ANSI IEEE 11073-10418-2011 Health informatics Personal health device communication Part 10418 Device specialization International Normalized Ratio (INR) monitor《健康信息学.个人健康装置通信.装置专业.pdf

1、g3g3g3Part 10418: Device specialization International Normalized Ratio (INR) monitor g3Sponsored by the IEEE 11073 Standards Committee g3IEEE 3 Park Avenue New York, NY 10016-5997 USA 9 November 2011 IEEE Engineering in Medicine and Biology Society IEEE Std 11073-10418g4862011Health informaticsPerso

2、nal health device communication IEEE Std 11073-10418TM-2011 Health informaticsPersonal health device communication Part 10418: Device specialization International Normalized Ratio (INR) monitor Sponsor IEEE 11073TMStandards Committee of the IEEE Engineering in Medicine and Biology Society Approved 1

3、0 September 2011 IEEE-SA Standards Board Approved 12 December 2012 American National Standards Institute Abstract: A normative definition of communication between personal telehealth International Normalized Ratio (INR) devices (agents) and managers (e.g., cell phones, personal computers, personal h

4、ealth appliances, and set top boxes) is established in this standard in a manner that enables plug-and-play interoperability. Work done in other ISO/IEEE 11073 standards is leveraged, including existing terminology, information profiles, application profile standards, and transport standards. The us

5、e 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 functionality of INR devices is defined in this standard. In the context of personal health devices, the measurement of t

6、he prothrombin time (PT) that is used to assess the level of anticoagulant therapy and its presentation as the International Normalized Ratio compared to the prothrombin time of normal blood plasma is referred to in INR monitoring. Applications of the INR monitor include the management of the therap

7、eutic level of anticoagulant used in the treatment of a variety of conditions. The data modeling and its transport shim layer according to ISO/IEEE 11073-20601:2010 are provided by this standard, and the measurement method is not specified. Keywords: IEEE 11073-10418, International Normalized Ratio

8、(INR) monitor, medical device communication, personal health devices The Institute of Electrical and Electronics Engineers, Inc. 3 Park Avenue, New York, NY 10016-5997, USA Copyright 2011 by the Institute of Electrical and Electronics Engineers, Inc. All rights reserved. Published 9 November 2011. P

9、rinted in the United States of America. IEEE is a registered trademark in the U.S. Patent +1 978 750 8400. Permission to photocopy portions of any individual standard for educational classroom use can also be obtained through the Copyright Clearance Center.ivCopyright 2011 IEEE. All rights reserved.

10、 IntroductionThis introduction is not part of IEEE Std 11073-10418-2011, Health informaticsPersonal health device communicationPart 10418: Device specializationInternational Normalized Ratio (INR) monitor. ISO/IEEE 11073 standards enable communication between medical devices and external computer sy

11、stems. Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between medication monitoring devices and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes

12、) 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 ambiguity in base

13、 frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth INR devices. In this context, the measurement of the prothrombin time (PT) that is used to assess the level of anticoagulant therapy and its presentation as the Intern

14、ational Normalized Ratio (INR) compared with the PT of normal blood plasma is referred to in INR monitoring. Applications of the INR monitor include the management of the therapeutic level of anticoagulant used in the treatment of a variety of conditions. Notice to users Laws and regulations Users o

15、f 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 requirements

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21、s.ieee.org.vCopyright 2011 IEEE. All rights reserved. ErrataErrata, if any, for this and all other standards can be accessed at the following URL: http:/standards.ieee.org/findstds/errata/index.html. Users are encouraged to check this URL for errata periodically. InterpretationsCurrent interpretatio

22、ns can be accessed at the following URL: http:/standards.ieee.org/findstds/interps/index.html.PatentsAttention 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 with resp

23、ect 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 determining whether any licensing ter

24、ms 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 the risk of infringement of such ri

25、ghts, is entirely their own responsibility. Further information may be obtained from the IEEE Standards Association. viCopyright 2011 IEEE. All rights reserved. ParticipantsAt the time this standard was submitted to the IEEE-SA Standards Board for approval, the Personal Health Device Working Group h

26、ad the following membership: Douglas P. Bogia, ChairMalcom Clarke, Vice ChairKarsten Aalders Charles R. Abbruscato Nabil Abujbara Maher Abuzaid Jon Adams Manfred Aigner Jorge Alberola Murtaza Ali Prasad Alva Rolf Ambuehl David Aparisi Lawrence Arne Serafin Arroyo Muhammad Asim Merat Bagha Doug Baird

