Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM) (ISO/IEEE 11073-10425:2019)

This standard establishes a normative definition of communication between personal health continuous
glucose monitor (CGM) devices (agents) and managers (e.g., cell phones, personal computers, personal
health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages work
done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application
profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors
in telehealth environments, restricting optionality in base frameworks in favor of interoperability. This
standard defines a common core of communication functionality of CGM devices. In this context, CGM
refers to the measurement of the level of glucose in the body on a regular (typically 5 minute) basis through
a sensor continuously attached to the person.

Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit - Teil 10425: Gerätespezifikation - Kontinuierlicher Glukose-Monitor (ISO/IEEE 11073-10425:2019)

Informatique de santé - Communication entre dispositifs de santé personnels - Partie 10425: Spécialisation du dispositif - Glucomètre continu (CGM) (ISO/IEEE 11073-10425:2019)

La présente norme établit une définition normative de la communication entre des dispositifs de santé personnels (agents) du type glucomètre continu (CGM) et des gestionnaires (par exemple, téléphones cellulaires, ordinateurs personnels, équipements de santé personnels et boîtiers décodeurs) d'une manière qui permet une interopérabilité du type prêt à l'emploi. Elle s'appuie sur le travail réalisé dans d'autres normes ISO/IEEE 11073, notamment la terminologie, les modèles d'informations, les normes de profils d'applications et les normes de transport. Elle spécifie l'utilisation de codes, de formats et de comportements liés à des termes spécifiques dans les environnements de télésanté, en limitant les choix à des cadres de travail de base favorisant l'interopérabilité. La présente norme définit un noyau commun de fonctionnalités de communication pour les dispositifs CGM. Dans ce contexte, CGM désigne la mesure régulière du niveau de glucose dans l'organisme (généralement toutes les 5 minutes) par le biais d'une sonde fixée en permanence sur la personne.

Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10425. del: Specialne naprave - Stalno spremljanje ravni glukoze (ISO/IEEE 11073-10425:2019)

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 navezuje na redno merjenje ravni glukoze v telesu (običajno na 5 minut) s senzorjem, ki je stalno pritrjen na osebo.

General Information

Status
Published
Public Enquiry End Date
02-Dec-2018
Publication Date
14-May-2019
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
29-Apr-2019
Due Date
04-Jul-2019
Completion Date
15-May-2019

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SLOVENSKI STANDARD
SIST EN ISO 11073-10425:2019
01-junij-2019
Nadomešča:
SIST EN ISO 11073-10425:2017
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10425. del:
Specialne naprave - Stalno spremljanje ravni glukoze (ISO/IEEE 11073-10425:2019)
Health informatics - Personal health device communication - Part 10425: Device
specialization - Continuous glucose monitor (CGM) (ISO/IEEE 11073-10425:2019)

Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit -

Teil 10425: Gerätespezifikation - Kontinuierlicher Glukose-Monitor (ISO/IEEE 11073-

10425:2019)

Informatique de santé - Communication entre dispositifs de santé personnels - Partie

10425: Spécialisation du dispositif - Glucomètre continu (CGM) (ISO/IEEE 11073-
10425:2019)
Ta slovenski standard je istoveten z: EN ISO 11073-10425:2019
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 11073-10425:2019 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 11073-10425:2019
---------------------- Page: 2 ----------------------
SIST EN ISO 11073-10425:2019
EN ISO 11073-10425
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2019
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 11073-10425:2016
English Version
Health informatics - Personal health device
communication - Part 10425: Device specialization -
Continuous glucose monitor (CGM) (ISO/IEEE 11073-
10425:2019)

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/IEEE 11073-10425:2019) (ISO/IEEE 11073-10425:2019)
This European Standard was approved by CEN on 22 February 2019.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-10425:2019 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 11073-10425:2019
EN ISO 11073-10425:2019 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
SIST EN ISO 11073-10425:2019
EN ISO 11073-10425:2019 (E)
European foreword

This document (EN ISO 11073-10425:2019) has been prepared by Technical Committee ISO/TC 215

"Health informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the

secretariat of which is held by NEN.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by October 2019, and conflicting national standards shall

be withdrawn at the latest by October 2019.

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

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 11073-10425:2016.

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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO/IEEE 11073-10425:2019 has been approved by CEN as EN ISO 11073-10425:2019

without any modification.
---------------------- Page: 5 ----------------------
SIST EN ISO 11073-10425:2019
---------------------- Page: 6 ----------------------
SIST EN ISO 11073-10425:2019
INTERNATIONAL ISO/IEEE
STANDARD 11073-10425
Second edition
2019-03
Health informatics — Personal health
device communication —
Part 10425:
Device specialization — Continuous
glucose monitor (CGM)
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 10425: Spécialisation du dispositif — Glucomètre continu (CGM)
Reference number
ISO/IEEE 11073-10425:2019(E)
IEEE 2018
---------------------- Page: 7 ----------------------
SIST EN ISO 11073-10425:2019
ISO/IEEE 11073-10425:2019(E)
COPYRIGHT PROTECTED DOCUMENT
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Institute of Electrical and Electronics Engineers, Inc
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Email: stds.ipr@ieee.org
Published in Switzerland
ii © IEEE 2018 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 11073-10425:2019
ISO/IEEE 11073-10425:2019(E)
Foreword

