Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM) (ISO 11073-10425:2016)

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 (PCs), 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.

Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit - Teil 10425: Gerätespezifikation - Kontinuierlicher Glukose-Monitor (ISO 11073-10425:2016)

Informatique de santé - Communication entre dispositifs de santé personnels - Partie 10425: (ISO 11073-10425:2016)

Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10425. del: Specialne naprave - Stalno spremljanje ravni glukoze (ISO 11073-10425:2016)

Ta standard določa normativno opredelitev komunikacije med osebnimi medicinskimi pripomočki za stalno spremljanje ravni glukoze (agenti) in upravljalnimi napravami (npr. mobilnimi telefoni, osebnimi računalniki, osebnimi medicinskimi pripomočki, digitalnimi sprejemniki) na način, ki omogoča interoperabilnost s takojšnjim učinkom (»vstavi in poženi«). 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 skupno jedro komunikacijske funkcionalnosti za naprave za stalno spremljanje ravni glukoze. V tem kontekstu se stalno spremljanje ravni glukoze nanaša na redno merjenje ravni glukoze v telesu (običajno na 5 minut) s senzorjem, ki je stalno pritrjen na osebo.

General Information

Status
Withdrawn
Public Enquiry End Date
14-Jan-2016
Publication Date
13-Nov-2016
Withdrawal Date
08-May-2019
Technical Committee
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
29-Apr-2019
Due Date
22-May-2019
Completion Date
09-May-2019

Relations

Buy Standard

Standard
EN ISO 11073-10425:2017 - BARVE
English language
81 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day
Draft
k FprEN ISO 11073-10425:2016
English language
81 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11073-10425:2017
01-januar-2017
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10425. del:
Specialne naprave - Stalno spremljanje ravni glukoze (ISO 11073-10425:2016)
Health informatics - Personal health device communication - Part 10425: Device
specialization - Continuous glucose monitor (CGM) (ISO 11073-10425:2016)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10425: Gerätespezifikation - Kontinuierlicher Glukose-Monitor (ISO 11073-
10425:2016)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie
10425: (ISO 11073-10425:2016)
Ta slovenski standard je istoveten z: EN ISO 11073-10425:2016
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 11073-10425:2017 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 11073-10425:2017

---------------------- Page: 2 ----------------------

SIST EN ISO 11073-10425:2017


EN ISO 11073-10425
EUROPEAN STANDARD

NORME EUROPÉENNE

June 2016
EUROPÄISCHE NORM
ICS 35.240.80
English Version

Health informatics - Personal health device
communication - Part 10425: Device specialization -
Continuous glucose monitor (CGM) (ISO 11073-
10425:2016)
Informatique de santé - Communication entre Medizinische Informatik - Kommunikation von Geräten
dispositifs de santé personnels - Partie 10425: für die persönliche Gesundheit - Teil 10425:
Spécialisation du dispositif - Glucomètre continu Gerätespezifikation - Kontinuierlicher Glukose-Monitor
(CGM) (ISO 11073-10425:2016) (ISO 11073-10425:2016)
This European Standard was approved by CEN on 21 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 11073-10425:2016 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 11073-10425:2017
EN ISO 11073-10425:2016 (E)
Contents Page
European foreword . 3
2

---------------------- Page: 4 ----------------------

SIST EN ISO 11073-10425:2017
EN ISO 11073-10425:2016 (E)
European foreword
The text of ISO/IEEE 11073-10425:2016 has been prepared by Technical Committee ISO/TC 215
“Health informatics” of the International Organization for Standardization (ISO) and has been taken
over as EN ISO 11073-10425:2016 by 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 11073-10425:2016 has been approved by CEN as EN ISO 11073-10425:2016
without any modification.

3

---------------------- Page: 5 ----------------------

SIST EN ISO 11073-10425:2017

---------------------- Page: 6 ----------------------

SIST EN ISO 11073-10425:2017

INTERNATIONAL ISO/IEEE
STANDARD 11073-10425
First edition
2016-06-15

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
ISO/IEEE 11073-10425:2016(E)

©
ISO 2016
©
IEEE 2014

---------------------- Page: 7 ----------------------

SIST EN ISO 11073-10425:2017
ISO/IEEE 11073-10425:2016(E)


COPYRIGHT PROTECTED DOCUMENT


©  ISO 2016
©  IEEE 2014
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 stds.ipr@ieee.org
Fax + 41 22 749 09 47 Web www.ieee.org
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland

