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Withdrawn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

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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

---------------------- 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.
---------------------- Page: 5 ----------------------
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
---------------------- 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,

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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

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© 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
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© ISO 2016 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 11073-10425:2017
ISO/IEEE 11073-10425:2016(E)
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© ISO 2016 – All rights reserved
---------------------- Page: 11 ----------------------
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
---------------------- 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
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
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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
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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
...

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