BS EN ISO 11073-10424-2016 Health informatics Personal health device communication Device specialization Sleep apnoea breathing therapy equipment (SABTE)《健康信息学 个人保健装置通信 装置专业化 睡眠窒息呼.pdf

1、BS EN ISO 11073-10424:2016Health informatics Personalhealth device communicationPart 10424: Device specialization Sleepapnoea breathing therapy equipment(SABTE) (ISO/IEEE 11073-10424:2016)BSI Standards PublicationBS EN ISO 11073-10424:2016 BRITISH STANDARDNational forewordThis British Standard is th

2、e UK implementation of EN ISO 11073-10424:2016.The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all th

3、e necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 92557 3 ICS 35.240.80 Compliance with a British Standard cannot confer immunity from legal obligations.This British St

4、andard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2016.Amendments/corrigenda issued since publicationDate Text affectedg3g3g3g8g24g21g18g19g8g4g17g3g22g23g4g17g7g4g21g7g3g17g18g21g16g8g3g8g24g21g18g19g50g8g17g17g8g3g8g24g21g18g19g34g12g22g6g11g8g3g17g

5、18g21g16g3EN ISO 11073-10424 g3 g3g3 g13g151g144g135g3g884g882g883g888g3g12g6g22g3g885g887g484g884g886g882g484g890g882g3g8g144g137g142g139g149g138g3g25g135g148g149g139g145g144g3g3g11g135g131g142g150g138g3g139g144g136g145g148g143g131g150g139g133g149g3g486g3g19g135g148g149g145g144g131g142g3g138g135g13

6、1g142g150g138g3g134g135g152g139g133g135g3g133g145g143g143g151g144g139g133g131g150g139g145g144g3g486g3g19g131g148g150g3g883g882g886g884g886g483g3g7g135g152g139g133g135g3g149g146g135g133g139g131g142g139g156g131g150g139g145g144g3g486g3g22g142g135g135g146g3g131g146g144g145g135g131g3g132g148g135g131g150g

7、138g139g144g137g3g150g138g135g148g131g146g155g3g135g147g151g139g146g143g135g144g150g3g523g22g4g5g23g8g524g3g523g12g22g18g512g12g8g8g8g3g883g883g882g889g885g486g883g882g886g884g886g483g884g882g883g888g524g3g12g144g136g145g148g143g131g150g139g147g151g135g3g134g135g3g142g131g3g149g131g144g150g177g3g486

8、g3g6g145g143g143g151g144g139g133g131g150g139g145g144g3g135g144g150g148g135g3g134g139g149g146g145g149g139g150g139g136g149g3g134g135g3g149g131g144g150g177g3g146g135g148g149g145g144g144g135g142g149g3g486g3g19g131g148g150g139g135g3g883g882g886g884g886g483g3g22g146g177g133g139g131g142g139g149g131g150g139

9、g145g144g3g134g135g3g134g139g149g146g145g149g139g150g139g136g3g486g3g50g147g151g139g146g135g143g135g144g150g3g134g135g3g150g138g177g148g131g146g139g135g3g148g135g149g146g139g148g131g150g145g139g148g135g3g134g135g3g142g821g131g146g144g177g135g3g134g151g3g149g145g143g143g135g139g142g3g523g22g4g5g23g8g

10、524g3g523g12g22g18g512g12g8g8g8g3g883g883g882g889g885g486g883g882g886g884g886g483g884g882g883g888g524g3g3 g16g135g134g139g156g139g144g139g149g133g138g135g3g12g144g136g145g148g143g131g150g139g141g3g486g3g14g145g143g143g151g144g139g141g131g150g139g145g144g3g152g145g144g3g10g135g148g161g150g135g144g3g1

11、36g242g148g3g134g139g135g3g146g135g148g149g218g144g142g139g133g138g135g3g10g135g149g151g144g134g138g135g139g150g3g486g3g23g135g139g142g3g883g882g886g884g886g483g3g10g135g148g161g150g135g149g146g135g156g139g136g139g141g131g150g139g145g144g3g486g3g22g133g138g142g131g136g131g146g144g145g135g486g4g150g1