© ISO 2016 – All rights reserved
ii © IEEE 2014 – All rights reserved

---------------------- Page: 8 ----------------------

SIST EN ISO 11073-10425:2017
ISO/IEEE 11073-10425:2016(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 11073-10425 was prepared by the IEEE 11073 Standards Comittee of the IEEE Engineering in
Medicine and Biology Society (as IEEE Std 11073-10425-2014). 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 2016 – All rights reserved
© IEEE 2014 – All rights reserved iii

---------------------- Page: 9 ----------------------

SIST EN ISO 11073-10425:2017
ISO/IEEE 11073-10425:2016(E)
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, and 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
Copyright © 2014 by The Institute of Electrical and Electronics Engineers, Inc.
All rights reserved. Published 10 October 2014. 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 978-0-7381-9318-2 STD98795
Print: ISBN 978-0-7381-9319-9 STDPD98795
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 2016 – All rights reserved

---------------------- Page: 10 ----------------------

SIST EN ISO 11073-10425:2017
ISO/IEEE 11073-10425:2016(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
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.
Volunteers 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 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.
© ISO 2016 – All rights reserved

---------------------- Page: 11 ----------------------

SIST EN ISO 11073-10425:2017
ISO/IEEE 11073-10425:2016(E)
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.
© ISO 2016 – All rights reserved

---------------------- Page: 12 ----------------------

SIST EN ISO 11073-10425:2017
ISO/IEEE 11073-10425:2016(E)
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,
corrigenda, or errata. An official IEEE document at any point in time consists of the current edition of the
document together with any amendments, corrigenda, or errata then in effect.
Every IEEE standard is subjected to review at least every ten years. When a document is more than ten
years old and has not undergone a revision process, it is reasonable to conclude that its contents, although
still of some value, do not wholly reflect the present state of the art. Users are cautioned to check to
determine that they have the latest edition of any IEEE standard.
In order to determine whether a given document is the current edition and whether it has been amended
through the issuance of amendments, corrigenda, or errata, visit the IEEE-SA Website at
http://ieeexplore.ieee.org/xpl/standards.jsp or contact IEEE at the address listed previously. For more
information about the IEEE SA or IEEE’s standards development process, visit the IEEE-SA Website at
http://standards.ieee.org.
Errata
Errata, if any, for all IEEE standards can be accessed on the IEEE-SA Website at the following URL:
http://standards.ieee.org/findstds/errata/index.html. Users are encouraged to check this URL for errata
periodically.
Patents
Attention is called to the possibility that implementation of this standard may require use of subject matter
covered by patent rights. By publication of this standard, no position is taken by the IEEE with respect to
the existence or validity of any patent rights in connection therewith. If a patent holder or patent applicant
has filed a statement of assurance via an Accepted Letter of Assurance, then the statement is listed on the
IEEE-SA Website at http://standards.ieee.org/about/sasb/patcom/patents.html. Letters of Assurance may
indicate whether the Submitter is willing or unwilling to grant licenses under patent rights without
compensation or under reasonable rates, with reasonable terms and conditions that are demonstrably free of
any unfair discrimination to applicants desiring to obtain such licenses.
Essential Patent Claims may exist for which a Letter of Assurance has not been received. The IEEE is not
responsible for identifying Essential Patent Claims for which a license may be required, for conducting
inquiries into the legal validity or scope of Patents Claims, or determining whether any licensing terms or
conditions provided in connection with submission of a Letter of Assurance, 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 the IEEE Standards Association.
© ISO 2016 – All rights reserved

