SIST EN ISO 11073-20601:2017

SLOVENSKI STANDARD
kSIST FprEN ISO 11073-20601:2015
01-december-2015
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 20601. del:
Profil aplikacije - Optimalni protokol izmenjave podatkov (ISO/IEEE FDIS 11073-
20601)
Health informatics - Personal health device communication - Part 20601: Application
profile - Optimized exchange protocol (ISO/IEEE FDIS 11073-20601)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 20601: Anwendungsprofil - Optimiertes Datenübertragungsprotokoll (ISO/IEEE FDIS
11073-20601)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie
20601: Profil d'application - Protocole d'échange optimisé (ISO/IEEE FDIS 11073-20601)
Ta slovenski standard je istoveten z: FprEN ISO 11073-20601
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
kSIST FprEN ISO 11073-20601:2015 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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kSIST FprEN ISO 11073-20601:2015

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kSIST FprEN ISO 11073-20601:2015
FINAL
INTERNATIONAL ISO/IEEE
DRAFT
STANDARD FDIS
11073-20601
ISO/TC 215
Health informatics — Personal health
Secretariat: ANSI
device communication —
ISO voting begins on:
2015-08-20
Part 20601:
Application profile — Optimized
ISO voting terminates on:
2016-01-20
exchange protocol

Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 20601: Profil d'application — Protocole d'échange optimisé


Please see the administrative notes on page ii-1


RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPORT-
ING DOCUMENTATION.
Reference number
IN ADDITION TO THEIR EVALUATION AS
ISO/IEEE FDIS 11073-20601:2015(E)
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
©
IEEE 2014

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kSIST FprEN ISO 11073-20601:2015
ISO/IEEE 11073-20601:2015(E)
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Copyright notice
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ii © IEEE 2011 – All rights reserved

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kSIST FprEN ISO 11073-20601:2015
ISO/IEEE 11073-20601:2015(E)


FAST-TRACK PROCEDURE



This document is submitted under the fast-track procedure in accordance with the Partner
Standards Development Organization cooperation agreement between ISO and IEEE, as approved
by Council Resolution 2/2011, and is submitted to all ISO member bodies for voting within
5 months.
Positive votes shall not be accompanied by comments.
Negative votes shall be accompanied by the relevant technical reasons.

In accordance with the provisions of Council Resolution 15/1993, this document is circulated in the
English language only.

© IEEE 2014 – All rights reserved ii-1

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kSIST FprEN ISO 11073-20601:2015

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kSIST FprEN ISO 11073-20601:2015
ISO/IEEE 11073-20601:2015(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
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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 11073-20601 was prepared by the IEEE 11073 Standards Comittee of the IEEE Engineering in
Medicine and Biology Society (as IEEE Std 11073-20601-2014). 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.

© IEEE 2014 – All rights reserved iii

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kSIST FprEN ISO 11073-20601:2015

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kSIST FprEN ISO 11073-20601:2015
Health informatics—Personal health device communication

Part 20601: Application profile—
Optimized Exchange Protocol
IEEE Engineering in Medicine and Biology Society
Sponsored by the
IEEE 11073™ Standards Committee
IEEE
IEEE Std 11073-20601™-2014
3 Park Avenue
(Revision of
New York, NY 10016-5997
ISO/IEEE 11073-20601:2010)
USA

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kSIST FprEN ISO 11073-20601:2015

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kSIST FprEN ISO 11073-20601:2015
ISO/IEEE 11073-20601:2015(E)
IEEE Std 11073-20601™-2014
(Revision of
ISO/IEEE 11073-20601:2010)
Health informatics—Personal health device communication
Part 20601: Application profile—
Optimized Exchange Protocol
Sponsor
IEEE 11073™ Standards Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 21 August 2014
IEEE-SA Standards Board
© IEEE 2014 – All rights reserved

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kSIST FprEN ISO 11073-20601:2015
ISO/IEEE 11073-20601:2015(E)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device
communication, this standard defines a common framework for making an abstract model of
personal health data available in transport-independent transfer syntax required to establish
logical connections between systems and to provide presentation capabilities and services
needed to perform communication tasks. The protocol is optimized to personal health usage
requirements and leverages commonly used methods and tools wherever possible.
•
Keywords: IEEE 11073-20601™, medical device communication, personal health devices
The Institute of Electrical and Electronics Engineers, Inc.
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Copyright © 2014 by The Institute of Electrical and Electronics Engineers, Inc.
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© IEEE 2014 – All rights reserved

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kSIST FprEN ISO 11073-20601:2015
ISO/IEEE 11073-20601:2015(E)
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© IEEE 2014 – All rights reserved

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kSIST FprEN ISO 11073-20601:2015
ISO/IEEE 11073-20601:2015(E)
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© IEEE 2014 – All rights reserved

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kSIST FprEN ISO 11073-20601:2015
ISO/IEEE 11073-20601:2015(E)
Updating of IEEE Standards documents
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© IEEE 2014 – All rights reserved