12、35g143g150g138g135g148g131g146g139g135g137g135g148g161g150g135g3g523g12g22g18g512g12g8g8g8g3g883g883g882g889g885g486g883g882g886g884g886g483g884g882g883g888g524g3g23g138g139g149g3g8g151g148g145g146g135g131g144g3g22g150g131g144g134g131g148g134g3g153g131g149g3g131g146g146g148g145g152g135g134g3g132g155

13、g3g6g8g17g3g145g144g3g884g883g3g9g135g132g148g151g131g148g155g3g884g882g883g888g484g3g3g3g6g8g17g3g143g135g143g132g135g148g149g3g131g148g135g3g132g145g151g144g134g3g150g145g3g133g145g143g146g142g155g3g153g139g150g138g3g150g138g135g3g6g8g17g512g6g8g17g8g15g8g6g3g12g144g150g135g148g144g131g142g3g21g13

14、5g137g151g142g131g150g139g145g144g149g3g153g138g139g133g138g3g149g150g139g146g151g142g131g150g135g3g150g138g135g3g133g145g144g134g139g150g139g145g144g149g3g136g145g148g3g137g139g152g139g144g137g3g150g138g139g149g3g8g151g148g145g146g135g131g144g3g22g150g131g144g134g131g148g134g3g150g138g135g3g149g150

15、g131g150g151g149g3g145g136g3g131g3g144g131g150g139g145g144g131g142g3g149g150g131g144g134g131g148g134g3g153g139g150g138g145g151g150g3g131g144g155g3g131g142g150g135g148g131g150g139g145g144g484g3g24g146g486g150g145g486g134g131g150g135g3g142g139g149g150g149g3g131g144g134g3g132g139g132g142g139g145g137g14

16、8g131g146g138g139g133g131g142g3g148g135g136g135g148g135g144g133g135g149g3g133g145g144g133g135g148g144g139g144g137g3g149g151g133g138g3g144g131g150g139g145g144g131g142g3g149g150g131g144g134g131g148g134g149g3g143g131g155g3g132g135g3g145g132g150g131g139g144g135g134g3g145g144g3g131g146g146g142g139g133g13

17、1g150g139g145g144g3g150g145g3g150g138g135g3g6g8g17g486g6g8g17g8g15g8g6g3g16g131g144g131g137g135g143g135g144g150g3g6g135g144g150g148g135g3g145g148g3g150g145g3g131g144g155g3g6g8g17g3g143g135g143g132g135g148g484g3g3g23g138g139g149g3g8g151g148g145g146g135g131g144g3g22g150g131g144g134g131g148g134g3g135g1

18、54g139g149g150g149g3g139g144g3g150g138g148g135g135g3g145g136g136g139g133g139g131g142g3g152g135g148g149g139g145g144g149g3g523g8g144g137g142g139g149g138g481g3g9g148g135g144g133g138g481g3g10g135g148g143g131g144g524g484g3g4g3g152g135g148g149g139g145g144g3g139g144g3g131g144g155g3g145g150g138g135g148g3g14

19、2g131g144g137g151g131g137g135g3g143g131g134g135g3g132g155g3g150g148g131g144g149g142g131g150g139g145g144g3g151g144g134g135g148g3g150g138g135g3g148g135g149g146g145g144g149g139g132g139g142g139g150g155g3g145g136g3g131g3g6g8g17g3g143g135g143g132g135g148g3g139g144g150g145g3g139g150g149g3g145g153g144g3g142

20、g131g144g137g151g131g137g135g3g131g144g134g3g144g145g150g139g136g139g135g134g3g150g145g3g150g138g135g3g6g8g17g486g6g8g17g8g15g8g6g3g16g131g144g131g137g135g143g135g144g150g3g6g135g144g150g148g135g3g138g131g149g3g150g138g135g3g149g131g143g135g3g149g150g131g150g151g149g3g131g149g3g150g138g135g3g145g136

21、g136g139g133g139g131g142g3g152g135g148g149g139g145g144g149g484g3g3g6g8g17g3g143g135g143g132g135g148g149g3g131g148g135g3g150g138g135g3g144g131g150g139g145g144g131g142g3g149g150g131g144g134g131g148g134g149g3g132g145g134g139g135g149g3g145g136g3g4g151g149g150g148g139g131g481g3g5g135g142g137g139g151g143g

