SIST EN ISO 11073-10424:2016
(Main)Health informatics - Personal health device communication - Part 10424: Device Specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) (ISO 11073-10424:2016)
Health informatics - Personal health device communication - Part 10424: Device Specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) (ISO 11073-10424:2016)
Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between sleep apnoea breathing therapy equipment 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 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. This standard defines a common core of communication functionality for sleep apnoea breathing therapy equipment. In this
context, sleep apnoea breathing therapy equipment are defined as devices that are intended to alleviate the symptoms of a patient who suffers from sleep apnoea by delivering a therapeutic breathing pressure to the patient. Sleep apnoea breathing therapy equipment are primarily used in the home health-care environment by a lay operator without direct professional supervision.
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit - Teil 10424: Gerätespezifikation - Schlafapnoe-Atemtherapiegeräte (ISO 11073-10424:2016)
Informatique de la santé - Communication entre dispositifs de santé personnels - Partie 10424: Spécialisation de dispositif - Équipement de thérapie respiratoire de l'apnée du sommeil (SABTE) (ISO 11073-10424:2016)
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10424. del: Specialne naprave - Naprava za zdravljenje motenj dihanja v spanju (ISO 11073-10424:2016)
Ta standard v okviru skupine standardov za komunikacijo naprav ISO/IEEE 11073 vzpostavlja normativno opredelitev komunikacije med napravo za zdravljenje motenj dihanja v spanju in upravljalnimi napravami (npr. mobilnimi telefoni, osebnimi računalniki, osebnimi medicinskimi napravami, digitalnimi sprejemniki) na način, ki omogoča interoperabilnost Plug and Play. Standard temelji na ustreznih delih obstoječih standardov, vključno s terminologijo iz standarda ISO/IEEE 11073, informacijskimi modeli, standardi za profile aplikacije in standardi za prevoz. 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 napravo za zdravljenje motenj dihanja v spanju. Naprava za zdravljenje motenj dihanja v spanju je v tem kontekstu opredeljena kot naprava, ki je namenjena ublažitvi simptomov pri bolniku z motnjami dihanja v spanju, tako da bolniku dovaja terapevtski tlak v dihalnih poteh. Naprava za zdravljenje motenj dihanja v spanju primarno uporabljajo laiki brez neposrednega strokovnega nadzora v okolju domače zdravstvene oskrbe.
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11073-10424:2016
01-december-2016
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10424. del:
Specialne naprave - Naprava za zdravljenje motenj dihanja v spanju (ISO 11073-
10424:2016)
Health informatics - Personal health device communication - Part 10424: Device
Specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) (ISO 11073-
10424:2016)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10424: Gerätespezifikation - Schlafapnoe-Atemtherapiegeräte (ISO 11073-
10424:2016)
Informatique de la santé - Communication entre dispositifs de santé personnels - Partie
10424: Spécialisation de dispositif - Équipement de thérapie respiratoire de l'apnée du
sommeil (SABTE) (ISO 11073-10424:2016)
Ta slovenski standard je istoveten z: EN ISO 11073-10424:2016
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 11073-10424:2016 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11073-10424:2016
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SIST EN ISO 11073-10424:2016
EN ISO 11073-10424
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2016
EUROPÄISCHE NORM
ICS 35.240.80
English Version
Health informatics - Personal health device
communication - Part 10424: Device specialization - Sleep
apnoea breathing therapy equipment (SABTE) (ISO/IEEE
11073-10424:2016)
Informatique de la santé - Communication entre Medizinische Informatik - Kommunikation von Geräten
dispositifs de santé personnels - Partie 10424: für die persönliche Gesundheit - Teil 10424:
Spécialisation de dispositif - Équipement de thérapie Gerätespezifikation - Schlafapnoe-Atemtherapiegeräte
respiratoire de l'apnée du sommeil (SABTE) (ISO/IEEE (ISO/IEEE 11073-10424:2016)
11073-10424:2016)
This European Standard was approved by CEN on 21 February 2016.
