SIST EN ISO 11073-10441:2017

Health informatics - Personal health device communication - Part 10441: Device specialization - Cardiovascular fitness and activity monitor (ISO/IEEE 11073-10441:2015)

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between personal cardiovascular fitness and activity monitoring devices and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology and information models. 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 of communication functionality for personal telehealth cardiovascular fitness and activity monitor devices. In
this context, cardiovascular fitness and activity monitor devices are being used broadly to cover cardiovascular fitness and activity monitor devices that measure physical actions and the body’s various physiological responses to that activity.

Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit - Teil 10441: Gerätespezifikation - Monitor für die Herz-Kreislauf-Fitness und -Aktivität (ISO/IEEE 11073-10441:2015)

Informatique de santé - Communication entre dispositifs de santé personnels - Partie 10441: Spécialisation des dispositifs - Moniteur d'activité et de forme cardiovasculaire (ISO/IEEE 11073-10441:2015)

Dans le contexte de la famille de normes ISO/IEEE 11073 relatives à la communication entre dispositifs, la présente norme établit une définition normative de la communication entre les dispositifs de télésanté moniteurs d'activité et de forme cardiovasculaire 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 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. La présente norme définit un noyau commun de fonctionnalités de communication pour les dispositifs personnels de télésanté moniteurs d'activité et de forme cardiovasculaire.

Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10441. del: Specialne naprave - Monitor aktivnost in kardiovaskularni fitnes (ISO / IEEE 11.073-10.441: 2015)

Ta standard v okviru skupine standardov za komunikacijo naprav ISO/IEEE 11073 določa normativno opredelitev komunikacije med osebnimi napravami za spremljanje aktivnosti in kardiovaskularnega fitnesa ter upravljalnimi napravami (npr. mobilnimi telefoni, osebnimi računalniki, osebnimi medicinskimi napravami, digitalnimi sprejemniki) na način, ki omogoča interoperabilnost Plug and Play (PnP, »vstavi in poženi«). Standard temelji na ustreznih delih obstoječih standardov, vključno s terminologijo iz standarda ISO/IEEE 11073 in informacijskimi modeli. Določa uporabo posebnih kod izrazov, formatov in vedenj v telemedicinskih okoljih, kjer v korist interoperabilnosti omejuje izbirnost osnovnih okvirov. Ta standard določa skupno jedro komunikacijske funkcionalnosti za osebne telemedicinske naprave za spremljanje kardiovaskularnega fitnesa in aktivnosti. Naprave za spremljanje kardiovaskularnega fitnesa in aktivnosti v tem kontekstu na splošno zajemajo naprave za spremljanje kardiovaskularnega fitnesa in aktivnosti, ki merijo fizično aktivnost in različne fiziološke odzive telesa na to aktivnost.

General Information

• Status: Published
• 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 11073-10441:2017 - Health informatics - Personal health device communication - Part 10441: Device specialization - Cardiovascular fitness and activity monitor (ISO/IEEE 11073-10441:2015)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11073-10441:2017
01-september-2017
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10441. del:
Specialne naprave - Monitor aktivnost in kardiovaskularni fitnes (ISO / IEEE 11.073
-10.441: 2015)
Health informatics - Personal health device communication - Part 10441: Device
specialization - Cardiovascular fitness and activity monitor (ISO/IEEE 11073-
10441:2015)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10441: Gerätespezifikation - Monitor für die Herz-Kreislauf-Fitness und -Aktivität
(ISO/IEEE 11073-10441:2015)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie
10441: Spécialisation des dispositifs - Moniteur d'activité et de forme cardiovasculaire
(ISO/IEEE 11073-10441:2015)
Ta slovenski standard je istoveten z: EN ISO 11073-10441:2017
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 11073-10441:2017 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11073-10441:2017

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SIST EN ISO 11073-10441:2017


EN ISO 11073-10441
EUROPEAN STANDARD

NORME EUROPÉENNE

February 2017
EUROPÄISCHE NORM
ICS 11.040.55; 35.240.80
English Version

Health informatics - Personal health device
communication - Part 10441: Device specialization -
Cardiovascular fitness and activity monitor (ISO/IEEE
11073-10441:2015)
Informatique de santé - Communication entre Medizinische Informatik - Kommunikation von Geräten
dispositifs de santé personnels - Partie 10441: für die persönliche Gesundheit - Teil 10441:
Spécialisation des dispositifs - Moniteur d'activité et de Gerätespezifikation - Monitor für die Herz-Kreislauf-
forme cardiovasculaire (ISO/IEEE 11073-10441:2015) Fitness und -Aktivität (ISO/IEEE 11073-10441:2015)
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 11073-10441:2017 E
worldwide for CEN national Members.

