EN ISO 11073-10419:2016

Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump (ISO/IEEE 11073-10419:2016, Corrected version 2018-03)

ISO/IEEE 11073-10419:2016 defines the device specialization for the insulin pump, being a specific agent type, and provides a description of the device concepts, its capabilities, and its implementation according to this standard.
ISO/IEEE 11073-10419:2016 is based on IEEE Std 11073-20601-2014, which in turn draw information from both ISO/IEEE 11073-10201:2004 [B7]2 and ISO/IEEE 11073-20101:2004 [B8]. The medical device encoding rules (MDERs) used within this standard are fully described in IEEE Std 11073-20601-2014.
ISO/IEEE 11073-10419:2016 reproduces relevant portions of the nomenclature found in ISO/IEEE 11073-10101:2004 [B6] and adds new nomenclature codes for the purposes of this standard. Among this standard and IEEE Std 11073-20601-2014, all required nomenclature codes for implementation are documented.

Medizinsche Informatik - Kommunikation von Geräten für die persönliche Gesundheit - Teil 10419: Gerätespezifikation - Insulinpumpe (ISO/IEEE 11073-10419:2016)

Informatique de santé - Communication entre dispositifs de santé personnels - Partie 10419: Spécialisation du dispositif - Pompe à insuline (ISO/IEEE 11073-10419:2016)

Le domaine d'application de l'ISO/IEEE 11073-10419:2016 consiste à établir une définition normative de la communication entre des dispositifs (agents) pompes à insuline personnels de télésanté et des gestionnaires (par exemple, des téléphones cellulaires, des ordinateurs personnels, des équipements personnels de santé et des 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, y compris la terminologie, des modèles d'informations, des normes de profils d'applications et des normes de transport. Elle spécifie l'utilisation de codes, de formats et de comportements en termes spécifiques dans les environnements de télésanté, en limitant les choix à des cadres de travail de base en faveur de l'interopérabilité. La présente norme définit un noyau commun de fonctionnalités des dispositifs pompes à insuline personnels de télésanté.
Dans le contexte des dispositifs de santé personnels, une pompe à insuline est un dispositif médical utilisé pour administrer de l'insuline en traitement du diabète, également connu sous le nom de thérapie par perfusion sous-cutanée continue d'insuline (PSCI).
ISO/IEEE 11073-10419:2016 fournit la modélisation des données conformément à la norme ISO/IEEE 11073-20601 et ne spécifie pas la méthode de mesurage.

Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10419. del: Specialne naprave - Inzulinska črpalka (ISO/IEEE 11073-10419:2016, popravljena različica 2018-03)

Področje uporabe tega standarda vzpostavlja normativno opredelitev komunikacije med osebnimi telemedicinskimi napravami za črpanje inzulina in upravljalnimi napravami (npr. mobilnimi telefoni, osebnimi računalniki, osebnimi medicinskimi napravami, digitalnimi sprejemniki) na način, ki omogoča interoperabilnost Plug and Play. Standard temelji na delu, doseženem v drugih standardih ISO/IEEE 11073, vključno z obstoječo terminologijo, informacijskimi profili, standardi za profile aplikacije in standardi za prevoz. Določa uporabo posebnih kod izrazov, formatov in vedenj v telemedicinskih okoljih, kjer v korist interoperabilnosti omejuje izbirnost osnovnih okvirov. Ta standard določa funkcionalnost skupnega jedra za osebne telemedicinske naprave za črpanje inzulina. Inzulinska črpalka se v okviru osebnih medicinskih pripomočkov uporablja za dovajanje inzulina pri zdravljenju sladkorne bolezni, poznanem tudi kot terapija s stalno subkutano infuzijo inzulina (CSII). Ta standard podaja napotke za modeliranje podatkov v skladu s standardom ISO/IEEE 11073-20601 in ne določa merske metode.

General Information

• Status: Withdrawn
• Publication Date: 28-Jun-2016
• Withdrawal Date: 29-Aug-2023
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: CEN/TC 251 - Medical informatics
• Drafting Committee: CEN/TC 251/WG 2 - Terminology and knowledge representation
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 30-Aug-2023
• Ref Project: SIST EN ISO 11073-10419:2016 - Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump (ISO/IEEE 11073-10419:2016, Corrected version 2018-03)