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kSIST FprEN ISO 11073-20601:2015
ISO/IEEE 11073-20601:2015(E)
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, Co-Chair
Michael J. Kirwan, Co-Chair
Douglas P. Bogia, Co-Chair
Charles R. Abbruscato Jinhan Chung Raul Gonzalez Gomez
Nabil Abujbara Malcolm Clarke Chris Gough
Maher Abuzaid John A. Cogan Channa Gowda
Manfred Aigner John T. Collins Charles M. Gropper
Jorge Alberola Cory Condek Amit Gupta
Karsten Alders Todd H. Cooper Jeff Guttmacher
Murtaza Ali David Cornejo Rasmus Haahr
Rolf Ambuehl Douglas Coup Christian Habermann
David Aparisi Nigel Cox Michael Hagerty
Lawrence Arne Hans Crommenacker Jerry Hahn
Diego B. Arquillo Tomio Crosley Robert Hall
Serafin Arroyo David Culp Nathaniel Hamming
Muhammad Asim Allen Curtis Rickey L. Hampton
Merat Bagha Ndifor Cyril Fru Sten Hanke
Doug Baird Jesús Daniel Trigo Jordan Hartmann
David Baker Eyal Dassau Kai Hassing
Anindya Bakshi David Davenport Marc Daniel Haunschild
Ananth Balasubramanian Russell Davis Wolfgang Heck
Sunlee Bang Ed Day Charles Henderson
M. Jonathan Barkley Sushil K. Deka Jun-Ho Her
Gilberto Barrón Pedro de-las-Heras-Quiros Takashi Hibino
David Bean Jim DelloStritto Timothy L. Hirou
John Bell Matthew d’Entremont Allen Hobbs
Rudy Belliardi Lane Desborough Alex Holland
Kathryn M. Bennett Kent Dicks Arto Holopainen
Daniel Bernstein Hyoungho Do Robert Hoy
George A. Bertos Xiaolian Duan Frank Hsu
Chris Biernacki Anne Huang
Brian Dubreuil
Ola Björsne Jakob Ehrensvard Sen-Der Huang
Thomas Blackadar Fredrik Einberg Zhiqiang Huang
Marc Blanchet
Roger M. Ellingson Ron Huby
Thomas Bluethner Michihiro Enokida Robert D. Hughes
Xavier Boniface Javier Escayola Calvo David Hughes
Leonardo Estevez
Shannon Boucousis Jiyoung Huh
Julius Broma Roger Feeley Hugh Hunter
Lyle G. Bullock Bosco T. Fernandes Hitoshi Ikeda
Bernard Burg Christoph Fischer Yutaka Ikeda
Chris Burns Morten Flintrup Philip O. Isaacson
Anthony Butt Joseph W. Forler Atsushi Ito
Jeremy Byford-Rew Russell Foster Michael Jaffe
Satya Calloji Eric Freudenthal Praduman Jain
Carole C. Carey Matthias Frohner Danny Jochelson
Santiago Carot-Nemesio Ken Fuchs Chris Johnson
Randy W. Carroll Jing Gao Phaneeth Junga
Simon Carter Marcus Garbe Akiyoshi Kabe
Seungchul Chae John Garguilo Steve Kahle
Rahul Chauhan Rick Geimer Tomio Kamioka
James Cheng Igor Gejdos Kei Kariya
Peggy Chien Ferenc Gerbovics Andy Kaschl
Chia-Chin Chong Nicolae Goga Junzo Kashihara
Saeed A. Choudhary Julian Goldman Kohichi Kashiwagi
vi
Copyright © 2014 IEEE. All rights reserved.
© IEEE 2014 – All rights reserved

