ANSI IEEE 11073-10420-2010 Health informatics Personal health device communication Part 10420 Device specialization-Body composition analyzer《健康信息学.个人健康设备通讯.设备规范.身体组成分析仪》.pdf

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ANSI IEEE 11073-10420-2010 Health informatics Personal health device communication Part 10420 Device specialization-Body composition analyzer《健康信息学.个人健康设备通讯.设备规范.身体组成分析仪》.pdf_第1页
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4、5g48IEEE Std 11073-10420-2010 Health informaticsPersonal health device communication Part 10420: Device specializationBody composition analyzer Sponsor IEEE 11073 Standards Committee of the IEEE Engineering in Medicine and Biology Society Approved 17 June 2010 IEEE-SA Standards Board Approved 25 Apr

5、il 2011 American National Standards Institute Abstract: 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 body composition analyzing devices and managers (e.g., cell phones, pe

6、rsonal 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 and IEEE 11073-20601 information models. It specifies the use of specific term codes, for

7、mats, 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 body composition analyzer devices. In this context, body composition analyzer devices are

8、 being used broadly to cover body composition analyzer devices that measure body impedances, and compute the various body components including body fat from the impedance. Keywords: body composition analyzer, medical device communication, personal health devices The Institute of Electrical and Elect

9、ronics Engineers, Inc. 3 Park Avenue, New York, NY 10016-5997, USA Copyright 2010 by the Institute of Electrical and Electronics Engineers, Inc. All rights reserved. Published 3 August 2010. Printed in the United States of America. IEEE is a registered trademark in the U.S. Patent +1 978 750 8400. P

10、ermission to photocopy portions of any individual standard for educational classroom use can also be obtained through the Copyright Clearance Center. iv Copyright 2010 IEEE. All rights reserved. Introduction This introduction is not part of IEEE Std 11073-10420-2010, Health InformaticsPersonal healt

11、h device communication Part 10420: Device specializationBody composition analyzer. ISO/IEEE 11073 standards enable communication between medical devices and external computer systems. Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a n

12、ormative definition of the communication between medication monitoring devices 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 IS

13、O/IEEE 11073 terminology and information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting ambiguity in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal teleh

14、ealth body composition analyzer devices. In this context, body composition analyzer devices are being used broadly to cover body composition analyzer devices that measure body impedances, and compute the various body components including body fat from the impedance. Notice to users Laws and regulati

15、ons Users of these documents should consult all applicable laws and regulations. Compliance with the provisions of this standard does not imply compliance to any applicable regulatory requirements. Implementers of the standard are responsible for observing or referring to the applicable regulatory r

16、equirements. IEEE does not, by the publication of its standards, intend to urge action that is not in compliance with applicable laws, and these documents may not be construed as doing so. Copyrights This document is copyrighted by the IEEE. It is made available for a wide variety of both public and

17、 private uses. These include both use, by reference, in laws and regulations, and use in private self-regulation, standardization, and the promotion of engineering practices and methods. By making this document available for use and adoption by public authorities and private users, the IEEE does not

18、 waive any rights in copyright to this document. Updating of IEEE documents Users of IEEE standards should be aware that these documents may be superseded at any time by the issuance of new editions or may be amended from time to time through the issuance of amendments, corrigenda, or errata. An off

19、icial IEEE document at any point in time consists of the current edition of the document together with any amendments, corrigenda, or errata then in effect. In order to determine whether a given document is the current edition and whether it has been amended through the issuance of amendments, corri

20、genda, or errata, visit the IEEE Standards Association web site at http:/ieeexplore.ieee.org/xpl/standards.jsp, or contact the IEEE at the address listed previously. For more information about the IEEE Standards Association or the IEEE standards development process, visit the IEEE-SA web site at htt

21、p:/standards.ieee.org. v Copyright 2010 IEEE. All rights reserved. Errata Errata, if any, for this and all other standards can be accessed at the following URL: http:/standards.ieee.org/reading/ieee/updates/errata/index.html. Users are encouraged to check this URL for errata periodically. Interpreta

22、tions Current interpretations can be accessed at the following URL: http:/standards.ieee.org/reading/ieee/interp/ index.html. 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 standar

23、d, no position is taken with respect to the existence or validity of any patent rights in connection therewith. The IEEE is not responsible for identifying Essential Patent Claims for which a license may be required, for conducting inquiries into the legal validity or scope of Patents Claims or dete

24、rmining whether any licensing terms or conditions provided in connection with submission of a Letter of Assurance, 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 th

25、e risk of infringement of such rights, is entirely their own responsibility. Further information may be obtained from the IEEE Standards Association. vi Copyright 2010 IEEE. All rights reserved. Participants At the time this standard was submitted to the IEEE-SA Standards Board for approval, the Per

