Health informatics -- Device interoperability

This document defines 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 communication.

Informatique de santé -- Interopérabilité des dispositifs

La présente norme définit une nomenclature pour la communication d’informations à partir de dispositifs médicaux aux sites des soins. L’accent est mis principalement sur les dispositifs médicaux de soins actifs et les informations relatives aux signes vitaux du patient. La nomenclature prend également en charge les concepts dans un modèle d’information orienté objet destiné à la communication entre les dispositifs médicaux.

General Information

Status
Published
Publication Date
27-Aug-2020
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
22-May-2020
Completion Date
21-May-2020
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ISO/IEEE
INTERNATIONAL
11073-10101
STANDARD
Second edition
2020-08
Health informatics — Device
interoperability —
Part 10101:
Point-of-care medical device
communication — Nomenclature
Informatique de santé — Interopérabilité des dispositifs —
Partie 10101: Communication entre dispositifs médicaux sur le site
des soins — Nomenclature
Reference number
ISO/IEEE 11073-10101:2020(E)
IEEE 2019
---------------------- Page: 1 ----------------------
ISO/IEEE 11073-10101:2020(E)
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© IEEE 2019

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

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Published in Switzerland
ii © IEEE 2019 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/IEEE 11073-10101:2020(E)
Foreword

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IEEE Standards documents are developed within the IEEE Societies and the Standards Coordinating

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ISO/IEEE 11073-10101 was prepared by the IEEE 11073 Standards Committee of the IEEE

Engineering in Medicine and Biology Society (as IEEE Std 11073-10101-2019) and drafted in

accordance with its editorial rules. It was adopted, under the “fast-track procedure” defined in the Partner

Standards Development Organization cooperation agreement between ISO and IEEE, by Technical

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.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www.iso.org/members.html.
© IEEE 2019 – All rights reserved iii
---------------------- Page: 3 ----------------------
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
IEEE Engineering in Medicine and Biology Society
Approved 13 June 2019
IEEE SA Standards Board
---------------------- Page: 4 ----------------------
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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Incorporated.
HL7 is a registered trademark of Health Level Seven, Inc. (http://www.hl7.org).

SNOMED is a registered trademark of the College of American Pathologists (http://www.cap.org).

PDF: ISBN 978-1-5044-5981-5 STD23760
Print: ISBN 978-1-5044-5982-2 STDPD23760
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Copyright © 2018 IEEE. All rights reserved.
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ISO/IEEE 11073-10101:2020(E)
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ISO/IEEE 11073-10101:2020(E)
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ISO/IEEE 11073-10101:2020(E)
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ISO/IEEE 11073-10101:2020(E)
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 Beth Pumo Daidi Zhong
Stefan Schlichting

When the IEEE SA Standards Board approved this standard on 13 June 2019, it had the following

membership:
Gary Hoffman, Chair
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
Copyright © 2019 IEEE. All rights reserved.
---------------------- Page: 9 ----------------------
ISO/IEEE 11073-10101:2020(E)
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

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.

IEEE Std 11073-10101 was originally published in 2004 in conjunction with the International Organization

for Standardization (ISO). In 2015, IEEE published an amendment that expanded the nomenclature and

definitions covered 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

nomenclature and definitions.
Copyright © 2019 IEEE. All rights reserved.
---------------------- Page: 10 ----------------------
ISO/IEEE 11073-10101:2020(E)
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

7.4 Deprecated terms ............................................................................................................................... 29

7.5 Withdrawn terms ............................................................................................................................... 29

8. Syntax ....................................................................................................................................................... 29

8.1 Transfer .............................................................................................................................................. 29

8.1.1 Types .......................................................................................................................................... 29

8.1.2 Notation ..................................................................................................................................... 30

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

Copyright © 2019 IEEE. All rights reserved.
---------------------- Page: 11 ----------------------
ISO/IEEE 11073-10101:2020(E)

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 ou
...

