ISO/IEEE 11073-10419:2016
(Main)Health informatics — Personal health device communication — Part 10419: Device specialization — Insulin pump
Health informatics — Personal health device communication — Part 10419: Device specialization — Insulin pump
ISO/IEEE 11073-10419:2016 defines the device specialization for the insulin pump, being a specific agent type, and provides a description of the device concepts, its capabilities, and its implementation according to this standard. ISO/IEEE 11073-10419:2016 is based on IEEE Std 11073-20601-2014, which in turn draw information from both ISO/IEEE 11073-10201:2004 [B7]2 and ISO/IEEE 11073-20101:2004 [B8]. The medical device encoding rules (MDERs) used within this standard are fully described in IEEE Std 11073-20601-2014. ISO/IEEE 11073-10419:2016 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 and IEEE Std 11073-20601-2014, all required nomenclature codes for implementation are documented.
Informatique de santé — Communication entre dispositifs de santé personnels — Partie 10419: Spécialisation du dispositif — Pompe à insuline
Le domaine d'application de l'ISO/IEEE 11073-10419:2016 consiste à établir une définition normative de la communication entre des dispositifs (agents) pompes à insuline personnels de télésanté et des gestionnaires (par exemple, des téléphones cellulaires, des ordinateurs personnels, des équipements personnels de santé et des 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, y compris la terminologie, des modèles d'informations, des normes de profils d'applications et des normes de transport. Elle spécifie l'utilisation de codes, de formats et de comportements en termes spécifiques dans les environnements de télésanté, en limitant les choix à des cadres de travail de base en faveur de l'interopérabilité. La présente norme définit un noyau commun de fonctionnalités des dispositifs pompes à insuline personnels de télésanté. Dans le contexte des dispositifs de santé personnels, une pompe à insuline est un dispositif médical utilisé pour administrer de l'insuline en traitement du diabète, également connu sous le nom de thérapie par perfusion sous-cutanée continue d'insuline (PSCI). ISO/IEEE 11073-10419:2016 fournit la modélisation des données conformément à la norme ISO/IEEE 11073-20601 et ne spécifie pas la méthode de mesurage.
General Information
Relations
Buy Standard
Standards Content (Sample)
INTERNATIONAL
ISO/IEEE
STANDARD
11073-10419
First edition
2016-06-15
Corrected version
2018-03
Health informatics — Personal health
device communication —
Part 10419:
Device specialization — Insulin pump
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 10419: Spécialisation du dispositif — Pompe à insuline
Reference number
ISO/IEEE 11073-10419:2016(E)
©
IEEE 2015
---------------------- Page: 1 ----------------------
ISO/IEEE 11073-10419:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© IEEE 2015
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or
by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written
permission. Permission can be requested from either ISO or IEEE at the address below or ISO’s member body in the country of
the requester.
ISO copyright office Institute of Electrical and Electronics Engineers, Inc
Ch. de Blandonnet 8 • CP 401 3 Park Avenue, New York
CH-1214 Vernier, Geneva, Switzerland NY 10016-5997, USA
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org stds.ipr@ieee.org
www.iso.org www.ieee.org
ii © IEEE 2015 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/IEEE 11073-10419:2016(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national
standards bodies (ISO member bodies). The work of preparing International Standards is normally
carried out through ISO technical committees. Each member body interested in a subject for which a
technical committee has been established has the right to be represented on that committee.
International organizations, governmental and non-governmental, in liaison with ISO, also take part
in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all
matters of electrotechnical standardization.
IEEE Standards documents are developed within the IEEE Societies and the Standards Coordinating
Committees of the IEEE Standards Association (IEEE-SA) Standards Board. The IEEE develops its
standards through a consensus development process, approved by the American National Standards
Institute, which brings together volunteers representing varied viewpoints and interests to achieve
the final product. Volunteers are not necessarily members of the Institute and serve without
compensation. While the IEEE administers the process and establishes rules to promote fairness in
the consensus development process, the IEEE does not independently evaluate, test, or verify the
accuracy of any of the information contained in its standards.
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies
casting a vote.
Attention is called to the possibility that implementation of this standard may require the use of
subject matter covered by patent rights. By publication of this standard, no position is taken with
respect to the existence or validity of any patent rights in connection therewith. ISO/IEEE is not
responsible for identifying essential patents or patent claims for which a license may be required,
for conducting inquiries into the legal validity or scope of patents or patent claims or determining
whether any licensing terms or conditions provided in connection with submission of a Letter of
Assurance or a Patent Statement and Licensing Declaration Form, if any, or in any licensing
agreements are reasonable or non-discriminatory. Users of this standard are expressly advised that
determination of the validity of any patent rights, and the risk of infringement of such rights, is
entirely their own responsibility. Further information may be obtained from ISO or the IEEE
Standards Association.
ISO/IEEE 11073-10419 was prepared by the IEEE 11073 Standards Committee of the IEEE
Engineering in Medicine and Biology Society (as IEEE Std 11073-10419-2015). 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.
This corrected version of ISO/IEEE 11073-10419:2016 incorporates the following
corrections:
— corrected footers and formatting.
ISO/IEEE 11073 consists of the following parts, under the general title Health informatics —
Personal health device communication (text in parentheses gives a variant of subtitle):
— Part 10101: (Point-of-care medical device communication) Nomenclature
— Part 10102: (Point-of-care medical device communication) Nomenclature: Annotated ECG
© IEEE 2015 – All rights reserved
iii
---------------------- Page: 3 ----------------------
ISO/IEEE 11073-10419:2016(E)
— Part 10103: (Point-of-care medical device communication) Nomenclature: Implantable device,
cardiac
— Part 10201: (Point-of-care medical device communication) Domain information model
— Part 10404: Device specialization — Pulse oximeter
— Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG)
— Part 10407: Device specialization — Blood pressure monitor
— Part 10408: Device specialization — Thermometer
— Part 10415: Device specialization — Weighing scale
— Part 10417: Device specialization — Glucose meter
— Part 10418: Device specialization — International Normalized Ratio (INR) monitor
— Part 10420: Device specialization — Body composition analyzer
— Part 10421: Device specialization — Peak expiratory flow monitor (peak flow)
— Part 10471: Device specialization — Independant living activity hub
— Part 10472: Device specialization — Medication monitor
— Part 20101: (Point-of-care medical device communication) Application profiles — Base
standard — Part 20601: Application profile — Optimized exchange protocol
— Part 30200: (Point-of-care medical device communication) Transport profile — Cable
connected — Part 30300: (Point-of-care medical device communication) Transport profile —
Infrared wireless — Part 30400: (Point-of-care medical device communication) Interface profile
— Cabled Ethernet — Part 90101: (Point-of-care medical device communication) Analytical
instruments — Point-of-care test — Part 91064: (Standard communication protocol) Computer-
assisted electrocardiography
— Part 92001: (Medical waveform format) — Encoding rules [Technical Specification]
iv © IEEE 2015 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/IEEE 11073-10419:2016(E)
IEEE Std 11073-10419™-2015
Health informatics—Personal health device communication
Part 10419: Device Specialization—
Insulin Pump
Sponsor
IEEE 11073™ Standards Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 16 February 2015
IEEE-SA Standards Board
---------------------- Page: 5 ----------------------
ISO/IEEE 11073-10419:2016(E)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device
communication, a normative definition of communication between personal telehealth insulin
pump devices and compute engines (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. Appropriate portions of existing standards including ISO/IEEE 11073
terminology, information models, application profile standards, and transport standards are
leveraged. The use of specific term codes, formats, and behaviors in telehealth environments
restricting optionality in base frameworks in favor of interoperability are specified. A common core
of communication functionality for personal telehealth insulin pump devices is defined.
Keywords: IEEE 11073-10419™, insulin pump, medical device communication, personal health
devices
•
The Institute of Electrical and Electronics Engineers, Inc.
3 Park Avenue, New York, NY 10016-5997, USA
Copyright © 2015 by The Institute of Electrical and Electronics Engineers, Inc.
All rights reserved. Published 10 April 2015. Printed in the United States of America.
IEEE is a registered trademark in the U.S. Patent & Trademark Office, owned by The Institute of Electrical and Electronics
Engineers, Incorporated.
PDF: ISBN 978-0-7381-9610-7 STD20158
Print: ISBN 978-0-7381-9611-4 STDPD20158
IEEE prohibits discrimination, harassment, and bullying.
For more information, visit http://www.ieee.org/web/aboutus/whatis/policies/p9-26.html.
No part of this publication may be reproduced in any form, in an electronic retrieval system or otherwise, without the prior written permission
of the publisher.
vi
Copyright © 2015 IEEE. All rights reserved.
© IEEE 2015 – All rights reserved
---------------------- Page: 6 ----------------------
ISO/IEEE 11073-10419:2016(E)
Important Notices and Disclaimers Concerning IEEE Standards Documents
IEEE documents are made available for use subject to important notices and legal disclaimers. These
notices and disclaimers, or a reference to this page, appear in all standards and may be found under the
heading “Important Notice” or “Important Notices and Disclaimers Concerning IEEE Standards
Documents.”
Notice and Disclaimer of Liability Concerning the Use of IEEE Standards
Documents
IEEE Standards documents (standards, recommended practices, and guides), both full-use and trial-use, are
developed within IEEE Societies and the Standards Coordinating Committees of the IEEE Standards
Association (“IEEE-SA”) Standards Board. IEEE (“the Institute”) develops its standards through a
consensus development process, approved by the American National Standards Institute (“ANSI”), which
brings together volunteers representing varied viewpoints and interests to achieve the final product.
Volunteers are not necessarily members of the Institute and participate without compensation from IEEE.
While IEEE administers the process and establishes rules to promote fairness in the consensus development
process, IEEE does not independently evaluate, test, or verify the accuracy of any of the information or the
soundness of any judgments contained in its standards.
IEEE does not warrant or represent the accuracy or content of the material contained in its standards, and
expressly disclaims all warranties (express, implied and statutory) not included in this or any other
document relating to the standard, including, but not limited to, the warranties of: merchantability; fitness
for a particular purpose; non-infringement; and quality, accuracy, effectiveness, currency, or completeness
of material. In addition, IEEE disclaims any and all conditions relating to: results; and workmanlike effort.