---------------------- Page: 13 ----------------------

SIST EN ISO 11073-10425:2017
ISO/IEEE 11073-10425:2016(E)
Participants
At the time this IEEE standard was completed, the Personal Health Devices Working Group had the
following membership:
Daidi Zhong, Chair
Michael J. Kirwan, Chair
Nathaniel M. Hamming, Vice Chair
Charles R. Abbruscato Saeed A. Choudhary Julian Goldman
Nabil Abujbara Jinhan Chung Raul Gonzalez Gomez
Maher Abuzaid Malcolm Clarke Chris Gough
Manfred Aigner John A. Cogan Channa Gowda
Jorge Alberola John T. Collins Charles M. Gropper
Karsten Alders Cory Condek Amit Gupta
Murtaza Ali Todd H. Cooper Jeff Guttmacher
Rolf Ambuehl David Cornejo Rasmus Haahr
David Aparisi Douglas Coup Christian Habermann
Lawrence Arne Nigel Cox Michael Hagerty
Diego B. Arquillo Hans Crommenacker Jerry Hahn
Serafin Arroyo Tomio Crosley Robert Hall
Muhammad Asim David Culp Rickey L. Hampton
Merat Bagha Allen Curtis Sten Hanke
Doug Baird Ndifor Cyril Fru Jordan Hartmann
David Baker Eyal Dassau Kai Hassing
Anindya Bakshi David Davenport Marc Daniel Haunschild
Ananth Balasubramanian Russell Davis Wolfgang Heck
Sunlee Bang Ed Day Charles Henderson
M. Jonathan Barkley Sushil K. Deka Jun-Ho Her
Gilberto Barrón Pedro de-las-Heras-Quiros Takashi Hibino
David Bean Jim DelloStritto Timothy L. Hirou
John Bell Matthew d’Entremont Allen Hobbs
Rudy Belliardi Lane Desborough Alex Holland
Daniel Bernstein Kent Dicks Arto Holopainen
George A. Bertos Hyoungho Do Robert Hoy
Chris Biernacki Xiaolian Duan Frank Hsu
Ola Björsne Brian Dubreuil Anne Huang
Thomas Blackadar Jakob Ehrensvard Sen-Der Huang
Marc Blanchet Fredrik Einberg Zhiqiang Huang
Thomas Bluethner Roger M. Ellingson Ron Huby
Douglas P. Bogia Michihiro Enokida Robert D. Hughes
Xavier Boniface Javier Escayola Calvo David Hughes
Shannon Boucousis Leonardo Estevez Jiyoung Huh
Julius Broma Roger Feeley Hugh Hunter
Lyle G. Bullock, Jr. Bosco T. Fernandes Hitoshi Ikeda
Bernard Burg Christoph Fischer Yutaka Ikeda
Chris Burns Morten Flintrup Philip O. Isaacson
Anthony Butt Joseph W. Forler Atsushi Ito
Jeremy Byford-Rew Russell Foster Michael Jaffe
Satya Calloji Eric Freudenthal Praduman Jain
Carole C. Carey Matthias Frohner Danny Jochelson
Santiago Carot-Nemesio Ken Fuchs Chris Johnson
Randy W. Carroll Jing Gao Phaneeth Junga
Simon Carter Marcus Garbe Akiyoshi Kabe
Seungchul Chae John Garguilo Steve Kahle
Rahul Chauhan Rick Geimer Tomio Kamioka
James Cheng Igor Gejdos Kei Kariya
Peggy Chien Ferenc Gerbovics Andy Kaschl
Chia-Chin Chong Nicolae Goga Junzo Kashihara