NORME ISO/IEEE
INTERNATIONALE 11073-
10101
Deuxième édition
2020-08
Informatique de santé —
Interopérabilité des dispositifs —
Partie 10101:
Communication entre dispositifs
médicaux sur le site des soins —
Nomenclature
Health informatics — Device interoperability —
Part 10101: Point-of-care medical device communication —
Nomenclature
Numéro de référence
ISO/IEEE 11073-10101:2020(F)
IEEE 2019
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ISO/IEEE 11073-10101:2020(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© IEEE 2019

Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette

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être demandée à l’IEEE à l’adresse ci-après.
Institute of Electrical and Electronics Engineers, Inc
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E-mail: stds.ipr@ieee.org
Website: www.ieee.org
Publié en Suisse
ii © IEEE 2019 – Tous droits réservés
---------------------- Page: 2 ----------------------
ISO/IEEE 11073-10101:2020(F)
Avant-propos

L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes

nationaux de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales

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L'ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui

concerne la normalisation électrotechnique.

Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont

décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier de prendre note des

différents critères d'approbation requis pour les différents types de documents ISO (voir

www.iso.org/directives).

Les documents normatifs de l’IEEE sont développés au sein des sociétés de l’IEEE et des Comités de

Coordination des Normes du Conseil des Normes de l’Association des normes IEEE (IEEE-SA). L’IEEE

élabore ses normes par le biais d’un processus d'élaboration du consensus approuvé par l’American

National Standards Institute, qui rassemble des volontaires représentant divers points de vue et

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L'attention est attirée sur le fait que certains des éléments du présent document peuvent faire l'objet

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Les appellations commerciales éventuellement mentionnées dans le présent document sont données

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Pour une explication de la nature volontaire des normes, la signification des termes et expressions

spécifiques de l'ISO liés à l'évaluation de la conformité, ou pour toute information au sujet de

l'adhésion de l'ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les

obstacles techniques au commerce (OTC), voir www.iso.org/iso/fr/avant-propos.

ISO/IEEE 11073-10101 a été élaborée par le Comité des normes IEEE 11073 de la Société

d’Ingénierie en Médecine et Biologie de l’IEEE (en tant que norme IEEE 11073-10101-2019) et

rédigée conformément à ses règles de rédaction. Elle a été adoptée par le comité technique

ISO/TC 215, Informatique de santé, dans le cadre de la «procédure par voie express» définie par

l’accord de coopération PSDO (Organisation partenaire élaboratrice de norme) entre l’ISO et l’IEEE.

Cette deuxième édition annule et remplace la première édition (ISO/IEEE 11073-10101:2004), qui a

fait l’objet d’une révision technique. Elle intègre également l’Amendement ISO/IEEE 11073-

10101:2004/Amd.1:2017.

Une liste de toutes les parties de la série ISO/IEEE 11073 se trouve sur le site web de l’ISO.

© IEEE 2019 – Tous droits réservés
iii
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ISO/IEEE 11073-10101:2020(F)

Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent

document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits

organismes se trouve à l’adresse www.iso.org/fr/members.html.
© IEEE 2019 – Tous droits réservés
---------------------- Page: 4 ----------------------
IEEE 11073-10101™-2019
(Révision de
l’ISO/IEEE 11073-10101:2004)
Informatique de santé — Communication entre dispositifs
médicaux sur le site des soins
Partie 10101 : — Nomenclature
Élaborée par le
Comité des normes IEEE 11073™
de la
Société d’Ingénierie en Médecine et Biologie de l’IEEE
Approuvée le 13 juin 2019
Conseil des Normes IEEE SA
---------------------- Page: 5 ----------------------
ISO/IEEE 11073-10101:2020(F)
Résumé : dans le contexte de l’ensemble de normes ISO/IEEE 11073 relatives aux

dispositifs médicaux sur les sites des soins et à la communication entre dispositifs de

santé personnels, la présente norme fournit la nomenclature qui prend en charge à la

fois le modèle d’information du domaine et les composantes de modèle de service de la

famille de normes, ainsi que le contenu sémantique échangé entre les dispositifs

médicaux. La nomenclature est spécialisée dans la représentation des informations

