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本文(IEEE 11073-10425-2017 - Health informatics--Personal health device communication - Part 10425 Device Specialization--Continuous Glucose Monitor (CGM).pdf)为本站会员(李朗)主动上传,麦多课文库仅提供信息存储空间,仅对用户上传内容的表现方式做保护处理,对上载内容本身不做任何修改或编辑。 若此文所含内容侵犯了您的版权或隐私,请立即通知麦多课文库(发送邮件至master@mydoc123.com或直接QQ联系客服),我们立即给予删除!

IEEE 11073-10425-2017 - Health informatics--Personal health device communication - Part 10425 Device Specialization--Continuous Glucose Monitor (CGM).pdf

1、 Part 10425: Device Specialization Continuous Glucose Monitor (CGM) Health informaticsPersonal health device communication Sponsored by the IEEE 11073 Standards Committee IEEE 3 Park Avenue New York, NY 10016-5997 USA IEEE Engineering in Medicine and Biology Society IEEE Std 11073-10425-2017 (Revisi

2、on of IEEE Std 11073-10425-2014) IEEE Std 11073-10425-2017 (Revision of IEEE Std 11073-10425-2014) Health informaticsPersonal health device communication Part 10425: Device SpecializationContinuous Glucose Monitor (CGM) Sponsor IEEE 11073 Standards Committee of the IEEE Engineering in Medicine and B

3、iology Society Approved 28 September 2017 IEEE-SA Standards Board 2 Copyright 2018 IEEE. All rights reserved. Abstract: Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of the communication between continuous glucose monitor (CGM) devices

4、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 and information mode

5、ls. 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 of CGM devices. In this context, CGM refers to the measureme

6、nt of the level of glucose in the body on a regular (typically 5 minute) basis through a sensor continuously attached to the person. Keywords: continuous glucose monitor, IEEE 11073-10425, medical device communication, personal health devices The Institute of Electrical and Electronics Engineers, In

7、c. 3 Park Avenue, New York, NY 10016-5997, USA Copyright 2018 by The Institute of Electrical and Electronics Engineers, Inc. All rights reserved. Published 25 January 2018. Printed in the United States of America. IEEE is a registered trademark in the U.S. Patent fitness for a particular purpose; no

8、n-infringement; and quality, accuracy, effectiveness, currency, or completeness of material. In addition, IEEE disclaims any and all conditions relating to: results; and workmanlike effort. IEEE standards documents are supplied “AS IS” and “WITH ALL FAULTS.” Use of an IEEE standard is wholly volunta

9、ry. The existence of an IEEE standard does not imply that there are no other ways to produce, test, measure, purchase, market, or provide other goods and services related to the scope of the IEEE standard. Furthermore, the viewpoint expressed at the time a standard is approved and issued is subject

10、to change brought about through developments in the state of the art and comments received from users of the standard. In publishing and making its standards available, IEEE is not suggesting or rendering professional or other services for, or on behalf of, any person or entity nor is IEEE undertaki

11、ng to perform any duty owed by any other person or entity to another. Any person utilizing any IEEE Standards document, should rely upon his or her own independent judgment in the exercise of reasonable care in any given circumstances or, as appropriate, seek the advice of a competent professional i

12、n determining the appropriateness of a given IEEE standard. IN NO EVENT SHALL IEEE BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO: PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTE

13、RRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE PUBLICATION, USE OF, OR RELIANCE UPON ANY STANDARD, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE AND REGARDLESS OF WHETHER SU

14、CH DAMAGE WAS FORESEEABLE. 4 Copyright 2018 IEEE. All rights reserved. Translations The IEEE consensus development process involves the review of documents in English only. In the event that an IEEE standard is translated, only the English version published by IEEE should be considered the approved

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16、n as, a formal position of IEEE. At lectures, symposia, seminars, or educational courses, an individual presenting information on IEEE standards shall make it clear that his or her views should be considered the personal views of that individual rather than the formal position of IEEE. Comments on s

17、tandards Comments for revision of IEEE Standards documents are welcome from any interested party, regardless of membership affiliation with IEEE. However, IEEE does not provide consulting information or advice pertaining to IEEE Standards documents. Suggestions for changes in documents should be in

18、the form of a proposed change of text, together with appropriate supporting comments. Since IEEE standards represent a consensus of concerned interests, it is important that any responses to comments and questions also receive the concurrence of a balance of interests. For this reason, IEEE and the

