EN ISO 11073-10425:2016

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

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.

Contents Page
European foreword . 3
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.
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
ISO/IEEE 11073-10425:2016(E)
©  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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ISO/IEEE 11073-10425:2016(E)
Foreword
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ISO/IEEE 11073-10425 was prepared by the IEEE 11073 Standards Comittee of the IEEE Engineering in
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© IEEE 2014 – All rights reserved iii

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/IEEE 11073-10425:2016(E)
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ISO/IEEE 11073-10425:2016(E)
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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
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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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
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 Standards Board liaisons:
Richard DeBlasio, DOE Representative
Michael Janezic, NIST Representative
Don Messina
IEEE-SA Content Publishing
Kathryn Bennett
IEEE-SA Technical Community Programs

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ISO/IEEE 11073-10425:2016(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 enable communication between medical devices and external computer
systems. This document uses the optimized framework created in ISO/IEEE 11073-20601:2010 and
a
describes a specific, interoperable communication approach for continuous glucose monitors (CGMs).
These standards align with and draw on the existing clinically focused standards to provide support for
communication of data from clinical or personal health devices (PHDs).
a
Information on references can be found in Clause 2.

x
ISO/IEEE 11073-10425:2016(E)
Contents
1. Overview . 1
1.1 Scope . 1
1.2 Purpose . 1
1.3 Context . 2
2. Normative references . 2
3. Definitions, acronyms, and abbreviations . 2
3.1 Definitions . 2
3.1 Acronyms and abbreviations . 3
4. Introduction to IEEE 11073™ personal health devices . 4
4.1 General . 4
4.2 Introduction to IEEE 11073-20601 modeling constructs. 4
4.3 Compliance with other standards . 5
5. Glucose monitoring concepts and modalities . 5
5.1 General . 5
5.2 Device types . 7
5.3 CGM Agent to manager communication . 7
5.4 Collected data . 8
5.5 Stored data .10
6. Continuous glucose monitor domain information model .10
6.1 Overview .10
6.2 Class extensions .10
6.3 Object instance diagram .10
6.4 Types of configuration .11
6.5 Profiles .12
6.6 Medical device system object .12
6.7 Numeric objects .16
6.8 Real-time sample array objects .25
6.9 Enumeration objects .25
6.10 PM-store objects .29
6.11 Scanner objects .33
6.12 Class extension objects .33
6.13 CGM information model extensibility rules .33
7. Continuous glucose monitor service model .34
7.1 General .34
7.2 Object access services.34
7.3 Object access event report services .35
8. Continuous glucose monitor communication model .36
8.1 Overview .36
8.2 Communication characteristics .36
8.3 Association procedure .37
8.4 Configuring procedure .38
8.5 Operating procedure .40
8.6 Time synchronization .40

xi
ISO/IEEE 11073-10425:2016(E)
9. Test associations .40
9.1 Behavior with standard configuration .41
9.2 Behavior with extended configurations .41
10. Conformance .41
10.1 Applicability .41
10.2 Conformance specification .41
10.3 Levels of conformance .42
10.4 Implementation conformance statements .42
Annex A (informative) Bibliography .47
Annex B (normative) Any additional ASN.1 definitions .48
Annex C (normative) Allocation of identifiers .50
Annex D (informative) Message sequence examples .54
Annex E (informative) Protocol data unit examples .56

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ISO/IEEE 11073-10425:2016(E)
Health informatics—Personal health device communication
Part 10425: Device Specialization—
Continuous Glucose Monitor (CGM)
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1. Overview
1.1 Scope
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.
1.2 Purpose
This standard addresses a need for an openly defined, independent standard for controlling information
exchange to and from personal health devices (PHDs) and compute engines (e.g., cell phones, personal
computers, personal health appliances, and set top boxes). Interoperability is the key to growing the
potential market for these devices and to enabling people to be better informed participants in the
management of their health.
ISO/IEEE 11073-10425:2016(E)
IEEE Std 11073-10425-2014
Health informatics—Personal health device communication—Part 10425: Device Specialization—
Continuous Glucose Monitor (CGM)
1.3 Context
™ 1
See IEEE Std 11073-20601a for an overview of the environment within which this standard is written.
This standard defines the device specialization for the CGM, being a specific agent type, and it provides a
description of the device concepts, its capabilities, and its implementation according to this standard.
This standard is based on IEEE Std 11073-20601a-2010 and ISO/IEEE 11073-20601:2010, which in turn
draw information from both ISO/IEEE 11073-10201:2004 [B7] and ISO/IEEE 11073-20101:2004 [B8].
The medical device encoding rules (MDERs) used within this standard are fully described in
ISO/IEEE 11073-20601:2010.
This standard reproduces relevant portions of the nomenclature found in ISO/IEEE 11073-10101:2004 [B6]
and adds new nomenclature codes for the purposes of this standard. Among this standard,
™
ISO/IEEE 11073-20601:2010, and IEEE Std 11073-20601 -2014, all required nomenclature codes for
implementation are documented.
NOTE 1—IEEE Std 11073-20601-2014 is a revision of ISO/IEEE 11073-20601:2010. It contains new material and
corrections and does not copy the content of ISO/IEEE 11073-20601:2010. Throughout this standard, a reference to
IEEE Std 11073-20601-2014 refers to the document that is obtained after applying this new material and corrections to
ISO/IEEE 11073-20601:2010.
NOTE 2—In this standard, ISO/IEEE 11073-104zz is used to refer to the collection of device specialization standards
that utilize IEEE Std 11073-20601:2014, where zz can be any number from 01 to 99, inclusive.
2. Normative references
The following referenced documents are indispensable for the application of this document (i.e., they must
be understood and used, so each referenced document is cited in text and its relationship to this document is
explained). For dated references, only the edition cited applies. For undated references, the latest edition of
the referenced document (including any amendments or corrigenda) applies.
ISO/IEEE 11073-20601:2010, Health informatics—Personal health device communication—Part 20601:
Application profile—Optimized Exchange Protocol.
IEEE Std 11073-20601a-2010, Health informatics—Personal health device comm
...