SIST EN ISO 11073-00103:2017

Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015)

Within the context of the ISO/IEEE 11073 family of standards for device communication, this guide describes the landscape of transport-independent applications and information profiles for personal telehealth devices. These profiles define data exchange, data representation, and terminology for communication between personal health devices and compute engines (e.g., health appliances, set top boxes, cell phones, and personal computers). The guide provides a definition of personal telehealth devices as devices used for life activity, wellness monitoring, and/or health monitoring in domestic home, communal home, and/or mobile applications as well as professional medical usage. Use cases relevant to these scenarios and environments are also presented.

Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit- Teil 00103: Überblick (ISO/IEEE 11073-00103:2015)

Informatique de santé - Communication entre dispositifs de santé personnels - Partie 00103: Aperçu général (ISO/IEEE 11073-00103:2015)

Dans le contexte de la famille de normes ISO/IEEE 11073 pour la communication entre dispositifs, ISO/IEEE 11073-00103:2015 décrit l'environnement des applications indépendantes du transport et des profils d'information pour les dispositifs personnels de télésanté. Ces profils définissent l'échange de données, la représentation des données et la terminologie pour la communication entre les dispositifs personnels de télésanté et les moteurs informatiques (par exemple équipements de santé, boîtiers décodeurs, téléphones cellulaires et ordinateurs personnels). Le guide donne une définition des dispositifs personnels de télésanté en tant que dispositifs utilisés pour l'activité quotidienne, la surveillance du bien-être et/ou la surveillance de la santé à domicile, dans des lieux publics et/ou sur des applications mobiles. Des cas d'utilisation relevant de ces scénarios et de ces environnements sont également présentés.

Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 00103. del: Pregled (ISO/IEEE 11073-00103:2015)

Ta smernica v okviru skupine standardov za komunikacijo naprav ISO/IEEE 11073 opisuje območja aplikacij, neodvisnih od oblike prenosa, in informacijske profile za osebne telemedicinske naprave. Ti profili določajo izmenjavo podatkov, predstavitev podatkov in terminologijo za komunikacijo med osebnimi medicinskimi napravami in upravljalnimi napravami (npr. medicinskimi pripomočki, digitalnimi sprejemniki, mobilnimi telefoni in osebnimi računalniki). Vodilo podaja definicijo osebnih telemedicinskih naprav kot naprav, ki se uporabljajo za življenjsko dejavnost, spremljanje dobrega počutja in/ali zdravja doma, v ustanovah, in/ali mobilne aplikacije kot tudi za profesionalno medicinsko uporabo. Predstavljeni so tudi primeri uporabe, ki zadevajo te scenarije in okolja.

General Information

• Status: Published
• Public Enquiry End Date: 30-Dec-2016
• Publication Date: 15-Aug-2017
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ITC - Information technology
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 02-Mar-2017
• Due Date: 07-May-2017
• Completion Date: 16-Aug-2017
• Ref Project: EN ISO 11073-00103:2017 - Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11073-00103:2017
01-september-2017
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 00103. del:
Pregled (ISO/IEEE 11073-00103:2015)
Health informatics - Personal health device communication - Part 00103: Overview
(ISO/IEEE 11073-00103:2015)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit-
Teil 00103: Überblick (ISO/IEEE 11073-00103:2015)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie
00103: Aperçu général (ISO/IEEE 11073-00103:2015)
Ta slovenski standard je istoveten z: EN ISO 11073-00103:2017
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 11073-00103:2017 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11073-00103:2017

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SIST EN ISO 11073-00103:2017


EN ISO 11073-00103
EUROPEAN STANDARD

NORME EUROPÉENNE

February 2017
EUROPÄISCHE NORM
ICS 11.040.55; 35.240.80
English Version

Health informatics - Personal health device
communication - Part 00103: Overview (ISO/IEEE 11073-
00103:2015)
Informatique de santé - Communication entre Medizinische Informatik - Kommunikation von Geräten
dispositifs de santé personnels - Partie 00103: Aperçu für die persönliche Gesundheit- Teil 00103: Überblick
général (ISO/IEEE 11073-00103:2015) (ISO/IEEE 11073-00103:2015)
This European Standard was approved by CEN on 16 January 2017.

