EN ISO 11073-10441-2017 en Health informatics - Personal health device communication - Part 10441 Device specialization - Cardiovascular fitness and activity monitor《健康信息学的个人健康设备的通.pdf

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1、BS ISO/IEEE 11073-10441:2015Health informatics Personalhealth device communicationPart 10441: Device specialization Cardiovascular fitness and activity monitor(ISO/IEEE 11073-10441:2015)BS EN ISO 11073-10441:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN I

2、SO 11073-10441:2017 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 11073-10441:2017. It is identical to ISO/IEEE 11073-10441:2015. It supersedes BS ISO/IEEE 11073-10441:2015 which is withdrawn.The UK participation in its preparation was entrusted to Technic

3、al 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 the necessary provisions of a contract. Users are responsible for its correct application. The British Standards

4、Institution 2017. Published by BSI Standards Limited 2017ISBN 978 0 580 93165 9ICS 11.040.55; 35.240.80Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2

5、015.Amendments/corrigenda issued since publicationDate Text affected31 March 2017 This corrigendum renumbers BS ISO/IEEE 11073-10441:2015 as BS EN ISO 11073-10441:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11073-10441 February 2017 ICS 11.040.55; 35.240.80 English Version Health in

6、formatics - Personal health device communication - Part 10441: Device specialization - Cardiovascular fitness and activity monitor (ISO/IEEE 11073-10441:2015) Informatique de sant - Communication entre dispositifs de sant personnels - Partie 10441: Spcialisation des dispositifs - Moniteur dactivit e

7、t de forme cardiovasculaire (ISO/IEEE 11073-10441:2015)Medizinische Informatik - Kommunikation von Gerten fr die persnliche Gesundheit - Teil 10441: Gertespezifikation - Monitor fr die Herz-Kreislauf-Fitness und -Aktivitt (ISO/IEEE 11073-10441:2015)This European Standard was approved by CEN on 16 Ja

8、nuary 2017. 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 o

9、btained 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

10、 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, Irel

11、and, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Manage

12、ment Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11073-10441:2017 EBS ISO/IEEE 11073-10441:2015ISO/IEEE 11073-10441:2015(E) IEEE 2013 All rights reserved iiiForeword ISO (the I

13、nternational 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 technical committee

14、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 matters of electrotechnica

15、l 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 American National Standa

16、rds 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 promote fairness in the c

17、onsensus 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 technical committees ar

18、e 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 covered by patent rights. B

19、y 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 inquiries into the legal val

20、idity 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-discriminatory. Users

21、 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 11073-10441 was prepared by the

22、 11073 Committee of the Engineering in Medicine and Biology Society of the IEEE (as IEEE 11073-10441-2013). 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” defined in the Partner Standards

23、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. ISO/IEEE 11073 consists of the following parts, under the general title Health informatics Personal health device communi

24、cation (text in parentheses gives a variant of subtitle): Part 00103: Overview Part 10101: (Point-of-care medical device communication) Nomenclature Part 10102: (Point-of-care medical device communication) Nomenclature Annotated ECG Part 10103: (Point-of-care medical device communication) Nomenclatu

25、re Implantable device, cardiac Part 10201: (Point-of-care medical device communication) Domain information model Part 10404: Device specialization Pulse oximeter EN ISO 11073-10441:2017 (E) 3 European foreword The text of ISO/IEEE 11073-10441:2015 has been prepared by Technical Committee ISO/TC 215

26、“Health informatics” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 11073-10441:2017 by 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,

27、 either by publication of an identical text or by endorsement, at the latest by August 2017, and conflicting national standards shall be withdrawn at the latest by August 2017. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN a

28、nd/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, Cz

29、ech 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the Unit

30、ed Kingdom. Endorsement notice The text of ISO/IEEE 11073-10441:2015 has been approved by CEN as EN ISO 11073-10441:2017 without any modification. BS EN ISO 11073-10441:2017EN ISO 11073-10441:2017 (E)BS ISO/IEEE 11073-10441:2015ISO/IEEE 11073-10441:2015(E) IEEE 2013 All rights reserved iiiForeword I

31、SO (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 technical c

32、ommittee 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 matters of electr

33、otechnical 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 American Nation

34、al 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 promote fairness

35、 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 technical comm

36、ittees 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 covered by patent

37、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 inquiries into the

38、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-discriminato

39、ry. 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 11073-10441 was prepar

40、ed by the 11073 Committee of the Engineering in Medicine and Biology Society of the IEEE (as IEEE 11073-10441-2013). 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” defined in the Partner S

41、tandards 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. ISO/IEEE 11073 consists of the following parts, under the general title Health informatics Personal health devic

42、e communication (text in parentheses gives a variant of subtitle): Part 00103: Overview Part 10101: (Point-of-care medical device communication) Nomenclature Part 10102: (Point-of-care medical device communication) Nomenclature Annotated ECG Part 10103: (Point-of-care medical device communication) N

43、omenclature Implantable device, cardiac Part 10201: (Point-of-care medical device communication) Domain information model Part 10404: Device specialization Pulse oximeter BS EN ISO 11073-10441:2017ISO/IEEE 11073-10441:2015(E)BS ISO/IEEE 11073-10441:2015ISO/IEEE 11073-10441:2015(E) iv IEEE 2013 All r

44、ights reserved Part 10406: Device specialization Basic electrocardiograph (ECG) (1- to 3-lead ECG) Part 10407: Device specialization Blood pressure monitor Part 10408: Device specialization Thermometer Part 10415: Device specialization Weighing scale Part 10417: Device specialization Glucose meter P

45、art 10418: Device specialization International Normalized Ratio (INR) monitor Part 10420: Device specialization Body composition analyzer Part 10421: Device specialization Peak expiratory flow monitor (peak flow) Part 10441: Device specialization Cardiovascular fitness and activity monitor Part 1044

46、2: (Point-of-care medical device communication) Device specialization Strength fitness equipment Part 10471: Device specialization Independent living activity hub Part 10472: Device specialization Medication monitor Part 20101: (Point-of-care medical device communication) Application profiles Base s

47、tandard Part 20601: Application profile Optimized exchange protocol Part 30200: (Point-of-care medical device communication) Transport profile Cable connected Part 30300: (Point-of-care medical device communication) Transport profile Infrared wireless Part 30400: (Point-of-care medical device commun

48、ication) Interface profile Cabled Ethernet Part 90101: (Point-of-care medical device communication) Analytical instruments Point-of-care test Part 91064: (Standard communication protocol) Computer-assisted electrocardiography Part 92001: (Medical waveform format) Encoding rules BS ISO/IEEE 11073-104

49、41:2015Part 10441: Device specializationCardiovascular fitness and activity monitor Sponsored by the IEEE 11073 Standards Committee IEEE 3 Park Avenue New York, NY 10016-5997 USA 29 March 2013 IEEE Engineering in Medicine and Biology Society IEEE Std 11073-10441-2013(Revision of IEEE Std 11073-10441-2008) Health InformaticsPersonal health device communicationBS ISO/IEEE 11073-10441:2015IS