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SIST EN ISO 11073-10441:2017
EN ISO 11073-10441:2017 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 11073-10441:2017
EN ISO 11073-10441:2017 (E)
European foreword
The text of ISO/IEEE 11073-10441:2015 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 11073-10441:2017 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/IEEE 11073-10441:2015 has been approved by CEN as EN ISO 11073-10441:2017
without any modification.
3

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SIST EN ISO 11073-10441:2017

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SIST EN ISO 11073-10441:2017

INTERNATIONAL ISO/IEEE
STANDARD 11073-10441
First edition
2015-03-01

Health informatics — Personal health
device communication —
Part 10441:
Device specialization — Cardiovascular
fitness and activity monitor
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 10441: Spécialisation des dispositifs — Moniteur d'activité et de
forme cardiovasculaire




Reference number
ISO/IEEE 11073-10441:2015(E)

©
IEEE 2013

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SIST EN ISO 11073-10441:2017
ISO/IEEE 11073-10441:2015(E)

COPYRIGHT PROTECTED DOCUMENT


©  IEEE 2013
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 2013 – All rights reserved

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SIST EN ISO 11073-10441:2017
ISO/IEEE 11073-10441:2015(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 11073-10441 was prepared by the 11073 Committee of the Engineering in Medicine and Biology
Society of the IEEE (as IEEE 11073-10441-2013). 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 2013 – All rights reserved iii

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SIST EN ISO 11073-10441:2017
ISO/IEEE 11073-10441:2015(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 2013 – All rights reserved

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SIST EN ISO 11073-10441:2017


Health Informatics—Personal health device communication

Part 10441: Device specialization—
Cardiovascular fitness and activity
monitor

IEEE Engineering in Medicine and Biology Society

Sponsored by the
IEEE 11073™ Standards Committee


IEEE
IEEE Std 11073-10441™-2013
3 Park Avenue
(Revision of
New York, NY 10016-5997
IEEE Std 11073-10441-2008)
USA

29 March 2013

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SIST EN ISO 11073-10441:2017

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SIST EN ISO 11073-10441:2017
TM
IEEE Std 11073-10441 -2013
(Revision of
IEEE Std 11073-10441-2008)
Health informatics—Personal health device communication
Part 10441: Device specialization—
Cardiovascular fitness and activity
monitor
Sponsor
TM
IEEE 11073 Standards Committee
of the
IEEE Engineering in Medicine and Biology Society

Approved 6 February 2013
IEEE-SA Standards Board

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SIST EN ISO 11073-10441:2017
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device
communication, a normative definition of communication between personal telehealth
cardiovascular fitness and activity monitor devices and managers (e.g., cell phones, personal
computers, personal health appliances, and set top boxes) is established in this standard in a
manner that enables plug-and-play interoperability. Appropriate portions of existing standards are
leveraged including ISO/IEEE 11073 terminology, information models, application profile
standards, and transport standards. The use of specific term codes, formats, and behaviors in
telehealth environments restricting optionality in base frameworks in favor of interoperability is
specified. A common core of communication functionality for personal telehealth cardiovascular
fitness and activity monitor devices is defined in this standard.
TM
Keywords: activity monitor, cardiovascular fitness, IEEE 11073-10441 , medical device
communication, personal health devices






The Institute of Electrical and Electronics Engineers, Inc.
3 Park Avenue, New York, NY 10016-5997, USA

Copyright © 2013 by The Institute of Electrical and Electronics Engineers, Inc.
All rights reserved. Published 29 March 2013. Printed in the United States of America.

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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.

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SIST EN ISO 11073-10441:2017
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SIST EN ISO 11073-10441:2017

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iv
Copyright © 2013 IEEE. All rights reserved.

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SIST EN ISO 11073-10441:2017

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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their own responsibility. Further information may be obtained from the IEEE Standards Association.
v
Copyright © 2013 IEEE. All rights reserved.

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SIST EN ISO 11073-10441:2017

