ISO/IEEE 11073-10425:2019
(Main)Health informatics — Personal health device communication — Part 10425: Device specialization — Continuous glucose monitor (CGM)
Health informatics — Personal health device communication — Part 10425: Device specialization — Continuous glucose monitor (CGM)
This standard establishes a normative definition of communication between personal health continuous glucose monitor (CGM) devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments, restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality of CGM devices. In this context, CGM refers to the measurement of the level of glucose in the body on a regular (typically 5 minute) basis through a sensor continuously attached to the person.
Informatique de santé — Communication entre dispositifs de santé personnels — Partie 10425: Spécialisation du dispositif — Glucomètre continu (CGM)
La présente norme établit une définition normative de la communication entre des dispositifs de santé personnels (agents) du type glucomètre continu (CGM) et des gestionnaires (par exemple, téléphones cellulaires, ordinateurs personnels, équipements de santé personnels et boîtiers décodeurs) d'une manière qui permet une interopérabilité du type prêt à l'emploi. Elle s'appuie sur le travail réalisé dans d'autres normes ISO/IEEE 11073, notamment la terminologie, les modèles d'informations, les normes de profils d'applications et les normes de transport. Elle spécifie l'utilisation de codes, de formats et de comportements liés à des termes spécifiques dans les environnements de télésanté, en limitant les choix à des cadres de travail de base favorisant l'interopérabilité. La présente norme définit un noyau commun de fonctionnalités de communication pour les dispositifs CGM. Dans ce contexte, CGM désigne la mesure régulière du niveau de glucose dans l'organisme (généralement toutes les 5 minutes) par le biais d'une sonde fixée en permanence sur la personne.
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INTERNATIONAL ISO/IEEE
STANDARD 11073-10425
Second edition
2019-03
Health informatics — Personal health
device communication —
Part 10425:
Device specialization — Continuous
glucose monitor (CGM)
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 10425: Spécialisation du dispositif — Glucomètre continu (CGM)
Reference number
©
IEEE 2018
© IEEE 2018
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.
Institute of Electrical and Electronics Engineers, Inc
3 Park Avenue, New York
NY 10016-5997, USA
Email: stds.ipr@ieee.org
Published in Switzerland
ii © IEEE 2018 – All rights reserved
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 11073‐10425 was prepared by the IEEE 11073 Standards Committee of the IEEE
Engineering in Medicine and Biology Society (as IEEE Std 11073‐10425‐2017) 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 11073‐10425:2016), which has
been technically revised.
A list of all parts in the ISO 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 2018– All rights reserved iii
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device
communication, a normative definition of the communication between continuous glucose monitor
(CGM) devices and managers (e.g., cell phones, personal computers, personal health appliances,
set top boxes), in a manner that enables plug-and-play interoperability, is established in this
standard. It leverages appropriate portions of existing standards including ISO/IEEE 11073
terminology and information models. It specifies the use of specific term codes, formats, and
behaviors in telehealth environments, restricting optionality in base frameworks in favor of
interoperability. This standard defines a common core of communication functionality of CGM
devices. In this context, CGM refers to the measurement of the level of glucose in the body on a
regular (typically 5 minute) basis through a sensor continuously attached to the person.
Keywords: continuous glucose monitor, IEEE 11073-10425™, medical device communication,
personal health devices
The Institute of Electrical and Electronics Engineers, Inc.
3 Park Avenue, New York, NY 10016-5997, USA
All rights reserved. Published 25 January 2018. Printed in the United States of America.
IEEE is a registered trademark in the U.S. Patent & Trademark Office, owned by The Institute of Electrical and Electronics Engineers,
Incorporated.
PDF: ISBN 978-1-5044-4293-0 STD22759
Print: ISBN 978-1-5044-4294-7 STDPD22759
IEEE prohibits discrimination, harassment, and bullying.
For more information, visit http://www.ieee.org/web/aboutus/whatis/policies/p9-26.html.
No part of this publication may be reproduced in any form, in an electronic retrieval system or otherwise, without the prior written permission
of the publisher.