Relations

• Replaced By: EN ISO/IEEE 11073-10419:2023 - Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump (ISO/IEEE 11073-10419:2019)
• Effective Date: 30-Aug-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2016
=GUDYVWYHQDLQIRUPDWLND.RPXQLNDFLMDRVHEQLKPHGLFLQVNLKQDSUDYGHO
6SHFLDOQHQDSUDYH,Q]XOLQVNDþUSDOND,62,(((
Health informatics - Personal health device communication - Part 10419: Device
specialization - Insulin pump (ISO/IEEE 11073-10419:2016)
Medizinsche Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10419: Gerätespezifikation - Insulinpumpe (ISO/IEEE 11073-10419:2016)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie
10419: Spécialisation du dispositif - Pompe à insuline (ISO/IEEE 11073-10419:2016)
Ta slovenski standard je istoveten z: EN ISO 11073-10419:2016
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 11073-10419
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2016
EUROPÄISCHE NORM
ICS 35.240.80
English Version
Health informatics - Personal health device
communication - Part 10419: Device specialization -
Insulin pump (ISO/IEEE 11073-10419:2016)
Informatique de santé - Communication entre Medizinsche Informatik - Kommunikation von Geräten
dispositifs de santé personnels - Partie 10419: für die persönliche Gesundheit - Teil 10419:
Spécialisation du dispositif - Pompe à insuline Gerätespezifikation - Insulinpumpe (ISO/IEEE 11073-
(ISO/IEEE 11073-10419:2016) 10419:2016)
This European Standard was approved by CEN on 28 February 2016.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-10419:2016 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11073-10419:2016) has been prepared by Technical Committee ISO/TC 215
“Health informatics” in collaboration with Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by December 2016, and conflicting national standards
shall be withdrawn at the latest by December 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO/IEEE 11073-10419:2016 has been approved by CEN as EN ISO 11073-10419:2016
without any modification.
INTERNATIONAL ISO/IEEE
STANDARD 11073-10419
First edition
2016-06-15
Health informatics — Personal health
device communication —
Part 10419:
Device specialization — Insulin pump
Informatique de santé — Communication entre dispositifs de santé
personnels
Partie 10419: Spécialisation du dispositif — Pompe à insuline

Reference number
ISO/IEEE 11073-10419:2016(E)
©
ISO 2016
©
IEEE 2015
ISO/IEEE 11073-10419:2016(E)
©  ISO 2016
©  IEEE 2015
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO or IEEE at the respective
address below.
ISO copyright office Institute of Electrical and Electronics Engineers, Inc.
Case postale 56  CH-1211 Geneva 20 3 Park Avenue, New York  NY 10016-5997, USA
Tel. + 41 22 749 01 11 E-mail [e-mail]
Fax + 41 22 749 09 47 Web www.ieee.org
E-mail [e-mail]
Web www.iso.org
Published in Switzerland
ii © IEEE 2015 – All rights reserved

ISO/IEEE 11073-10419:2016(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.
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.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is called to the possibility that implementation of this standard may require the use of subject matter
covered by patent rights. By publication of this standard, no position is taken with respect to the existence or
validity of any patent rights in connection therewith. ISO/IEEE is not responsible for identifying essential
patents or patent claims for which a license may be required, for conducting inquiries into the legal validity or
scope of patents or patent claims or determining whether any licensing terms or conditions provided in
connection with submission of a Letter of Assurance or a Patent Statement and Licensing Declaration Form, if
any, or in any licensing agreements are reasonable or non-discriminatory. Users of this standard are expressly
advised that determination of the validity of any patent rights, and the risk of infringement of such rights, is
entirely their own responsibility. Further information may be obtained from ISO or the IEEE Standards
Association.
ISO/IEEE 11073-10419 was prepared by the IEEE 11073 Standards Comittee of the IEEE Engineering in
Medicine and Biology Society (as IEEE Std 11073-10419-2015). It was adopted by Technical Committee
ISO/TC 215, Health informatics, in parallel with its approval by the ISO member bodies, under the “fast-track
procedure” defined in the Partner Standards Development Organization cooperation agreement between ISO
and IEEE. IEEE is responsible for the maintenance of this document with participation and input from ISO
member bodies.
ISO/IEEE 11073 consists of the following parts, under the general title Health informatics — Personal health
device communication (text in parentheses gives a variant of subtitle):
 Part 10101: (Point-of-care medical device communication) Nomenclature
 Part 10102: (Point-of-care medical device communication) Nomenclature: Annotated ECG
 Part 10103: (Point-of-care medical device communication) Nomenclature: Implantable device, cardiac
 Part 10201: (Point-of-care medical device communication) Domain information model
4: Device specialization — Pulse oximeter
 Part 1040
 Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG)
© IEEE 2015 – All rights reserved iii