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© IEEE 2018– All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 11073-10425:2019
ISO/IEEE 11073-10425:2019(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,

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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Copyright © 2018 IEEE. All rights reserved.
---------------------- Page: 10 ----------------------
SIST EN ISO 11073-10425:2019
ISO/IEEE 11073-10425:2019(E)
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Copyright © 2018 IEEE. All rights reserved.
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SIST EN ISO 11073-10425:2019
ISO/IEEE 11073-10425:2019(E)
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SIST EN ISO 11073-10425:2019
ISO/IEEE 11073-10425:2019(E)
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---------------------- Page: 13 ----------------------
SIST EN ISO 11073-10425:2019
ISO/IEEE 11073-10425:2019(E)
Participants

At the time this standard was submitted to the IEEE-SA Standards Board for approval, the Personal Health

Device Working Group had the following membership:
Daidi Zhong, Chair
Michael J. Kirwan, Chair
Nathaniel M. Hamming, Vice Chair
Akib Uddin, Vice Chair
Karsten Aalders Seungchul Chae Ken Fuchs
Charles R. Abbruscato Rahul Chauhan Jing Gao
Nabil Abujbara James Cheng Xuemei Gao
Maher Abuzaid Peggy Chien Marcus Garbe
James Agnew David Chiu John Garguilo
Haidar Ahmad Jinyong Choi Rick Geimer
Manfred Aigner Chia-Chin Chong Igor Gejdos
Jorge Alberola Saeed A. Choudhary Ferenc Gerbovics
Murtaza Ali Jinhan Chung Nicolae Goga
Rolf Ambuehl Malcolm Clarke Julian Goldman
David Aparisi John A. Cogan Raul Gonzalez Gomez
Paolo Ariano John T. Collins Chris Gough
Lawrence Arne Cory Condek Channa Gowda
Diego B. Arquillo Todd H. Cooper Charles M. Gropper
Serafin Arroyo David Cornejo Amit Gupta
Muhammad Asim Douglas Coup Jeff Guttmacher
Merat Bagha Rasmus Haahr
Nigel Cox
Doug Baird Hans Crommenacker Christian Habermann
David Baker Tomio Crosley Michael Hagerty
Anindya Bakshi Allen Curtis Jerry Hahn
Ananth Balasubramanian Ndifor Cyril Fru Robert Hall
Sunlee Bang Jesús Daniel Trigo Rickey L. Hampton
M. Jonathan Barkley Eyal Dassau Sten Hanke
Gilberto Barrón David Davenport Aki Harma
David Bean Russell Davis Jordan Hartmann
John Bell Sushil K. Deka Kai Hassing
Rudy Belliardi Ciro de la Vega Marc Daniel Haunschild
Kathryn M. Bennett Pedro de-las-Heras-Quiros Wolfgang Heck
Daniel Bernstein Jim DelloStritto Nathaniel Heintzman
George A. Bertos Matthew d’Entremont Charles Henderson
Chris Biernacki Kent Dicks Jun-Ho Her
Ola Björsne Hyoungho Do Helen B. Hernandez
Thomas Blackadar Alistair Donaldson Takashi Hibino
Marc Blanchet Xiaolian Duan
Timothy L. Hirou
Thomas Bluethner Brian Dubreuil Allen Hobbs
Douglas P. Bogia Sourav Dutta Alex Holland
Xavier Boniface Jakob Ehrensvard Arto Holopainen
Shannon Boucousis Fredrik Einberg Kris Holtzclaw
Julius Broma Michihiro Enokida Robert Hoy
Lyle G. Bullock Javier Escayola Calvo Frank Hsu
Bernard Burg Mark Estes Anne Huang
Chris Burns Leonardo Estevez Sen-Der Huang
Anthony Butt Roger Feeley Zhiqiang Huang
Jeremy Byford-Rew Hailing Feng Ron Huby
Satya Calloji Bosco T. Fernandes David Hughes
Xiaoying Cao Christoph Fischer Robert D. Hughes
Carole C. Carey Morten Flintrup Jiyoung Huh
Craig Carlson Joseph W. Forler Hugh Hunter
Santiago Carot-Nemesio Russell Foster Hitoshi Ikeda
Randy W. Carroll Eric Freudenthal Yutaka Ikeda
Matthias Frohner
Simon Carter Philip O. Isaacson
Copyright © 2018 IEEE. All rights reserved.