IEEE standards documents are supplied “AS IS” and “WITH ALL FAULTS.”
Use of an IEEE standard is wholly voluntary. The existence of an IEEE standard does not imply that there
are no other ways to produce, test, measure, purchase, market, or provide other goods and services related
to the scope of the IEEE standard. Furthermore, the viewpoint expressed at the time a standard is approved
and issued is subject to change brought about through developments in the state of the art and comments
received from users of the standard.
In publishing and making its standards available, IEEE is not suggesting or rendering professional or other
services for, or on behalf of, any person or entity nor is IEEE undertaking to perform any duty owed by any
other person or entity to another. Any person utilizing any IEEE Standards document, should rely upon his
or her own independent judgment in the exercise of reasonable care in any given circumstances or, as
appropriate, seek the advice of a competent professional in determining the appropriateness of a given
IEEE standard.
IN NO EVENT SHALL IEEE BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL,
EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO:
PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS;
OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY,
WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR
OTHERWISE) ARISING IN ANY WAY OUT OF THE PUBLICATION, USE OF, OR RELIANCE
UPON ANY STANDARD, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE AND
REGARDLESS OF WHETHER SUCH DAMAGE WAS FORESEEABLE.
Translations
The IEEE consensus development process involves the review of documents in English only. In the event
that an IEEE standard is translated, only the English version published by IEEE should be considered the
approved IEEE standard.
vii
Copyright © 2015 IEEE. All rights reserved.
© IEEE 2015 – All rights reserved
---------------------- Page: 7 ----------------------
ISO/IEEE 11073-10419:2016(E)
Official statements
A statement, written or oral, that is not processed in accordance with the IEEE-SA Standards Board
Operations Manual shall not be considered or inferred to be the official position of IEEE or any of its
committees and shall not be considered to be, or be relied upon as, a formal position of IEEE. At lectures,
symposia, seminars, or educational courses, an individual presenting information on IEEE standards shall
make it clear that his or her views should be considered the personal views of that individual rather than the
formal position of IEEE.
Comments on standards
Comments for revision of IEEE Standards documents are welcome from any interested party, regardless of
membership affiliation with IEEE. However, IEEE does not provide consulting information or advice
pertaining to IEEE Standards documents. Suggestions for changes in documents should be in the form of a
proposed change of text, together with appropriate supporting comments. Since IEEE standards represent a
consensus of concerned interests, it is important that any responses to comments and questions also receive
the concurrence of a balance of interests. For this reason, IEEE and the members of its societies and
Standards Coordinating Committees are not able to provide an instant response to comments or questions
except in those cases where the matter has previously been addressed. For the same reason, IEEE does not
respond to interpretation requests. Any person who would like to participate in revisions to an IEEE
standard is welcome to join the relevant IEEE working group.
Comments on standards should be submitted to the following address:
Secretary, IEEE-SA Standards Board
445 Hoes Lane
Piscataway, NJ 08854 USA
Laws and regulations
Users of IEEE Standards documents should consult all applicable laws and regulations. Compliance with
the provisions of any IEEE Standards document does not imply compliance to any applicable regulatory
requirements. Implementers of the standard are responsible for observing or referring to the applicable
regulatory requirements. IEEE does not, by the publication of its standards, intend to urge action that is not
in compliance with applicable laws, and these documents may not be construed as doing so.
Copyrights
IEEE draft and approved standards are copyrighted by IEEE under U.S. and international copyright laws.
They are made available by IEEE and are adopted for a wide variety of both public and private uses. These
include both use, by reference, in laws and regulations, and use in private self-regulation, standardization,
and the promotion of engineering practices and methods. By making these documents available for use and
adoption by public authorities and private users, IEEE does not waive any rights in copyright to the
documents.
Photocopies
Subject to payment of the appropriate fee, IEEE will grant users a limited, non-exclusive license to
photocopy portions of any individual standard for company or organizational internal use or individual,
non-commercial use only. To arrange for payment of licensing fees, please contact Copyright Clearance
Center, Customer Service, 222 Rosewood Drive, Danvers, MA 01923 USA; +1 978 750 8400. Permission
to photocopy portions of any individual standard for educational classroom use can also be obtained
through the Copyright Clearance Center.
viii
Copyright © 2015 IEEE. All rights reserved.
© IEEE 2015 – All rights reserved
---------------------- Page: 8 ----------------------
ISO/IEEE 11073-10419:2016(E)
Updating of IEEE Standards documents
Users of IEEE Standards documents should be aware that these documents may be superseded at any time
by the issuance of new editions or may be amended from time to time through the issuance of amendments,
corrigenda, or errata. An official IEEE document at any point in time consists of the current edition of the
document together with any amendments, corrigenda, or errata then in effect.
Every IEEE standard is subjected to review at least every ten years. When a document is more than ten
years old and has not undergone a revision process, it is reasonable to conclude that its contents, although
still of some value, do not wholly reflect the present state of the art. Users are cautioned to check to
determine that they have the latest edition of any IEEE standard.
In order to determine whether a given document is the current edition and whether it has been amended
through the issuance of amendments, corrigenda, or errata, visit the IEEE-SA Website at
http://ieeexplore.ieee.org/xpl/standards.jsp or contact IEEE at the address listed previously. For more
information about the IEEE SA or IEEE’s standards development process, visit the IEEE-SA Website at
http://standards.ieee.org.
Errata
Errata, if any, for all IEEE standards can be accessed on the IEEE-SA Website at the following URL:
http://standards.ieee.org/findstds/errata/index.html. Users are encouraged to check this URL for errata
periodically.
Patents
Attention is called to the possibility that implementation of this standard may require use of subject matter
covered by patent rights. By publication of this standard, no position is taken by the IEEE with respect to
the existence or validity of any patent rights in connection therewith. If a patent holder or patent applicant
has filed a statement of assurance via an Accepted Letter of Assurance, then the statement is listed on the
IEEE-SA Website at http://standards.ieee.org/about/sasb/patcom/patents.html. Letters of Assurance may
indicate whether the Submitter is willing or unwilling to grant licenses under patent rights without
compensation or under reasonable rates, with reasonable terms and conditions that are demonstrably free of
any unfair discrimination to applicants desiring to obtain such licenses.
Essential Patent Claims may exist for which a Letter of Assurance has not been received. The IEEE is not
responsible for identifying Essential Patent Claims for which a license may be required, for conducting
inquiries into the legal validity or scope of Patents Claims, or determining whether any licensing terms or
conditions provided in connection with submission of a Letter of Assurance, if any, or in any licensing
agreements are reasonable or non-discriminatory. Users of this standard are expressly advised that
determination of the validity of any patent rights, and the risk of infringement of such rights, is entirely
their own responsibility. Further information may be obtained from the IEEE Standards Association.
ix
Copyright © 2015 IEEE. All rights reserved.
© IEEE 2015 – All rights reserved
---------------------- Page: 9 ----------------------
ISO/IEEE 11073-10419:2016(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
Melanie S. Yeung, Vice-Chair
Karsten Aalders Nicolae Goga
Saeed A. Choudhary
Charles R. Abbruscato Julian Goldman
Jinhan Chung
Nabil Abujbara
Malcolm Clarke Raul Gonzalez Gomez
Maher Abuzaid John A. Cogan Chris Gough
Manfred Aigner John T. Collins Channa Gowda
Jorge Alberola Cory Condek Charles M. Gropper
Murtaza Ali Todd H. Cooper Amit Gupta
Rolf Ambuehl David Cornejo Jeff Guttmacher
David Aparisi Douglas Coup Rasmus Haahr
Lawrence Arne Nigel Cox Christian Habermann
Diego B. Arquilo Hans Crommenacker Michael Hagerty
Serafin Arroyo Tomio Crosley Jerry Hahn
Muhammad Asim David Culp Robert Hall
Merat Bagha Allen Curtis Nathaniel Hamming
Doug Baird Ndifor Cyril Fru Rickey L. Hampton
David Baker Jesús Daniel Trigo Sten Hanke
Anindya Bakshi Eyal Dassau Jordan Hartmann
Ananth Balasubramanian David Davenport Kai Hassing
Sunlee Bang Marc Daniel Haunschild
Russell Davis
M. Jonathan Barkley Wolfgang Heck
Ed Day
Gilberto Barrón Sushil K. Deka Charles Henderson
David Bean Ciro de la Vega Jun-Ho Her
John Bell Pedro de-las-Heras-Quiros Takashi Hibino
Rudy Belliardi Jim DelloStritto Timothy L. Hirou
Kathryn M. Bennett Matthew d’Entremont Allen Hobbs
Daniel Bernstein Lane Desborough Alex Holland
George A. Bertos Kent Dicks Arto Holopainen
Chris Biernacki Hyoungho Do Robert Hoy
Ola Björsne Xiaolian Duan Frank Hsu
Thomas Blackadar Brian Dubreuil Anne Huang
Marc Blanchet Jakob Ehrensvard Sen-Der Huang
Thomas Bluethner Fredrik Einberg Zhiqiang Huang
Douglas P. Bogia Roger M. Ellingson Ron Huby
Xavier Boniface Michihiro Enokida David Hughes
Shannon Boucousis Javier Escayola Calvo Robert D. Hughes
Julius Broma Leonardo Estevez Jiyoung Huh
Lyle G. Bullock, Jr. Roger Feeley Hugh Hunter
Bosco T. Fernandes
Bernard Burg Hitoshi Ikeda
Christoph Fischer
Chris Burns Yutaka Ikeda
Anthony Butt Morten Flintrup Philip O. Isaacson
Jeremy Byford-Rew Joseph W. Forler Atsushi Ito
Satya Calloji Russell Foster Michael Jaffe
Carole C. Carey Eric Freudenthal Praduman Jain
Santiago Carot-Nemesio Matthias Frohner Danny Jochelson
Randy W. Carroll Ken Fuchs Chris Johnson
Simon Carter Jing Gao Phaneeth Junga
Seungchul Chae Marcus Garbe Akiyoshi Kabe
Rahul Chauhan John Garguilo Steve Kahle
James Cheng Rick Geimer Tomio Kamioka
Peggy Chien Igor Gejdos Kei Kariya
Chia-Chin Chong Ferenc Gerbovics Andy Kaschl
x
Copyright © 2015 IEEE. All rights reserved.