27、 David Baker Anindya Bakshi Ananth Balasubramanian Sunlee Bang M. Jonathan Barkley Gilberto Barrn David Bean John Bell Rudy Belliardi Daniel Bernstein George A. Bertos Ola Bjrsne Thomas Blackadar Marc Blanchet Thomas Bluethner Xavier Boniface Shannon Boucousis Kevin Braun Julius Broma Lyle G. Bulloc

28、k, Jr. Bernard Burg Chris Burns Anthony Butt Jeremy Byford-Rew Satya Calloji Carole C. Carey Santiago Carot-Nemesio Randy W. Carroll Seungchul Chae Rahul Chauhan James Cheng Peggy Chien Silviu Chiricescu Chia-Chin Chong Saeed A. Choudhary Jinhan Chung John A. Cogan John T. Collins Cory Condek Todd H

29、. Cooper David Cornejo Douglas Coup Nigel Cox Tomio Crosley Allen Curtis Ed Day Joost De Folter Sushil K. Deka Pedro de-las-Heras-Quiros Jim DelloStritto Matthew dEntremont Kent Dicks Hyoungho Do Amy Droitcour Xiaolian Duan Brian Dubreuil Jakob Ehrensvard Fredrik Einberg Roger M. Ellingson Michihiro

30、 Enokida Javier Escayola Calvo Leonardo Estevez Roger Feeley Bosco T. Fernandes Morten Flintrup Joseph W. Forler Michael Fortner Russell Foster Eric Freudenthal Matthias Frohner Jing Gao Marcus Garbe Gracinda Garca Lago John Garguilo Rick Geimer Igor Gejdos Ferenc Gerbovics Nicolae Goga Julian Goldm

31、an Raul Gonzalez Gomez Chris Gough Channa Gowda Niclas Granqvist Charles Gropper Amit Gupta Jeff Guttmacher Rasmus Haahr Christian Habermann Mikey Hagerty Jerry Hahn Robert Hall Nathaniel Hamming Rickey L. Hampton Sten Hanke Kai Hassing Marc Daniel Haunschild Mike Hayes Charles Henderson Jun-Ho Her

32、Takashi Hibino Timothy L. Hirou Allen Hobbs Alex Holland Arto Holopainen Robert Hoy Frank Hsu Anne Huang Sen-Der Huang David Hughes Robert D. Hughes Jiyoung Huh Hugh Hunter Hitoshi Ikeda Yutaka Ikeda Philip O. Isaacson Atsushi Ito Praduman Jain Danny Jochelson Chris Johnson Phaneeth Junga Akiyoshi K

33、abe Steve Kahle Tomio Kamioka Kei Kariya Andy Kaschl Junzo Kashihara Kohichi Kashiwagi Ralph Kent Kurt M. Kermes Ikuo Keshi Junhyung Kim Min-Joon Kim Minho Kim Taekon Kim Tetsuya Kimura Michael Kirwan Alfred Kloos viiCopyright 2011 IEEE. All rights reserved. Jeongmee Koh Jean-Marc Koller Patty Krant

34、z Alexander Kraus Ramesh Krishna Falko Kuester Rafael Lajara Pierre Landau Jaechul Lee Kyong Ho Lee Rami Lee Sungkee 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 Espronceda CmaraPeter Ma

35、yhew Jim McCain Richard McPartland Chris Mcvay Lszl Meleg Ethan Metsger Jinsei Miyazaki Darr Moore Piotr Murawski Soundharya Nagasubramanian Jae-Wook Nah Alex Neefus Trong-Nghia Nguyen-Dobinsky Michael E. Nidd Tetsu Nishimura Jim Niswander Hiroaki Niwamoto Thomas Norgall Yoshiteru Nozoe Brett Olive

36、Charles Palmer Bud Panjwani Carl Pantiskas Mikey Paradis Jong-Tae Park Myungeun Park Soojun Park Phillip E. Pash TongBi Pei Soren Petersen Jeff Price Arif Rahman Tim Reilly Barry Reinhold Brian Reinhold Melvin I. Reynolds John G. Rhoads Jeffrey S. Robbins Scott Robertson Timothy Robertson David Rosa

37、les Bill Saltzstein Benedikt Salzbrunn Giovanna Sannino Jose A. Santos-Cadenas Stefan Sauermann John Sawyer Guillaume Schatz Alois Schloegl Paul S. Schluter Johannes Schmidt Lars Schmitt Mark G. Schnell Richard A. Schrenker Antonio Scorpiniti Jungmin Seo Kwang Seok Seo Riccardo Serafin Sid Shaw Fran

38、k Shen Min Shih Mazen Shihabi Krishna Shingala Redmond Shouldice Marjorie Skubic Robert Smith Ivan Soh Motoki Sone Emily Sopensky Rajagopalan Srinivasan Andreas Staubert Nick Steblay Lars Steubesand John (Ivo) Stivoric Raymond Strickland Hermanni Suominen Lee Surprenant Ravi Swami Ray SweidanKunihir