---------------------- Page: 14 ----------------------
SIST EN ISO 11073-10425:2019
ISO/IEEE 11073-10425:2019(E)
Atsushi Ito Jinsei Miyazaki Mark G. Schnell
Michael Jaffe Erik Moll Richard A. Schrenker
Praduman Jain
Darr Moore Antonio Scorpiniti
Wei Jin Carsten Mueglitz Kwang Seok Seo
Danny Jochelson Piotr Murawski Riccardo Serafin
Phaneeth Junga Soundharya Nagasubramanian Sid Shaw
Akiyoshi Kabe Jae-Wook Nah Frank Shen
Steve Kahle Alex Neefus Bozhi Shi
Tomio Kamioka Trong-Nghia Nguyen-Dobinsky Min Shih
James Jin Kang Michael E. Nidd Mazen Shihabi
Kei Kariya Tetsu Nishimura Redmond Shouldice
Andy Kaschl Jim Niswander Sternly K. Simon
Junzo Kashihara Hiroaki Niwamoto Marjorie Skubic
Kohichi Kashiwagi Thomas Norgall Robert Smith
Ralph Kent Anand Noubade Ivan Soh
Laurie M. Kermes Yoshiteru Nozoe Motoki Sone
Ikuo Keshi Abraham Ofek Emily Sopensky
Junhyung Kim Brett Olive Rajagopalan Srinivasan
Minho Kim Begonya Otal Andreas Staubert
Min-Joon Kim Nicholas Steblay
Marco Paleari
Taekon Kim Charles Palmer Lars Steubesand
Tetsuya Kimura Bud Panjwani John (Ivo) Stivoric
Alfred Kloos Carl Pantiskas Raymond A. Strickland
Jeongmee Koh Harry P. Pappas Chandrasekaran Subramaniam
Jean-Marc Koller Hanna Park Hermanni Suominen
John Koon Jong-Tae Park Lee Surprenant
Patty Krantz Myungeun Park Ravi Swami
Raymond Krasinski Soojun Park Ray Sweidan
Alexander Kraus Phillip E. Pash Jin Tan
Ramesh Krishna TongBi Pei Yi Tang
Geoffrey Kruse Lucian Pestritu Haruyuyki Tatsumi
Falko Kuester Soren Petersen John W. Thomas
Rafael Lajara James Petisce Jonas Tirén
Pierre Landau Peter Piction Alexandra Todiruta
Jaechul Lee Michael Pliskin Janet Traub
JongMuk Lee Varshney Prabodh Gary Tschautscher
Masato Tsuchid
Kyong Ho Lee Jeff Price
Rami Lee Harald Prinzhorn Ken Tubman
Sungkee Lee Harry Qiu Yoshihiro Uchida
Woojae Lee Arif Rahman Sunil Unadkat
Yonghee Lee Tanzilur Rahman Fabio Urbani
Joe Lenart Steve Ray Philipp Urbauer
Kathryn A. Lesh Phillip Raymond Laura Vanzago
Catherine Li Tim Reilly Alpo Värri
Qiong Li Barry Reinhold Dalimar Velez
Patrick Lichter Brian Reinhold Rudi Voon
Jisoon Lim Melvin I. Reynolds Barry Vornbrock
Joon-Ho Lim John G. Rhoads Isobel Walker
John Lin Jeffrey S. Robbins David Wang
Wei-Jung Lo Chris Roberts Jerry P. Wang
Charles Lowe Moskowitz Robert Yao Wang
Don Ludolph Timothy Robertson Yi Wang
Christian Luszick David Rosales Steve Warren
Bob MacWilliams Fatemeh Saki Fujio Watanabe
Srikkanth Madhurbootheswaran Bill Saltzstein Toru Watsuji
Miriam L. Makhlouf Benedikt Salzbrunn Mike Weng
Romain Marmot Giovanna Sannino Kathleen Wible
Sandra Martinez Jose A. Santos-Cadenas Paul Williamson
Miguel Martínez de Espronceda Stefan Sauermann Jan Wittenber
Cámara John Sawyer Jia-Rong Wu
Peter Mayhew Guillaume Schatz Will Wykeham
Jim McCain Alois Schloegl Ariton Xhafa
László Meleg Paul S. Schluter Dan Xiao
Alexander Mense Lars Schmitt Yaxi Yan
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SIST EN ISO 11073-10425:2019
ISO/IEEE 11073-10425:2019(E)
Qifeng Yan Qiang Yin Zhiqiang Zhang
Junjie Yang Done-Sik Yoo Thomas Zhao
Ricky Yang Jianchao Zeng Miha Zoubek
Melanie S. Yeung Jason Zhang Szymon Zyskoter

The following members of the individual balloting committee voted on this standard. Balloters may have

voted for approval, disapproval, or abstention.
Charles Barest Nathaniel M. Hamming Paul Schluter
Lyle G. Bullock
Werner Hoelzl Steven Smith
Craig Carlson Noriyuki Ikeuchi Walter Struppler
Malcolm Clarke Atsushi Ito Karl Weber
David Fuschi Piotr Karocki Jan Wittenber
Randall Groves Joerg-Uwe Meyer Or
...

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