Important Notices and Disclaimers Concerning IEEE Standards Documents
IEEE documents are made available for use subject to important notices and legal disclaimers. These
notices and disclaimers, or a reference to this page, appear in all standards and may be found under the
heading “Important Notices and Disclaimers Concerning IEEE Standards Documents.” They can also be
obtained on request from IEEE or viewed at http://standards.ieee.org/IPR/disclaimers.html.
Notice and Disclaimer of Liability Concerning the Use of IEEE Standards
Documents
IEEE Standards documents (standards, recommended practices, and guides), both full-use and trial-use, are
developed within IEEE Societies and the Standards Coordinating Committees of the IEEE Standards
Association (“IEEE-SA”) Standards Board. IEEE (“the Institute”) develops its standards through a
consensus development process, approved by the American National Standards Institute (“ANSI”), which
brings together volunteers representing varied viewpoints and interests to achieve the final product. IEEE
Standards are documents developed through scientific, academic, and industry-based technical working
groups. Volunteers in IEEE working groups are not necessarily members of the Institute and participate
without compensation from IEEE. While IEEE administers the process and establishes rules to promote
fairness in the consensus development process, IEEE does not independently evaluate, test, or verify the
accuracy of any of the information or the soundness of any judgments contained in its standards.
IEEE Standards do not guarantee or ensure safety, security, health, or environmental protection, or ensure
against interference with or from other devices or networks. Implementers and users of IEEE Standards
documents are responsible for determining and complying with all appropriate safety, security,
environmental, health, and interference protection practices and all applicable laws and regulations.
IEEE does not warrant or represent the accuracy or content of the material contained in its standards, and
expressly disclaims all warranties (express, implied and statutory) not included in this or any other
document relating to the standard, including, but not limited to, the warranties of: merchantability; fitness
for a particular purpose; non-infringement; and quality, accuracy, effectiveness, currency, or completeness
of material. In addition, IEEE disclaims any and all conditions relating to: results; and workmanlike effort.
IEEE standards documents are supplied “AS IS” and “WITH ALL FAULTS.”
Use of an IEEE standard is wholly voluntary. The existence of an IEEE standard does not imply that there
are no other ways to produce, test, measure, purchase, market, or provide other goods and services related
to the scope of the IEEE standard. Furthermore, the viewpoint expressed at the time a standard is approved
and issued is subject to change brought about through developments in the state of the art and comments
received from users of the standard.
In publishing and making its standards available, IEEE is not suggesting or rendering professional or other
services for, or on behalf of, any person or entity nor is IEEE undertaking to perform any duty owed by any
other person or entity to another. Any person utilizing any IEEE Standards document, should rely upon his
or her own independent judgment in the exercise of reasonable care in any given circumstances or, as
appropriate, seek the advice of a competent professional in determining the appropriateness of a given
IEEE standard.
IN NO EVENT SHALL IEEE BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL,
EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO:
PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS;
OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY,
WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR
OTHERWISE) ARISING IN ANY WAY OUT OF THE PUBLICATION, USE OF, OR RELIANCE
UPON ANY STANDARD, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE AND
REGARDLESS OF WHETHER SUCH DAMAGE WAS FORESEEABLE.
Translations
The IEEE consensus development process involves the review of documents in English only. In the event
that an IEEE standard is translated, only the English version published by IEEE should be considered the
approved IEEE standard.
Official statements
A statement, written or oral, that is not processed in accordance with the IEEE-SA Standards Board
Operations Manual shall not be considered or inferred to be the official position of IEEE or any of its
committees and shall not be considered to be, or be relied upon as, a formal position of IEEE. At lectures,
symposia, seminars, or educational courses, an individual presenting information on IEEE standards shall
make it clear that his or her views should be considered the personal views of that individual rather than the
formal position of IEEE.
Comments on standards
Comments for revision of IEEE Standards documents are welcome from any interested party, regardless of
membership affiliation with IEEE. However, IEEE does not provide consulting information or advice
pertaining to IEEE Standards documents. Suggestions for changes in documents should be in the form of a
proposed change of text, together with appropriate supporting comments. Since IEEE standards represent a
consensus of concerned interests, it is important that any responses to comments and questions also receive
the concurrence of a balance of interests. For this reason, IEEE and the members of its societies and
Standards Coordinating Committees are not able to provide an instant response to comments or questions
except in those cases where the matter has previously been addressed. For the same reason, IEEE does not
respond to interpretation requests. Any person who would like to participate in revisions to an IEEE
standard is welcome to join the relevant IEEE working group.