39、o Takiuchi Francis Tam Haruyuyki Tatsumi John W. Thomas Brad Tipler Jonas Tirn James Tomcik Janet Traub Jess Daniel Trigo Gary Tschautscher Masato Tsuchid Ken Tubman Yoshihiro Uchida Sunil Unadkat Philipp Urbauer Laura Vanzago Alpo Vrri Dalimar Velez Naveen Verma Daniel von Bren Rudi Voon Isobel Wal

40、ker David Wang Jerry P. Wang Yao Wang Yi Wang Steve Warren Fujio Watanabe Toru Watsuji Mike Weng Kathleen Wible Paul Williamson Jan Wittenber Jia-Rong Wu Will Wykeham Ariton Xhafa Ricky Yang Done-Sik Yoo Jason Zhang Zhiqiang Zhang Thomas Zhao Daidi Zhong Miha Zoubek Szymon Zysko The following member

41、s of the individual balloting committee voted on this standard. Balloters may have voted for approval, disapproval, or abstention. Vered Bar Christopher Biernacki Douglas P. Bogia Lyle G. Bullock, Jr. Randy W. Carroll Peng Chen Keith Chow Malcolm Clarke Randall Groves Jon Hagar Kai Hassing Werner Ho

42、elzl Atsushi Ito Piotr Karocki Greg Luri Melvin I. Reynolds Bartien Sayogo Lars Schmitt Gil Shultz James E. Smith Lars Steubesand Oren Yuen viiiCopyright 2011 IEEE. All rights reserved.When the IEEE-SA Standards Board approved this standard on 10 September 2011, it had the following membership: Rich

43、ard H. Hulett, ChairJohn Kulick, Vice ChairRobert Grow, Past ChairJudith Gorman, SecretaryMasayuki Ariyoshi William Bartley Ted Burse Clint Chaplin Wael Diab Jean-Philippe Faure Alex Gelman Paul Houz Jim Hughes Joseph L. Koepfinger* David Law Thomas Lee Hung Ling Oleg Logvinov Ted Olsen Gary Robinso

44、n Jon Rosdahl Sam Sciacca Mike Seavey Curtis Siller Phil Winston Howard Wolfman Don Wright *Member Emeritus Also included are the following nonvoting IEEE-SA Standards Board liaisons: Satish Aggarwal, NRC RepresentativeRichard DeBlasio, DOE RepresentativeMichael Janezic, NIST RepresentativeDon Messi

45、na IEEE Standards Program Manager, Document Development Kathryn M. Bennett IEEE Standards Program Manager, Technical Program DevelopmentixCopyright 2011 IEEE. All rights reserved.Contents1. Overview 1 1.1 Scope . 1 1.2 Purpose 2 1.3 Context 2 2. Normative references 2 3. Definitions, acronyms, and a

46、bbreviations 3 3.1 Definitions . 3 3.2 Acronyms and abbreviations . 3 4. Introduction to ISO/IEEE 11073 personal health devices 4 4.1 General 4 4.2 Introduction to ISO/IEEE 11073-20601 modeling constructs . 4 4.3 Compliance with other standards . 5 5. INR monitor device concepts and modalities . 5 5

47、.1 General 5 5.2 Prothrombin time . 6 5.3 Quick value 6 5.4 International Sensitivity Index (ISI) 6 5.5 International Normalized Ratio . 6 5.6 Control calibration. 7 5.7 Batch/code number 7 5.8 Device and sensor status 7 5.9 Device alarm conditions 7 5.10 INR value out of bounds 7 5.11 Extended capa

48、bilities. 7 5.12 Target level for INR. 7 5.13 Current level of medication . 8 5.14 Recommended new level of medication 8 5.15 Context information . 8 6. International Normalized Ratio monitor domain information model . 8 6.1 Overview . 8 6.2 Class extensions . 8 6.3 Object instance diagram 8 6.4 Typ

49、es of configuration . 10 6.5 Medical device system object 10 6.6 Numeric objects . 14 6.7 Real-time sample array objects 20 6.8 Enumeration objects 20 6.9 PM-store objects 24 6.10 Scanner objects 27 6.11 Class extension objects 27 6.12 INR monitor information model extensibility rules . 27 xCopyright 2011 IEEE. All rights reserved.7. INR monitor service model 28 7.1 General 28 7.2 Object access services 28 7.3 Object access event report services . 30 8. INR monitor communication model . 30 8.1 Overview . 30 8.2 Communications characteristics 30 8.3