EN ISO/IEEE 11073-10419:2023
(Main)Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump (ISO/IEEE 11073-10419:2019)
Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump (ISO/IEEE 11073-10419:2019)
This standard establishes a normative definition of communication between personal telehealth insulin
pump devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other
ISO/IEEE 11073 standards including existing terminology, information profiles, application profile
standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in
telehealth environments, restricting optionality in base frameworks in favor of interoperability. This
standard defines a common core functionality of personal telehealth insulin pump devices.
In the context of personal health devices (PHDs), an insulin pump is a medical device used for the
administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous
insulin infusion (CSII) therapy. This standard provides the data modeling according to ISO/IEEE 11073-20601 and does not specify the measurement method.
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit - Teil 10419: Gerätespezifikation - Insulinpumpe (ISO/IEEE 11073-10419:2019)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie 10419: Spécialisation des dispositifs - Pompe à insuline (ISO/IEEE 11073-10419:2019)
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10419. del: Specialne naprave - Inzulinska črpalka (ISO/IEEE 11073-10419:2019)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO/IEEE 11073-10419:2023
01-julij-2023
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10419. del:
Specialne naprave - Inzulinska črpalka (ISO/IEEE 11073-10419:2019)
Health informatics - Personal health device communication - Part 10419: Device
specialization - Insulin pump (ISO/IEEE 11073-10419:2019)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10419: Gerätespezifikation - Insulinpumpe (ISO/IEEE 11073-10419:2019)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie
10419: Spécialisation des dispositifs - Pompe à insuline (ISO/IEEE 11073-10419:2019)
Ta slovenski standard je istoveten z: prEN ISO/IEEE 11073-10419
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
oSIST prEN ISO/IEEE 11073-10419:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO/IEEE 11073-10419:2023
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oSIST prEN ISO/IEEE 11073-10419:2023
ISO/IEEE
INTERNATIONAL
11073-10419
STANDARD
Second edition
2019-03
Health informatics — Personal health
device communication —
Part 10419:
Device specialization — Insulin pump
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 10419: Spécialisation des dispositifs — Pompe à insuline
Reference number
ISO/IEEE 11073-10419:2019(E)
©
IEEE 2018
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oSIST prEN ISO/IEEE 11073-10419:2023
ISO/IEEE 11073-10419:2019(E)
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oSIST prEN ISO/IEEE 11073-10419:2023
ISO/IEEE 11073-10419:2019(E)
Foreword
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ISO/IEEE 11073-10419 was prepared by the IEEE 11073 Standards Committee of the IEEE
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oSIST prEN ISO/IEEE 11073-10419:2023
ISO/IEEE 11073-10419:2019(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. It leverages appropriate portions of existing standards including ISO/IEEE 11073
terminology, information models, application profile standards, and transport standards. It
specifies the use of specific term codes, formats, and behaviors in telehealth environments
restricting optionality in base frameworks in favor of interoperability. The standard defines a
common core of communication functionality for personal telehealth insulin pump devices.
Keywords: IEEE 11073-10419™, insulin pump, medical device communication, personal health