relatives aux signes vitaux d’un patient et l’informatique des dispositifs médicaux, avec

des domaines majeurs tels que des concepts pour l’électrocardiographe (ECG),

l’hémodynamique, la respiration, le gaz sanguin, l’urine, les mesurages liés aux fluides et

la neurologie, ainsi que des unités de mesure spécialisées, les événements de dispositifs

généraux, les alarmes et les sites corporels. La norme définit à la fois l’architecture et les

principaux composants de la nomenclature, ainsi que des définitions étendues pour

chaque domaine conceptuel.
Mots-clés : codes, IEEE 11073-10101™, IHE PCD-01, vie autonome, modèle

d’information, communication entre dispositifs médicaux, nomenclature, ontologie,

patient, dispositifs de santé personnels, PHD, POC, site des soins, sémantique, modèle de

service, terminologie
Copyright © 2019 IEEE. Tous droits réservés.
---------------------- Page: 6 ----------------------
ISO/IEEE 11073-10101:2020(F)
Notes importantes et rejets de responsabilité concernant les documents
normatifs de l’IEEE

Les documents de l’IEEE sont mis à disposition pour utilisation sous réserve de notes

importantes et de rejets de responsabilité légale. Ces notes et rejets de responsabilité, ou

une référence à cette page, apparaissent dans toutes les normes et peuvent être trouvés

sous l’en-tête « Notes importantes et rejets de responsabilité concernant les documents

normatifs de l’IEEE ». Ils peuvent également être obtenus sur demande auprès de l’IEEE

ou visualisés sur le site : http://standards.ieee.org/ipr/disclaimers.html.
Note et rejet de responsabilité concernant l’utilisation des documents
normatifs de l’IEEE

Les documents normatifs de l’IEEE (normes, usages recommandés et guides), à la fois

pour une utilisation pleine et un essai d’utilisation, sont développés au sein des sociétés

de l’IEEE et des Comités de Coordination des Normes du Conseil des Normes de

l’Association des normes IEEE (IEEE-SA). L’IEEE (« l’Institut ») élabore ses normes par

le biais d’un processus de développement de consensus approuvé par l’American

National Standards Institute (« ANSI »), qui rassemble des volontaires représentant

divers points de vue et divers intérêts pour parvenir au produit final. Les normes de

l’IEEE sont des documents élaborés par des groupes de travail scientifiques,

universitaires et techniques (issus du secteur industriel). Les volontaires collaborant

aux groupes de travail de l’IEEE ne sont pas nécessairement des membres de l’Institut et

aucune compensation ne leur est attribuée pour leur participation. Bien que l’IEEE

administre le processus et établisse des règles pour favoriser l’équité au cours du

processus de développement du consensus, l’IEEE n’évalue pas, ne soumet pas à essai ou

ne vérifie pas de manière indépendante l’exactitude des informations ni le bien-fondé de

tous les jugements contenus dans ses normes.

Les normes de l’IEEE ne fournissent ni garantie, ni assurance quant à la sûreté, la

sécurité, la santé ou la protection environnementale, et n’assurent pas de protection

contre les interférences avec d’autres dispositifs ou réseaux ou provenant de ceux-ci. Les

personnes qui mettent en œuvre et celles qui utilisent les documents normatifs de l’IEEE

sont responsables de la détermination appropriée de la sûreté, de la sécurité, des

pratiques environnementales, sanitaires et de protection contre les interférences et de

toutes les lois et réglementations applicables ainsi que de la conformité à celles-ci.