Comments on standards should be submitted to the following address:
Secretary, IEEE-SA Standards Board
445 Hoes Lane
Piscataway, NJ 08854 USA
Laws and regulations
Users of IEEE Standards documents should consult all applicable laws and regulations. Compliance with
the provisions of any IEEE Standards document does not imply compliance to any applicable regulatory
requirements. Implementers of the standard are responsible for observing or referring to the applicable
regulatory requirements. IEEE does not, by the publication of its standards, intend to urge action that is not
in compliance with applicable laws, and these documents may not be construed as doing so.
Copyrights
IEEE draft and approved standards are copyrighted by IEEE under U.S. and international copyright laws.
They are made available by IEEE and are adopted for a wide variety of both public and private uses. These
include both use, by reference, in laws and regulations, and use in private self-regulation, standardization,
and the promotion of engineering practices and methods. By making these documents available for use and
adoption by public authorities and private users, IEEE does not waive any rights in copyright to the
documents.
Photocopies
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photocopy portions of any individual standard for company or organizational internal use or individual,
non-commercial use only. To arrange for payment of licensing fees, please contact Copyright Clearance
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Updating of IEEE Standards documents
Users of IEEE Standards documents should be aware that these documents may be superseded at any time
by the issuance of new editions or may be amended from time to time through the issuance of amendments,
...
INTERNATIONAL ISO/IEEE
STANDARD 11073-10425
Second edition
2019-03
Health informatics — Personal health
device communication —
Part 10425:
Device specialization — Continuous
glucose monitor (CGM)
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 10425: Spécialisation du dispositif — Glucomètre continu (CGM)
Reference number
©
IEEE 2018
© IEEE 2018
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.
Institute of Electrical and Electronics Engineers, Inc
3 Park Avenue, New York
NY 10016-5997, USA
Email: stds.ipr@ieee.org
Published in Switzerland
ii © IEEE 2018 – All rights reserved
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 11073‐10425 was prepared by the IEEE 11073 Standards Committee of the IEEE
Engineering in Medicine and Biology Society (as IEEE Std 11073‐10425‐2017) 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 11073‐10425:2016), which has
been technically revised.
A list of all parts in the ISO 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 2018– All rights reserved iii
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device
communication, a normative definition of the communication between continuous glucose monitor
(CGM) devices and managers (e.g., cell phones, personal computers, personal health appliances,
set top boxes), in a manner that enables plug-and-play interoperability, is established in this
standard. It leverages appropriate portions of existing standards including ISO/IEEE 11073
terminology and information models. It specifies the use of specific term codes, formats, and
behaviors in telehealth environments, restricting optionality in base frameworks in favor of
interoperability. This standard defines a common core of communication functionality of CGM
devices. In this context, CGM refers to the measurement of the level of glucose in the body on a
regular (typically 5 minute) basis through a sensor continuously attached to the person.
Keywords: continuous glucose monitor, IEEE 11073-10425™, medical device communication,
personal health devices
The Institute of Electrical and Electronics Engineers, Inc.
3 Park Avenue, New York, NY 10016-5997, USA
All rights reserved. Published 25 January 2018. Printed in the United States of America.
IEEE is a registered trademark in the U.S. Patent & Trademark Office, owned by The Institute of Electrical and Electronics Engineers,
Incorporated.
PDF: ISBN 978-1-5044-4293-0 STD22759
Print: ISBN 978-1-5044-4294-7 STDPD22759
IEEE prohibits discrimination, harassment, and bullying.
For more information, visit http://www.ieee.org/web/aboutus/whatis/policies/p9-26.html.
No part of this publication may be reproduced in any form, in an electronic retrieval system or otherwise, without the prior written permission
of the publisher.