26、sonal Health Devices Working Group had the following membership: Douglas P. Bogia, Chair Sungkee Lee, Vice Chair Karsten Aalders Charles R. Abbruscato Nabil Abujbara Maher Abuzaid Jon Adams Manfred Aigner Murtaza Ali Rolf Ambuehl Lawrence Arne Serafin Arroyo Kevin Arruda Muhammad Asim Merat Bagha Do

27、ug Baird David Baker Anindya Bakshi Ananth Balasubramanian Sunlee Bang M. Jonathan Barkley Gilberto Barrn David Bean John Bell Rudy Belliardi Yazid Benazzouz George A. Bertos Ola Bjrsne Thomas Blackadar Marc Blanchet Thomas Bluethner Xavier Boniface Shannon Boucousis Julius Broma Lyle G. Bullock, Jr

28、. Bernard Burg Chris Burns Anthony Butt Jeremy Byford-Rew Satya Calloji Carole C. Carey Santiago Carot-Nemesio Randy W. Carroll Rahul Chauhan James Cheng Maria Cherkaoui Peggy Chien Silviu Chiricescu Jiho Choi Chia-Chin Chong Saeed A. Choudhary Jinhan Chung Malcolm Clarke Rick A. Cnossen John A. Cog

29、an Moshe Cohen John T. Collins Cory Condek Todd H. Cooper Nigel Cox Tomio Crosley Jeremy Cummin Allen Curtis Kathryn Cush Rupert Dance Jess Daniel Trigo Sushil K. Deka Pedro de-las-Heras-Quiros Jim DelloStritto Matthew dEntremont Kent Dicks Hyoungho Do Amy Droitcour Brian Dubreuil Jakob Ehrensvard F

30、redrik Einberg Roger M. Ellingson Michihiro Enokida Javier Escayola Calvo Leonardo Estevez Roger Feeley Bosco T. Fernandes Gear Fisher Julie N. Fleischer Roger Florkowski Joseph W. Forler Russell Foster Eric Freudenthal Matthias Frohner Miguel Galarraga Jing Gao Marcus Garbe Gracinda Garca Lago Juan

31、 Garca-Prieto Cuesta John Garguilo Rick Geimer Igor Gejdos Ferenc Gerbovics Nicolae Goga Julian Goldman Raul Gonzalez Gomez Chris Gough Channa Gowda Niclas Granqvist Charles Gropper Amit Gupta Jeff Guttmacher Christian Habermann Mikey Hagerty Jerry Hahn Robert Hall Rickey L. Hampton Sten Hanke Kai H

32、assing Marc Daniel Haunschild Mike Hayes Mike Hayes Charles Henderson Timothy L. Hirou Allen Hobbs Alex Holland Arto Holopainen Robert Hoy Frank Hsu Anne Huang Sen-Der Huang David Hughes Robert D. Hughes Nick Hunn Hugh Hunter Hitoshi Ikeda Yutaka Ikeda Philip O. Isaacson Atsushi Ito Praduman Jain Ho

33、-In Jeon Danny Jochelson Chris Johnson Phaneeth Junga Akiyoshi Kabe Steve Kahle Tomio Kamioka Kei Kariya Andy Kaschl Junzo Kashihara Kohichi Kashiwagi Ralph Kent Kurt M. Kermes Ikuo Keshi Minho Kim Min-Joon Kim Taekon Kim Tetsuya Kimura Michael Kirwin Alfred Kloos vii Copyright 2010 IEEE. All rights

34、 reserved. Jeongmee Koh Jean-Marc Koller Thomas Kottler Patty Krantz Alexander Kraus Ramesh Krishna Falko Kuester Pierre Landau Rami Lee Woojae Lee Yonghee Lee Kathryn A. Lesh Qiong Li Patrick Lichter Jisoon Lim Joon-Ho Lim John Lin Wei-Jung Lo Charles Lowe Sandra Martinez Miguel Martnez de Espronce

35、da Cmara Dennis Mathews Peter Mayhew Jim McCain Richard McPartland Lszl Meleg Jinsei Miyazaki Darr Moore Joe Morrissey Piotr Murawski Soundharya Nagasubramanian Jae-Wook Nah Alex Neefus Michael E. Nidd Tetsu Nishimura Jim Niswander Hiroaki Niwamoto Thomas Norgall Yoshiteru Nozoe Brett Olive Charles

36、Palmer Bud Panjwani Carl Pantiskas Mikey Paradis Jong-Tae Park Soojun Park Phillip E. Pash TongBi Pei Soren Petersen Arnie Pittler Carol Primdahl Arif Rahman Barry Reinhold Brian Reinhold Melvin I. Reynolds Jeffrey S. Robbins Scott Robertson Timothy Robertson David Rosales Bill Saltzstein Jose A. Sa

37、ntos-Cadenas Stefan Sauermann John Sawyer Paul S. Schluter Johannes Schmidt Lars Schmitt Mark G. Schnell Richard A. Schrenker Antonio Scorpiniti Kwang Seok Seo Riccardo Serafin Sid Shaw Frank Shen Min Shih Mazen Shihabi Tommy Shing Krishna Shingala Redmond Shouldice Robert Smith Ivan Soh Motoki Sone