L’IEEE ne garantit ni ne représente l’exactitude ou le contenu des informations

contenues dans ses normes, et décline expressément toute garantie (explicite, implicite

et statutaire) non incluse dans le présent document ou tout autre document en rapport

avec la norme, y compris, sans toutefois s’y limiter, les garanties d’aptitude à la

commercialisation, d’adéquation à un usage particulier, de non-contrefaçon, ainsi que de

qualité, précision, efficacité, actualité ou intégrité des informations. De plus, l’IEEE

renonce à toutes les conditions relatives aux résultats et aux efforts professionnels. Les

documents normatifs de l’IEEE sont fournis « EN L’ÉTAT » et « AVEC TOUS LES
DÉFAUTS ».
vi7 i
Copyright © 2019 IEEE. Tous droits réservés.
Copyright © 2019 IEEE. Tous droits réservés.
---------------------- Page: 7 ----------------------
ISO/IEEE 11073-10101:2020(F)

L’utilisation d’une norme IEEE est totalement volontaire. L’existence d’une norme IEEE

n’implique pas qu’il n’y ait pas d’autres manières de produire, de soumettre à essai, de

mesurer, d’acheter, de commercialiser ou de fournir d’autres biens et services qui se

rapportent au domaine d’application de la norme IEEE. En outre, le point de vue

exprimé à l’instant où une norme est approuvée et publiée est soumis aux changements

provoqués par les développements dans l’état de la technique et les commentaires reçus

des utilisateurs de la norme.

En publiant ses normes et en les rendant disponibles, l’IEEE ne suggère pas ou ne rend

pas de services professionnels ou autres pour une personne ou une entité quelconque, et

n’entreprend pas non plus l’exécution d’une responsabilité quelconque de toute autre

personne ou entité envers une autre. Il est recommandé à toute personne utilisant un

document normatif de l’IEEE de s’appuyer sur son jugement indépendant en exerçant

une diligence raisonnable dans des circonstances données quelconques ou, selon le cas,

de demander l’avis d’un professionnel compétent pour déterminer la pertinence d’une

norme IEEE donnée.
EN AUCUN CAS L’IEEE NE SAURAIT ÊTRE TENUE POUR RESPONSABLE DE
QUELCONQUES DOMMAGES DIRECTS, INDIRECTS, INCIDENTS, SPÉCIAUX,
EXEMPLAIRES OU CONSÉCUTIFS (Y COMPRIS, SANS TOUTEFOIS S’Y LIMITER : ACHATS
DE MARCHANDISES OU SERVICES DE REMPLACEMENT ; PERTE D’UTILISATION, DE
DONNÉES OU DE BÉNÉFICES ; OU INTERRUPTION D’ACTIVITÉ) CAUSÉS DE QUELQUE
MANIÈRE QUE CE SOIT ET SELON TOUTE THÉORIE DE RESPONSABILITÉ, QUE CE SOIT
DANS LE CONTRAT, RESPONSABILITÉ STRICTE OU DÉLICTUELLE (Y COMPRIS LA
NÉGLIGENCE OU AUTRE), RÉSULTANT DE LA PUBLICATION, DE L’UTILISATION OU DE
LA CONFIANCE DE/EN TOUTE NORME, MÊME EN CAS D’INFORMATION DE LA
POSSIBILITÉ DE TELS DOMMAGES, ET INDÉPENDAMMENT DU FAIT QUE CES
DOMMAGES ÉTAIENT PRÉVISIBLES OU NON.
Traductions
Le processus de développement du consensus de l’IEEE implique l’examen de

documents en anglais uniquement. Si une norme de l’IEEE est traduite, il convient que

seule la version anglaise publiée par l’IEEE soit considérée comme la norme IEEE
approuvée.
Déclarations officielles

Une déclaration, écrite ou orale, qui n’est pas traitée conformément au manuel des

opérations du Conseil des Normes IEEE-SA ne doit pas être considérée ou supposée être

la position officielle de l’IEEE ou de l’un de ses comités et ne doit pas être considérée

comme une position officielle de l’IEEE, ni servir de base à une telle position. Lors de

conférences, de symposiums, de séminaires ou de cours de formation, une personne

présentant des informations sur les normes de l’IEEE doit indiquer clairement qu’il

convient que ses points de vue soient considérés comme les points de vue personnels de

cette personne plutôt que comme la position officielle de l’IEEE.
viii
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---------------------- Page: 8 ----------------------
ISO/IEEE 11073-10101:2020(F)
Commentaires relatifs aux normes