© IEEE 2015 – All rights reserved
---------------------- Page: 10 ----------------------
ISO/IEEE 11073-10419:2016(E)
Junzo Kashihara
Tetsu Nishimura Redmond Shouldice
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
Minho Kim Abraham Ofek Emily Sopensky
Min-Joon 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 Ravi Swami
Myungeun Park
Geoffrey Kruse Ray Sweidan
Soojun Park
Falko Kuester Jin Tan
Phillip E. Pash
Rafael Lajara
TongBi Pei Haruyuyki Tatsumi
Pierre Landau Soren Petersen John W. Thomas
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 Gary Tschautscher
Woojae Lee John Quinlan Masato Tsuchid
Yonghee Lee Arif Rahman Ken Tubman
Joe Lenart Tanzilur Rahman Yoshihiro Uchida
Kathryn A. Lesh Steve Ray Sunil Unadkat
Qiong Li Phillip Raymond Fabio Urbani
Ying Li Tim Reilly Philipp Urbauer
Patrick Lichter Barry Reinhold Laura Vanzago
Jisoon Lim Brian Reinhold Alpo Värri
Joon-Ho Lim Melvin I. Reynolds Dalimar Velez
John Lin John G. Rhoads Naveen Verma
Jiajia Liu Jeffrey S. Robbins Rudi Voon
Wei-Jung Lo Moskowitz Robert
Isobel Walker
Charles Lowe Timothy Robertson David Wang
Don Ludolph David Rosales Jerry P. Wang
Christian Luszick Bill Saltzstein Yao Wang
Bob MacWilliams Benedikt Salzbrunn Yi Wang
Srikkanth Madhurbootheswaran Giovanna Sannino Steve Warren
Romain Marmot Jose A. Santos-Cadenas Fujio Watanabe
Sandra Martinez Stefan Sauermann Toru Watsuji
Miguel Martínez de Espronceda John Sawyer Mike Weng
Cámara Guillaume Schatz Kathleen Wible
Peter Mayhew Alois Schloegl Paul Williamson
Jim McCain Paul S. Schluter Jan Wittenber
László Meleg Lars Schmitt Jia-Rong Wu
Alexander Mense Mark G. Schnell Will Wykeham
Ethan Metsger Richard A. Schrenker Ariton Xhafa
Yu Miao Antonio Scorpiniti Junjie Yang
Jinsei Miyazaki Kwang Seok Seo Ricky Yang
Erik Moll Riccardo Serafin Melanie S. Yeung
Sid Shaw
Darr Moore Done-Sik Yoo
Piotr Murawski Frank Shen Jason Zhang
Soundharya Nagasubramanian Liqun Shen Zhiqiang Zhang
Jae-Wook Nah Bozhi Shi Thomas Zhao
Alex Neefus Min Shih Daidi Zhong
Trong-Nghia Nguyen-Dobinsky Mazen Shihabi Miha Zoubek
Michael E. Nidd Szymon Zysko
xi
Copyright © 2015 IEEE. All rights reserved.
© IEEE 2015 – All rights reserved
---------------------- Page: 11 ----------------------
ISO/IEEE 11073-10419:2016(E)
The following members of the individual balloting committee voted on this standard. Balloters may have
voted for approval, disapproval, or abstention.
John Ballingall Noriyuki Ikeuchi Henry Pinto
Giberto Barrón Atsushi Ito Melvin I. Reynolds
Lyle G. Bullock, Jr. Piotr Karocki Bartien Sayogo
Keith Chow Patrick Keith-Hynes
Lars Schmitt
Joseph El Youssef Patrick Kinney Raymond A. Strickland
Randall Groves Robert Kircher Walter Struppler
Kai Hassing Michael J. Kirwan Jan Wittenber
Werner Hoelzl Nick S. A. Nikjoo Oren Yuen
When the IEEE-SA Standards Board approved this standard on 16 February 2015, 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 Law Yatin Trivedi
Stephen Dukes Hung Ling Phil Winston
Jean-Philippe Faure Oleg Logvinov Don Wright
Gary Hoffman T. W. Olsen Yu Yuan
Glenn Parsons
*Member Emeritus
Also included are the following non-voting IEEE-SA Standards Board liaisons:
Richard DeBlasio, DOE Representative
Michael Janezic, NIST Representative
Don Messina
IEEE-SA Content Production and Management
Kathryn Bennett
IEEE-SA Technical Program Operations
xii
Copyright © 2015 IEEE. All rights reserved.
© IEEE 2015 – All rights reserved
---------------------- Page: 12 ----------------------
ISO/IEEE 11073-10419:2016(E)
Introduction
This introduction is not part of IEEE Std 11073-10419-2015, Health informatics—Personal health device
communication—Part 10419: Device Specialization—Insulin Pump.
ISO/IEEE 11073 standards enable communication between medical devices and external computer
1
systems. This document uses the optimized framework created in ISO/IEEE 11073-20601:2010 and
describes a specific, interoperable communication approach for insulin pumps. 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.
1
For information on references, see Clause 2.
xiii
Copyright © 2015 IEEE. All rights reserved.
© IEEE 2015 – All rights reserved
---------------------- Page: 13 ----------------------
ISO/IEEE 11073-10419:2016(E)
Contents
1. Overview . 1
1.1 Scope . 1
1.2 Purpose . 2
1.3 Context . 2
2. Normative references . 2
3. Definitions, acronyms, and abbreviations . 3
3.1 Definitions . 3
3.2 Acronyms and abbreviations . 4
4. Introduction to ISO/IEEE 11073 personal health devices . 5
4.1 General . 5
4.2 Introduction to ISO/IEEE 11073-20601 modeling constructs . 6
4.3 Compliance with other standards . 6
5. Insulin pump device concepts and modalities . 7
5.1 General .
...
INTERNATIONAL ISO/IEEE
STANDARD 11073-10419
First edition
2016-06-15
Health informatics — Personal health
device communication —
Part 10419:
Device specialization — Insulin pump
Informatique de santé — Communication entre dispositifs de santé
personnels
Partie 10419: Spécialisation du dispositif — Pompe à insuline
Reference number
ISO/IEEE 11073-10419:2016(E)
©
ISO 2016
©
IEEE 2015
---------------------- Page: 1 ----------------------
ISO/IEEE 11073-10419:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016
© IEEE 2015
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO or IEEE at the respective
address below.
ISO copyright office Institute of Electrical and Electronics Engineers, Inc.
Case postale 56 CH-1211 Geneva 20 3 Park Avenue, New York NY 10016-5997, USA
Tel. + 41 22 749 01 11 E-mail stds.ipr@ieee.org
Fax + 41 22 749 09 47 Web www.ieee.org
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
© ISO 2016 – All rights reserved
ii © IEEE 2015 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/IEEE 11073-10419:2016(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
IEEE Standards documents are developed within the IEEE Societies and the Standards Coordinating
Committees of the IEEE Standards Association (IEEE-SA) Standards Board. The IEEE develops its standards
through a consensus development process, approved by the American National Standards Institute, which
brings together volunteers representing varied viewpoints and interests to achieve the final product. Volunteers
are not necessarily members of the Institute and serve without compensation. While the IEEE administers the
process and establishes rules to promote fairness in the consensus development process, the IEEE does not
independently evaluate, test, or verify the accuracy of any of the information contained in its standards.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is called to the possibility that implementation of this standard may require the use of subject matter
covered by patent rights. By publication of this standard, no position is taken with respect to the existence or
validity of any patent rights in connection therewith. ISO/IEEE is not responsible for identifying essential
patents or patent claims for which a license may be required, for conducting inquiries into the legal validity or
scope of patents or patent claims or determining whether any licensing terms or conditions provided in
connection with submission of a Letter of Assurance or a Patent Statement and Licensing Declaration Form, if
any, or in any licensing agreements are reasonable or non-discriminatory. Users of this standard are expressly
advised that determination of the validity of any patent rights, and the risk of infringement of such rights, is
entirely their own responsibility. Further information may be obtained from ISO or the IEEE Standards
Association.
ISO/IEEE 11073-10419 was prepared by the IEEE 11073 Standards Comittee of the IEEE Engineering in
Medicine and Biology Society (as IEEE Std 11073-10419-2015). It was adopted by Technical Committee
ISO/TC 215, Health informatics, in parallel with its approval by the ISO member bodies, under the “fast-track
procedure” defined in the Partner Standards Development Organization cooperation agreement between ISO
and IEEE. IEEE is responsible for the maintenance of this document with participation and input from ISO
member bodies.
ISO/IEEE 11073 consists of the following parts, under the general title Health informatics — Personal health
device communication (text in parentheses gives a variant of subtitle):
Part 10101: (Point-of-care medical device communication) Nomenclature
Part 10102: (Point-of-care medical device communication) Nomenclature: Annotated ECG
Part 10103: (Point-of-care medical device communication) Nomenclature: Implantable device, cardiac
Part 10201: (Point-of-care medical device communication) Domain information model
4: Device specialization — Pulse oximeter
Part 1040
Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG)
© ISO 2016 – All rights reserved
© IEEE 2015 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/IEEE 11073-10419:2016(E)
Part 10407: Device specialization — Blood pressure monitor
Part 10408: Device specialization — Thermometer
Part 10415: Device specialization — Weighing scale
Part 10417: Device specialization — Glucose meter
Part 10418: Device specialization — International Normalized Ratio (INR) monitor
Part 10420: Device specialization — Body composition analyzer
Part 10421: Device specialization — Peak expiratory flow monitor (peak flow)
Part 10471: Device specialization — Independant living activity hub
Part 10472: Device specialization — Medication monitor
Part 20101: (Point-of-care medical device communication) Application profiles — Base standard
Part 20601: Application profile — Optimized exchange protocol
Part 30200: (Point-of-care medical device communication) Transport profile — Cable connected
Part 30300: (Point-of-care medical device communication) Transport profile — Infrared wireless
Part 30400: (Point-of-care medical device communication) Interface profile — Cabled Ethernet
Part 90101: (Point-of-care medical device communication) Analytical instruments — Point-of-care test
Part 91064: (Standard communication protocol) Computer-assisted electrocardiography
Part 92001: (Medical waveform format) — Encoding rules [Technical Specification]
© ISO 2016 – All rights reserved
iv © IEEE 2015 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/IEEE 11073-10419:2016(E)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device
communication, a normative definition of communication between personal telehealth insulin
pump devices and compute engines (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. Appropriate portions of existing standards including ISO/IEEE 11073
terminology, information models, application profile standards, and transport standards are
leveraged. The use of specific term codes, formats, and behaviors in telehealth environments
restricting optionality in base frameworks in favor of interoperability are specified. A common core
of communication functionality for personal telehealth insulin pump devices is defined.
