1、BS EN ISO 11073-10425:2016Health informatics Personalhealth device communicationPart 10425: Device specialization Continuous glucose monitor (CGM) (ISO 11073-10425:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 11073-10425:2016 BRITISH STANDARDNationa
2、l forewordThis British Standard is the UK implementation of EN ISO 11073-10425:2016. 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 publicat
3、ion does not purport to include all the 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 88580 8 ICS 35.240.80 Compliance with a British Standard cannot confer immunity
4、from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11073-10425 June 2016 ICS 3
5、5.240.80 English Version Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM) (ISO 11073-10425:2016) Informatique de sant - Communication entre dispositifs de sant personnels - Partie 10425: Spcialisation du dispositif - Glu
6、comtre continu (CGM) (ISO 11073-10425:2016) Medizinische Informatik - Kommunikation von Gerten fr die persnliche Gesundheit - Teil 10425: Gertespezifikation - Kontinuierlicher Glukose-Monitor (ISO 11073-10425:2016) This European Standard was approved by CEN on 21 February 2016. CEN members are bound
7、 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 obtained on application to the CEN
8、-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 CEN-CENELEC Management Centre ha
9、s 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, Ireland, Italy, Latvia, Lithuania, Lu
10、xembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brus
11、sels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11073-10425:2016 EBS EN ISO 11073-10425:2016EN ISO 11073-10425:2016 (E) 3 European foreword The text of ISO/IEEE 11073-10425:2016 has been prepared by Technical Committe
12、e ISO/TC 215 “Health informatics” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 11073-10425:2016 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 natio
13、nal 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 document may be the subject of pat
14、ent 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: Austria, Belgium, Bulgaria, Cr
15、oatia, 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, Sweden, Switzerland, Turkey and
16、 the United Kingdom. Endorsement notice The text of ISO/IEEE 11073-10425:2016 has been approved by CEN as EN ISO 11073-10425:2016 without any modification. BS EN ISO 11073-10425:2016ISO/IEEE 11073-10425:2016(E) ISO 2016 All rights reserved IEEE 2014 All rights reserved iiiForeword ISO (the Internati
17、onal 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 has been
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22、ated 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. By public
23、ation 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 validity or
24、 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 of this
25、 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 11073-10425 was prepared by the IEEE 11
26、073 Standards Comittee of the IEEE Engineering in Medicine and Biology Society (as IEEE Std 11073-10425-2014). 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” defined in the Partner Standar
27、ds 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. BS EN ISO 11073-10425:2016Abstract: Within the context of the ISO/IEEE 11073 family of standards for device communicat
28、ion, a normative definition of the communication between continuous glucose monitor (CGM) devices and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes), in a manner that enables plug-and-play interoperability, is established in this standard. It leverage
29、s 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 optionality in base frameworks in favor of interoperability. This standard defines a co
30、mmon core of communication functionality of CGM devices. In this context, CGM refers to the measurement 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 de
31、vice communication, personal health devices The Institute of Electrical 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 10 October 2014. Printed in the United Stat
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