ISO/IEEE 11073-10419:2016(E)
 Part 10407: Device specialization — Blood pressure monitor
 Part 10408: Device specialization — Thermometer
 Part 10415: Device specialization — Weighing scale
 Part 10417: Device specialization — Glucose meter
 Part 10418: Device specialization — International Normalized Ratio (INR) monitor
 Part 10420: Device specialization — Body composition analyzer
 Part 10421: Device specialization — Peak expiratory flow monitor (peak flow)
 Part 10471: Device specialization — Independant living activity hub
 Part 10472: Device specialization — Medication monitor
 Part 20101: (Point-of-care medical device communication) Application profiles — Base standard
 Part 20601: Application profile — Optimized exchange protocol
 Part 30200: (Point-of-care medical device communication) Transport profile — Cable connected
 Part 30300: (Point-of-care medical device communication) Transport profile — Infrared wireless
 Part 30400: (Point-of-care medical device communication) Interface profile — Cabled Ethernet
 Part 90101: (Point-of-care medical device communication) Analytical instruments — Point-of-care test
 Part 91064: (Standard communication protocol) Computer-assisted electrocardiography
 Part 92001: (Medical waveform format) — Encoding rules [Technical Specification]

iv © IEEE 2015 – All rights reserved

ISO/IEEE 11073-10419:2016(E)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device
communication, a normative definition of communication between personal telehealth insulin
pump devices and compute engines (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. Appropriate portions of existing standards including ISO/IEEE 11073
terminology, information models, application profile standards, and transport standards are
leveraged. The use of specific term codes, formats, and behaviors in telehealth environments
restricting optionality in base frameworks in favor of interoperability are specified. A common core
of communication functionality for personal telehealth insulin pump devices is defined.
Keywords: IEEE 11073-10419™, insulin pump, 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 10 April 2015. 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 978-0-7381-9610-7 STD20158
Print: ISBN 978-0-7381-9611-4 STDPD20158
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.
ISO/IEEE 11073-10419:2016(E)
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 Notice” or “Important Notices and Disclaimers Concerning IEEE Standards
Documents.”
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
c
...

SLOVENSKI STANDARD
01-december-2016
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10419. del:
Specialne naprave - Inzulinska črpalka (ISO/IEEE 11073-10419:2016, popravljena
različica 2018-03)
Health informatics - Personal health device communication - Part 10419: Device
specialization - Insulin pump (ISO/IEEE 11073-10419:2016, Corrected version 2018-03)
Medizinsche Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10419: Gerätespezifikation - Insulinpumpe (ISO/IEEE 11073-10419:2016)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie
10419: Spécialisation du dispositif - Pompe à insuline (ISO/IEEE 11073-10419:2016)
Ta slovenski standard je istoveten z: EN ISO 11073-10419:2016
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 11073-10419
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2016
EUROPÄISCHE NORM
ICS 35.240.80
English Version
Health informatics - Personal health device
communication - Part 10419: Device specialization -
Insulin pump (ISO/IEEE 11073-10419:2016, Corrected
version 2018-03)
Informatique de santé - Communication entre Medizinsche Informatik - Kommunikation von Geräten
dispositifs de santé personnels - Partie 10419: für die persönliche Gesundheit - Teil 10419:
Spécialisation du dispositif - Pompe à insuline Gerätespezifikation - Insulinpumpe (ISO/IEEE 11073-
(ISO/IEEE 11073-10419:2016) 10419:2016)
This European Standard was approved by CEN on 28 February 2016.

This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 21 November 2018.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATIO N

EUROPÄISCHES KOMITEE FÜR NORMUN G

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-10419:2016 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11073-10419:2016) has been prepared by Technical Committee ISO/TC 215
“Health informatics” in collaboration with Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by December 2016, and conflicting national standards
shall be withdrawn at the latest by December 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO/IEEE 11073-10419:2016, Corrected version 2018-03 has been approved by CEN as
INTERNATIONAL
ISO/IEEE
STANDARD
11073-10419
First edition
2016-06-15
Corrected version
2018-03
Health informatics — Personal health
device communication —
Part 10419:
Device specialization — Insulin pump
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 10419: Spécialisation du dispositif — Pompe à insuline
Reference number
ISO/IEEE 11073-10419:2016(E)
©
IEEE 2015
ISO/IEEE 11073-10419:2016(E)
© IEEE 2015
All rights reserved. Unless otherwise specified, 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 either ISO or IEEE at the address below or ISO’s member body in the country of
the requester.
ISO copyright office Institute of Electrical and Electronics Engineers, Inc
Ch. de Blandonnet 8 • CP 401 3 Park Avenue, New York
CH-1214 Vernier, Geneva, Switzerland NY 10016-5997, USA
Tel. [phone]
Fax [phone]
[e-mail] [e-mail]
www.iso.org www.ieee.org
ii © IEEE 2015 – All rights reserved