Les commentaires visant à des révisions des documents normatifs de l’IEEE provenant

de toute partie intéressée sont les bienvenus, indépendamment de l’affiliation en tant

que membre de l’IEEE. Toutefois, l’IEEE ne fournit pas d’informations de consulting ou

de conseils relatifs aux documents normatifs de l’IEEE. Il convient que des suggestions

pour des modifications aux documents se présentent sous la forme d’une modification

de texte proposée accompagnée des commentaires d’appui appropriés. Comme les

normes de l’IEEE représentent un consensus des intérêts concernés, il est important que

toutes les réponses aux commentaires et aux questions aient également reçu l’attention

d’intérêts équilibrés. Pour cette raison, l’IEEE et les membres de ses sociétés et de ses

Comités de Coordination des Normes ne peuvent pas fournir une réponse instantanée

aux commentaires ou questions, excepté dans les cas où le sujet a précédemment été

traité. Pour la même raison, l’IEEE ne répond pas aux demandes d’interprétation. Toute

personne désirant participer aux révisions d’une norme IEEE est invitée à rejoindre le

groupe de travail IEEE concerné.
Il convient d’adresser les commentaires sur les normes à :
Secretary, IEEE SA Standards Board
445 Hoes Lane
Piscataway, NJ 08854 USA
Lois et règlements

Il est recommandé aux utilisateurs des documents normatifs de l’IEEE de consulter

toutes les lois et réglementations applicables. La conformité aux dispositions de tout

document normatif de l’IEEE n’implique pas la conformité à toutes les exigences

réglementaires applicables. Il incombe aux personnes ou organismes mettant en œuvre

la norme d’observer les exigences réglementaires applicables ou d’y faire référence.

L’IEEE n’a pas l’intention, du fait de la publication de ses normes, de provoquer des

actions qui ne sont pas conformes aux lois applicables et ces documents ne peuvent pas

être interprétés comme le faisant.
Copyrights

Les projets de norme et normes approuvées de l’IEEE sont propriétés intellectuelles de

l’IEEE en vertu des lois américaines et internationales sur les droits d’auteur. Ils sont

rendus disponibles par l’IEEE et sont adoptés pour une grande diversité d’utilisations à

la fois publiques et privées. Celles-ci incluent une utilisation, par référence, dans les lois

et réglementations et une utilisation dans l’auto-réglementation, la normalisation et la

promotion de pratiques et de méthodes d’ingénierie. En rendant ces documents

disponibles en vue de leur utilisation et de leur adoption par les autorités publiques et

les utilisateurs privés, l’IEEE ne renonce à aucun droit de copyright sur ce document.

xi9

Copyright © Copyright © 2019 IEEE. Tous droits réservés. 2019 IEEE. Tous droits réservés.

---------------------- Page: 9 ----------------------
ISO/IEEE 11073-10101:2020(F)
Photocopies

Sous réserve du paiement des droits correspondants, l’IEEE accordera aux utilisateurs

une licence limitée et non exclusive pour photocopier des parties de toute norme

individuelle en vue d’une utilisation interne par l’entreprise ou l’organisation ou une

utilisation exclusivement individuelle et non commerciale. Pour les dispositions

relatives au versement du droit de licence, contacter le Copyright Clearance Center,

Customer Service, 222 Rosewood Drive, Danvers, MA 01923 États-Unis ; Tél.

+1 978 750 8400. L’autorisation de photocopier des parties d’une norme individuelle à

des fins éducatives en classe peut également être obtenue auprès du Copyright
Clearance Center.
Mise à jour de documents normatifs de l’IEEE

Il convient que les utilisateurs des documents normatifs de l’IEEE soient informés du fait

que ces documents peuvent être remplacés à tout moment par la publication de
nouvelles éditions ou peuvent être amendés de temps à autre par le biais de la

publication d’amendements, de correctifs ou d’errata. Un document IEEE actuel, à un

instant quelconque, est constitué de l’édition actuelle du document accompagnée de

tous les amendements, correctifs ou errata alors en vigueur.
Chaque norme IEEE est soumise à un examen au moins tous les dix ans. Lorsqu’un
document a plus de dix ans et n’a pas été soumis à un processus d’examen, il est

raisonnable de conclure que son contenu, bien qu’il ait encore une certaine valeur, ne

reflète pas totalement l’état actuel de la technique. Les utilisateurs sont invités à

s’assurer qu’ils ont la dernière édition des normes IEEE.