38、 Emily Sopensky Andreas Staubert Nick Steblay Lars Steubesand John (Ivo) Stivoric Raymond Strickland Hermanni Suominen Lee Surprenant Ravi Swami Ray Sweidan Kunihiro Takiuchi Francis Tam Haruyuyki Tatsumi Brad Tipler Jonas Tirn James Tomcik Janet Traub Gary Tschautscher Masato Tsuchid Ken Tubman Yos

39、hihiro Uchida Sunil Unadkat Philipp Urbauer Laura Vanzago Alpo Vrri Daniel von Bren Rudi Voon Isobel Walker Jrg Walter David Wang Jerry P. Wang Yao Wang Steve Warren Fujio Watanabe Toru Watsuji Jeff Webber Paul Williamson Jan Wittenber Jia-Rong Wu Will Wykeham Ariton Xhafa Ricky Yang Done-Sik Yoo Ja

40、son Zhang Thomas Zhao Daidi Zhong Szymon Zysko The following members of the individual balloting committee voted on this standard. Balloters may have voted for approval, disapproval, or abstention. Christopher Biernacki Thomas Blackadar Douglas P. Bogia Nancy S. Bravin Lyle Bullock Randy W. Carroll

41、Peng Chen Keith Chow Malcolm Clarke Richard Doyle Sourav Dutta Sergiu Goma Randall Groves Kai Hassing Werner Hoelzl Atsushi Ito Christopher Johnson Piotr Karocki Gerald L. Kolbe Daniel Levesque William Lumpkins G. Luri Faramarz Maghsoodlou Wade Midkiff Melvin Reynolds John Rhoads Bartien Sayogo Lars

42、 Schmitt Gil Shultz James E. Smith Kapil Sood Lars Steubesand Fujio Watanabe Jan Wittenber Oren Yuen viii Copyright 2010 IEEE. All rights reserved. When the IEEE-SA Standards Board approved this guide on 17 June 2010, it had the following membership: Robert M. Grow, Chair Richard H. Hulett, Vice Cha

43、ir Steve M. Mills, Past Chair Judith Gorman, Secretary Karen Bartleson Victor Berman Ted Burse Clint Chaplin Andy Drozd Alexander Gelman Jim Hughes Young Kyun Kim Joseph L. Koepfinger* John Kulick David J. Law Hung Ling Oleg Logvinov Ted Olsen Ronald C. Petersen Thomas Prevost Jon Walter Rosdahl Sam

44、 Sciacca Mike Seavey Curtis Siller Don Wright *Member Emeritus Also included are the following nonvoting IEEE-SA Standards Board liaisons: Satish Aggarwal, NRC Representative Richard DeBlasio, DOE Representative Michael Janezic, NIST Representative Don Messina IEEE Standards Program Manager, Documen

45、t Development Kathryn Bennett IEEE Standards Program Manager, Technical Program Development ix Copyright 2010 IEEE. All rights reserved. Contents 1. Overview 1 1.1 Scope . 1 1.2 Purpose 2 1.3 Context 2 2. Normative references 2 3. Definitions, acronyms, and abbreviations 3 3.1 Definitions . 3 3.2 Ac

46、ronyms and abbreviations . 4 4. Introduction to ISO/IEEE 11073 personal health devices 4 4.1 General 4 4.2 Introduction to IEEE 11073-20601 modeling constructs 4 5. Body composition analyzer device concepts and modalities 5 5.1 General 5 5.2 Body fat . 6 5.3 Body height . 6 5.4 Body weight. 6 5.5 Bo

47、dy mass index 6 5.6 Fat free mass 6 5.7 Soft lean mass 6 5.8 Body water. 6 6. Body composition analyzer domain information model. 7 6.1 Overview . 7 6.2 Class extensions. 7 6.3 Object instance diagram 7 6.4 Types of configuration. 8 6.5 Medical device system object 9 6.6 Numeric objects. 12 6.7 Real

48、-time sample array objects 19 6.8 Enumeration objects 19 6.9 PM-store objects 20 6.10 Scanner objects 20 6.11 Class extension objects 20 6.12 Body composition analyzer information model extensibility rules . 20 7. Body composition analyzer service model . 20 7.1 General 20 7.2 Object access services

49、 20 7.3 Object access event report services . 21 8. Body composition analyzer communication model 22 8.1 Overview . 22 8.2 Communications characteristics 22 8.3 Association procedure . 22 8.4 Configuring procedure. 24 8.5 Operating procedure 26 8.6 Time synchronization 27 x Copyright 2010 IEEE. All rights reserved. 9. Test associations. 27 9.1 Behavior with standard configuration 27 9.2 Behavior with extended configurations . 28 10. Conformance 28 10.1 Applicability 28 10.2 Conformance specification 28 10.3 Levels of conformance 28 10.4 Implementatio

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