SIST EN ISO 11073-10425:2017
(Main)Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM) (ISO 11073-10425:2016)
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.
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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.
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SIST EN ISO 11073-10425:2017
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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.
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SIST EN ISO 11073-10425:2017
EN ISO 11073-10425:2016 (E)
Contents Page
European foreword . 3
2
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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
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SIST EN ISO 11073-10425:2017
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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
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SIST EN ISO 11073-10425:2017
ISO/IEEE 11073-10425:2016(E)
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© IEEE 2014
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© ISO 2016 – All rights reserved
ii © IEEE 2014 – All rights reserved
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SIST EN ISO 11073-10425:2017
ISO/IEEE 11073-10425:2016(E)
Foreword
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© IEEE 2014 – All rights reserved iii
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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
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© ISO 2016 – All rights reserved
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SIST EN ISO 11073-10425:2017
ISO/IEEE 11073-10425:2016(E)
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SIST EN ISO 11073-10425:2017
ISO/IEEE 11073-10425:2016(E)
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SIST EN ISO 11073-10425:2017
ISO/IEEE 11073-10425:2016(E)
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© ISO 2016 – All rights reserved
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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
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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
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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
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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
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Copyright notice
This ISO/IEEE document is a Final Draft International Standard and is copyright-protected by IEEE. Except
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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
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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
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Notice and Disclaimer of Liability Concerning the Use of IEEE Standards
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Volunteers are not necessarily members of the Institute and participate without compensation from IEEE.
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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
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© 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,
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Errata
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Patents
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Essential Patent Claims may exist for which a Letter of Assurance has not been received. The IEEE is not
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© 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
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