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 NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-00103:2017 E
worldwide for CEN national Members.

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SIST EN ISO 11073-00103:2017
EN ISO 11073-00103:2017 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 11073-00103:2017
EN ISO 11073-00103:2017 (E)
European foreword
The text of ISO/IEEE 11073-00103:2015 has been prepared by Technical Committee ISO/TC 215
“Health informatics” of the International Organization for Standardization (ISO) and has been taken
over as EN ISO 11073-00103:2017 by Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by August 2017, and conflicting national standards shall
be withdrawn at the latest by August 2017.
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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
the United Kingdom.
Endorsement notice
The text of ISO 11073-00103:2015 has been approved by CEN as EN ISO 11073-00103:2017 without
any modification.
3

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SIST EN ISO 11073-00103:2017

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SIST EN ISO 11073-00103:2017

INTERNATIONAL ISO/IEEE
STANDARD 11073-00103
First edition
2015-03-01

Health informatics — Personal health
device communication —
Part 00103:
Overview
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 00103: Aperçu général




Reference number
ISO/IEEE 11073-00103:2015(E)

©
IEEE 2012

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SIST EN ISO 11073-00103:2017
ISO/IEEE 11073-00103:2015(E)

COPYRIGHT PROTECTED DOCUMENT


©  IEEE 2012
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 [e-mail]
Fax + 41 22 749 09 47 Web www.ieee.org
E-mail [e-mail]
Web www.iso.org
Published in Switzerland

ii © IEEE 2012 – All rights reserved

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SIST EN ISO 11073-00103:2017
ISO/IEEE 11073-00103:2015(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
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 11073-00103 was prepared by the 11073 Committee of the Engineering in Medicine and Biology
Society of the IEEE (as IEEE 11073-00103-2012). 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 00103: Overview
 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
 Part 10404: Device specialization — Pulse oximeter
© IEEE 2012 – All rights reserved iii

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SIST EN ISO 11073-00103:2017
ISO/IEEE 11073-00103:2015(E)
 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 10441: Device specialization — Cardiovascular fitness and activity monitor
 Part 10442: (Point-of-care medical device communication) Device specialization — Strength fitness
equipment
 Part 10471: Device specialization — Independent 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
iv © IEEE 2012 – All rights reserved

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SIST EN ISO 11073-00103:2017


Health Informatics—Personal health device communication

Part 00103: Overview
IEEE Engineering in Medicine and Biology Society

Sponsored by the
IEEE 11073™ Standard Committee


IEEE
IEEE Std 11073-00103™-2012
3 Park Avenue

New York, NY 10016-5997
USA

31 August 2012

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SIST EN ISO 11073-00103:2017

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SIST EN ISO 11073-00103:2017
TM
IEEE Std 1173-00103 -2012
Health informatics—Personal health device communication
Part 00103: Overview
Sponsor
TM
IEEE 11073 Standards Committee
of the
IEEE Engineering in Medicine and Biology Society

Approved 14 May 2012
IEEE-SA Standards Board

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SIST EN ISO 11073-00103:2017
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device
communication, the landscape of transport-independent applications and information profiles for
personal telehealth devices is described in this guide. Defined in these profiles are data exchange,
data representation, and terminology for communication between personal telehealth devices and
compute engines (e.g., health appliances, set top boxes, cell phones, and personal computers). A
definition of personal telehealth devices as devices used for life activity, wellness monitoring,
and/or health monitoring in domestic home, communal home, and/or mobile applications is
provided in this guide. Use cases relevant to these scenarios and environments are also
presented.

Keywords: IEEE 11073-00103, medical device communication, personal health devices

•


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SIST EN ISO 11073-00103:2017
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SIST EN ISO 11073-00103:2017
Notice to users
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iv
Copyright © 2012 IEEE. All rights reserved.