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, 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
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-10424:2016 E
worldwide for CEN national Members.
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SIST EN ISO 11073-10424:2016
EN ISO 11073-10424:2016 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 11073-10424:2016
EN ISO 11073-10424:2016 (E)
European foreword
This document (EN ISO 11073-10424:2016) 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 11073-10424:2016 has been approved by CEN as EN ISO 11073-10424:2016
without any modification.
3
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SIST EN ISO 11073-10424:2016
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SIST EN ISO 11073-10424:2016
INTERNATIONAL ISO/IEEE
STANDARD 11073-10424
First edition
2016-06-15
Health informatics — Personal health
device communication —
Part 10424:
Device Specialization — Sleep Apnoea
Breathing Therapy Equipment (SABTE)
Informatique de santé — Communication entre dispositifs de santé
personnels
Partie 10424: Spécialisation de dispositif — Équipement de thérapie
respiratoire de l'apnée du sommeil (SABTE)
Reference number
ISO/IEEE 11073-10424:2016(E)
©
ISO 2016
©
IEEE 2014
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SIST EN ISO 11073-10424:2016
ISO/IEEE 11073-10424:2016(E)
COPYRIGHT PROTECTED DOCUMENT
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© ISO 2016 – All rights reserved
ii © IEEE 2014 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 11073-10424:2016
ISO/IEEE 11073-10424:2016(E)
Foreword
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© IEEE 2014 – All rights reserved iii
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SIST EN ISO 11073-10424:2016
ISO/IEEE 11073-10424:2016(E)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device
communication, a normative definition of the communication between sleep apnoea breathing
therapy equipment (SABTE) 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, 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. This standard defines a common core of communication functionality for SABTE.
In this context, SABTE is defined as a device that is intended to alleviate the symptoms of a
patient who suffers from sleep apnoea by delivering a therapeutic breathing pressure to the
patient. SABTE is primarily used in the home health-care environment by a lay operator without
direct professional supervision.
Keywords: IEEE 11073-10424™, medical device communication, personal health devices, sleep
apnoea breathing therapy equipment (SABTE)
•
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© ISO 2016 – All rights reserved
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SIST EN ISO 11073-10424:2016
ISO/IEEE 11073-10424:2016(E)
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SIST EN ISO 11073-10424:2016
ISO/IEEE 11073-10424:2016(E)
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SIST EN ISO 11073-10424:2016
ISO/IEEE 11073-10424:2016(E)
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© ISO 2016 – All rights reserved
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SIST EN ISO 11073-10424:2016
ISO/IEEE 11073-10424:2016(E)