Pour déterminer si un document donné est l’édition actuelle et s’il a été amendé par le

biais de la publication d’amendements, de correctifs ou d’errata, il convient de visiter le

site IEEE Xplore à l’adresse http://ieeexplore.ieee.org/ ou de contacter l’IEEE à l’adresse

citée précédemment. Pour de plus amples informations sur l’IEEE SA ou le processus de

développement des normes IEEE, visiter le site Web de l’IEEE SA à l’adresse
http://standards.ieee.org.
Errata

Les éventuels errata pour l’ensemble des normes de l’IEEE sont accessibles sur le

site Web de l’IEEE-SA à l’adresse suivante :

http://standards.ieee.org/findstds/errata/index.html. Les utilisateurs sont encouragés

à vérifier périodiquement cette URL pour rechercher d’éventuels errata.
Copyright © 2019 IEEE. Tous droits réservés.
---------------------- Page: 10 ----------------------
ISO/IEEE 11073-10101:2020(F)
Brevets

L’attention est appelée sur la possibilité que la mise en œuvre de la présente norme

puisse requérir l’utilisation d’un objet couvert par des droits de propriété intellectuelle

ou des droits analogues. Du fait de la publication de la présente norme, aucune position

n’est adoptée en ce qui concerne l’existence ou la validité de quelconques droits de

brevet en rapport avec celle-ci. Si le détenteur d’un brevet ou le demandeur d’un brevet

a déposé une déclaration d’assurance par l’intermédiaire d’une lettre d’assurance

acceptée, la déclaration est alors répertoriée sur le site Web de l’IEEE SA

http://standards.ieee.org/about/sasb/patcom/ patents.html. Les lettres d’assurance

peuvent indiquer si le déposant accepte ou non d’accorder des licences dans le cadre de

ces droits sans compensation ou avec des redevances raisonnables, avec des termes et

conditions raisonnables dont il peut être démontré qu’ils sont exempts de toute

discrimination inéquitable pour les demandeurs désirant obtenir de telles licences.

D’autres revendications essentielles de brevets peuvent exister, pour lesquelles une

lettre d’assurance n’a pas été reçue. Il n’incombe pas à l’IEEE d’identifier les Essential

Patent Claims (Revendications Essentielles de Brevets) pour lesquelles une licence peut

être requise, d’exécuter des enquêtes portant sur la validité légale ou la portée des

revendications de brevet ou de déterminer si des termes ou conditions d’attribution de

licence fournis en rapport avec la soumission d’une lettre d’assurance, le cas échéant, ou

dans des accords d’attribution de licence quelconques sont raisonnables ou non

discriminatoires. Les utilisateurs de la présente norme sont expressément avisés que la

détermination de la validité de tout droit de brevet et le risque de violation de ces droits

leur incombent entièrement. Des informations supplémentaires peuvent être obtenues

auprès de l’Association des normes IEEE.
Copyright © 2019 IEEE. Tous droits réservés.
---------------------- Page: 11 ----------------------
ISO/IEEE 11073-10101:2020(F)
Participants

Au moment de l’approbation du présent projet de norme par le Conseil des Normes IEEE

SA pour approbation, le Groupe de travail Dispositifs sur site de soin comprenait les

membres suivants :
Malcolm Clarke, Président
Paul Schluter, Vice-président
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

La présente norme a été votée par les membres suivants du comité de vote individuel.

Les votants peuvent avoir voté son approbation, sa désapprobation ou s’être abstenus.

