EN ISO 11073-10417-2017 en Health informatics - Personal health device communication - Part 10417 Device specialization - Glucose meter.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Health informatics Personal health device communicationPart 10417: Device specialization Glucose meter (ISO/IEEE 11073-10417:2017)BS EN ISO 11073-10417:2017EUROPEANSTANDARDNORME EUROPENNE EUROPISCHE NORMEN ISO 11073-104

2、17May 2017ICS 35.240.80 Supersedes EN ISO 11073-10417:2014EnglishVersionHealth informatics - Personal health device communication - Part 10417: Device specialization -Glucose meter (ISO/IEEE 11073-10417:2017)Informatique de sant - Communication entredispositifs mdicaux sur le sitedes soins- Partie10

3、417: Spcialisation des dispositifs - Glucomtre (ISO/IEEE 11073-10417:2017)This European Standard was approved by CEN on 8 October 2016.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving thisEuropean Standard the status of a national st

4、andard without any alteration.Up-to-date lists and bibliographical referencesconcerning such national standards may be obtained 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 a

5、ny other language made bytranslation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC ManagementCentre has the same status as the officialversions.CEN members are the nationalstandards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic

6、, 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 United Kingdom.EUROP

7、EAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reservedworldwide for CENnational Members.Ref. No. EN ISO 11073-10417:2017 EN

8、ational forewordThis British Standard is the UK implementation of EN ISO 1107310417:2017. It supersedes BS EN ISO 1107310417:2014, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics.A list of organizations represented on this co

9、mmittee 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 Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 52420 2ICS 35.2

10、40.80Compliance 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 December 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO

11、1107310417:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11073-10417 May 2017 ICS 35.240.80 Supersedes EN ISO 11073-10417:2014English Version Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter (ISO/IEEE 11073-10417:2017) Infor

12、matique de sant - Communication entre dispositifs mdicaux sur le site des soins - Partie 10417: Spcialisation des dispositifs - Glucomtre (ISO/IEEE 11073-10417:2017) This European Standard was approved by CEN on 8 October 2016. CEN members are bound to comply with the CEN/CENELEC Internal Regulation

13、s 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 obtained on application to the CEN-CENELEC Management Centre or to any CEN member. Th

14、is 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 CEN-CENELEC Management Centre has the same status as the official versions. CEN mem

15、bers 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, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portu

16、gal, 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 Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation i

17、n any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11073-10417:2017 EBS EN ISO 1107310417:2017EN ISO 11073-10417:2017 (E) 3 European foreword This document (EN ISO 11073-10417:2017) has been prepared by Technical Committee ISO/TC 215 “Health informatics” in coll

18、aboration with 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, either by publication of an identical text or by endorsement, at the latest by November 2017 and conflicting national s

19、tandards shall be withdrawn at the latest by November 2017. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes E

20、N ISO 11073-10417:2014. 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, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic o

21、f 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 United Kingdom. Endorsement notice The text of ISO/IEEE 11073-10417:201

22、7 has been approved by CEN as EN ISO 11073-10417:2017 without any modification. BS EN ISO 1107310417:2017Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is norm

23、ally carried out through ISO technical committees. Each member body interested in a subject for which a 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 t

24、he work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. IEEE Standards documents are developed within the IEEE Societies and the Standards Coordinating Committees of the IEEE Standards Association (IEEE-SA) Standa

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31、ty. Further information may be obtained from ISO or the IEEE Standards Association. ISO/IEEE 11073-10417 was prepared by the 11073 Committee of the Engineering in Medicine and Biology Society of the IEEE (as IEEE Std 11073-10417-2015). It was adopted by Technical Committee ISO/TC 215, Health informa

32、tics, in parallel with its approval by the ISO member bodies, under the “fast-track procedure” defined in the Partner Standards Development Organization cooperation agreement between ISO and IEEE. Both parties are responsible for the maintenance of this document. IEEE 2015 All rights reserved iii IS

33、O/IEEE 11073-10417:2017(E)BS EN ISO 1107310417:2017(Revision of IEEE Std 11073-10417-2011) Health informaticsPersonal health device communication Part 10417: Device SpecializationGlucose Meter Sponsor IEEE 11073 Standards Committee of the IEEE Engineering in Medicine and Biology Society Approved 11

34、June 2015 IEEE-SA Standards Board IEEE Std 11073-10417-2015 BS EN ISO 1107310417:2017Abstract: Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of communication between personal telehealth glucose meter devices and compute engines (e.g., c

35、ell phones, personal computers, personal health appliances, and set top boxes) is established by this standard in a manner that enables plug-and-play interoperability. Appropriate portions of existing standards are leveraged, including ISO/IEEE 11073 terminology, information models, application prof

36、ile standards, and transport standards. The use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability are specified. A common core of communication functionality for personal telehealth glucose meters is defi

37、ned in this standard. Keywords: glucose meter, IEEE 11073-10417, medical device communication, personal health devices The Institute of Electrical and Electronics Engineers, Inc. 3 Park Avenue, New York, NY 10016-5997, USA Copyright 2015 by The Institute of Electrical and Electronics Engineers, Inc.

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