EN ISO 11073-10419:2016

SLOVENSKI STANDARD
01-december-2016
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10419. del:
Specialne naprave - Inzulinska črpalka (ISO/IEEE 11073-10419:2016, popravljena
različica 2018-03)
Health informatics - Personal health device communication - Part 10419: Device
specialization - Insulin pump (ISO/IEEE 11073-10419:2016, Corrected version 2018-03)
Medizinsche Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10419: Gerätespezifikation - Insulinpumpe (ISO/IEEE 11073-10419:2016)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie
10419: Spécialisation du dispositif - Pompe à insuline (ISO/IEEE 11073-10419:2016)
Ta slovenski standard je istoveten z: EN ISO 11073-10419:2016
ICS:
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 11073-10419
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2016
EUROPÄISCHE NORM
ICS 35.240.80
English Version
Health informatics - Personal health device
communication - Part 10419: Device specialization -
Insulin pump (ISO/IEEE 11073-10419:2016, Corrected
version 2018-03)
Informatique de santé - Communication entre Medizinsche Informatik - Kommunikation von Geräten
dispositifs de santé personnels - Partie 10419: für die persönliche Gesundheit - Teil 10419:
Spécialisation du dispositif - Pompe à insuline Gerätespezifikation - Insulinpumpe (ISO/IEEE 11073-
(ISO/IEEE 11073-10419:2016) 10419:2016)
This European Standard was approved by CEN on 28 February 2016.

This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 21 November 2018.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATIO N

EUROPÄISCHES KOMITEE FÜR NORMUN G

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-10419:2016 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11073-10419:2016) has been prepared by Technical Committee ISO/TC 215
“Health informatics” in collaboration with Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by 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 11073-10419:2016, Corrected version 2018-03 has been approved by CEN as
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
ISO/IEEE 11073-10419:2016(E)
© 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

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
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

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
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
•
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ISO/IEEE 11073-10419:2016(E)
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ISO/IEEE 11073-10419:2016(E)
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ISO/IEEE 11073-10419:2016(E)
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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
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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
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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
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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
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.
For information on references, see Clause 2.
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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 .15
6. Insulin pump domain information model .15
6.1 Overview .15
6.2 Class extensions .15
6.3 Object instance diagram .15
6.4 Types of configuration .17
6.5 Profiles .18
6.6 Medical device system object .18
6.7 Numeric objects .21
6.8 Real-time sample array objects .35
6.9 Enumeration objects .36
6.10 PM-store objects .41
6.11 Schedule-store objects .46
6.12 Scanner objects .55
6.13 Class extension objects .55
6.14 Insulin pump information model extensibility rules .56
7. Insulin pump service model .56
7.1 General .56
7.2 Object access services.56
7.3 Object access event report services .58
8. Insulin pump communication model .59
8.1 Overview .59
8.2 Communications characteristics .59
8.3 Association procedure .60
8.4 Configuring procedure .61
8.5 Operating procedure .63
8.6 Time synchronization .64
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ISO/IEEE 11073-10419:2016(E)
9. Test associations .64
9.1 Behavior with standard configuration .64
9.2 Behavior with extended configurations .64
10. Conformance .64
10.1 Applicability .64
10.2 Conformance specification .65
10.3 Levels of conformance .65
10.4 Implementation conformance statements .66
Annex A (informative) Bibliography .71
Annex B (normative) Any additional ASN.1 definitions .72
B.1 Device status and insulin pump status bit mapping .72
Annex C (normative) Allocation of identifiers .74
C.1 General .74
C.2 Definitions of terms and codes .74
C.3 Systematic derivations of terms and codes .76
Annex D (informative) Message sequence examples .85
Annex E (normative) Schedule-store class .87
E.1 Schedule-store class .87
E.2 Schedule-segment class .91
Annex F (normative) Schedule class ASN.1 definitions .97
F.1 ACTION-method-related data types .97
F.2 Data types for new object attributes and object services .97
F.3 Data protocol definitions .100
Annex G (informative) The schedule-store concept .102
G.1 General .102
G.2 Schedule-store object hierarchy .103
Annex H (informative) Scedule communication model .107
H.1 Operating procedure .107
Annex I (informative) Protocol data unit examples .112
I.1 General .
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