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SIST EN ISO 11073-00103:2017
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
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Essential Patent Claims may exist for which a Letter of Assurance has not been received. The IEEE is not
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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 © 2012 IEEE. All rights reserved.

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SIST EN ISO 11073-00103:2017
Participants
At the time this guide was submitted to the IEEE-SA Standards Board for approval, the Personal Health
Devices Working Group had the following membership:
Douglas P. Bogia, Chair    Daidi Zhong, Chair    Michael J. Kirwan, Chair
Stefan Sauermann, Vice Chair  Jan Wittenber, Vice Chair  Benedikt Salzbrunn, Vice Chair

Charles R. Abbruscato Jinhan Chung Charles Gropper
Nabil Abujbara Malcolm Clarke Amit Gupta

Maher Abuzaid John A. Cogan Jeff Guttmacher
Manfred Aigner John T. Collins Rasmus Haahr
Jorge Alberola Cory Condek Christian Habermann
Karsten Alders Todd H. Cooper Michael Hagerty
Murtaza Ali David Cornejo Jerry Hahn
Prasad Alva Douglas Coup Robert Hall
Rolf Ambuehl Nigel Cox Nathaniel Hamming
David Aparisi Tomio Crosley Rickey L. Hampton
Lawrence Arne Allen Curtis Sten Hanke
Serafin Arroyo Jesús Daniel Trigo Kai Hassing
Muhammad Asim Eyal Dassau Marc Daniel Haunschild
Merat Bagha Russell Davis Charles Henderson
Doug Baird Ed Day Jun-Ho Her
David Baker Sushil K. Deka Takashi Hibino
Anindya Bakshi Pedro de-las-Heras-Quiros Timothy L. Hirou
Ananth Balasubramanian Jim DelloStritto Allen Hobbs
Sunlee Bang Matthew d'Entremont Alex Holland
M. Jonathan. Barkley Kent Dicks Arto Holopainen
Gilberto Barrón Hyoungho Do Robert Hoy
David Bean Xiaolian Duan Frank Hsu
John Bell Brian Dubreuil Anne Huang
Rudy Belliardi Jakob Ehrensvard Sen-Der Huang
Kathryn M. Bennett Fredrik Einberg Ron Huby
Daniel Bernstein Roger M. Ellingson Robert D. Hughes
George A. Bertos Michihiro Enokida David Hughes
Ola Björsne Javier Escayola Calvo Jiyoung Huh
Thomas Blackadar Leonardo Estevez Hugh Hunter
Marc Blanchet Roger Feeley Hitoshi Ikeda
Thomas Bluethner Bosco T. Fernandes Yutaka Ikeda
Douglas P. Bogia Christoph Fischer Philip O. Isaacson
Xavier Boniface Morten Flintrup Atsushi Ito
Shannon Boucousis Joseph W. Forler Praduman Jain
Kevin Braun Michael Fortner Danny Jochelson
Julius Broma Russell Foster Chris Johnson
Lyle G. Bullock, Jr. Eric Freudenthal Phaneeth Junga
Bernard Burg Matthias Frohner Akiyoshi Kabe
Chris Burns Ken Fuchs Steve Kahle
Anthony Butt Jing Gao Tomio Kamioka
Jeremy Byford-Rew Marcus Garbe Kei Kariya
Satya Calloji Gracinda García Lago Andy Kaschl
Carole C. Carey John Garguilo Junzo Kashihara
Santiago Carot-Nemesio Rick Geimer Kohichi Kashiwagi
Randy W. Carroll Igor Gejdos Ralph Kent
Seungchul Chae Ferenc Gerbovics Laurie M. Kermes
Rahul Chauhan Nicolae Goga Ikuo Keshi
James Cheng Julian Goldman Junhyung Kim
Peggy Chien Raul Gonzalez Gomez Min-Joon Kim
Silviu Chiricescu Chris Gough Minho Kim
Chia-Chin Chong Channa Gowda Taekon Kim
Saeed A. Choudhary Niclas Granqvist Tetsuya Kimura
vi
Copyright © 2012 IEEE. All rights reserved.