Important Notices and Disclaimers Concerning IEEE Standards Documents
IEEE documents are made available for use subject to important notices and legal disclaimers. These
notices and disclaimers, or a reference to this page, appear in all standards and may be found under the
heading “Important Notices and Disclaimers Concerning IEEE Standards Documents.” They can also be
obtained on request from IEEE or viewed at http://standards.ieee.org/IPR/disclaimers.html.
Notice and Disclaimer of Liability Concerning the Use of IEEE Standards
Documents
IEEE Standards documents (standards, recommended practices, and guides), both full-use and trial-use, are
developed within IEEE Societies and the Standards Coordinating Committees of the IEEE Standards
Association (“IEEE-SA”) Standards Board. IEEE (“the Institute”) develops its standards through a
consensus development process, approved by the American National Standards Institute (“ANSI”), which
brings together volunteers representing varied viewpoints and interests to achieve the final product. IEEE
Standards are documents developed through scientific, academic, and industry-based technical working
groups. Volunteers in IEEE working groups are not necessarily members of the Institute and participate
without compensation from IEEE. While IEEE administers the process and establishes rules to promote
fairness in the consensus development process, IEEE does not independently evaluate, test, or verify the
accuracy of any of the information or the soundness of any judgments contained in its standards.
IEEE Standards do not guarantee or ensure safety, security, health, or environmental protection, or ensure
against interference with or from other devices or networks. Implementers and users of IEEE Standards
documents are responsible for determining and complying with all appropriate safety, security,
environmental, health, and interference protection practices and all applicable laws and regulations.
IEEE does not warrant or represent the accuracy or content of the material contained in its standards, and
expressly disclaims all warranties (express, implied and statutory) not included in this or any other
document relating to the standard, including, but not limited to, the warranties of: merchantability; fitness
for a particular purpose; non-infringement; and quality, accuracy, effectiveness, currency, or completeness
of material. In addition, IEEE disclaims any and all conditions relating to: results; and workmanlike effort.
IEEE standards documents are supplied “AS IS” and “WITH ALL FAULTS.”
Use of an IEEE standard is wholly voluntary. The existence of an IEEE standard does not imply that there
are no other ways to produce, test, measure, purchase, market, or provide other goods and services related
to the scope of the IEEE standard. Furthermore, the viewpoint expressed at the time a standard is approved
and issued is subject to change brought about through developments in the state of the art and comments
received from users of the standard.
In publishing and making its standards available, IEEE is not suggesting or rendering professional or other
services for, or on behalf of, any person or entity nor is IEEE undertaking to perform any duty owed by any
other person or entity to another. Any person utilizing any IEEE Standards document, should rely upon his
or her own independent judgment in the exercise of reasonable care in any given circumstances or, as
appropriate, seek the advice of a competent professional in determining the appropriateness of a given
IEEE standard.
IN NO EVENT SHALL IEEE BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL,
EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO:
PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS;
OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY,
WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR
OTHERWISE) ARISING IN ANY WAY OUT OF THE PUBLICATION, USE OF, OR RELIANCE
UPON ANY STANDARD, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE AND
REGARDLESS OF WHETHER SUCH DAMAGE WAS FORESEEABLE.
Translations
The IEEE consensus development process involves the review of documents in English only. In the event
that an IEEE standard is translated, only the English version published by IEEE should be considered the
approved IEEE standard.
Official statements
A statement, written or oral, that is not processed in accordance with the IEEE-SA Standards Board
Operations Manual shall not be considered or inferred to be the official position of IEEE or any of its
committees and shall not be considered to be, or be relied upon as, a formal position of IEEE. At lectures,
symposia, seminars, or educational courses, an individual presenting information on IEEE standards shall
make it clear that his or her views should be considered the personal views of that individual rather than the
formal position of IEEE.
Comments on standards
Comments for revision of IEEE Standards documents are welcome from any interested party, regardless of
membership affiliation with IEEE. However, IEEE does not provide consulting information or advice
pertaining to IEEE Standards documents. Suggestions for changes in documents should be in the form of a
proposed change of text, together with appropriate supporting comments. Since IEEE standards represent a
consensus of concerned interests, it is important that any responses to comments and questions also receive
the concurrence of a balance of interests. For this reason, IEEE and the members of its societies and
Standards Coordinating Committees are not able to provide an instant response to comments or questions
except in those cases where the matter has previously been addressed. For the same reason, IEEE does not
respond to interpretation requests. Any person who would like to participate in revisions to an IEEE
standard is welcome to join the relevant IEEE working group.