Participants
At the time this IEEE standard was completed, the Personal Health Device Working Group had the
following membership:
Daidi Zhong, Chair
Michael J. Kirwan, Chair
Christoph Fischer, Vice Chair
Charles R. Abbruscato Jinhan Chung Channa Gowda
Nabil Abujbara Malcolm Clarke Charles M. Gropper
Maher Abuzaid John A. Cogan Amit Gupta
Manfred Aigner John T. Collins Jeff Guttmacher
Jorge Alberola Cory Condek Rasmus Haahr
Karsten Alders Todd H. Cooper Christian Habermann
Murtaza Ali David Cornejo Michael Hagerty
Rolf Ambuehl Douglas Coup Jerry Hahn
David Aparisi Nigel Cox Robert Hall
Lawrence Arne Hans Crommenacker Rickey L. Hampton
Diego B. Arquillo Tomio Crosley Sten Hanke
Serafin Arroyo David Culp Jordan Hartmann
Muhammad Asim Allen Curtis Kai Hassing
Merat Bagha Ndifor Cyril Fru Marc Daniel Haunschild
Doug Baird Eyal Dassau Wolfgang Heck
David Baker David Davenport Charles Henderson
Anindya Bakshi Russell Davis Jun-Ho Her
Ananth Balasubramanian Ed Day Takashi Hibino
Sunlee Bang Sushil K. Deka Timothy L. Hirou
M. Jonathan Barkley Pedro de-las-Heras-Quiros Allen Hobbs
Gilberto Barrón Jim DelloStritto Alex Holland
David Bean Matthew d’Entremont Arto Holopainen
John Bell Lane Desborough Robert Hoy
Rudy Belliardi Kent Dicks Frank Hsu
Daniel Bernstein Hyoungho Do Anne Huang
George A. Bertos Xiaolian Duan Sen-Der Huang
Chris Biernacki Brian Dubreuil Zhiqiang Huang
Ola Björsne Jakob Ehrensvard Ron Huby
Thomas Blackadar Fredrik Einberg Robert D. Hughes
Marc Blanchet Roger M. Ellingson David Hughes
Thomas Bluethner Michihiro Enokida Jiyoung Huh
Douglas P. Bogia Javier Escayola Calvo Hugh Hunter
Xavier Boniface Leonardo Estevez Hitoshi Ikeda
Shannon Boucousis Roger Feeley Yutaka Ikeda
Julius Broma Bosco T. Fernandes Philip O. Isaacson
Lyle G. Bullock, Jr. Morten Flintrup Atsushi Ito
Bernard Burg Joseph W. Forler Michael Jaffe
Chris Burns Russell Foster Praduman Jain
Anthony Butt Eric Freudenthal Danny Jochelson
Jeremy Byford-Rew Matthias Frohner Chris Johnson
Satya Calloji Ken Fuchs Phaneeth Junga
Carole C. Carey Jing Gao Akiyoshi Kabe
Santiago Carot-Nemesio Marcus Garbe Steve Kahle
Randy W. Carroll John Garguilo Tomio Kamioka
Simon Carter Rick Geimer Kei Kariya
Seungchul Chae Igor Gejdos Andy Kaschl
Rahul Chauhan Ferenc Gerbovics Junzo Kashihara
James Cheng Nicolae Goga Kohichi Kashiwagi
Peggy Chien Julian Goldman Ralph Kent
Chia-Chin Chong Raul Gonzalez Gomez Laurie M. Kermes
Saeed A. Choudhary Chris Gough Ikuo Keshi
vi
Copyright © 2014 IEEE. All rights reserved.
© ISO 2016 – All rights reserved
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SIST EN ISO 11073-10424:2016
ISO/IEEE 11073-10424:2016(E)
Junhyung Kim Thomas Norgall Robert Smith
Min-Joon Kim Anand Noubade Ivan Soh
Minho Kim Yoshiteru Nozoe Motoki Sone
Taekon Kim Abraham Ofek Emily Sopensky
Tetsuya Kimura Brett Olive Rajagopalan Srinivasan
Alfred Kloos Andreas Staubert
Begonya Otal
Jeongmee Koh Charles Palmer Nicholas Steblay
Jean-Marc Koller Bud Panjwani Beth Stephen
John Koon
Carl Pantiskas Lars Steubesand
Patty Krantz Harry P. Pappas John (Ivo) Stivoric
Alexander Kraus Mikey Paradis Raymond A. Strickland
Ramesh Krishna Hanna Park Hermanni Suominen
Geoffrey Kruse Jong-Tae Park Lee Surprenant