22、481g3g5g151g142g137g131g148g139g131g481g3g6g148g145g131g150g139g131g481g3g6g155g146g148g151g149g481g3g6g156g135g133g138g3g21g135g146g151g132g142g139g133g481g3g7g135g144g143g131g148g141g481g3g8g149g150g145g144g139g131g481g3g9g139g144g142g131g144g134g481g3g9g145g148g143g135g148g3g28g151g137g145g149g14

23、2g131g152g3g21g135g146g151g132g142g139g133g3g145g136g3g16g131g133g135g134g145g144g139g131g481g3g9g148g131g144g133g135g481g3g10g135g148g143g131g144g155g481g3g10g148g135g135g133g135g481g3g11g151g144g137g131g148g155g481g3g12g133g135g142g131g144g134g481g3g12g148g135g142g131g144g134g481g3g12g150g131g142g

24、155g481g3g15g131g150g152g139g131g481g3g15g139g150g138g151g131g144g139g131g481g3g15g151g154g135g143g132g145g151g148g137g481g3g16g131g142g150g131g481g3g17g135g150g138g135g148g142g131g144g134g149g481g3g17g145g148g153g131g155g481g3g19g145g142g131g144g134g481g3g19g145g148g150g151g137g131g142g481g3g21g145

25、g143g131g144g139g131g481g3g22g142g145g152g131g141g139g131g481g3g22g142g145g152g135g144g139g131g481g3g22g146g131g139g144g481g3g22g153g135g134g135g144g481g3g22g153g139g150g156g135g148g142g131g144g134g481g3g23g151g148g141g135g155g3g131g144g134g24g144g139g150g135g134g3g14g139g144g137g134g145g143g484g3g3

26、g3g3g3g8g24g21g18g19g8g4g17g3g6g18g16g16g12g23g23g8g8g3g9g18g21g3g22g23g4g17g7g4g21g7g12g29g4g23g12g18g17g3g6g18g16g12g23g50g3g8g24g21g18g19g50g8g17g3g7g8g3g17g18g21g16g4g15g12g22g4g23g12g18g17g3g8g24g21g18g19g34g12g22g6g11g8g22g3g14g18g16g12g23g8g8g3g9g111g21g3g17g18g21g16g24g17g10g3g3g3g3CEN-CENEL

27、ECg3Management Centre: Avenue Marnix 17, B-1000 Brussels g825g3g884g882g883g888g3g6g8g17g3 g4g142g142g3g148g139g137g138g150g149g3g145g136g3g135g154g146g142g145g139g150g131g150g139g145g144g3g139g144g3g131g144g155g3g136g145g148g143g3g131g144g134g3g132g155g3g131g144g155g3g143g135g131g144g149g3g148g135g

28、149g135g148g152g135g134g3g153g145g148g142g134g153g139g134g135g3g136g145g148g3g6g8g17g3g144g131g150g139g145g144g131g142g3g16g135g143g132g135g148g149g484g3g21g135g136g484g3g17g145g484g3g8g17g3g12g22g18g3g883g883g882g889g885g486g883g882g886g884g886g483g884g882g883g888g3g8BS EN ISO 11073-10424:2016EN IS

29、O 11073-10424:2016 (E) 3 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

30、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 docu

31、ment 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:

32、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, S

33、weden, 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. BS EN ISO 11073-10424:2016ISO/IEEE 11073-10424:2016(E) ISO 2016 All rights reserved IEEE 2014 All rights reserved

34、iiiForewordISO (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

35、 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 matte

36、rs 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 Ame

37、rican 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 prom

38、ote 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 te

39、chnical 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 covere

40、d 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 inquiri

41、es 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-

42、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 11073-10424

43、 was prepared by the IEEE 11073 Standards Comittee of the IEEE Engineering in Medicine and Biology Society (as IEEE Std 11073-10424-2014). 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” de

44、fined 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. Abstract: Within the context of the ISO/IEEE 11073 family of standards for device communic

45、ation, 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 thi

46、s 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

47、 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 pr

48、essure 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) g120The Institute of Electr

49、ical and Electronics Engineers, Inc. 3 Park Avenue, New York, NY 10016-5997, USA Copyright 2014 by The Institute of Electrical and Electronics Engineers, Inc. All rights reserved. Published 29 September 2014. Printed in the United States of America.IEEE is a registered trademark in the U.S. Patent fitness for a particular purpose; non-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 AL