Comments on standards should be submitted to the following address:
Secretary, IEEE-SA Standards Board
445 Hoes Lane
Piscataway, NJ 08854 USA
Laws and regulations
Users of IEEE Standards documents should consult all applicable laws and regulations. Compliance with
the provisions of any IEEE Standards document does not imply compliance to any applicable regulatory
requirements. Implementers of the standard are responsible for observing or referring to the applicable
regulatory requirements. IEEE does not, by the publication of its standards, intend to urge action that is not
in compliance with applicable laws, and these documents may not be construed as doing so.
Copyrights
IEEE draft and approved standards are copyrighted by IEEE under U.S. and international copyright laws.
They are made available by IEEE and are adopted for a wide variety of both public and private uses. These
include both use, by reference, in laws and regulations, and use in private self-regulation, standardization,
and the promotion of engineering practices and methods. By making these documents available for use and
adoption by public authorities and private users, IEEE does not waive any rights in copyright to the
documents.
Photocopies
Subject to payment of the appropriate fee, IEEE will grant users a limited, non-exclusive license to
photocopy portions of any individual standard for company or organizational internal use or individual,
non-commercial use only. To arrange for payment of licensing fees, please contact Copyright Clearance
Center, Customer Service, 222 Rosewood Drive, Danvers, MA 01923 USA; +1 978 750 8400. Permission
to photocopy portions of any individual standard for educational classroom use can also be obtained
through the Copyright Clearance Center.
Updating of IEEE Standards documents
Users of IEEE Standards documents should be aware that these documents may be superseded at any time
by the issuance of new editions or may be amended from time to time through the issuance of amendments,
...
ISO/IEEE
NORME
11073-10425
INTERNATIONALE
Deuxième édition
2019-03
Informatique de santé —
Communication entre dispositifs de
santé personnels —
Partie 10425:
Spécialisation du dispositif —
Glucomètre continu (CGM)
Health informatics — Personal health device communication —
Part 10425: Device specialization — Continuous glucose monitor
(CGM)
Numéro de référence
©
IEEE 2018
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© IEEE 2018
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’IEEE à l’adresse ci-après.
Institute of Electrical and Electronics Engineers, Inc
3 Park Avenue, New York
NY 10016-5997, USA
E-mail: stds.ipr@ieee.org
Publié en Suisse
ii © IEEE 2018 – Tous droits réservés
Sommaire Page
Avant-propos . v
Introduction . xvi
1 Présentation générale . 1
1.1 Domaine d'application . 1
1.2 Objet . 1
1.3 Contexte . 1
2 Références normatives . 2
3 Définitions, acronymes et abréviations . 2
3.1 Définitions . 2
3.2 Acronymes et abréviations . 3
4 Présentation des dispositifs personnels de santé (PHD) de l'ISO/IEEE 11073 . 4
4.1 Généralités . 4
4.2 Présentation des constructions de modélisation de l'ISO/IEEE 11073-20601 . 4
4.3 Conformité à d'autres normes . 5
5 Concepts et modalités relatifs à la surveillance du glucose . 5
5.1 Généralités . 5
5.2 Types de dispositifs . 7
5.3 Communication entre l'agent et le gestionnaire du CGM. 8
5.4 Données collectées . 9
5.5 Données stockées . 10
6 Modèle d'informations du domaine (DIM) du glucomètre continu (CGM) . 10
6.1 Présentation générale . 10
6.2 Extensions de classe . 10
6.3 Diagramme d'instance d'objet . 11
6.4 Types de configuration . 13
6.5 Profils . 13
6.6 Objet Système de dispositif médical (MDS) . 13
6.7 Objets numériques . 17
6.8 Objets Groupement d'échantillons en temps réel . 29