devices
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Participants
At the time this standard was submitted to the IEEE-SA Standards Board for approval, the Personal Health
Devices Working Group had the following membership:
Daidi Zhong, Chair
Michael J. Kirwan, Chair
Melanie S. Yeung, Vice Chair
Akib Uddin, Vice Chair
Karsten Aalders Seungchul Chae Ken Fuchs
Charles R. Abbruscato Rahul Chauhan Jing Gao
Nabil Abujbara James Cheng Xuemei Gao
Maher Abuzaid Peggy Chien Marcus Garbe
James Agnew David Chiu John Garguilo
Haidar Ahmad Jinyong Choi Rick Geimer
Manfred Aigner Chia-Chin Chong Igor Gejdos
Jorge Alberola Saeed A. Choudhary Ferenc Gerbovics
Murtaza Ali Jinhan Chung Nicolae Goga
Rolf Ambuehl Malcolm Clarke Julian Goldman
David Aparisi John A. Cogan Raul Gonzalez Gomez
Paolo Ariano John T. Collins Chris Gough
Lawrence Arne Cory Condek Channa Gowda
Diego B. Arquillo Todd H. Cooper Charles M. Gropper
Serafin Arroyo David Cornejo Amit Gupta
Muhammad Asim Douglas Coup Jeff Guttmacher
Merat Bagha
Nigel Cox Rasmus Haahr
Doug Baird Hans Crommenacker Christian Habermann
David Baker Tomio Crosley Michael Hagerty
Anindya Bakshi Allen Curtis Jerry Hahn
Ananth Balasubramanian Ndifor Cyril Fru Robert Hall
Sunlee Bang Jesús Daniel Trigo Nathaniel Hamming
M. Jonathan Barkley Eyal Dassau Rickey L. Hampton
Gilberto Barrón David Davenport Sten Hanke
David Bean Russell Davis Aki Harma
John Bell Sushil K. Deka Jordan Hartmann
Rudy Belliardi Ciro de la Vega Kai Hassing
Kathryn M. Bennett Pedro de-las-Heras-Quiros Marc Daniel Haunschild
Daniel Bernstein Jim DelloStritto Wolfgang Heck
George A. Bertos Matthew d’Entremont Nathaniel Heintzman
Chris Biernacki Kent Dicks Charles Henderson
Ola Björsne Hyoungho Do Jun-Ho Her
Thomas Blackadar Alistair Donaldson Helen B. Hernandez
Marc Blanchet Xiaolian Duan
Takashi Hibino
Thomas Bluethner Brian Dubreuil Timothy L. Hirou
Douglas P. Bogia Sourav Dutta Allen Hobbs
Xavier Boniface Jakob Ehrensvard Alex Holland
Shannon Boucousis Fredrik Einberg Arto Holopainen
Julius Broma Michihiro Enokida Kris Holtzclaw
Lyle G. Bullock Javier Escayola Calvo Robert Hoy
Bernard Burg Mark Estes Frank Hsu
Chris Burns Leonardo Estevez Anne Huang
Anthony Butt Roger Feeley Sen-Der Huang
Jeremy Byford-Rew Hailing Feng Zhiqiang Huang
Satya Calloji Bosco T. Fernandes Ron Huby
Xiaoying Cao Christoph Fischer David Hughes
Carole C. Carey Morten Flintrup Robert D. Hughes
Craig Carlson Joseph W. Forler Jiyoung Huh
Santiago Carot-Nemesio Russell Foster Hugh Hunter
Randy W. Carroll Eric Freudenthal Hitoshi Ikeda
Matthias Frohner
Simon Carter Yutaka Ikeda
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oSIST prEN ISO/IEEE 11073-10419:2023
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Philip O. Isaacson Jinsei Miyazaki Mark G. Schnell
Atsushi Ito Erik Moll Richard A. Schrenker
Michael Jaffe
Darr Moore Antonio Scorpiniti
Praduman Jain Carsten Mueglitz Kwang Seok Seo
Wei Jin Piotr Murawski Riccardo Serafin
Danny Jochelson Soundharya Nagasubramanian Sid Shaw
Phaneeth Junga Jae-Wook Nah Frank Shen
Akiyoshi Kabe Alex Neefus Bozhi Shi
Steve Kahle Trong-Nghia Nguyen-Dobinsky Min Shih
Tomio Kamioka Michael E. Nidd Mazen Shihabi
Kei Kariya Tetsu Nishimura Redmond Shouldice
Andy Kaschl Jim Niswander Sternly K. Simon
Junzo Kashihara Hiroaki Niwamoto Marjorie Skubic
Kohichi Kashiwagi Thomas Norgall Robert Smith
Ralph Kent Anand Noubade Ivan Soh
Laurie M. Kermes Yoshiteru Nozoe Motoki Sone
Ikuo Keshi Abraham Ofek Emily Sopensky
Junhyung Kim Brett Olive Rajagopalan Srinivasan
Minho Kim Begonya Otal Andreas Staubert
Min-Joon Kim
Marco Paleari Nicholas Steblay
Taekon Kim Charles Palmer Lars Steubesand
Tetsuya Kimura Bud Panjwani John (Ivo) Stivoric
Alfred Kloos Carl Pantiskas Raymond A. Strickland
Jeongmee Koh Harry P. Pappas Chandrasekaran Subramaniam