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 Beth Pumo Daidi Zhong
Stefan Schlichting

Lorsque le Conseil des Normes IEEE SA a approuvé la présente norme le 13 juin 2019,

il comprenait les membres suivants :
Gary Hoffman, Président
Ted Burse, Vice-président
Jean-Philippe Faure, Ancien président
Konstantinos Karachalios, Secrétaire
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
*Membre émérite
xii
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---------------------- Page: 12 ----------------------
ISO/IEEE 11073-10101:2020(F)
Introduction

Cette introduction ne fait pas partie de la norme IEEE 11073-10101-2019, Informatique

de santé — Communication entre dispositifs médicaux sur le site des soins —
Nomenclature.
Les normes ISO/IEEE 11073 permettent des communications entre des dispositifs
médicaux et des systèmes informatiques externes. Elles permettent une capture

automatique et détaillée de données électroniques concernant les informations relatives

aux signes vitaux du patient et les données opérationnelles du dispositif. Les objectifs

principaux consistent à :
 fournir une interopérabilité prête à l’emploi en temps réel aux dispositifs
médicaux connectés au patient ;

 faciliter l’échange efficace de signes vitaux et de données de dispositifs médicaux,

acquis sur le site des soins, dans tous les environnements de soins de santé.
« En temps réel » signifie que les données de plusieurs dispositifs peuvent être

récupérées, corrélées dans le temps et affichées ou traitées en une fraction de seconde.

« Prêt à l’emploi » signifie que le clinicien se contente de connecter le dispositif. Les

systèmes effectuent automatiquement les opérations de détection, de configuration et

de communication sans aucune autre interaction humaine.

« Échange efficace de données relatives aux dispositifs médicaux » signifie que les

informations saisies sur le site des soins (par exemple données relatives aux signes

vitaux des patients) peuvent être archivées, récupérées et traitées par différents types

d’applications sans support logiciel et matériel majeur et en évitant toute perte inutile

d’informations. Les normes se focalisent sur les dispositifs de soins actifs, tels que les

moniteurs patient, les ventilateurs, les pompes à perfusion, les ECG, etc., ainsi que les

dispositifs et systèmes personnels de santé. Elles comprennent une famille de normes

qui peuvent être superposées pour fournir une connectivité optimisée pour les
dispositifs spécifiques interfacés.
L’IEEE 11073-10101 a été publié, à l’origine, en 2004 en collaboration avec

l’Organisation internationale de normalisation (ISO). En 2015, l’IEEE a publié un

amendement qui a élargi la nomenclature et les définitions couvertes par la norme afin

de refléter l’innovation continue dans la conception des dispositifs et systèmes

médicaux. Cette révision de 2019 intègre l’amendement dans le texte d’origine et met à

jour et élargit la nomenclature et les définitions.
xiii
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ISO/IEEE 11073-10101:2020(F)
Sommaire

1 Domaine d’application .....................................................................................................................................1

2 Références normatives .....................................................................................................................................1

3 Termes, définitions, symboles et termes abrégés .................................................................................4

3.1 Termes et définitions ...............................................................................................................................4

3.2 Symboles et termes abrégés .................................................................................................................4

4 Conformité .............................................................................................................................................................8

5 Présentation de la norme ................................................................................................................................8

6 Application ............................................................................................................................................................8

7 Sémantique ...........................................................................................................................................................9

7.1 Attribution ...................................................................................................................................................9

7.2 Codage ........................................................................................................................................................ 11

7.2.1 Sensibilité au contexte ............................................................................................................. 11

7.2.2 Regroupement ............................................................................................................................ 12

7.3 Synonymes ................................................................................................................................................ 13

7.4 Termes déconseillés .............................................................................................................................. 13

7.5 Termes retirés ......................................................................................................................................... 13

8 Syntaxe ................................................................................................................................................................. 14

8.1 Transfert .................................................................................................................................................... 14

8.1.1 Types ............................................................................................................................................... 14

8.1.2 Notation ......................................................................................................................................... 15

8.2 Forme programmatique ...................................................................................................................... 17

8.2.1 Attribution .................................................................................................................................... 18

8.2.2 Notation ......................................................................................................................................... 18

9 Extensibilité ....................................................................................................................................................... 19

10 Export de version ............................................................................................................................................ 19

Annexe A (normative) Sémantique de nomenclature ........................................................................... 20

A.1 Aperçu général de la nomenclature des signes vitaux — sémantique ............................. 20

A.2 Attribution de code aux
...