vi
Copyright © 2014 IEEE. All rights reserved.
© ISO 2016 – All rights reserved

---------------------- Page: 14 ----------------------

SIST EN ISO 11073-10425:2017
ISO/IEEE 11073-10425:2016(E)
Kohichi Kashiwagi Jim Niswander Sternly K. Simon
Ralph Kent Hiroaki Niwamoto Marjorie Skubic
Laurie M. Kermes Thomas Norgall Robert Smith
Ikuo Keshi Anand Noubade Ivan Soh
Junhyung Kim Yoshiteru Nozoe Motoki Sone
Min-Joon Kim Emily Sopensky
Abraham Ofek
Minho Kim Brett Olive Rajagopalan Srinivasan
Taekon Kim Begonya Otal Andreas Staubert
Tetsuya Kimura
Charles Palmer Nicholas Steblay
Alfred Kloos Bud Panjwani Beth Stephen
Jeongmee Koh Carl Pantiskas Lars Steubesand
Jean-Marc Koller Harry P. Pappas John (Ivo) Stivoric
John Koon Mikey Paradis Raymond A. Strickland
Patty Krantz Hanna Park Hermanni Suominen
Alexander Kraus Jong-Tae Park Lee Surprenant
Ramesh Krishna Myungeun Park Ravi Swami
Geoffrey Kruse Soojun Park Ray Sweidan
Falko Kuester Phillip E. Pash Jin Tan
Rafael Lajara TongBi Pei Haruyuyki Tatsumi
Pierre Landau John W. Thomas
Soren Petersen
Jaechul Lee James Petisce Brad Tipler
JongMuk Lee Peter Piction Jonas Tirén
Kyong Ho Lee Michael Pliskin James Tomcik
Rami Lee Jeff Price Janet Traub
Sungkee Lee Harald Prinzhorn Jesús Daniel Trigo
Woojae Lee Gary Tschautscher
John Quinlan
Yonghee Lee Arif Rahman Masato Tsuchid
Joe Lenart Tanzilur Rahman Ken Tubman
Kathryn A. Lesh Steve Ray Yoshihiro Uchida
Qiong Li Phillip Raymond Sunil Unadkat
Ying Li Tim Reilly Fabio Urbani
Patrick Lichter Barry Reinhold Philipp Urbauer
Jisoon Lim Brian Reinhold Laura Vanzago
Joon-Ho Lim Melvin I. Reynolds Alpo Värri
John Lin John G. Rhoads Ciro de la Vega
Jiajia Liu Jeffrey S. Robbins Dalimar Velez
Wei-Jung Lo Moskowitz Robert Naveen Verma
Charles Lowe Timothy Robertson Rudi Voon
Don Ludolph David Rosales Isobel Walker
Christian Luszick Bill Saltzstein David Wang
Bob MacWilliams Benedikt Salzbrunn Jerry P. Wang
Srikkanth Madhurbootheswaran Giovanna Sannino Yao Wang
Romain Marmot Jose A. Santos-Cadenas Yi Wang
Sandra Martinez Stefan Sauermann Steve Warren
Miguel Martínez de Espronceda John Sawyer Fujio Watanabe
Cámara Guillaume Schatz
Toru Watsuji
Peter Mayhew Alois Schloegl Mike Weng
Jim McCain Paul S. Schluter Kathleen Wible
Lars Schmitt
László Meleg Paul Williamson
Alexander Mense Mark G. Schnell Jan Wittenber
Ethan Metsger Richard A. Schrenker Jia-Rong Wu
Antonio Scorpiniti
Yu Miao Will Wykeham
Jinsei Miyazaki Kwang Seok Seo Ariton Xhafa
Erik Moll Riccardo Serafin Junjie Yang
Darr Moore Sid Shaw Ricky Yang
Piotr Murawski Frank Shen Melanie Yeung
Soundharya Nagasubramanian Liqun Shen Done-Sik Yoo
Jae-Wook Nah Bozhi Shi Jason Zhang
Alex Neefus Min Shih Zhiqiang Zhang
Trong-Nghia Nguyen-Dobinsky Mazen Shihabi Thomas Zhao
Michael E. Nidd Redmond Shouldice Miha Zoubek
Tetsu Nishimura Szymon Zysko

vii
Copyright © 2014 IEEE. All rights reserved.
© ISO 2016 – All rights reserved

---------------------- Page: 15 ----------------------

SIST EN ISO 11073-10425:2017
ISO/IEEE 11073-10425:2016(E)
The following members of the individual balloting committee voted on this standard. Balloters may have
voted for approval, disapproval, or abstention.
Thomas Blackadar Werner Hoelzl Nick S. A. Nikjoo
Lyle G. Bullock, Jr. Noriyuki Ikeuchi Melvin I. Reynolds
Keith Chow Atsushi Ito Bartien Sayogo
Sourav Dutta Raj Jain Paul Schluter
Joseph El Youssef Piotr Karocki Lars Schmitt
Christoph Fischer Robert Kircher Eugene Stoudenmire
Hector Barron Gonzalez JongMuk Lee Walter Struppler
Randall Groves Jie Li Jan Wittenber
Kai Hassing William Lumpkins Oren Yuen
Wolfgang Heck Greg Luri Daidi Zhong

viii
Copyright © 2014 IEEE. All rights reserved.
© ISO 2016 – All rights reserved

---------------------- Page: 16 ----------------------

SIST EN ISO 11073-10425:2017
ISO/IEEE 11073-10425:2016(E)
When the IEEE-SA Standards Board approved this standard on 21 August 2014, it had the following
membership:
John Kulick, Chair
Jon Walter Rosdahl, Vice Chair
Richard H. Hulett, Past Chair
Konstantinos Karachalios, Secretary
Peter Balma Michael Janezic Ron Peterson
Farooq Bari Jeffrey Katz Adrian Stephens
Ted Burse Joseph L. Koepfinger* Peter Sutherland
Clint Chaplain David J. Law Yatin Trivedi
Stephen Dukes Hung Ling Phil Winston
Jean-Phillippe Faure Oleg Logvinov Don Wright
Gary Hoffman T. W. Olsen Yu Yuan
Glenn Parsons
*Member Emeritus
Also included are the following nonvoting IEEE-SA Standard
...