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SIST EN ISO 11073-00103:2017
Alfred Kloos Bud Panjwani Andreas Staubert
Jeongmee Koh Carl Pantiskas Nicholas Steblay
Jean-Marc Koller Mikey Paradis Lars Steubesand
Patty Krantz Hanna Park John (Ivo). Stivoric
Alexander Kraus Jong-Tae Park Raymond A. Strickland
Ramesh Krishna Myungeun Park Hermanni Suominen
Falko Kuester Soojun Park Lee Surprenant
Rafael Lajara Phillip E. Pash Ravi Swami
Pierre Landau TongBi Pei Ray Sweidan
Jaechul Lee Soren Petersen Kunihiro Takiuchi
Kyong Ho Lee Peter Piction Francis Tam
Rami Lee Jeff Price Haruyuyki Tatsumi
Sungkee Lee John Quinlan John W. Thomas
Woojae Lee Arif Rahman Brad Tipler
Yonghee Lee Tanzilur Rahman Jonas Tirén
Joe Lenart Steve Ray James Tomcik
Kathryn A. Lesh Tim Reilly Janet Traub
Qiong Li Barry Reinhold Gary Tschautscher
Patrick Lichter Brian Reinhold Masato Tsuchid
Jisoon Lim Melvin I. Reynolds Ken Tubman
Joon-Ho Lim John G. Rhoads Yoshihiro Uchida
John Lin Jeffrey S. Robbins Sunil Unadkat
Wei-Jung Lo Timothy Robertson Philipp Urbauer
Charles Lowe David Rosales Laura Vanzago
Don Ludolph Bill Saltzstein Alpo Värri
Bob MacWilliams Giovanna Sannino Dalimar Velez
Sandra Martinez Jose A. Santos-Cadenas Naveen Verma
Miguel Martínez de Espronceda Stefan Sauermann Daniel von Büren
Cámara John Sawyer Rudi Voon
Peter Mayhew Guillaume Schatz Isobel Walker
Jim McCain Alois Schloegl David Wang
Richard McPartland Paul S. Schluter Jerry P. Wang
Chris Mcvay Johannes Schmidt Yao Wang
László Meleg Lars Schmitt Yi Wang
Ethan Metsger Mark G. Schnell Steve Warren
Jinsei Miyazaki Richard A. Schrenker Fujio Watanabe
Darr Moore Antonio Scorpiniti Toru Watsuji
Piotr Murawski Jungmin Seo Mike Weng
Soundharya Nagasubramanian Kwang Seok Seo Kathleen Wible
Jae-Wook Nah Riccardo Serafin Paul Williamson
Alex Neefus Sid Shaw Jia-Rong Wu
Trong-Nghia Nguyen-Dobinsky Frank Shen Will Wykeham
Michael E. Nidd Min Shih Ariton Xhafa
Tetsu Nishimura Mazen Shihabi Ricky Yang
Jim Niswander Krishna Shingala Melanie Yeung
Hiroaki Niwamoto Redmond Shouldice Done-Sik Yoo
Thomas Norgall Marjorie Skubic Jason Zhang
Yoshiteru Nozoe Robert Smith Zhiqiang Zhang
Brett Olive Ivan Soh Thomas Zhao
Begonya Otal Motoki Sone Miha Zoubek
Charles Palmer Emily Sopensky Szymon Zysko
Rajagopalan Srinivasan




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SIST EN ISO 11073-00103:2017
The following members of the individual balloting committee voted on this guide. Balloters may have
voted for approval, disapproval, or abstention.
Thomas Blackadar Werner Hoelzl Lars Schmitt
Douglas P. Bogia Tetsushi Ikegami Gil Shultz
Lyle G. Bullock, Jr. Atsushi Ito Kapil Sood
William Byrd Piotr Karocki Walter Struppler
Keith Chow Greg Luri Mark Sturza
Malcolm Clarke Wayne W. Manges Thomas Tullia
Randall Groves Michael S. Newma
...