6.9 Objets d'énumération . 29
6.10 Objets PM-store . 34
6.11 Objets Analyseur . 39
6.12 Objets d'extension de classe . 39
6.13 Règles d'extensibilité du modèle d'informations du CGM . 39
7 Modèle de service du CGM . 39
7.1 Généralités . 39
7.2 Services d'accès aux objets . 40
7.3 Services de signalement d'événements d'accès aux objets . 43
8 Modèle de communication du CGM . 43
8.1 Présentation générale . 43
8.2 Caractéristiques de communication . 43
8.3 Procédure d'association . 44
© IEEE 2018 – Tous droits réservés
iii
8.4 Procédure de configuration . 46
8.5 Mode opératoire . 48
8.6 Synchronisation du temps . 48
9 Associations pour essai . 48
9.1 Comportement avec configuration normalisée . 49
9.2 Comportement avec configurations étendues . 49
10 Conformité . 49
10.1 Applicabilité . 49
10.2 Spécifications de la conformité . 49
10.3 Niveaux de conformité . 50
10.4 Déclarations de conformité de mise en œuvre (ICS) . 50
Annexe A (informative) Bibliographie . 57
Annexe B (normative) Toutes les définitions supplémentaires de l'ASN.1 . 59
B.1 Mappages des bits de l'état DM PHD, de l'état CGM et de l'état de mesure . 59
B.2 Extension numérique pour la confiance en la mesure . 61
B.3 Masque de capacité . 61
B.4 Indicateur d'état . 62
Annexe C (normative) Allocation d'identificateurs . 63
C.1 Généralités . 63
C.2 Définitions des termes et codes . 63
C.3 Déductions systématiques de termes et de codes . 65
Annexe D (informative) Exemples de séquences de messages . 69
Annexe E (informative) Exemples d'unités de données de protocole . 71
E.1 Généralités . 71
E.2 Échange d'informations d'association . 71
E.3 Échange d'informations de configuration . 75
E.4 Service GET des attributs de MDS . 78
E.5 Signalement de données . 79
E.6 Dissociation . 80
Annexe F (informative) Historique des révisions . 81
© IEEE 2018 – Tous droits réservés
iv
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 est en général
confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude a le droit de faire
partie du comité technique créé à cet effet. Les organisations internationales, gouvernementales et non
gouvernementales, en liaison avec l'ISO participent également aux travaux. 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
développe ses normes par le biais d'un processus de développement de consensus approuvé par
l'American National Standards Institute, qui rassemble des volontaires représentant divers points de vue
et divers intérêts pour parvenir au produit final. Les volontaires ne sont pas nécessairement des membres
de l'Institut et aucune compensation ne leur est attribuée. 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 contenues dans ses normes.
L'attention est attirée sur le fait que certains des éléments du présent document peuvent faire l'objet de
droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable de
ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant les
références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de l'élaboration
du document sont indiqués dans l'Introduction et/ou dans la liste des déclarations de brevets reçues par
l'ISO (voir www.iso.org/brevets).
Les appellations commerciales éventuellement mentionnées dans le présent document sont données pour
information, par souc
...
ISO/IEEE
NORME
11073-10425
INTERNATIONALE
Deuxième édition
2019-03
Informatique de santé —
Communication entre dispositifs de
santé personnels —
Partie 10425:
Spécialisation du dispositif —
Glucomètre continu (CGM)
Health informatics — Personal health device communication —
Part 10425: Device specialization — Continuous glucose monitor
(CGM)
Numéro de référence
©
IEEE 2018
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© IEEE 2018
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’IEEE à l’adresse ci-après.