SLOVENSKI STANDARD
kSIST FprEN ISO 11073-10425:2016
01-januar-2016
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10425. del:
Specialne naprave - Stalno spremljanje ravni glukoze (ISO/FDIS 11073-10425:2015)
Health informatics - Personal health device communication - Part 10425: Device
specialization - Continuous glucose monitor (CGM) (ISO/FDIS 11073-10425:2015)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10425: Gerätespezifikation - Kontinuierlicher Glukose-Monitor (ISO/FDIS 11073-
10425:2015)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie
10425: (ISO/FDIS 11073-10425:2015)
Ta slovenski standard je istoveten z: FprEN ISO 11073-10425
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
kSIST FprEN ISO 11073-10425:2016 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
kSIST FprEN ISO 11073-10425:2016

---------------------- Page: 2 ----------------------
kSIST FprEN ISO 11073-10425:2016
FINAL
INTERNATIONAL ISO/IEEE
DRAFT
STANDARD FDIS
11073-10425
ISO/TC 215
Health informatics — Personal health
Secretariat: ANSI
device communication —
ISO voting begins on:
2015-08-20
Part 10425:
Device specialization — Continuous
ISO voting terminates on:
2016-01-20
glucose monitor (CGM)

Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 10425:


Please see the administrative notes on page ii-1


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 SUPPORT-
ING DOCUMENTATION.
Reference number
IN ADDITION TO THEIR EVALUATION AS
ISO/IEEE FDIS 11073-10425:2015(E)
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
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 2014

---------------------- Page: 3 ----------------------
kSIST FprEN ISO 11073-10425:2016
ISO/IEEE 11073-10425:2015(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. Neither the ISO Central
Secretariat nor IEEE accepts any liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies
and IEEE members. In the unlikely event that a problem relating to it is found, please inform the ISO Central Secretariat or IEEE at the
address given below.


Copyright notice
This ISO/IEEE document is a Final Draft International Standard and is copyright-protected by IEEE. Except
as permitted under the applicable laws of the user’s country, neither this ISO/IEEE draft nor any extract
from it may be reproduced, stored in a retrieval system or transmitted in any form or by any means,
electronic, photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO’s
member body in the country of the requester. In the United States, such requests should be sent to IEEE.
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 stds.ipr@ieee.org
Fax + 41 22 749 09 47 Web www.ieee.org
E-mail copyright@iso.org
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.

ii © IEEE 2011 – All rights reserved

---------------------- Page: 4 ----------------------
kSIST FprEN ISO 11073-10425:2016
ISO/IEEE 11073-10425:2015(E)


FAST-TRACK PROCEDURE



This document is submitted under the fast-track procedure in accordance with the Partner
Standards Development Organization cooperation agreement between ISO and IEEE, as approved
by Council Resolution 2/2011, and is submitted to all ISO member bodies for voting within
5 months.
Positive votes shall not be accompanied by comments.
Negative votes shall be accompanied by the relevant technical reasons.

In accordance with the provisions of Council Resolution 15/1993, this document is circulated in the
English language only.

© IEEE 2014 – All rights reserved ii-1

---------------------- Page: 5 ----------------------
kSIST FprEN ISO 11073-10425:2016

---------------------- Page: 6 ----------------------
kSIST FprEN ISO 11073-10425:2016
ISO/IEEE 11073-10425:2015(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 11073-10425 was prepared by the IEEE 11073 Standards Comittee of the IEEE Engineering in
Medicine and Biology Society (as IEEE Std 11073-10425-2014). 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.

© IEEE 2014 – All rights reserved iii

---------------------- Page: 7 ----------------------
kSIST FprEN ISO 11073-10425:2016

---------------------- Page: 8 ----------------------
kSIST FprEN ISO 11073-10425:2016







---------------------- Page: 9 ----------------------
kSIST FprEN ISO 11073-10425:2016

---------------------- Page: 10 ----------------------
kSIST FprEN ISO 11073-10425:2016
ISO/IEEE 11073-10425:2015(E)
IEEE Std 11073-10425™-2014
Health informatics—Personal health device communication
Part 10425: Device Specialization—
Continuous Glucose Monitor (CGM)
Sponsor

IEEE 11073™ Standards Committee
of the
IEEE Engineering in Medicine and Biology Society


Approved 21 August 2014

IEEE-SA Standards Board


© IEEE 2014 – All rights reserved

---------------------- Page: 11 ----------------------
kSIST FprEN ISO 11073-10425:2016
ISO/IEEE 11073-10425:2015(E)

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, and 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

Copyright © 2014 by The Institute of Electrical and Electronics Engineers, Inc.
All rights reserved. Published 10 October 2014. 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 978-0-7381-9318-2 STD98795
Print: ISBN 978-0-7381-9319-9 STDPD98795

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.