Keywords: IEEE 11073-10419™, insulin pump, medical device communication, personal health
devices
•
The Institute of Electrical and Electronics Engineers, Inc.
3 Park Avenue, New York, NY 10016-5997, USA
Copyright © 2015 by The Institute of Electrical and Electronics Engineers, Inc.
All rights reserved. Published 10 April 2015. Printed in the United States of America.
IEEE is a registered trademark in the U.S. Patent & Trademark Office, owned by The Institute of Electrical and Electronics
Engineers, Incorporated.
PDF: ISBN 978-0-7381-9610-7 STD20158
Print: ISBN 978-0-7381-9611-4 STDPD20158
IEEE prohibits discrimination, harassment, and bullying.
For more information, visit http://www.ieee.org/web/aboutus/whatis/policies/p9-26.html.
No part of this publication may be reproduced in any form, in an electronic retrieval system or otherwise, without the prior written permission
of the publisher.
© ISO 2016 – All rights reserved
---------------------- Page: 5 ----------------------
ISO/IEEE 11073-10419:2016(E)
Important Notices and Disclaimers Concerning IEEE Standards Documents
IEEE documents are made available for use subject to important notices and legal disclaimers. These
notices and disclaimers, or a reference to this page, appear in all standards and may be found under the
heading “Important Notice” or “Important Notices and Disclaimers Concerning IEEE Standards
Documents.”
Notice and Disclaimer of Liability Concerning the Use of IEEE Standards
Documents
IEEE Standards documents (standards, recommended practices, and guides), both full-use and trial-use, are
developed within IEEE Societies and the Standards Coordinating Committees of the IEEE Standards
Association (“IEEE-SA”) Standards Board. IEEE (“the Institute”) develops its standards through a
consensus development process, approved by the American National Standards Institute (“ANSI”), which
brings together volunteers representing varied viewpoints and interests to achieve the final product.
Volunteers are not necessarily members of the Institute and participate without compensation from IEEE.
While IEEE administers the process and establishes rules to promote fairness in the consensus development
process, IEEE does not independently evaluate, test, or verify the accuracy of any of the information or the
soundness of any judgments contained in its standards.
IEEE does not warrant or represent the accuracy or content of the material contained in its standards, and
expressly disclaims all warranties (express, implied and statutory) not included in this or any other
document relating to the standard, including, but not limited to, the warranties of: merchantability; fitness
for a particular purpose; non-infringement; and quality, accuracy, effectiveness, currency, or completeness
of material. In addition, IEEE disclaims any and all conditions relating to: results; and workmanlike effort.
IEEE standards documents are supplied “AS IS” and “WITH ALL FAULTS.”
Use of an IEEE standard is wholly voluntary. The existence of an IEEE standard does not imply that there
are no other ways to produce, test, measure, purchase, market, or provide other goods and services related
to the scope of the IEEE standard. Furthermore, the viewpoint expressed at the time a standard is approved
and issued is subject to change brought about through developments in the state of the art and comments
received from users of the standard.
In publishing and making its standards available, IEEE is not suggesting or rendering professional or other
services for, or on behalf of, any person or entity nor is IEEE undertaking to perform any duty owed by any
other person or entity to another. Any person utilizing any IEEE Standards document, should rely upon his
or her own independent judgment in the exercise of reasonable care in any given circumstances or, as
appropriate, seek the advice of a competent professional in determining the appropriateness of a given
IEEE standard.
IN NO EVENT SHALL IEEE BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL,
EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO:
PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS;
OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY,
WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR
OTHERWISE) ARISING IN ANY WAY OUT OF THE PUBLICATION, USE OF, OR RELIANCE
UPON ANY STANDARD, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE AND
REGARDLESS OF WHETHER SUCH DAMAGE WAS FORESEEABLE.
Translations
The IEEE consensus development process involves the review of documents in English only. In the event
that an IEEE standard is translated, only the English version published by IEEE should be considered the
approved IEEE standard.
© ISO 2016 – All rights reserved
---------------------- Page: 6 ----------------------
ISO/IEEE 11073-10419:2016(E)
Official statements
A statement, written or oral, that is not processed in accordance with the IEEE-SA Standards Board
Operations Manual shall not be considered or inferred to be the official position of IEEE or any of its
committees and shall not be considered to be, or be relied upon as, a formal position of IEEE. At lectures,
symposia, seminars, or educational courses, an individual presenting information on IEEE standards shall
make it clear that his or her views should be considered the personal views of that individual rather than the
formal position of IEEE.
Comments on standards
Comments for revision of IEEE Standards documents are welcome from any interested party, regardless of
membership affiliation with IEEE. However, IEEE does not provide consulting information or advice
pertaining to IEEE Standards documents. Suggestions for changes in documents should be in the form of a
proposed change of text, together with appropriate supporting comments. Since IEEE standards represent a
consensus of concerned interests, it is important that any responses to comments and questions also receive
the concurrence of a balance of interests. For this reason, IEEE and the members of its societies and
Standards Coordinating Committees are not able to provide an instant response to comments or questions
except in those cases where the matter has previously been addressed. For the same reason, IEEE does not
respond to interpretation requests. Any person who would like to participate in revisions to an IEEE
standard is welcome to join the relevant IEEE working group.
Comments on standards should be submitted to the following address:
Secretary, IEEE-SA Standards Board
445 Hoes Lane
Piscataway, NJ 08854 USA
Laws and regulations
Users of IEEE Standards documents should consult all applicable laws and regulations. Compliance with
the provisions of any IEEE Standards document does not imply compliance to any applicable regulatory
requirements. Implementers of the standard are responsible for observing or referring to the applicable
regulatory requirements. IEEE does not, by the publication of its standards, intend to urge action that is not
in compliance with applicable laws, and these documents may not be construed as doing so.
Copyrights
IEEE draft and approved standards are copyrighted by IEEE under U.S. and international copyright laws.
They are made available by IEEE and are adopted for a wide variety of both public and private uses. These
include both use, by reference, in laws and regulations, and use in private self-regulation, standardization,
and the promotion of engineering practices and methods. By making these documents available for use and
adoption by public authorities and private users, IEEE does not waive any rights in copyright to the
documents.
Photocopies
Subject to payment of the appropriate fee, IEEE will grant users a limited, non-exclusive license to
photocopy portions of any individual standard for company or organizational internal use or individual,
non-commercial use only. To arrange for payment of licensing fees, please contact Copyright Clearance
Center, Customer Service, 222 Rosewood Drive, Danvers, MA 01923 USA; +1 978 750 8400. Permission
to photocopy portions of any individual standard for educational classroom use can also be obtained
through the Copyright Clearance Center.
© ISO 2016 – All rights reserved
---------------------- Page: 7 ----------------------
ISO/IEEE 11073-10419:2016(E)
Updating of IEEE Standards documents
Users of IEEE Standards documents should be aware that these documents may be superseded at any time
by the issuance of new editions or may be amended from time to time through the issuance of amendments,
corrigenda, or errata. An official IEEE document at any point in time consists of the current edition of the
document together with any amendments, corrigenda, or errata then in effect.
Every IEEE standard is subjected to review at least every ten years. When a document is more than ten
years old and has not undergone a revision process, it is reasonable to conclude that its contents, although
still of some value, do not wholly reflect the present state of the art. Users are cautioned to check to
determine that they have the latest edition of any IEEE standard.
In order to determine whether a given document is the current edition and whether it has been amended
through the issuance of amendments, corrigenda, or errata, visit the IEEE-SA Website at
http://ieeexplore.ieee.org/xpl/standards.jsp or contact IEEE at the address listed previously. For more
information about the IEEE SA or IEEE’s standards development process, visit the IEEE-SA Website at
http://standards.ieee.org.
Errata
Errata, if any, for all IEEE standards can be accessed on the IEEE-SA Website at the following URL:
http://standards.ieee.org/findstds/errata/index.html. Users are encouraged to check this URL for errata
periodically.
Patents
Attention is called to the possibility that implementation of this standard may require use of subject matter
covered by patent rights. By publication of this standard, no position is taken by the IEEE with respect to
the existence or validity of any patent rights in connection therewith. If a patent holder or patent applicant
has filed a statement of assurance via an Accepted Letter of Assurance, then the statement is listed on the
IEEE-SA Website at http://standards.ieee.org/about/sasb/patcom/patents.html. Letters of Assurance may
indicate whether the Submitter is willing or unwilling to grant licenses under patent rights without
compensation or under reasonable rates, with reasonable terms and conditions that are demonstrably free of
any unfair discrimination to applicants desiring to obtain such licenses.
Essential Patent Claims may exist for which a Letter of Assurance has not been received. The IEEE is not
responsible for identifying Essential Patent Claims for which a license may be required, for conducting
inquiries into the legal validity or scope of Patents Claims, or determining whether any licensing terms or
conditions provided in connection with submission of a Letter of Assurance, if any, or in any licensing
agreements are reasonable or non-discriminatory. Users of this standard are expressly advised that
determination of the validity of any patent rights, and the risk of infringement of such rights, is entirely
their own responsibility. Further information may be obtained from the IEEE Standards Association.
v
Copyright © 2015 IEEE. All rights reserved.