ISO/IEEE 11073-10419:2016(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.
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.
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies
casting a vote.
Attention is called to the possibility that implementation of this standard may require the use of
subject matter covered by patent rights. By publication of this standard, no position is taken with
respect to the existence or validity of any patent rights in connection therewith. ISO/IEEE is not
responsible for identifying essential patents or patent claims for which a license may be required,
for conducting inquiries into the legal validity or scope of patents or patent claims or determining
whether any licensing terms or conditions provided in connection with submission of a Letter of
Assurance or a Patent Statement and Licensing Declaration Form, if any, or in any licensing
agreements are reasonable or non-discriminatory. Users of this standard are expressly advised that
determination of the validity of any patent rights, and the risk of infringement of such rights, is
entirely their own responsibility. Further information may be obtained from ISO or the IEEE
Standards Association.
ISO/IEEE 11073-10419 was prepared by the IEEE 11073 Standards Committee of the IEEE
Engineering in Medicine and Biology Society (as IEEE Std 11073-10419-2015). It was adopted by
Technical Committee ISO/TC 215, Health informatics, in parallel with its approval by the
ISO member bodies, under the “fast-track procedure” defined in the Partner Standards
Development Organization cooperation agreement between ISO and IEEE. IEEE is
responsible for the maintenance of this document with participation and input from ISO
member bodies.
This corrected version of ISO/IEEE 11073-10419:2016 incorporates the following
corrections:
— corrected footers and formatting.
ISO/IEEE 11073 consists of the following parts, under the general title Health informatics —
Personal health device communication (text in parentheses gives a variant of subtitle):
— Part 10101: (Point-of-care medical device communication) Nomenclature
— Part 10102: (Point-of-care medical device communication) Nomenclature: Annotated ECG
© IEEE 2015 – All rights reserved
iii
ISO/IEEE 11073-10419:2016(E)
— Part 10103: (Point-of-care medical device communication) Nomenclature: Implantable device,
cardiac
— Part 10201: (Point-of-care medical device communication) Domain information model
— Part 10404: Device specialization — Pulse oximeter
— Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG)
— Part 10407: Device specialization — Blood pressure monitor
— Part 10408: Device specialization — Thermometer
— Part 10415: Device specialization — Weighing scale
— Part 10417: Device specialization — Glucose meter
— Part 10418: Device specialization — International Normalized Ratio (INR) monitor
— Part 10420: Device specialization — Body composition analyzer
— Part 10421: Device specialization — Peak expiratory flow monitor (peak flow)
— Part 10471: Device specialization — Independant living activity hub
— Part 10472: Device specialization — Medication monitor
— Part 20101: (Point-of-care medical device communication) Application profiles — Base
standard — Part 20601: Application profile — Optimized exchange protocol
— Part 30200: (Point-of-care medical device communication) Transport profile — Cable
connected — Part 30300: (Point-of-care medical device communication) Transport profile —
Infrared wireless — Part 30400: (Point-of-care medical device communication) Interface profile
— Cabled Ethernet — Part 90101: (Point-of-care medical device communication) Analytical
instruments — Point-of-care test — Part 91064: (Standard communication protocol) Computer-
assisted electrocardiography
— Part 92001: (Medical waveform format) — Encoding rules [Technical Specification]
iv © IEEE 2015 – All rights reserved

ISO/IEEE 11073-10419:2016(E)
IEEE Std 11073-10419™-2015
Health informatics—Personal health device communication
Part 10419: Device Specialization—
Insulin Pump
Sponsor
IEEE 11073™ Standards Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 16 February 2015
IEEE-SA Standards Board
ISO/IEEE 11073-10419:2016(E)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device
communication, a normative definition of communication between personal telehealth insulin
pump devices and compute engines (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. Appropriate portions of existing standards including ISO/IEEE 11073
terminology, information models, application profile standards, and transport standards are
leveraged. The use of specific term codes, formats, and behaviors in telehealth environments
restricting optionality in base frameworks in favor of interoperability are specified. A common core
of communication functionality for personal telehealth insulin pump devices is defined.
Keywords: IEEE 11073-10419™, insulin pump, 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 10 April 2015. 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 978-0-7381-9610-7 STD20158
Print: ISBN 978-0-7381-9611-4 STDPD20158
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.
vi
© IEEE 2015 – All rights reserved

ISO/IEEE 11073-10419:2016(E)
Important Notices and Disclaimers Concerning IEEE Standards D
...