© IEEE 2014 – All rights reserved

---------------------- Page: 12 ----------------------
kSIST FprEN ISO 11073-10425:2016
ISO/IEEE 11073-10425:2015(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
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.
Volunteers 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 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.

© IEEE 2014 – All rights reserved

---------------------- Page: 13 ----------------------
kSIST FprEN ISO 11073-10425:2016
ISO/IEEE 11073-10425:2015(E)

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.

© IEEE 2014 – All rights reserved

---------------------- Page: 14 ----------------------
kSIST FprEN ISO 11073-10425:2016
ISO/IEEE 11073-10425:2015(E)

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,
corrigenda, or errata. An official IEEE document at any point in time consists of the current edition of the
document together with any amendments, corrigenda, or errata then in effect.
Every IEEE standard is subjected to review at least every ten years. When a document is more than ten
years old and has not undergone a revision process, it is reasonable to conclude that its contents, although
still of some value, do not wholly reflect the present state of the art. Users are cautioned to check to
determine that they have the latest edition of any IEEE standard.
In order to determine whether a given document is the current edition and whether it has been amended
through the issuance of amendments, corrigenda, or errata, visit the IEEE-SA Website at
http://ieeexplore.ieee.org/xpl/standards.jsp or contact IEEE at the address listed previously. For more
information about the IEEE SA or IEEE’s standards development process, visit the IEEE-SA Website at
http://standards.ieee.org.
Errata
Errata, if any, for all IEEE standards can be accessed on the IEEE-SA Website at the following URL:
http://standards.ieee.org/findstds/errata/index.html. Users are encouraged to check this URL for errata
periodically.
Patents
Attention is called to the possibility that implementation of this standard may require use of subject matter
covered by patent rights. By publication of this standard, no position is taken by the IEEE with respect to
the existence or validity of any patent rights in connection therewith. If a patent holder or patent applicant
has filed a statement of assurance via an Accepted Letter of Assurance, then the statement is listed on the
IEEE-SA Website at http://standards.ieee.org/about/sasb/patcom/patents.html. Letters of Assurance may
indicate whether the Submitter is willing or unwilling to grant licenses under patent rights without
compensation or under reasonable rates, with reasonable terms and conditions that are demonstrably free of
any unfair discrimination to applicants desiring to obtain such licenses.
Essential Patent Claims may exist for which a Letter of Assurance has not been received. The IEEE is not
responsible for identifying Essential Patent Claims for which a license may be required, for conducting
inquiries into the legal validity or scope of Patents Claims, or determining whether any licensing terms or
conditions provided in connection with submission of a Letter of Assurance, 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 the IEEE Standards Association.

© IEEE 2014 – All rights reserved

---------------------- Page: 15 ----------------------
kSIST FprEN ISO 11073-10425:2016
ISO/IEEE 11073-10425:2015(E)

Participants
At the time this IEEE standard was completed, the Personal Health Devices Working Group had the
following membership:
Daidi Zhong, Chair
Michael J. Kirwan, Chair
Nathaniel M. Hamming, Vice Chair