© ISO 2016 – All rights reserved
---------------------- Page: 8 ----------------------
ISO/IEEE 11073-10419:2016(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
Melanie S. Yeung, Vice-Chair
Karsten Aalders Saeed A. Choudhary Nicolae Goga
Charles R. Abbruscato Jinhan Chung Julian Goldman
Nabil Abujbara Malcolm Clarke Raul Gonzalez Gomez
Maher Abuzaid John A. Cogan Chris Gough
Manfred Aigner John T. Collins Channa Gowda
Jorge Alberola Cory Condek Charles M. Gropper
Murtaza Ali Todd H. Cooper Amit Gupta
Rolf Ambuehl David Cornejo Jeff Guttmacher
David Aparisi Douglas Coup Rasmus Haahr
Lawrence Arne Nigel Cox Christian Habermann
Diego B. Arquilo Michael Hagerty
Hans Crommenacker
Serafin Arroyo Tomio Crosley Jerry Hahn
Muhammad Asim David Culp Robert Hall
Merat Bagha Allen Curtis Nathaniel Hamming
Doug Baird Ndifor Cyril Fru Rickey L. Hampton
David Baker Jesús Daniel Trigo Sten Hanke
Anindya Bakshi
Eyal Dassau Jordan Hartmann
Ananth Balasubramanian David Davenport Kai Hassing
Sunlee Bang Russell Davis Marc Daniel Haunschild
M. Jonathan Barkley Wolfgang Heck
Ed Day
Gilberto Barrón Sushil K. Deka Charles Henderson
David Bean Ciro de la Vega Jun-Ho Her
John Bell Pedro de-las-Heras-Quiros Takashi Hibino
Rudy Belliardi Jim DelloStritto Timothy L. Hirou
Kathryn M. Bennett Matthew d’Entremont Allen Hobbs
Daniel Bernstein Lane Desborough Alex Holland
George A. Bertos Kent Dicks Arto Holopainen
Chris Biernacki Hyoungho Do Robert Hoy
Ola Björsne Xiaolian Duan Frank Hsu
Thomas Blackadar Brian Dubreuil Anne Huang
Marc Blanchet Jakob Ehrensvard Sen-Der Huang
Thomas Bluethner Fredrik Einberg Zhiqiang Huang
Douglas P. Bogia Roger M. Ellingson Ron Huby
Xavier Boniface Michihiro Enokida David Hughes
Shannon Boucousis Javier Escayola Calvo Robert D. Hughes
Julius Broma Leonardo Estevez Jiyoung Huh
Lyle G. Bullock, Jr. Roger Feeley Hugh Hunter
Bernard Burg Bosco T. Fernandes Hitoshi Ikeda
Chris Burns Christoph Fischer Yutaka Ikeda
Anthony Butt Morten Flintrup Philip O. Isaacson
Jeremy Byford-Rew Joseph W. Forler Atsushi Ito
Satya Calloji Russell Foster Michael Jaffe
Carole C. Carey Eric Freudenthal Praduman Jain
Santiago Carot-Nemesio Matthias Frohner Danny Jochelson
Randy W. Carroll Ken Fuchs Chris Johnson
Simon Carter Jing Gao Phaneeth Junga
Seungchul Chae Marcus Garbe Akiyoshi Kabe
Rahul Chauhan John Garguilo Steve Kahle
James Cheng Rick Geimer
Tomio Kamioka
Peggy Chien Igor Gejdos Kei Kariya
Chia-Chin Chong Ferenc Gerbovics Andy Kaschl
vi
Copyright © 2015 IEEE. All rights reserved.
© ISO 2016 – All rights reserved
---------------------- Page: 9 ----------------------
ISO/IEEE 11073-10419:2016(E)
Junzo Kashihara Tetsu Nishimura Redmond Shouldice
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 Motoki Sone
Yoshiteru Nozoe
Minho Kim Abraham Ofek Emily Sopensky
Min-Joon Kim Brett Olive Rajagopalan Srinivasan
Taekon Kim Andreas Staubert
Begonya Otal
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 Hermanni Suominen
Hanna Park
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 Soren Petersen John W. Thomas
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 Gary Tschautscher
Woojae Lee John Quinlan Masato Tsuchid
Yonghee Lee Arif Rahman Ken Tubman
Joe Lenart Tanzilur Rahman Yoshihiro Uchida
Kathryn A. Lesh Steve Ray Sunil Unadkat
Qiong Li Phillip Raymond Fabio Urbani
Ying Li Tim Reilly Philipp Urbauer
Patrick Lichter Barry Reinhold Laura Vanzago
Jisoon Lim Brian Reinhold Alpo Värri
Joon-Ho Lim Melvin I. Reynolds Dalimar Velez
John Lin John G. Rhoads Naveen Verma
Jiajia Liu Jeffrey S. Robbins Rudi Voon
Wei-Jung Lo Moskowitz Robert Isobel Walker
Charles Lowe Timothy Robertson David Wang
Don Ludolph David Rosales Jerry P. Wang
Christian Luszick Bill Saltzstein Yao Wang
Bob MacWilliams Benedikt Salzbrunn Yi Wang
Srikkanth Madhurbootheswaran Giovanna Sannino Steve Warren
Romain Marmot Jose A. Santos-Cadenas
Fujio Watanabe
Sandra Martinez Stefan Sauermann Toru Watsuji
Miguel Martínez de Espronceda John Sawyer Mike Weng
Cámara Guillaume Schatz
Kathleen Wible
Peter Mayhew Alois Schloegl Paul Williamson
Jim McCain Paul S. Schluter Jan Wittenber
Lars Schmitt
László Meleg Jia-Rong Wu
Alexander Mense Mark G. Schnell Will Wykeham
Ethan Metsger Richard A. Schrenker Ariton Xhafa
Antonio Scorpiniti
Yu Miao Junjie Yang
Jinsei Miyazaki Kwang Seok Seo Ricky Yang
Erik Moll Riccardo Serafin Melanie S. Yeung
Darr Moore Sid Shaw Done-Sik Yoo
Piotr Murawski Frank Shen Jason Zhang
Soundharya Nagasubramanian Liqun Shen Zhiqiang Zhang
Bozhi Shi
Jae-Wook Nah Thomas Zhao
Alex Neefus Min Shih Daidi Zhong
Trong-Nghia Nguyen-Dobinsky Mazen Shihabi Miha Zoubek
Michael E. Nidd Szymon Zysko
vii
Copyright © 2015 IEEE. All rights reserved.
© ISO 2016 – All rights reserved
---------------------- Page: 10 ----------------------
ISO/IEEE 11073-10419:2016(E)
The following members of the individual balloting committee voted on this standard. Balloters may have
voted for approval, disapproval, or abstention.
John Ballingall Noriyuki Ikeuchi Henry Pinto
Giberto Barrón Atsushi Ito Melvin I. Reynolds
Lyle G. Bullock, Jr. Piotr Karocki Bartien Sayogo
Keith Chow Patrick Keith-Hynes Lars Schmitt
Joseph El Youssef Patrick Kinney Raymond A. Strickland
Randall Groves Robert Kircher Walter Struppler
Kai Hassing Michael J. Kirwan Jan Wittenber
Werner Hoelzl Nick S. A. Nikjoo Oren Yuen
When the IEEE-SA Standards Board approved this standard on 16 February 2015, 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 Law Yatin Trivedi
Stephen Dukes Hung Ling Phil Winston
Jean-Philippe Faure Oleg Logvinov Don Wright
Gary Hoffman T. W. Olsen Yu Yuan
Glenn Parsons
*Member Emeritus
Also included are the following non-voting IEEE-SA Standards Board liaisons:
Richard DeBlasio, DOE Representative
Michael Janezic, NIST Representative
Don Messina
IEEE-SA Content Production and Management
Kathryn Bennett
IEEE-SA Technical Program Operations
viii
Copyright © 2015 IEEE. All rights reserved.
© ISO 2016 – All rights reserved
---------------------- Page: 11 ----------------------
ISO/IEEE 11073-10419:2016(E)
Introduction
This introduction is not part of IEEE Std 11073-10419-2015, Health informatics—Personal health device
communication—Part 10419: Device Specialization—Insulin Pump.
ISO/IEEE 11073 standards enable communication between medical devices and external computer
1
systems. This document uses the optimized framework created in ISO/IEEE 11073-20601:2010 and
describes a specific, interoperable communication approach for insulin pumps. 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.
1
For information on references, see Clause 2.
ix
Copyright © 2015 IEEE. All rights reserved.
© ISO 2016 – All rights reserved
---------------------- Page: 12 ----------------------
ISO/IEEE 11073-10419:2016(E)
Contents
1. Overview . 1
1.1 Scope . 1
1.2 Purpose . 2
1.3 Context . 2
2. Normative references . 2
3. Definitions, acronyms, and abbreviations . 3
3.1 Definitions . 3
3.2 Acronyms and abbreviations . 4
4. Introduction to ISO/IEEE 11073 personal health devices . 5
4.1 General . 5
4.2 Introduction to ISO/IEEE 11073-20601 modeling constructs . 6
4.3 Compliance with other standards . 6
5. Insulin pump device concepts and modalities . 7
5.1 General . 7
5.2 Device types . 8
5.3 Collected data . 8
5.4 Stored data .14
5.5 Scheduled data .
...
NORME
ISO/IEEE
INTERNATIONALE
11073-10419
Première édition
2016-06-15
Informatique de santé —
Communication entre dispositifs de
santé personnels —
Partie 10419:
Spécialisation du dispositif — Pompe
à insuline
Health informatics — Personal health device communication —
Part 10419: Device specialization — Insulin pump
Numéro de référence
ISO/IEEE 11073-10419:2016(F)
©
IEEE 2015
---------------------- Page: 1 ----------------------
ISO/IEEE 11073-10419:2016(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© IEEE 2015
Droits de reproduction réservés. Sauf prescription différente, aucune partie de cette publication ne peut être reproduite ni
utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie et les
microfilms, sans l’accord écrit soit de l’ISO soit de l’IEEE, à l’une ou l’autre des adresses ci-après.
ISO copyright office Institute of Electrical and Electronics Engineers, Inc
Ch. de Blandonnet 8 • CP 401 3 Park Avenue, New York
CH-1214 Vernier, Geneva, Switzerland NY 10016-5997, USA
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org stds.ipr@ieee.org
www.iso.org www.ieee.org
ii © IEEE 2015 – Tous droits réservés
---------------------- Page: 2 ----------------------
ISO/IEEE 11073-10419:2016(F)
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes
nationaux de normalisation (comités membres ISO). L’élaboration des Normes internationales est en
général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude a le
droit de faire partie du comité technique créé à cet effet. Les organisations internationales,
gouvernementales et non gouvernementales, en liaison avec l’ISO participent également aux travaux.
L’ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui
concerne la normalisation électrotechnique.