Falko Kuester Myungeun Park Ravi Swami
Rafael Lajara Soojun Park Ray Sweidan
Pierre Landau Phillip E. Pash Jin Tan
Jaechul Lee TongBi Pei Haruyuyki Tatsumi
JongMuk Lee Soren Petersen John W. Thomas
Kyong Ho Lee James Petisce Brad Tipler
Rami Lee Jonas Tirén
Peter Piction
Sungkee Lee Michael Pliskin James Tomcik
Woojae Lee Jeff Price Janet Traub
Yonghee Lee Harald Prinzhorn Jesús Daniel Trigo
Joe Lenart John Quinlan Gary Tschautscher
Kathryn A. Lesh Arif Rahman Masato Tsuchid
Qiong Li Ken Tubman
Tanzilur Rahman
Ying Li Steve Ray Yoshihiro Uchida
Patrick Lichter Phillip Raymond Sunil Unadkat
Jisoon Lim Tim Reilly Fabio Urbani
Joon-Ho Lim Barry Reinhold Philipp Urbauer
John Lin Brian Reinhold Laura Vanzago
Jiajia Liu Melvin I. Reynolds Alpo Värri
Wei-Jung Lo John G. Rhoads Ciro de la Vega
Charles Lowe Jeffrey S. Robbins Dalimar Velez
Moskowitz Robert
Don Ludolph Naveen Verma
Christian Luszick Timothy Robertson Rudi Voon
Bob MacWilliams David Rosales Isobel Walker
Srikkanth Madhurbootheswaran Bill Saltzstein David Wang
Romain Marmot Benedikt Salzbrunn Jerry P. Wang
Sandra Martinez Giovanna Sannino Yao Wang
Miguel Martínez de Espronceda Jose A. Santos-Cadenas Yi Wang
Cámara Stefan Sauermann Steve Warren
Peter Mayhew John Sawyer Fujio Watanabe
Jim McCain Guillaume Schatz Toru Watsuji
László Meleg Alois Schloegl Mike Weng
Alexander Mense Paul S. Schluter
Kathleen Wible
Ethan Metsger Lars Schmitt Paul Williamson
Yu Miao Mark G. Schnell Jan Wittenber
Richard A. Schrenker
Jinsei Miyazaki Jia-Rong Wu
Erik Moll Antonio Scorpiniti Will Wykeham
Darr Moore Kwang Seok Seo Ariton Xhafa
Riccardo Serafin
Piotr Murawski Junjie Yang
Soundharya Nagasubramanian Sid Shaw Ricky Yang
Jae-Wook Nah Frank Shen Melanie Yeung
Alex Neefus Liqun Shen Done-Sik Yoo
Trong-Nghia Nguyen-Dobinsky Bozhi Shi Jason Zhang
Michael E. Nidd Min Shih Zhiqiang Zhang
Tetsu Nishimura Mazen Shihabi Thomas Zhao
Jim Niswander Redmond Shouldice Miha Zoubek
Hiroaki Niwamoto Sternly K. Simon Szymon Zysko
Marjorie Skubic
vii
Copyright © 2014 IEEE. All rights reserved.
© ISO 2016 – All rights reserved
---------------------- Page: 15 ----------------------
SIST EN ISO 11073-10424:2016
ISO/IEEE 11073-10424:2016(E)
The following members of the individual balloting committee voted on this standard. Balloters may have
voted for approval, disapproval, or abstention.
Pieter Botman Werner Hoelzl Greg Luri
Lyle G. Bullock, Jr. Ruimin Hu Michael Newman
Juan Carreon Ronald Huby Charles Ngethe
Jianwen Chen Noriyuki Ikeuchi Satoshi Oyama
Keith Chow Akio Iso Melvin I. Reynolds
Raul Colcher Atsushi Ito
Bartien Sayogo
Charles Cook Mark Jaeger Lars Schmitt
Paul Croll Raj Jain Shusaku Shimada
Russell Davis Shinkyo Kaku Steven Smith
Sourav Dutta Piotr Karocki Kapil Sood
Christoph Fischer Stuart Kerry Walter Struppler
David Friscia
Bruce Kraemer Jiande Sun
David Fuschi Geoff Ladwig Hung-Yu Wei
Hector Barron Gonzalez Richard Lancaster Jan Wittenber
Randall Groves Vincent Lipsio Oren Yuen
Kai Hassing Daidi Zhong
viii
Copyright © 2014 IEEE. All rights reserved.
© ISO 2016 – All rights reserved
---------------------- Page: 16 ----------------------
SIST EN ISO 11073-10424:2016
ISO/IEEE 11073
...
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