Charles R. Abbruscato Saeed A. Choudhary Julian Goldman
Nabil Abujbara Jinhan Chung Raul Gonzalez Gomez
Maher Abuzaid Malcolm Clarke Chris Gough
Manfred Aigner John A. Cogan Channa Gowda
Jorge Alberola John T. Collins Charles M. Gropper
Karsten Alders Cory Condek Amit Gupta
Murtaza Ali Todd H. Cooper Jeff Guttmacher
Rolf Ambuehl David Cornejo Rasmus Haahr
David Aparisi Douglas Coup Christian Habermann
Lawrence Arne Nigel Cox Michael Hagerty
Diego B. Arquillo Hans Crommenacker Jerry Hahn
Serafin Arroyo Tomio Crosley Robert Hall
Muhammad Asim David Culp Rickey L. Hampton
Merat Bagha Allen Curtis Sten Hanke
Doug Baird Ndifor Cyril Fru Jordan Hartmann
David Baker Eyal Dassau Kai Hassing
Anindya Bakshi David Davenport Marc Daniel Haunschild
Ananth Balasubramanian Russell Davis Wolfgang Heck
Sunlee Bang Ed Day Charles Henderson
M. Jonathan Barkley Sushil K. Deka Jun-Ho Her
Gilberto Barrón Pedro de-las-Heras-Quiros Takashi Hibino
David Bean Jim DelloStritto Timothy L. Hirou
John Bell Matthew d’Entremont Allen Hobbs
Rudy Belliardi Lane Desborough Alex Holland
Daniel Bernstein Kent Dicks Arto Holopainen
George A. Bertos Hyoungho Do Robert Hoy
Chris Biernacki Xiaolian Duan Frank Hsu
Ola Björsne Brian Dubreuil Anne Huang
Thomas Blackadar Jakob Ehrensvard Sen-Der Huang
Marc Blanchet Fredrik Einberg Zhiqiang Huang
Thomas Bluethner Roger M. Ellingson Ron Huby
Douglas P. Bogia Michihiro Enokida Robert D. Hughes
Xavier Boniface Javier Escayola Calvo David Hughes
Shannon Boucousis Leonardo Estevez Jiyoung Huh
Julius Broma Roger Feeley Hugh Hunter
Lyle G. Bullock, Jr. Bosco T. Fernandes Hitoshi Ikeda
Bernard Burg Christoph Fischer Yutaka Ikeda
Chris Burns Morten Flintrup Philip O. Isaacson
Anthony Butt Joseph W. Forler Atsushi Ito
Jeremy Byford-Rew Russell Foster Michael Jaffe
Satya Calloji Eric Freudenthal Praduman Jain
Carole C. Carey Matthias Frohner Danny Jochelson
Santiago Carot-Nemesio Ken Fuchs Chris Johnson
Randy W. Carroll Jing Gao Phaneeth Junga
Simon Carter Marcus Garbe Akiyoshi Kabe
Seungchul Chae John Garguilo Steve Kahle
Rahul Chauhan Rick Geimer Tomio Kamioka
James Cheng Igor Gejdos Kei Kariya
Peggy Chien Ferenc Gerbovics Andy Kaschl
Chia-Chin Chong Nicolae Goga Junzo Kashihara

vi
Copyright © 2014 IEEE. All rights reserved.
© IEEE 2014 – All rights reserved

---------------------- Page: 16 ----------------------
kSIST FprEN ISO 11073-10425:2016
ISO/IEEE 11073-10425:2015(E)

Kohichi Kashiwagi Jim Niswander Sternly K. Simon
Ralph Kent Hiroaki Niwamoto Marjorie Skubic
Laurie M. Kermes Thomas Norgall Robert Smith
Ikuo Keshi Anand Noubade Ivan Soh
Junhyung Kim Yoshiteru Nozoe Motoki Sone
Min-Joon Kim Emily Sopensky
Abraham Ofek
Minho Kim Brett Olive Rajagopalan Srinivasan
Taekon Kim Begonya Otal Andreas Staubert
Tetsuya Kimura
Charles Palmer Nicholas Steblay
Alfred Kloos Bud Panjwani Beth Stephen
Jeongmee Koh Carl Pantiskas Lars Steubesand
Jean-Marc Koller Harry P. Pappas John (Ivo) Stivoric
John Koon Mikey Paradis Raymond A. Strickland
Patty Krantz Hanna Park Hermanni Suominen
Alexander Kraus Jong-Tae Park Lee Surprenant
Ramesh Krishna Myungeun Park Ravi Swami
Geoffrey Kruse Soojun Park Ray Sweidan
Falko Kuester Phillip E. Pash Jin Tan
Rafael Lajara TongBi Pei Haruyuyki Tatsumi
Pierre Landau John W. Thomas
Soren Petersen
Jaechul Lee James Petisce Brad Tipler
JongMuk Lee Peter Piction Jonas Tirén
Kyong Ho Lee Michael Pliskin James Tomcik
Rami Lee Jeff Price Janet Traub
Sungkee Lee Harald Prinzhorn Jesús Daniel Trigo
Woojae Lee Gary Tschautscher
John Quinlan
Yonghee Lee Arif Rahman Masato Tsuchid
Joe Lenart Tanzilur Rahman Ken Tubman
Kathryn A. Lesh Steve Ray Yoshihiro Uchida
Qiong Li Phillip Raymond Sunil Unadkat
Ying Li Tim Reilly Fabio Urbani
Patrick Lichter Barry Reinhold Philipp Urbauer
Jisoon Lim Brian Reinhold Laura Vanzago
Joon-Ho Lim Melvin I. Reynolds Alpo Värri
John Lin John G. Rhoads Ciro de la Vega
Jiajia Liu Jeffrey S. Robbins Dalimar Velez
Wei-Jung Lo Moskowitz Robert Naveen Verma
Charles Lowe Timothy Robertson Rudi Voon
Don Ludolph David Rosales Isobel Walker
Christian Luszick Bill Saltzstein David Wang
Bob MacWilliams Benedikt Salzbrunn Jerry P. Wang
Srikkanth Madhurbootheswaran Giovanna Sannino Yao Wang
Romain Marmot Jose A. Santos-Cadenas Yi Wang
Sandra Martinez Stefan Sauermann Steve Warren
Miguel Martínez de Espronceda John Sawyer Fujio Watanabe
Cámara Guillaume Schatz
Toru Watsuji
Peter Mayhew Alois Schloegl Mike Weng
Jim McCain Paul S. Schluter Kathleen Wible
Lars Schmitt
László Meleg Paul Williamson
Alexander Mense Mark G. Schnell Jan Wittenber
Ethan Metsger Richard A. Schrenker Jia-Rong Wu
Antonio Scorpiniti
Yu Miao Will Wykeham
Jinsei Miyazaki Kwang Seok Seo Ariton Xhafa
Erik Moll Riccardo Serafin Junjie Yang
Darr Moore Sid Shaw Ricky Yang
Piotr Murawski Frank Shen Melanie Yeung
Soundharya Nagasubramanian Liqun Shen Done-Sik Yoo
Jae-Wook Nah Bozhi Shi Jason Zhang
Alex Neefus Min Shih Zhiqiang Zhang
Trong-Nghia Nguyen-Dobinsky Mazen Shihabi Thomas Zhao
Michael E. Nidd Redmond Shouldice Miha Zoubek
Tetsu Nishimura Szymon Zysko