FINAL
INTERNATIONAL ISO/IEEE
DRAFT
STANDARD FDIS
11073-10101
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
2020-01-02
Part 10101:
Voting terminates on:
Point-of-care medical device
2020-05-21
communication — Nomenclature
This document is circulated as received from the committee secretariat.
FAST TRACK PROCEDURE
ISO/CEN PARALLEL PROCESSING
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 SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/IEEE FDIS 11073-10101:2020(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. IEEE 2019
---------------------- Page: 1 ----------------------
ISO/IEEE FDIS 11073-10101:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© IEEE 2019

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from IEEE at the address below.

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ii © IEEE 2019 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/IEEE FDIS 11073-10101:2020(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national

standards bodies (ISO member bodies). The work of preparing International Standards is normally carried

out through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO

collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted (see www.iso.org/directives).

IEEE Standards documents are developed within the IEEE Societies and the Standards Coordinating

Committees of the IEEE Standards Association (IEEE-SA) Standards Board. The IEEE develops its

standards through a consensus development process, approved by the American National Standards

Institute, which brings together volunteers representing varied viewpoints and interests to achieve the

final product. Volunteers are not necessarily members of the Institute and serve without

compensation. While the IEEE administers the process and establishes rules to promote fairness in the

consensus development process, the IEEE does not independently evaluate, test, or verify the accuracy of

any of the information contained in its standards.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any

patent rights identified during the development of the document will be in the Introduction and/or on the

ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the World

Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/

iso/foreword.html.

ISO/IEEE 11073-10101 was prepared by the IEEE 11073 Standards Committee of the IEEE

Engineering in Medicine and Biology Society (as IEEE Std 11073-10101-2019) and drafted in

accordance with its editorial rules. It was adopted, under the “fast-track procedure” defined in the Partner

Standards Development Organization cooperation agreement between ISO and IEEE, by Technical

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.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www.iso.org/members.html.
© IEEE 2019 – All rights reserved iii
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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
IEEE Engineering in Medicine and Biology Society
Approved 13 June 2019
IEEE SA Standards Board
---------------------- Page: 4 ----------------------
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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Incorporated.
HL7 is a registered trademark of Health Level Seven, Inc. (http://www.hl7.org).

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ISO/IEEE 11073-10101:2020(E)
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ISO/IEEE 11073-10101:2020(E)
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ISO/IEEE 11073-10101:2020(E)
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ISO/IEEE 11073-10101:2020(E)
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 Beth Pumo Daidi Zhong
Stefan Schlichting

When the IEEE SA Standards Board approved this standard on 13 June 2019, it had the following

membership:
Gary Hoffman, Chair
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
Copyright © 2019 IEEE. All rights reserved.
---------------------- Page: 9 ----------------------
ISO/IEEE 11073-10101:2020(E)
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

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.

IEEE Std 11073-10101 was originally published in 2004 in conjunction with the International Organization

for Standardization (ISO). In 2015, IEEE published an amendment that expanded the nomenclature and

definitions covered 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

nomenclature and definitions.
Copyright © 2019 IEEE. All rights reserved.
---------------------- Page: 10 ----------------------
ISO/IEEE 11073-10101:2020(E)
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

7.4 Deprecated terms ............................................................................................................................... 29

7.5 Withdrawn terms ............................................................................................................................... 29

8. Syntax ....................................................................................................................................................... 29

8.1 Transfer .............................................................................................................................................. 29

8.1.1 Types .......................................................................................................................................... 29

8.1.2 Notation ..................................................................................................................................... 30

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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ISO/IEEE 11073-10101:2020(E)

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 ..........
...

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