Les documents normatifs de l’IEEE sont développés au sein des sociétés de l’IEEE et des Comités de
Coordination des Normes du Conseil des Normes de l’Association des normes IEEE (IEEE‐SA). L’IEEE
élabore ses normes par le biais d’un processus de développement de consensus approuvé par
l’American National Standards Institute, qui rassemble des volontaires représentant divers points de
vue et divers intérêts pour parvenir au produit final. Les volontaires ne sont pas nécessairement des
membres de l’Institut et aucune compensation ne leur est attribuée. Bien que l’IEEE administre le
processus et établisse des règles pour favoriser l’équité au cours du processus de développement du
consensus, l’IEEE n’évalue pas, ne soumet pas à essai ou ne vérifie pas de manière indépendante
l’exactitude des informations contenues dans ses normes.
La tâche principale des comités techniques est d’élaborer les Normes internationales. Les projets de
Normes internationales adoptés par les comités techniques sont soumis aux comités membres pour
vote. Leur publication comme Normes internationales requiert l’approbation de 75 % au moins des
comités membres votants.
L’attention est appelée sur la possibilité que la mise en œuvre de la présente norme puisse requérir
l’utilisation d’un objet couvert par des droits de propriété intellectuelle ou des droits analogues. Du fait
de la publication de la présente norme, aucune position n’est adoptée en ce qui concerne l’existence ou
la validité de quelconques droits de brevet en rapport avec celle‐ci. Il n’incombe pas à l’ISO/IEEE
d’identifier les brevets ou revendications de brevet essentiels pour lesquels une licence peut être
requise, d’exécuter des enquêtes portant sur la validité légale ou la portée des brevets ou revendications
de brevet ou de déterminer si des termes ou conditions d’attribution de licence fournis en rapport avec
la soumission d’une lettre d’assurance ou d’une déclaration de brevet et du formulaire de déclaration
d’attribution de licence, le cas échéant, ou dans des accords d’attribution de licence quelconques, sont
raisonnables ou non discriminatoires. Les utilisateurs de la présente norme sont expressément avisés
que la détermination de la validité de tout droit de brevet et le risque de violation de ces droits leur
incombent entièrement. Des informations supplémentaires peuvent être obtenues auprès de l’ISO ou de
l’Association des normes IEEE.
L’ISO/IEEE 11073‐10419 a été préparée par le Comité des normes IEEE 11073 de la Société d’Ingénierie
en Médecine et Biologie de l’IEEE (en tant que norme IEEE 11073‐10419‐2015). Elle a été adoptée par
le Comité technique ISO/TC 215, Informatique de santé, en parallèle avec son approbation par les
comités membres de l’ISO, dans le cadre de la « procédure rapide » définie par l’accord de coopération
entre les Organisations Partenaires de Développement de Normes que sont l’ISO et l’IEEE. L’IEEE est
responsable de la tenue à jour du présent document, avec la participation et la contribution des comités
membres de l’ISO.
L’ISO/IEEE 11073 comprend les parties suivantes, présentées sous le titre général Informatique de
santé — Communication entre dispositifs de santé personnels (le texte entre parenthèses donne une
variante du sous‐titre):
: (Communication entre dispositifs médicaux sur le site des soins) Nomenclature
Partie 10101
Partie 10102: (Communication entre dispositifs médicaux sur le site des soins) Nomenclature: ECG
annoté
iii
© IEEE 2015 – Tous droits réservés
---------------------- Page: 3 ----------------------
ISO/IEEE 11073-10419:2016(F)
Partie 10103: (Communication entre dispositifs médicaux sur le site des soins) Nomenclature:
dispositif implantable, cardiaque
Partie 10201: (Communication entre dispositifs médicaux sur le site des soins) Modèle d’information
du domaine
Partie 10404: Spécialisation des dispositifs — Oxymètre de pouls
Partie 10406: Spécialisation des dispositifs — Électrocardiographe de base (ECG) (ECG 1 à 3)
Partie 10407: Spécialisation des dispositifs — Moniteur de pression sanguine
Partie 10408: Spécialisation des dispositifs — Thermomètre
Partie 10415: Spécialisation des dispositifs — Plateau de balance
Partie 10417: Spécialisation des dispositifs — Glucomètre
Partie 10418: Spécialisation des dispositifs — Surveillance du rapport normalisé international (INR)
Partie 10420: Spécialisation des dispositifs — Analyseur de la composition corporelle
Partie 10421: Spécialisation des dispositifs — Moniteur de surveillance du débit expiratoire de pointe
(débit de pointe)
Partie 10471: Spécialisation des dispositifs — Concentrateur d’activité pour une vie autonome
Partie 10472: Spécialisation des dispositifs — Moniteur de surveillance de médication
Partie 20101: (Communication entre dispositifs médicaux sur le site des soins) Profils d’applications —
Norme de base
Partie 20601: Profil d’application — Protocole d’échange optimisé
Partie 30200: (Communication entre dispositifs médicaux sur le site des soins) Profil de transport —
Connexion par câble
Partie 30300: (Communication entre dispositifs médicaux sur le site des soins) Profil de transport —
Faisceau infrarouge
Partie 30400: (Communication entre dispositifs médicaux sur le site des soins) Profil d’interface —
Ethernet câblé
Partie 90101: (Communication entre dispositifs médicaux sur le site des soins) Instruments
analytiques — Essai sur le site des soins
Partie 91064: (Communication entre dispositifs médicaux sur le site des soins) Protocole de
communication standard pour l’électrocardiographie assistée par ordinateur
Partie 92001: (Forme d’onde médicale) — Règles d’encodage [Spécification technique]
© IEEE 2015 — Tous droits réservés
iv
---------------------- Page: 4 ----------------------
ISO/IEEE 11073-10419:2016(F)
Résumé: Dans le contexte de la famille de normes ISO/IEEE 11073 relatives à la communication entre
des dispositifs, la présente norme établit une définition normative de la communication entre des
dispositifs pompes à insuline personnels de télésanté et des moteurs informatiques (par exemple, des
téléphones cellulaires, des ordinateurs personnels, des équipements personnels de santé, des boîtiers
décodeurs) d’une manière qui permet une interopérabilité du type prêt à l’emploi. Elle s’appuie sur les
parties appropriées de normes existantes, y compris la terminologie, des modèles d’informations, des
normes de profils d’applications et des normes de transport de l’ISO/IEEE 11073. Elle spécifie
l’utilisation de codes, de formats et de comportements en termes spécifiques dans les environnements
de télésanté en limitant les choix à des cadres de travail de base en faveur de l’interopérabilité. Un
noyau commun de fonctionnalités de communication pour les dispositifs pompes à insuline personnels
de télésanté est défini.
Mots-clés: IEEE 11073‐10419™, pompe à insuline, communication entre dispositifs médicaux,
dispositifs de santé personnels
The Institute of Electrical and Electronics Engineers, Inc.
3 Park Avenue, New York, NY 10016‐5997, États‐Unis
Copyright © 2013 by The Institute of Electrical and Electronics Engineers, Inc.
Tous droits réservés. Publié le 29 mars 2013. Imprimé aux États‐Unis.
IEEE est une marque de commerce déposée à l’Office des brevets et des marques des États‐Unis, détenue par l’Institute of Electrical and
Electronics Engineers, Incorporated.
PDF: ISBN 978‐0‐7381‐9610‐7 STD20158
Copie papier: ISBN 978‐0‐7381‐9611‐4 STDPD20158
L’IEEE interdit toute discrimination, tout harcèlement et toute intimidation.
Pour plus d’informations, visiter http://www.ieee.org/web/aboutus/whatis/policies/p9-26.html.
Toute reproduction, même partielle, de cette publication, sous quelque forme et par quelque procédé que ce soit, y compris par système de
localisation électronique, est interdite sans l’autorisation écrite préalable de l’éditeur.
v
Copyright © 2015 IEEE. Tous droits réservés.
© IEEE 2015 – Tous droits réservés
---------------------- Page: 5 ----------------------
ISO/IEEE 11073-10419:2016(F)
Notes importantes et rejets de responsabilité concernant les documents normatifs de
l’IEEE
Les documents de l’IEEE sont mis à disposition pour utilisation sous réserve de notes importantes et de
rejets de responsabilité légale. Ces notes et rejets de responsabilité, ou une référence à cette page,
apparaissent dans toutes les normes et peuvent être trouvés sous l’en‐tête « Note importante » ou
« Notes importantes et rejets de responsabilité concernant les documents normatifs de l’IEEE ».
Note et rejet de responsabilité concernant l’utilisation des documents normatifs de
l’IEEE
Les documents normatifs de l’IEEE (normes, usages recommandés et guides), à la fois pour une
utilisation pleine et un essai d’utilisation, sont développés au sein des sociétés de l’IEEE et des Comités
de Coordination des Normes du Conseil des Normes de l’Association des normes IEEE (IEEE‐SA). L’IEEE
(« l’Institut ») élabore ses normes par le biais d’un processus de développement de consensus approuvé
par l’American National Standards Institute (« ANSI »), qui rassemble des volontaires représentant
divers points de vue et divers intérêts pour parvenir au produit final. Les volontaires ne sont pas
nécessairement des membres de l’Institut et aucune compensation ne leur est attribuée pour leur
participation. Bien que l’IEEE administre le processus et établisse des règles pour favoriser l’équité au
cours du processus de développement du consensus, l’IEEE n’évalue pas, ne soumet pas à essai ou ne
vérifie pas de manière indépendante l’exactitude des informations ni le bien‐fondé de tous les
jugements contenus dans ses normes.
L’IEEE ne garantit ni ne représente l’exactitude ou le contenu des informations contenues dans ses
normes, et décline expressément toute garantie (explicite, implicite et statutaire) non incluse dans le
présent document ou tout autre document en rapport avec la norme, y compris, sans toutefois s’y
limiter, les garanties d’aptitude à la commercialisation, d’adéquation à un usage particulier, de non‐
contrefaçon, ainsi que de qualité, précision, efficacité, actualité ou intégrité des informations. De plus,
l’IEEE renonce à toutes les conditions relatives aux résultats et aux efforts professionnels. Les
documents normatifs de l’IEEE sont fournis « EN L’ÉTAT » et « AVEC TOUS LES DÉFAUTS ».