vii
Copyright © 2014 IEEE. All rights reserved.
© IEEE 2014 – All rights reserved

---------------------- Page: 17 ----------------------
kSIST FprEN ISO 11073-10425:2016
ISO/IEEE 11073-10425:2015(E)


The following members of the individual balloting committee voted on this standard. Balloters may have
voted for approval, disapproval, or abstention.
Thomas Blackadar Werner Hoelzl Nick S. A. Nikjoo
Lyle G. Bullock, Jr. Noriyuki Ikeuchi Melvin I. Reynolds
Keith Chow Atsushi Ito Bartien Sayogo
Sourav Dutta Raj Jain Paul Schluter
Joseph El Youssef Piotr Karocki Lars Schmitt
Christoph Fischer Robert Kircher Eugene Stoudenmire
Hector Barron Gonzalez JongMuk Lee Walter Struppler
Randall Groves Jie Li Jan Wittenber
Kai Hassing William Lumpkins Oren Yuen
Wolfgang Heck Greg Luri Daidi Zhong


viii
Copyright © 2014 IEEE. All rights reserved.
© IEEE 2014 – All rights reserved

---------------------- Page: 18 ----------------------
kSIST FprEN ISO 11073-10425:2016
ISO/IEEE 11073-10425:2015(E)


When the IEEE-SA Standards Board approved this standard on 21 August 2014, it had the following
membership:
John Kulick, Chair
Jon Walter Rosdahl, Vice Chair
Richard H. Hulett, Past Chair
Konstantinos Karachalios, Secretary
Peter Balma Michael Janezic Ron Peterson
Farooq Bari Jeffrey Katz Adrian Stephens
Ted Burse Joseph L. Koepfinger* Peter Sutherland
Clint Chaplain David J. Law Yatin Trivedi
Stephen Dukes Hung Ling Phil Winston
Jean-Phillippe Faure Oleg Logvinov Don Wright
Gary Hoffman T. W. Olsen Yu Yuan
Glenn Parsons
*Member Emeritus

Also included are the following nonvoting IEEE-SA Standards Board liaisons:
Richard DeBlasio, DOE Representative
Michael Janezic, NIST Representative


Don Messina
IEEE-SA Content Publishing


Kathryn Bennett
IEEE-SA Technical Community Programs


ix
Copyright © 2014 IEEE. All rights reserved.
© IEEE 2014 – All rights reserved

---------------------- Page: 19 ----------------------
kSIST FprEN ISO 11073-10425:2016
ISO/IEEE 11073-10425:2015(E)

Introduction
This introduction is not part of IEEE Std 11073-10425-2014, Health informatics—Personal health device
communication—Part 10425: Device Specialization—Continuous Glucose Monitor (CGM).
ISO/IEEE 11073 standards
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.