19、members of its societies and Standards Coordinating Committees are not able to provide an instant response to comments or questions except in those cases where the matter has previously been addressed. For the same reason, IEEE does not respond to interpretation requests. Any person who would like t

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21、ld consult all applicable laws and regulations. Compliance with the provisions of any IEEE Standards document does not imply compliance to any applicable regulatory requirements. Implementers of the standard are responsible for observing or referring to the applicable regulatory requirements. IEEE d

22、oes 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 IEEE draft and approved standards are copyrighted by IEEE under U.S. and international copyright laws. They are made av

23、ailable by IEEE and are adopted for a wide variety of both public and 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 these documents available for use

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27、ded from time to time through the issuance of amendments, corrigenda, or errata. An official 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. Every IEEE standard is subjected to review at least ever

28、y ten years. When a document is more than ten years old and has not undergone a revision process, it is reasonable to conclude that its contents, although still of some value, do not wholly reflect the present state of the art. Users are cautioned to check to determine that they have the latest edit

29、ion of any IEEE standard. In order to determine whether a given document is the current edition and whether it has been amended through the issuance of amendments, corrigenda, or errata, visit the IEEE Xplore at http:/ieeexplore.ieee.org/ or contact IEEE at the address listed previously. For more in

30、formation about the IEEE-SA or IEEEs standards development process, visit the IEEE-SA Website at http:/standards.ieee.org. Errata Errata, if any, for all IEEE standards can be accessed on the IEEE-SA Website at the following URL: http:/standards.ieee.org/findstds/errata/index.html. Users are encoura

31、ged to check this URL for errata periodically. 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 o

32、f any patent rights in connection therewith. If a patent holder or patent applicant has filed a statement of assurance via an Accepted Letter of Assurance, then the statement is listed on the IEEE-SA Website at http:/standards.ieee.org/about/sasb/patcom/patents.html. Letters of Assurance may indicat

33、e whether the Submitter is willing or unwilling to grant licenses under patent rights without compensation or under reasonable rates, with reasonable terms and conditions that are demonstrably free of any unfair discrimination to applicants desiring to obtain such licenses. Essential Patent Claims m

34、ay exist for which a Letter of Assurance has not been received. 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 determining whether any licensing terms or conditio

35、ns 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 the risk of infringement of such rights, is entir

36、ely their own responsibility. Further information may be obtained from the IEEE Standards Association. 6 Copyright 2018 IEEE. All rights reserved. Participants At the time this standard was submitted to the IEEE-SA Standards Board for approval, the Personal Health Device Working Group had the follow

37、ing membership: Daidi Zhong, Chair Michael J. Kirwan, Chair Nathaniel M. Hamming, Vice Chair Akib Uddin, Vice Chair Karsten Aalders Charles R. Abbruscato Nabil Abujbara Maher Abuzaid James Agnew Haidar Ahmad Manfred Aigner Jorge Alberola Murtaza Ali Rolf Ambuehl David Aparisi Paolo Ariano Lawrence A

38、rne Diego B. Arquillo Serafin Arroyo Muhammad Asim Merat Bagha Doug Baird David Baker Anindya Bakshi Ananth Balasubramanian Sunlee Bang M. Jonathan Barkley Gilberto Barrn David Bean John Bell Rudy Belliardi Kathryn M. Bennett Daniel Bernstein George A. Bertos Chris Biernacki Ola Bjrsne Thomas Blacka

39、dar Marc Blanchet Thomas Bluethner Douglas P. Bogia Xavier Boniface Shannon Boucousis Julius Broma Lyle G. Bullock Bernard Burg Chris Burns Anthony Butt Jeremy Byford-Rew Satya Calloji Xiaoying Cao Carole C. Carey Craig Carlson Santiago Carot-Nemesio Randy W. Carroll Simon Carter Seungchul Chae Rahu

40、l Chauhan James Cheng Peggy Chien David Chiu Jinyong Choi Chia-Chin Chong Saeed A. Choudhary Jinhan Chung Malcolm Clarke John A. Cogan John T. Collins Cory Condek Todd H. Cooper David Cornejo Douglas Coup Nigel Cox Hans Crommenacker Tomio Crosley Allen Curtis Ndifor Cyril Fru Jess Daniel Trigo Eyal