Institute of Electrical and Electronics Engineers, Inc
3 Park Avenue, New York
NY 10016-5997, USA
E-mail: stds.ipr@ieee.org
Publié en Suisse
ii © IEEE 2018 – Tous droits réservés
Sommaire Page
Avant-propos . v
Introduction . xvi
1 Présentation générale . 1
1.1 Domaine d'application . 1
1.2 Objet . 1
1.3 Contexte . 1
2 Références normatives . 2
3 Définitions, acronymes et abréviations . 2
3.1 Définitions . 2
3.2 Acronymes et abréviations . 3
4 Présentation des dispositifs personnels de santé (PHD) de l'ISO/IEEE 11073 . 4
4.1 Généralités . 4
4.2 Présentation des constructions de modélisation de l'ISO/IEEE 11073-20601 . 4
4.3 Conformité à d'autres normes . 5
5 Concepts et modalités relatifs à la surveillance du glucose . 5
5.1 Généralités . 5
5.2 Types de dispositifs . 7
5.3 Communication entre l'agent et le gestionnaire du CGM. 8
5.4 Données collectées . 9
5.5 Données stockées . 10
6 Modèle d'informations du domaine (DIM) du glucomètre continu (CGM) . 10
6.1 Présentation générale . 10
6.2 Extensions de classe . 10
6.3 Diagramme d'instance d'objet . 11
6.4 Types de configuration . 13
6.5 Profils . 13
6.6 Objet Système de dispositif médical (MDS) . 13
6.7 Objets numériques . 17
6.8 Objets Groupement d'échantillons en temps réel . 29
6.9 Objets d'énumération . 29
6.10 Objets PM-store . 34
6.11 Objets Analyseur . 39
6.12 Objets d'extension de classe . 39
6.13 Règles d'extensibilité du modèle d'informations du CGM . 39
7 Modèle de service du CGM . 39
7.1 Généralités . 39
7.2 Services d'accès aux objets . 40
7.3 Services de signalement d'événements d'accès aux objets . 43
8 Modèle de communication du CGM . 43
8.1 Présentation générale . 43
8.2 Caractéristiques de communication . 43
8.3 Procédure d'association . 44
© IEEE 2018 – Tous droits réservés
iii
8.4 Procédure de configuration . 46
8.5 Mode opératoire . 48
8.6 Synchronisation du temps . 48
9 Associations pour essai . 48
9.1 Comportement avec configuration normalisée . 49
9.2 Comportement avec configurations étendues . 49
10 Conformité . 49
10.1 Applicabilité . 49
10.2 Spécifications de la conformité . 49
10.3 Niveaux de conformité . 50
10.4 Déclarations de conformité de mise en œuvre (ICS) . 50
Annexe A (informative) Bibliographie . 57
Annexe B (normative) Toutes les définitions supplémentaires de l'ASN.1 . 59
B.1 Mappages des bits de l'état DM PHD, de l'état CGM et de l'état de mesure . 59
B.2 Extension numérique pour la confiance en la mesure . 61
B.3 Masque de capacité . 61
B.4 Indicateur d'état . 62
Annexe C (normative) Allocation d'identificateurs . 63
C.1 Généralités . 63
C.2 Définitions des termes et codes . 63
C.3 Déductions systématiques de termes et de codes . 65
Annexe D (informative) Exemples de séquences de messages . 69
Annexe E (informative) Exemples d'unités de données de protocole . 71
E.1 Généralités . 71
E.2 Échange d'informations d'association . 71
E.3 Échange d'informations de configuration . 75
E.4 Service GET des attributs de MDS . 78
E.5 Signalement de données . 79
E.6 Dissociation . 80
Annexe F (informative) Historique des révisions . 81
© IEEE 2018 – Tous droits réservés
iv
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 est en général
confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude a le droit de faire
partie du comité technique créé à cet effet. Les organisations internationales, gouvernementales et non
gouvernementales, en liaison avec l'ISO participent également aux travaux. 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
développe ses normes par le biais d'un processus de développement de consensus approuvé par
l'American National Standards Institute, qui rassemble des volontaires représentant divers points de vue
et divers intérêts pour parvenir au produit final. Les volontaires ne sont pas nécessairement des membres
de l'Institut et aucune compensation ne leur est attribuée. 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 contenues dans ses normes.
L'attention est attirée sur le fait que certains des éléments du présent document peuvent faire l'objet de
droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable de
ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant les
références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de l'élaboration
du document sont indiqués dans l'Introduction et/ou dans la liste des déclarations de brevets reçues par
l'ISO (voir www.iso.org/brevets).
Les appellations commerciales éventuellement mentionnées dans le présent document sont données pour
information, par souc
...
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