Jean-Marc Koller Hanna Park Hermanni Suominen
John Koon Jong-Tae Park Lee Surprenant
Patty Krantz Myungeun Park Ravi Swami
Raymond Krasinski Soojun Park Ray Sweidan
Alexander Kraus Phillip E. Pash Jin Tan
Ramesh Krishna TongBi Pei Yi Tang
Geoffrey Kruse Lucian Pestritu Haruyuyki Tatsumi
Falko Kuester Soren Petersen John W. Thomas
Rafael Lajara James Petisce Jonas Tirén
Pierre Landau Peter Piction Alexandra Todiruta
Jaechul Lee Michael Pliskin Janet Traub
JongMuk Lee Varshney Prabodh Gary Tschautscher
Jeff Price
Kyong Ho Lee Masato Tsuchid
Rami Lee Harald Prinzhorn Ken Tubman
Sungkee Lee Harry Qiu Yoshihiro Uchida
Woojae Lee Arif Rahman Sunil Unadkat
Yonghee Lee Tanzilur Rahman Fabio Urbani
Joe Lenart Steve Ray Philipp Urbauer
Kathryn A. Lesh Phillip Raymond Laura Vanzago
Catherine Li Tim Reilly Alpo Värri
Qiong Li Barry Reinhold Dalimar Velez
Patrick Lichter Brian Reinhold Rudi Voon
Jisoon Lim Melvin I. Reynolds Barry Vornbrock
Joon-Ho Lim John G. Rhoads Isobel Walker
John Lin Jeffrey S. Robbins David Wang
Wei-Jung Lo Chris Roberts Jerry P. Wang
Charles Lowe Moskowitz Robert Yao Wang
Don Ludolph Timothy Robertson Yi Wang
Christian Luszick David Rosales Steve Warren
Fatemeh Saki
Bob MacWilliams Fujio Watanabe
Srikkanth Madhurbootheswaran Bill Saltzstein Toru Watsuji
Miriam L. Makhlouf Benedikt Salzbrunn Mike Weng
Romain Marmot Giovanna Sannino Kathleen Wible
Sandra Martinez Jose A. Santos-Cadenas Paul Williamson
Miguel Martínez de Espronceda Stefan Sauermann Jan Wittenber
Cámara John Sawyer Jia-Rong Wu
Peter Mayhew Guillaume Schatz Will Wykeham
Jim McCain Alois Schloegl Ariton Xhafa
László Meleg Paul S. Schluter Dan Xiao
Alexander Mense Lars Schmitt Yaxi Yan
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Qifeng Yan Done-Sik Yoo Zhiqiang Zhang
Junjie Yang Jianchao Zeng Thomas Zhao
Ricky Yang Jason Zhang Miha Zoubek
Qiang Yin Szymon Zyskoter
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 Melvin I. Reynolds
Hector Barron Gonzalez
Atsushi Ito Bartien Sayogo
Lyle G. Bullock Piotr Karocki Lars Schmitt
Keith Chow Patrick Keith-Hynes Raymond Strickland
Joseph El Youssef Patrick Kinney Walter Struppler
Randall Groves Robert Kircher Jan Wittenber
Kai Hassing Michael J. Kirwan Oren Yuen
Werner Hoelzl Nick S. A. Nikjoo Daidi Zhong
Henry Pinto
When the IEEE-SA Standards Board approved this standard on 28 September 2017, it had the following
membership:
Jean-Philippe Faure, Chair
Gary Hoffman, Vice Chair
John D. Kulick, Past Chair
Konstantinos Karachalios, Secretary
Chuck Adams Thomas Koshy Robby Robson
Masayuki Ariyoshi Joseph L. Koepfinger* Dorothy Stanley
Ted Burse Kevin Lu Adrian Stephens
Stephen Dukes Daleep Mohla Mehmet Ulema
Doug Edwards Damir Novosel Phil Wennblom
J. Travis Griffith Ronald C. Petersen Howard Wolfman
Michael Janezic Annette D. Reilly Yu Yuan
*Member Emeritus
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Introduction
This introduction is not part of IEEE Std 11073-10419-2017, 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 11073-20601:2016 and describes a
1
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 (PHDs).
1
Information on references can be found in Clause 2.
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Contents
1. Overview . 12
1.1 Scope . 12
1.2 Purpose . 12
1.3 Context . 12
2. Normative references . 13
3. Definitions, acronyms, and abbreviations . 13
3.1 Definitions . 13
3.2 Acronyms and abbreviations . 15
4. Introduction to ISO/IEEE 11073 personal health devices (PHDs) . 16
4.1 General . 16
4.2 Introduction to ISO/IEEE 11073-20601 modeling constructs . 16
4.3 Compliance with other standards . 17
5. Insulin pump device concepts and modalities . 17
5.1 General . 17
5.2 Device types . 18
5.3 Collected data . 19
5.4 Stored data .
...
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