1、BSI Standards PublicationBS EN ISO 11073-10417:2014Health informatics Personalhealth denullce commnullicationPart 10417: Device specialization Glucose meterBS EN ISO 11073-10417:2014Incorporating corrigendum June 2014BS EN ISO 11073-10417:2014 BRITISH STANDARDNational forewordThis British Standard i
2、s the UK implementation of EN ISO 11073-10417:2014. It is identical to ISO/IEEE 11073-10417:2014. It supersedes BS EN ISO 11073-10417:2011 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics.A list of organizations represented on
3、 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 Institution 2014. Published by BSI Standards Limited 2014ISBN 978 0 580 86987
4、7ICS 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 2014.Amendments/corrigenda issued since publicationDate Text affected30 June 2014 Implemen
5、tation of CEN correction notice 21 May 2014: Implements ISO/IEEE corrected text 01 May 2014, which removes IEEE licensing text from footersEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11073-10417 March 2014 ICS 35.240.80 Supersedes EN ISO 11073-10417:2011English Version Health informatic
6、s - Personal health device communication - Part 10417: Device specialization - Glucose meter (ISO/IEEE 11073-10417:2014, Corrected version 2014-05-01) Informatique de sant - Communication entre dispositifs mdicaux sur le site des soins - Partie 10417: Spcialisation des dispositifs - Glucomtre (ISO/I
7、EEE 11073-10417:2014, Version corrige 2014-05-01) Medizinische Informatik - Kommunikation von Gerten fr die persnliche Gesundheit - Teil 10417: Gertespezifikation: Blutzuckermessgert (ISO/IEEE 11073-10417:2014, korrigierte Fassung 2014-05-01) This European Standard was approved by CEN on 14 December
8、 2013. 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 obtain
9、ed 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 CEN-
10、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, Ireland,
11、Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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:
12、Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11073-10417:2014 EEN ISO 11073-10417:2014 (E) 3 Foreword This document (EN ISO 11073-10417:2014) has been prepared by Technical Committee IS
13、O/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 be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by Sep
14、tember 2014, and conflicting national standards shall be withdrawn at the latest by September 2014. 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 p
15、atent rights. This document supersedes EN ISO 11073-10417:2011. 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, Esto
16、nia, 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 the United Kingdom. Endorsement notice The
17、text of ISO/IEEE 11073-10417:2014, Corrected version 2014-05-01 has been approved by CEN as EN ISO 11073-10417:2014 without any modification. BS EN ISO 11073-10417:2014EN ISO 11073-10417:2014 (E)ISO/IEEE 11073-10417:2014(E) IEEE 2012 All rights reserved iiiForeword ISO (the International Organizatio
18、n 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 established has
19、 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 electrotechnical standardization. IEEE
20、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 Standards Institute, which bri
21、ngs 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 consensus development pro
22、cess, 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 are circulated to the memb
23、er 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 publication of this st
24、andard, 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 scope of patent
25、s 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 standard are ex
26、pressly 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. This second edition of ISO/IEEE 11073-10417 cancels and replaces
27、 the first edition (ISO/IEEE 11073-10417:2010). ISO/IEEE 11073-10417 was prepared by the Substations Committee of the IEEE Power Engineering Society of the IEEE (as IEEE 11073-10417-2011). It was adopted by Technical Committee ISO/TC 215, Respiratory and anaesthetic equipment, in parallel with its a
28、pproval by the ISO member bodies, under the “fast-track procedure” defined 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. ISO/IEEE 11073 consis
29、ts of the following parts, under the general title Health informatics Personal health device 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 communica
30、tion) Nomenclature Annotated ECG Part 10103: (Point-of-care medical device communication) Nomenclature Implantable device, cardiac Part 10201: (Point-of-care medical device communication) Domain information model BS EN ISO 11073-10417:2014ISO/IEEE 11073-10417:2014(E) iv IEEE 2012 All rights reserved
31、 Part 10404: Device specialization Pulse oximeter 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: De
