.11 ECG Extension – Partition 10 ........................................................................................................810
6876486bf213/iso-ieee-11073-10101-2020
B.12 ICDO Extension – Partition 11 ......................................................................................................810
B.13 PHD Disease Management – Partition 128 ....................................................................................810
B.14 PHD Health Fitness – Partition 129 ...............................................................................................820
B.15 PHD Aging Independently – Partition 130 ....................................................................................824
B.16 Return Codes – Partition 255 .........................................................................................................835
B.17 External nomenclature – Partition 256 ...........................................................................................836
B.18 Device Settings – Partition 258 ......................................................................................................837
B.19 Device Predicted Values – Partition 514........................................................................................840

Annex C (normative) Terms, discriminators, and numeric codes ...............................................................843

C.1 Overview ..........................................................................................................................................843
C.2 Discriminators ..................................................................................................................................843
C.3 Discriminator sets ............................................................................................................................844
C.3.1 Device Type [MVC] discriminator set .....................................................................................844
C.3.2 Statistical [MMM] discriminator set ........................................................................................844
C.3.3 Haemodynamic pressure measurements [SDM] discriminator set ...........................................844
C.3.4 Rates for countable events [RCE] discriminator set .................................................................845
C.3.5 Rates for countable neurological events [RCN] discriminator set............................................845
C.3.6 Body Site Orientation (laterally) [LAT] discriminator set .......................................................845
C.3.7 Unit of Measure [UoM] discriminator set ................................................................................846
C.3.8 Unit of Measure (singular) [UoM1] discriminator ...................................................................846
C.3.9 No [1] Discriminator ................................................................................................................847
C.3.10 Event [2] discriminator set .....................................................................................................847
C.3.11 Statistical profile [PN3] discriminator set ..............................................................................847

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Copyright © 2019 IEEE. All rights reserved.