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
Bernard Burg, Vice Chair
Charles R. Abbruscato Malcolm Clarke Amit Gupta
Nabil Abujbara John A. Cogan Jeff Guttmacher
Maher Abuzaid John T. Collins Rasmus Haahr
Manfred Aigner Cory Condek Christian Habermann
Jorge Alberola Todd H. Cooper Michael Hagerty
Karsten Alders David Cornejo Jerry Hahn
Murtaza Ali Douglas Coup Robert Hall
Prasad Alva Nigel Cox Nathaniel Hamming
Rolf Ambuehl Tomio Crosley Rickey L. Hampton
David Aparisi Allen Curtis Sten Hanke
Lawrence Arne Jesús Daniel Trigo Kai Hassing
Serafin Arroyo Eyal Dassau Marc Daniel Haunschild
Muhammad Asim Russell Davis Charles Henderson
Merat Bagha Ed Day Jun-Ho Her
Doug Baird Sushil K. Deka Takashi Hibino
David Baker Pedro de-las-Heras-Quiros Timothy L. Hirou
Anindya Bakshi Jim DelloStritto Allen Hobbs
Ananth Balasubramanian Matthew d'Entremont Alex Holland
Sunlee Bang Kent Dicks
Arto Holopainen
M. Jonathan. Barkley Hyoungho Do Robert Hoy
Gilberto Barrón Xiaolian Duan Frank Hsu
David Bean Brian Dubreuil
Anne Huang
John Bell Jakob Ehrensvard Sen-Der Huang
Rudy Belliardi Fredrik Einberg Ron Huby
Kathryn M. Bennett
Roger M. Ellingson Robert D. Hughes
Daniel Bernstein Michihiro Enokida David Hughes
George A. Bertos Javier Escayola Calvo Jiyoung Huh
Ola Björsne
Leonardo Estevez Hugh Hunter
Thomas Blackadar Roger Feeley Hitoshi Ikeda
Marc Blanchet Bosco T. Fernandes Yutaka Ikeda
Thomas Bluethner Christoph Fischer Philip O. Isaacson
Douglas P. Bogia Morten Flintrup Atsushi Ito
Xavier Boniface Joseph W. Forler Praduman Jain
Shannon Boucousis Michael Fortner Danny Jochelson
Kevin Braun Russell Foster Chris Johnson
Julius Broma Eric Freudenthal Phaneeth Junga
Lyle G. Bullock, Jr. 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
Jinhan Chung Charles Gropper Alfred Kloos
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Jeongmee Koh Carl Pantiskas Andreas Staubert
Jean-Marc Koller Mikey Paradis Nicholas Steblay
Patty Krantz Hanna Park Lars Steubesand
Alexander Kraus Jong-Tae Park John (Ivo) Stivoric
Ramesh Krishna Myungeun Park Raymond A. Strickland
Falko Kuester Soojun Park Hermanni Suominen
Rafael Lajara Phillip E. Pash Lee Surprenant
Pierre Landau TongBi Pei Ravi Swami
Jaechul Lee Soren Petersen Ray Sweidan
Kyong Ho Lee Peter Piction Kunihiro Takiuchi
Rami Lee Jeff Price Francis Tam
Sungkee Lee John Quinlan
Haruyuyki Tatsumi
Woojae Lee Arif Rahman John W. Thomas
Yonghee Lee Tanzilur Rahman Brad Tipler
Joe Lenart Steve Ray
Jonas Tirén
Kathryn A. Lesh Tim Reilly James Tomcik
Qiong Li Barry Reinhold Janet Traub
Patrick Lichter
Brian Reinhold Gary Tschautscher
Jisoon Lim Melvin I. Reynolds Masato Tsuchid
Joon-Ho Lim John G. Rhoads Ken Tubman
John Lin
Jeffrey S. Robbins Yoshihiro Uchida
Wei-Jung Lo Timothy Robertson Sunil Unadkat
Charles Lowe David Rosales Philipp Urbauer
Don Ludolph Bill Saltzstein Laura Vanzago
Bob MacWilliams Giovanna Sannino Alpo Värri
Sandra Martinez Jose A. Santos-Cadenas Dalimar Velez
Miguel Martínez de Espronceda Stefan Sauermann Naveen Verma
Cámara John Sawyer Daniel von Büren
Peter Mayhew Guillaume Schatz Rudi Voon
Jim McCain Alois Schloegl Isobel Walker
Richard McPartland Paul S. Schluter David Wang
Chris Mcvay Johannes Schmidt Jerry P. Wang
László Meleg Lars Schmitt Yao Wang
Ethan Metsger Mark G. Schnell Yi Wang
Jinsei Miyazaki Richard A. Schrenker Steve Warren
Darr Moore Antonio Scorpiniti Fujio Watanabe
Piotr Murawski Jungmin Seo Toru Watsuji
Soundharya Nagasubramanian Kwang Seok Seo Mike Weng
Jae-Wook Nah Riccardo Serafin Kathleen Wible
Alex Neefus Sid Shaw Paul Williamson
Trong-Nghia Nguyen-Dobinsky Frank Shen Jia-Rong Wu
Michael E. Nidd Min Shih Will Wykeham
Tetsu Nishimura Mazen Shihabi Ariton Xhafa
Jim Niswander Krishna Shin
...