L’utilisation d’une norme IEEE est totalement volontaire. L’existence d’une norme IEEE n’implique pas
qu’il n’y ait pas d’autres manières de produire, de soumettre à essai, de mesurer, d’acheter, de
commercialiser ou de fournir d’autres biens et services qui se rapportent au domaine d’application de la
norme IEEE. En outre, le point de vue exprimé à l’instant où une norme est approuvée et publiée est
soumis aux changements provoqués par les développements techniques et les commentaires reçus des
utilisateurs de la norme.
En publiant ses normes et en les rendant disponibles, l’IEEE ne suggère pas ou ne rend pas de services
professionnels ou autres pour une personne ou une entité quelconque, et n’entreprend pas non plus
l’exécution d’une responsabilité quelconque de toute autre personne ou entité envers une autre. Il est
recommandé à toute personne utilisant un document normatif de l’IEEE de s’appuyer sur son jugement
indépendant en exerçant une diligence raisonnable dans des circonstances données quelconques ou, si
approprié, de demander l’avis d’un professionnel compétent pour déterminer la pertinence d’une
norme IEEE donnée.
EN AUCUN CAS L’IEEE NE SAURAIT ÊTRE TENUE POUR RESPONSABLE DE QUELCONQUES DOMMAGES
DIRECTS, INDIRECTS, INCIDENTS, SPÉCIAUX, EXEMPLAIRES OU CONSÉCUTIFS (Y COMPRIS, SANS
TOUTEFOIS S’Y LIMITER: ACHATS DE MARCHANDISES OU SERVICES DE REMPLACEMENT; PERTE
D’UTILISATION, DE DONNÉES OU DE BÉNÉFICES; OU INTERRUPTION D’ACTIVITÉ) CAUSÉS DE
QUELQUE MANIÈRE QUE CE SOIT ET SELON TOUTE THÉORIE DE RESPONSABILITÉ, QUE CE SOIT
DANS LE CONTRAT, RESPONSABILITÉ STRICTE OU DÉLICTUELLE (Y COMPRIS LA NÉGLIGENCE OU
AUTRE), RÉSULTANT DE LA PUBLICATION, DE L’UTILISATION OU DE LA CONFIANCE DE/EN TOUTE
vi
Copyright © 2015 IEEE. Tous droits réservés.
© IEEE 2015 – Tous droits réservés
---------------------- Page: 6 ----------------------
ISO/IEEE 11073-10419:2016(F)
NORME, MÊME EN CAS D’INFORMATION DE LA POSSIBILITÉ DE TELS DOMMAGES, ET
INDÉPENDAMMENT DU FAIT QUE CES DOMMAGES ÉTAIENT PRÉVISIBLES OU NON.
Traductions
Le processus de développement du consensus de l’IEEE implique l’examen de documents en anglais
uniquement. Si une norme de l’IEEE est traduite, il convient que seule la version anglaise publiée par
l’IEEE soit considérée comme la norme IEEE approuvée.
Déclarations officielles
Une déclaration, écrite ou orale, qui n’est pas traitée conformément au manuel des opérations du
Conseil des Normes IEEE‐SA ne doit pas être considérée ou supposée être la position officielle de l’IEEE
ou de l’un de ses comités et ne doit pas être considérée comme une position officielle de l’IEEE, ni servir
de base à une telle position. Lors de conférences, de symposiums, de séminaires ou de cours de
formation, une personne présentant des informations sur les normes de l’IEEE doit indiquer clairement
qu’il convient que ses points de vue soient considérés comme les points de vue personnels de cette
personne plutôt que comme la position officielle de l’IEEE.
Commentaires relatifs aux normes
Les commentaires visant à des révisions des documents normatifs de l’IEEE provenant de toute partie
intéressée sont les bienvenus, indépendamment de l’affiliation en tant que membre de l’IEEE. Toutefois,
l’IEEE ne fournit pas d’informations de consulting ou de conseils relatifs aux documents normatifs de
l’IEEE. Il convient que des suggestions pour des modifications aux documents se présentent sous la
forme d’une modification de texte proposée accompagnée des commentaires d’appui appropriés.
Comme les normes de l’IEEE représentent un consensus des intérêts concernés, il est important que
toutes les réponses aux commentaires et aux questions aient également reçu l’attention d’intérêts
équilibrés. Pour cette raison, l’IEEE et les membres de ses sociétés et de ses Comités de Coordination
des Normes ne peuvent pas fournir une réponse instantanée aux commentaires ou questions, excepté
dans les cas où le sujet a précédemment été traité. Pour la même raison, l’IEEE ne répond pas aux
demandes d’interprétation. Toute personne désirant participer aux révisions d’une norme IEEE est
invitée à rejoindre le groupe de travail IEEE concerné.
Il convient d’adresser les commentaires sur les normes à:
Secretary, IEEE‐SA Standards Board
445 Hoes Lane
Piscataway, NJ 08854 USA
Lois et règlements
Il est recommandé aux utilisateurs des documents normatifs de l’IEEE de consulter toutes les lois et
réglementations applicables. La conformité aux dispositions de tout document normatif de l’IEEE
n’implique pas la conformité à toutes les exigences réglementaires applicables. Il incombe aux
personnes ou organismes mettant en œuvre la norme d’observer les exigences réglementaires
applicables ou d’y faire référence. L’IEEE n’a pas l’intention, du fait de la publication de ses normes, de
provoquer des actions qui ne sont pas conformes aux lois applicables et ces documents ne peuvent pas
être interprétés comme le faisant.
vii
Copyright © 2015 IEEE. Tous droits réservés.
© IEEE 2015 – Tous droits réservés
---------------------- Page: 7 ----------------------
ISO/IEEE 11073-10419:2016(F)
Copyrights
Les projets de norme et normes approuvées de l’IEEE sont propriétés intellectuelles de l’IEEE en vertu
des lois américaines et internationales sur les droits d’auteur. Ils sont rendus disponibles par l’IEEE et
sont adoptés pour une grande diversité d’utilisations à la fois publiques et privées. Celles‐ci incluent une
utilisation, par référence, dans les lois et réglementations et une utilisation dans l’auto‐réglementation,
la normalisation et la promotion de pratiques et de méthodes d’ingénierie. En rendant ces documents
disponibles en vue de leur utilisation et de leur adoption par les autorités publiques et les utilisateurs
privés, l’IEEE ne renonce à aucun droit de copyright sur ce document.
Photocopies
Sous réserve du paiement des droits correspondants, l’IEEE accordera aux utilisateurs une licence
limitée et non exclusive pour photocopier des parties de toute norme individuelle en vue d’une
utilisation interne par l’entreprise ou l’organisation ou une utilisation exclusivement individuelle et non
commerciale. Pour les dispositions relatives au versement du droit de licence, contacter le Copyright
Clearance Center, Customer Service, 222 Rosewood Drive, Danvers, MA 01923 États‐Unis;
Tél. +1 978 750 8400. L’autorisation de photocopier des parties d’une norme individuelle à des fins
éducatives en classe peut également être obtenue auprès du Copyright Clearance Center.
Mise à jour de documents normatifs de l’IEEE
Il convient que les utilisateurs des documents normatifs de l’IEEE soient informés du fait que ces
documents peuvent être remplacés à tout moment par la publication de nouvelles éditions ou peuvent
être amendés de temps à autre par le biais de la publication d’amendements, de correctifs ou d’errata.
Un document IEEE officiel, à un instant quelconque, est constitué de l’édition actuelle du document
accompagnée de tous les amendements, correctifs ou errata alors en vigueur.
Chaque norme IEEE est soumise à un examen au moins tous les dix ans. Lorsqu’un document a plus de
dix ans et n’a pas été soumis à un processus d’examen, il est raisonnable de conclure que son contenu,
bien qu’il ait encore une certaine valeur, ne reflète pas totalement l’état actuel de la technique.
Les utilisateurs sont invités à s’assurer qu’ils ont la dernière édition des normes IEEE.
Pour déterminer si un document donné est l’édition actuelle et s’il a été amendé par le biais de la
publication d’amendements, de correctifs ou d’errata, il convient de visiter le site Web de l’IEEE‐SA à
l’adresse http://ieeexplore.ieee.org/xpl/standards.jsp ou de contacter l’IEEE à l’adresse citée
précédemment. Pour plus d’informations sur l’IEEE Standards Association ou le processus de
développement des normes IEEE, visiter le site Web de l’IEEE‐SA à l’adresse http://standards.ieee.org.
Errata
Les éventuels errata pour l’ensemble des normes de l’IEEE sont accessibles sur le site Web de l’IEEE‐SA
à l’adresse suivante: http://standards.ieee.org/findstds/errata/index.html. Les utilisateurs sont
encouragés à vérifier périodiquement cette URL pour rechercher d’éventuels errata.
Brevets
L’attention est appelée sur la possibilité que la mise en œuvre de la présente norme puisse requérir
l’utilisation d’un objet couvert par des droits de propriété intellectuelle ou des droits analogues. Du fait
de la publication de la présente norme, aucune position n’est adoptée en ce qui concerne l’existence ou
la validité de quelconques droits de brevet en rapport avec celle‐ci. Si le détenteur d’un brevet ou le
demandeur d’un brevet a déposé une déclaration d’assurance par l’intermédiaire d’une lettre
d’assurance acceptée, la déclaration est alors répertoriée sur le site Web de l’IEEE‐
SA http://standards.ieee.org/about/sasb/patcom/patents.html. Les lettres d’assurance peuvent
viii
Copyright © 2015 IEEE. Tous droits réservés.
© IEEE 2015 – Tous droits réservés
---------------------- Page: 8 ----------------------
ISO/IEEE 11073-10419:2016(F)
indiquer si le déposant accepte ou non d’accorder des licences dans le cadre de ces droits sans
compensation ou avec des redevances raisonnables, avec des termes et conditions raisonnables dont il
peut être démontré qu’ils sont exempts de toute discrimination inéquitable pour les demandeurs
désirant obtenir de telles licences.