41、Dassau David Davenport Russell Davis Sushil K. Deka Ciro de la Vega Pedro de-las-Heras-Quiros Jim DelloStritto Matthew dEntremont Kent Dicks Hyoungho Do Alistair Donaldson Xiaolian Duan Brian Dubreuil Sourav Dutta Jakob Ehrensvard Fredrik Einberg Michihiro Enokida Javier Escayola Calvo Mark Estes Le

42、onardo Estevez Roger Feeley Hailing Feng Bosco T. Fernandes Christoph Fischer Morten Flintrup Joseph W. Forler Russell Foster Eric Freudenthal Matthias Frohner Ken Fuchs Jing Gao Xuemei Gao Marcus Garbe John Garguilo Rick Geimer Igor Gejdos Ferenc Gerbovics Nicolae Goga Julian Goldman Raul Gonzalez

43、Gomez Chris Gough Channa Gowda Charles M. Gropper Amit Gupta Jeff Guttmacher Rasmus Haahr Christian Habermann Michael Hagerty Jerry Hahn Robert Hall Rickey L. Hampton Sten Hanke Aki Harma Jordan Hartmann Kai Hassing Marc Daniel Haunschild Wolfgang Heck Nathaniel Heintzman Charles Henderson Jun-Ho He

44、r Helen B. Hernandez Takashi Hibino Timothy L. Hirou Allen Hobbs Alex Holland Arto Holopainen Kris Holtzclaw Robert Hoy Frank Hsu Anne Huang Sen-Der Huang Zhiqiang Huang Ron Huby David Hughes Robert D. Hughes Jiyoung Huh Hugh Hunter Hitoshi Ikeda Yutaka Ikeda Philip O. Isaacson 7 Copyright 2018 IEEE

45、. All rights reserved. Atsushi Ito Michael Jaffe Praduman Jain Wei Jin Danny Jochelson Phaneeth Junga Akiyoshi Kabe Steve Kahle Tomio Kamioka James Jin Kang Kei Kariya Andy Kaschl Junzo Kashihara Kohichi Kashiwagi Ralph Kent Laurie M. Kermes Ikuo Keshi Junhyung Kim Minho Kim Min-Joon Kim Taekon Kim

46、Tetsuya Kimura Alfred Kloos Jeongmee Koh Jean-Marc Koller John Koon Patty Krantz Raymond Krasinski Alexander Kraus Ramesh Krishna Geoffrey Kruse Falko Kuester Rafael Lajara Pierre Landau Jaechul Lee JongMuk Lee Kyong Ho Lee Rami Lee Sungkee Lee Woojae Lee Yonghee Lee Joe Lenart Kathryn A. Lesh Cathe

47、rine Li Qiong Li Patrick Lichter Jisoon Lim Joon-Ho Lim John Lin Wei-Jung Lo Charles Lowe Don Ludolph Christian Luszick Bob MacWilliams Srikkanth Madhurbootheswaran Miriam L. Makhlouf Romain Marmot Sandra Martinez Miguel Martnez de Espronceda Cmara Peter Mayhew Jim McCain Lszl Meleg Alexander Mense

48、Jinsei Miyazaki Erik Moll Darr Moore Carsten Mueglitz Piotr Murawski Soundharya Nagasubramanian Jae-Wook Nah Alex Neefus Trong-Nghia Nguyen-Dobinsky Michael E. Nidd Tetsu Nishimura Jim Niswander Hiroaki Niwamoto Thomas Norgall Anand Noubade Yoshiteru Nozoe Abraham Ofek Brett Olive Begonya Otal Marco

49、 Paleari Charles Palmer Bud Panjwani Carl Pantiskas Harry P. Pappas Hanna Park Jong-Tae Park Myungeun Park Soojun Park Phillip E. Pash TongBi Pei Lucian Pestritu Soren Petersen James Petisce Peter Piction Michael Pliskin Varshney Prabodh Jeff Price Harald Prinzhorn Harry Qiu Arif Rahman Tanzilur Rahman Steve Ray Phillip Raymond Tim Reilly Barry Reinhold Brian Reinhold Melvin I. Reynolds John G. Rhoads Jeffrey S. Robbins Chris Roberts Moskowitz Robert Timothy Robertson David Rosales Fatemeh Saki Bill Saltzstein Benedikt Salzbrunn Giovanna Sannino Jose A. Santos

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