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kSIST FprEN ISO 11073-20601:2015
ISO/IEEE 11073-20601:2015(E)
Ralph Kent Jim Niswander Sternly K. Simon
Laurie M. Kermes Hiroaki Niwamoto Marjorie Skubic
Ikuo Keshi Thomas Norgall Robert Smith
Junhyung Kim Anand Noubade Ivan Soh
Min-Joon Kim Yoshiteru Nozoe Motoki Sone
Minho Kim Abraham Ofek Emily Sopensky
Taekon Kim Brett Olive Rajagopalan Srinivasan
Tetsuya Kimura Begonya Otal Andreas Staubert
Alfred Kloos Charles Palmer Nicholas Steblay
Jeongmee Koh Bud Panjwani Beth Stephen
Jean-Marc Koller Carl Pantiskas Lars Steubesand
John Koon Harry P. Pappas John (Ivo) Stivoric
Patty Krantz Mikey Paradis Raymond A. Strickland
Alexander Kraus Hanna Park Hermanni Suominen
Ramesh Krishna Lee Surprenant
Jong-Tae Park
Geoffrey Kruse Myungeun Park Ravi Swami
Falko Kuester Soojun Park Ray Sweidan
Rafael Lajara
Phillip E. Pash Jin Tan
Pierre Landau TongBi Pei Haruyuyki Tatsumi
Jaechul Lee Soren Petersen John W. Thomas
JongMuk Lee
James Petisce Brad Tipler
Kyong Ho Lee Peter Piction Jonas Tirén
Rami Lee Michael Pliskin James Tomcik
Sungkee Lee Jeff Price Janet Traub
Woojae Lee Harald Prinzhorn Gary Tschautscher
Yonghee Lee John Quinlan Masato Tsuchid
Joe Lenart Arif Rahman Ken Tubman
Kathryn A. Lesh Tanzilur Rahman Yoshihiro Uchida
Qiong Li Steve Ray Sunil Unadkat
Ying Li Phillip Raymond Fabio Urbani
Patrick Lichter Tim Reilly Philipp Urbauer
Jisoon Lim Barry Reinhold Laura Vanzago
Joon-Ho Lim Brian Reinhold Alpo Värri
John Lin Melvin I. Reynolds Ciro de la Vega
Jiajia Liu John G. Rhoads Dalimar Velez
Wei-Jung Lo Jeffrey S. Robbins Naveen Verma
Charles Lowe Moskowitz Robert Rudi Voon
Don Ludolph Timothy Robertson Isobel Walker
Christian Luszick David Rosales David Wang
Bob MacWilliams Bill Saltzstein Jerry P. Wang
Srikkanth Madhurbootheswaran Benedikt Salzbrunn Yao Wang
Romain Marmot Giovanna Sannino Yi Wang
Sandra Martinez Jose A. Santos-Cadenas Steve Warren
Miguel Martínez de Espronceda Stefan Sauermann Fujio Watanabe
Cámara John Sawyer Toru Watsuji
Peter Mayhew Guillaume Schatz Mike Weng
Jim McCain Alois Schloegl Kathleen Wible
László Meleg Paul S. Schluter Paul Williamson
Alexander Mense Lars Schmitt Jan Wittenber
Ethan Metsger Mark G. Schnell Jia-Rong Wu
Yu Miao Richard A. Schrenker Will Wykeham
Jinsei Miyazaki Antonio Scorpiniti Ariton Xhafa
Erik Moll Kwang Seok Seo Junjie Yang
Darr Moore Riccardo Serafin Ricky Yang
Piotr Murawski Sid Shaw Melanie Yeung
Soundharya Nagasubramanian Frank Shen Done-Sik Yoo
Jae-Wook Nah Liqun Shen Jason Zhang
Alex Neefus Bozhi Shi Zhiqiang Zhang
Trong-Nghia Nguyen-Dobinsky Min Shih
Thomas Zhao
Michael E. Nidd Mazen Shihabi Miha Zoubek
Tetsu Nishimura Redmond Shouldice Szymon Zysko
vii
Copyright © 2014 IEEE. All rights reserved.
© IEEE 2014 – All rights reserved

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kSIST FprEN ISO 11073-20601:2015
ISO/IEEE 11073-20601:2015(E)
The following members of the balloting committee voted on this standard. Balloters may have voted for
approval, disapproval, or abstention.
Hector Barron Gonzalez David Friscia Charles Ngethe
Pieter Botman David Fuschi Melvin I. Reynolds
Lyle G. Bullock Randall Groves Terence Rout
Juan Carreon Kai Hassing Bartien Sayogo
Randy W. Carroll Werner Hoelzl Lars Schmitt
Lawrence Catchpole Ruimin Hu Carl Singer
Jianwen Chen Noriyuki Ikeuchi Kapil Sood
Keith Chow Akio Iso Raymond A. Strickland
Donald Cragun Atsushi Ito Walter Struppler
Paul Croll Raj Jain Jiande Sun
Russell Davis Junghoon Jee Hung-Yu Wei
Douglas Dorr Piotr Karocki Jan Wittenber
Sourav Dutta Stuart Kerry Oren Yuen
Christoph Fischer Geoff Ladwig Daidi Zhong
Richard Lancaster
When the IEEE-SA Standards Board approved this standard on 21 August 2014, it had the following
membership:
John Kulick, Chair
Jon Walter Rosdahl, Vice-chair
Richard H. Hulett, Past Chair
Konstantinos Karachalios, Secretary
Peter Balma Michael Janezic Ron Peterson
Farooq Bari Jeffrey Katz Adrian Stephens
Ted Burse Joseph L. Koepfinger* Peter Sutherland
Clint Chaplain David Law Yatin Trivedi
Stephen Dukes Hung Ling Phil Winston
Jean-Phillippe Faure Oleg Logvinov Don Wright
Gary Hoffman T. W. Olsen Yu Yuan
Glenn Parsons
*Member Emeritus
Also included are the following nonvoting IEEE-SA Standards Board liaisons:
Richard DeBlasio, DOE Representative
Michael Janezic, NIST Representative
Don Messina
IEEE-SA Content Publishing
Kathryn Bennett
IEEE-SA Technical Community Programs
viii
Copyright © 2014 IEEE. All rights reserved.
© IEEE 2014 – All rights reserved

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kSIST FprEN ISO 11073-20601:2015
ISO/IEEE 11073-20601:2015(E)
Introduction
This introduction is not part of IEEE Std 11073-20601-2014, Health informatics—Personal health device
communication—Part 20601: Application profile—Optimized Exchange Protocol.
ISO and IEEE 11073 standards enable communication between medical devices and external computer
systems. This standard and corresponding IEEE 11073-104zz standards address a need
...