D’autres revendications essentielles de brevets peuvent exister, pour lesquelles une lettre d’assurance
n’a pas été reçue. Il n’incombe pas à l’IEEE d’identifier les Essential Patent Claims (Revendications
Essentielles de Brevets) pour lesquelles une licence peut être requise, d’exécuter des enquêtes portant
sur la validité légale ou la portée des revendications de brevet ou de déterminer si des termes ou
conditions d’attribution de licence fournis en rapport avec la soumission d’une lettre d’assurance, le cas
échéant, ou dans des accords d’attribution de licence quelconques sont raisonnables ou non
discriminatoires. Les utilisateurs de la présente norme sont expressément avisés que la détermination
de la validité de tout droit de brevet et le risque de violation de ces droits leur incombent entièrement.
Des informations supplémentaires peuvent être obtenues auprès de l’Association des normes IEEE.
ix
Copyright © 2015 IEEE. Tous droits réservés.
© IEEE 2015 – Tous droits réservés
---------------------- Page: 9 ----------------------
ISO/IEEE 11073-10419:2016(F)
Participants
Au moment de l’achèvement de la présente norme IEEE, le Groupe de travail Dispositifs de santé
personnels comprenait les membres suivants:
Daidi Zhong, Président
Michael J. Kirwan, Président
Melanie S. Yeung, Vice-présidente
Karsten Aalders Cory Condek Michael Hagerty
Charles R. Abbruscato Todd H. Cooper Jerry Hahn
Nabil Abujbara David Cornejo Robert Hall
Maher Abuzaid Douglas Coup Nathaniel Hamming
Manfred Aigner Nigel Cox Rickey L. Hampton
Jorge Alberola Hans Crommenacker Sten Hanke
Murtaza Ali Tomio Crosley Jordan Hartmann
Rolf Ambuehl David Culp Kai Hassing
David Aparisi Allen Curtis Marc Daniel Haunschild
Lawrence Arne Ndifor Cyril Fru Wolfgang Heck
Diego B. Arquilo Jesus Daniel Trigo Charles Henderson
Serafin Arroyo Eyal Dassau Jun-Ho Her
Muhammad Asim David Davenport Takashi Hibino
Merat Bagha Russell Davis Timothy L. Hirou
Doug Baird Ed Day Allen Hobbs
David Baker Sushil K. Deka Alex Holland
Anindya Bakshi Ciro de la Vega Arto Holopainen
Ananth Balasubramanian Pedro de-las-Heras-Quiros Robert Hoy
Sunlee Bang Jim DelloStritto Frank Hsu
M. Jonathan Barkley Matthew d'Entremont Anne Huang
Gilberto Barrón Lane Desborough Sen-Der Huang
David Bean Kent Dicks Zhiqiang Huang
John Bell Hyoungho Do Ron Huby
Rudy Belliardi Xiaolian Duan David Hughes
Kathryn M. Bennett Brian Dubreuil Robert D. Hughes
Daniel Bernstein Jakob Ehrensvard Jiyoung Huh
George A. Bertos Fredrik Einberg Hugh Hunter
Chris Biernacki Roger M. Ellingson Hitoshi Ikeda
Ola Björsne Michihiro Enokida Yutaka Ikeda
Thomas Blackadar Javier Escayola Calvo Philip O. Isaacson
Marc Blanchet Leonardo Estevez Atsushi Ito
Thomas Bluethner Roger Feeley Michael Jaffe
Douglas P. Bogia
Bosco T. Fernandes Praduman Jain
Xavier Boniface Christoph Fischer Danny Jochelson
Shannon Boucousis Morten Flintrup Chris Johnson
Julius Broma Joseph W. Forler Phaneeth Junga
Russell Foster
Lyle G. Bullock, Jr. Akiyoshi Kabe
Bernard Burg Eric Freudenthal Steve Kahle
Chris Burns Matthias Frohner Tomio Kamioka
Anthony Butt
Ken Fuchs Kei Kariya
Jeremy Byford-Rew Jing Gao Andy Kaschl
Satya Calloji Marcus Garbe Junzo Kashihara
Carole C. Carey John Garguilo Kohichi Kashiwagi
Santiago Carot-Nemesio Rick Geimer Ralph Kent
Randy W. Carroll Igor Gejdos Laurie M. Kermes
Simon Carter Ferenc Gerbovics Ikuo Keshi
Seungchul Chae Nicolae Goga Junhyung Kim
Rahul Chauhan Julian Goldman Minho Kim
James Cheng Raul Gonzalez Gomez Min-Joon Kim
Peggy Chien Chris Gough Taekon Kim
Chia-Chin Chong Channa Gowda Tetsuya Kimura
Saeed A. Choudhary Charles M. Gropper Alfred Kloos
Jeongmee Koh
Jinhan Chung Amit Gupta
Jean-Marc Koller
Malcolm Clarke Jeff Guttmacher
John Koon
John A. Cogan Rasmus Haahr
Patty Krantz
John T. Collins Christian Habermann
x
Copyright © 2015 IEEE. Tous droits réservés.
© IEEE 2015 – Tous droits réservés
---------------------- Page: 10 ----------------------
ISO/IEEE 11073-10419:2016(F)
Alexander Kraus Bud Panjwani Emily Sopensky
Ramesh Krishna Carl Pantiskas Rajagopalan Srinivasan
Geoffrey Kruse Harry P. Pappas Andreas Staubert
Falko Kuester Mikey Paradis Nicholas Steblay
Rafael Lajara Hanna Park Beth Stephen
Pierre Landau Jong-Tae Park Lars Steubesand
Jaechul Lee Myungeun Park John (Ivo) Stivoric
JongMuk Lee Soojun Park Raymond A. Strickland
Kyong Ho Lee Phillip E. Pash Hermanni Suominen
Rami Lee TongBi Pei Lee Surprenant
Sungkee Lee Soren Petersen Ravi Swami
Woojae Lee James Petisce Ray Sweidan
Yonghee Lee Peter Piction Jin Tan
Joe Lenart Michael Pliskin Haruyuyki Tatsumi
Kathryn A. Lesh Jeff Price John W. Thomas
Qiong Li Harald Prinzhorn Brad Tipler
Ying Li John Quinlan Jonas Tiren
Patrick Lichter Arif Rahman James Tomcik
Jisoon Lim Tanzilur Rahman Janet Traub
Joon-Ho Lim Steve Ray Gary Tschautscher
John Lin Phillip Raymond Masato Tsuchid
Jiajia Liu Tim Reilly Ken Tubman
Wei-Jung Lo Barry Reinhold Yoshihiro Uchida
Charles Lowe Brian Reinhold Sunil Unadkat
Don Ludolph Melvin I. Reynolds Fabio Urbani
Christian Luszick John G. Rhoads Philipp Urbauer
Bob MacWilliams Jeffrey S. Robbins Laura Vanzago
Srikkanth Madhurbootheswaran Moskowitz Robert Alpo Varri
Romain Marmot Timothy Robertson Dalimar Velez
Sandra Martinez David Rosales Naveen Verma
Miguel Martinez de Espronceda Bill Saltzstein Rudi Voon
Camara Benedikt Salzbrunn Isobel Walker
Peter Mayhew Giovanna Sannino David Wang
Jim McCain Jose A. Santos-Cadenas Jerry P. Wang
László Meleg Stefan Sauermann Yao Wang
Alexander Mense John Sawyer Yi Wang
Ethan Metsger Guillaume Schatz Steve Warren
Yu Miao Alois Schloegl Fujio Watanabe
Jinsei Miyazaki Paul S. Schluter Toru Watsuji
Erik Moll Lars Schmitt Mike Weng
Darr Moore Mark G. Schnell Kathleen Wible
Piotr Murawski Richard A. Schrenker Paul Williamson
Soundharya Nagasubramanian Antonio Scorpiniti Jan Wittenber
Jae-Wook Nah Kwang Seok Seo Jia-Rong Wu
Alex Neefus Riccardo Serafin Will Wykeham
Trong-Nghia Nguyen-Dobinsky Sid Shaw Ariton Xhafa
Michael E. Nidd Frank Shen Junjie Yang
Tetsu Nishimura Liqun Shen Ricky Yang
Jim Niswander Bozhi Shi Melanie S. Yeung
Hiroaki Niwamoto Min Shih Done-Sik Yoo
Thomas Norgall Mazen Shihabi Jason Zhang
Anand Noubade Redmond Shouldice Zhiqiang Zhang
Yoshiteru Nozoe Sternly K. Simon Thomas Zhao
Abraham Ofek Marjorie Skubic Daidi Zhong
Brett Olive Robert Smith Miha Zoubek
Begonya Otal Ivan Soh Szymon Zysko
Charles Palmer Motoki Sone
xi
Copyright © 2015 IEEE. Tous droits réservés.
© IEEE 2015 – Tous droits réservés
---------------------- Page: 11 ----------------------
ISO/IEEE 11073-10419:2016(F)
La présente norme a été votée par les membres suivants du comité de vote individuel. Les votants
peuvent avoir voté son approbation, sa désapprobation ou s’être abstenus.
John Ballingall Noriyuki Ikeuchi Henry Pinto
Giberto Barrón Atsushi Ito Melvin I. Reynolds
Lyle G. Bullock, Jr. Piotr Karocki Bartien Sayogo
Keith Chow Patrick Keith-Hynes Lars Schmitt
Joseph El Youssef Patrick Kinney Raymond A. Strickland
Randall Groves Robert Kircher Walter Struppler
Kai Hassing Michael J. Kirwan Jan Wittenber
Werner Hoelzl Nick S. A. Nikjoo Oren Yuen
Lorsque le Conseil des Normes IEEE‐SA a approuvé la présente norme le 16 février 2015, il comprenait
les membres suivants:
John Kulick, Président
Jon Walter Rosdahl, Vice-président
Richard H. Hulett, Ancien président
Konstantinos Karachalios, Secrétaire
Peter Balma Michael Janezic Ron Peterson
Farooq Bari Jeffrey Katz Adrian Stephens
Ted Burse Joseph L. Koepfinger* Peter Sutherland
Clint Chaplain David Law Yatin Trivedi
Stephen Dukes Hung Ling Phil Winston
Jean-Philippe Faure Oleg Logvinov Don Wright
Gary Hoffman T. W. Olsen Yu Yuan
Glenn Parsons
*Membre émérite
Il comprenait également les agents de liaison (non votants) avec le Conseil des Normes IEEE‐SA
suiva
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.