32、vice specialization Glucose meter Part 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 fit
33、ness and activity monitor Part 10471: Device specialization Independant living activity hub Part 10472: Device specialization Medication monitor Part 20101: (Point-of-care medical device communication) Application profiles Base standard Part 20601: Application profile Optimized exchange protocol Par
34、t 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 communication) Interface profile Cabled Ethernet Part 90101: (Point-of-care m
35、edical device communication) Analytical instruments Point-of-care test Part 91064: (Standard communication protocol) Computer-assisted electrocardiography Part 92001: (Medical waveform format) Encoding rules This corrected version of ISO 11073-10417:2014 incorporates the following corrections: The t
36、ext “Authorized licensed use limited to: IEEE Standards Staff and authorized IEEE Sponsor Ballot Participants. Downloaded on May 28,2013 at 14:27:23 UTC from IEEE Xplore. Restrictions apply.“ has been deleted from the footer. On the cover page “First edition“ has been replaced by “Second edition“ an
37、d a sentence giving this revision information has been added in the Foreword. BS EN ISO 11073-10417:2014Part 10417: Device TQFDJBMJBUJPOGlucose meter Sponsored by the IEEE 11073 Standards Committee IEEE 3 Park Avenue New York, NY 10016-5997 USA 27 January 2012 IEEE Engineering in Medicine and Biolog
38、y Society IEEE Std 11073-10417-2011(Revision of IEEE Std 11073-10417-2009) Health InformaticsPersonal health device communicationBS EN ISO 11073-10417:2014ISO/IEEE 11073-10417:2014(E)BS EN ISO 11073-10417:2014ISO/IEEE 11073-10417:2014(E),(6WG70 5HYLVLRQRI,(6WG +HDOWKLQIRUPDWLFV3HUVRQDOKHDOWKGHYLFHFR
39、PPXQLFDWLRQ 3DUWHYLFHVSHFLDOLDWLRQ*OXFRVHPHWHU6SRQVRU,(706WDQGDUGV +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. BS EN ISO 11073-10417:2014ISO/IEEE 11073-10417:2014(E)iv however,
40、 only glucose levels are regulated via insulin and glucagon. Countries that use the metric system generally use mmol/L. The United States uses mg/dL. To convert blood glucose readings, utilize the following conversions: Divide the mg/dL by 18 to get mmol/L (or multiply by 0.055) Multiply the mmol/L
41、by 18 to get mg/dL (or divide by 0.055) The glucose meters considered in this specialization are typically handheld instruments that require a sample of blood or body fluid to perform the glucose measurement. The glucose concentration measured by various techniques can be classified into different t
42、ypes defined by three elements: sample type, sample source, and concentration reference method. Table 1 shows all the glucose concentration types defined in this standard. ,62,( ( BS EN ISO 11073-10417:2014IEEE Std 11073-10417-2011 Health informaticsPersonal health device communication Part 10417: D
43、evice specializationGlucose meter 6 Copyright 2012 IEEE. All rights reserved. Table 1 Glucose concentration types Sample type Sample source Reference methodBlood Capillary Whole blood Plasma Venous Whole blood Plasma Arterial Whole blood Plasma Undetermined Whole blood Plasma Interstitial fluid N/A
44、N/A Control solution N/A N/A NOTEThe blood glucose concentration may be indirectly derived from an interstitial fluid (ISF) sample, which is a common technique used in continuous glucose monitoring. A control solution is normally used for glucose meter quality control. In addition to glucose measure
45、ment, glucose meters generally provide a means for the user to associate information on meals, exercise, and medications with a glucose measurement. Advanced devices may also allow users to customize device settings and to provide additional information related to their diabetes treatment and diseas
46、e management. Glucose meters are usually small, portable devices that are carried around by the user so that blood glucose measurements may be taken as needed, whether or not the user is in a network environment where communications with a manager can be established. Hence, measurement data are typi
47、cally logged within the meter and can be retrieved at a later time, either in whole or in part, when the meter is connected to a manager network. There are two typical use cases for the transfer of measurement data to a manager: By the user in a non-health-care environment. A user may connect the me
48、ter to a personal manager device such as a personal computer or a portable communications device such as a cell phone. In this case, the user would download the most recent logged measurement data from the meter for near-term trend analysis or for transfer of data to an external electronic health network service. The transfer of data would happen immediately on connection with the
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