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BS EN ISO 11073-10472-2012

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BS EN ISO 11073-10472-2012

BSI Standards Publication BS EN ISO 11073-104722012 Health Informatics Personal health device communication Part 10472 Device specialization Medication monitor ISO 11073-104722012BS EN ISO 11073-104722012 BRITISH STANDARD National foreword This British Standard is the UK implementation of EN ISO 11073-104722012. 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 the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2012. Published by BSI Standards Limited 2012 ISBN 978 0 580 79084 3 ICS 35.240.80 Compliance 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 30 November 2012. Amendments issued since publication Date Text affected EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11073-10472 November 2012 ICS 35.240.80 English Version Health Informatics - Personal health device communication - Part 10472 Device specialization - Medication monitor ISO 11073-104722012 Informatique de sant - Communication entre dispositifs de sant personnels - Partie 10472 Spcialisation des dispositifs - Moniteur de surveillance de mdication ISO 11073-104722012 Medizinische Informatik - Kommunikation von Gerten fr die persnliche Gesundheit - Teil 10472 Gertespezifikation - Medikamentenmonitoring ISO 11073- 104722012 This European Standard was approved by CEN on 20 October 2012. 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 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 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 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, 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 Management Centre Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11073-104722012 EBS EN ISO 11073-104722012 EN ISO 11073-104722012 E 3 Foreword This document EN ISO 11073-104722012 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 be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by May 2013, and conflicting national standards shall be withdrawn at the latest by May 2013. 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. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard 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, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11073-104722012 has been approved by CEN as a EN ISO 11073-104722012 without any modification. BS EN ISO 11073-104722012 ISO/IEEE 11073-104722012E ISO 2012 – All rights reserved IEEE 2012 – All rights reserved iiiContents 1. Overview 1 1.1 Scope . 1 1.2 Purpose 2 1.3 Context 2 2. Normative references 2 3. Definitions, acronyms, and abbreviations 2 3.1 Definitions . 3 3.2 Acronyms and abbreviations . 3 4. Introduction to ISO/IEEE 11073 personal health devices 4 4.1 General 4 4.2 Introduction to IEEE 11073-20601 modeling constructs 4 5. Medication monitor device concepts and modalities 5 5.1 General 5 5.2 Model usage examples. 6 5.3 Medication dispensed 7 5.4 Status reporter 8 5.5 User feedback 8 5.6 Usage patterns 9 6. Medication monitor domain information model. 9 6.1 Overview . 9 6.2 Class extensions. 9 6.3 Object instance diagram 10 6.4 Types of configuration. 11 6.5 Medical device system object 12 6.6 Numeric objects. 16 6.7 Real-time sample array objects 22 6.8 Enumeration objects 22 6.9 PM-store objects 27 6.10 Scanner objects 30 6.11 Class extension objects 31 6.12 Medication monitor information model extensibility rules . 31 7. Medication monitor service model . 31 7.1 General 31 7.2 Object access services 31 7.3 Object access event report services . 32 8. Medication monitor communication model 33 8.1 Overview . 33 8.2 Communications characteristics 33 8.3 Association procedure . 33 8.4 Configuring procedure. 35 8.5 Operating procedure 41 8.6 Time synchronization 42 9. Test associations. 42 BS EN ISO 11073-104722012 ISO/IEEE 11073-104722012E iv ISO 2012 – All rights reserved IEEE 2012 – All rights reserved9.1 Behavior with standard configuration 42 9.2 Behavior with extended configurations . 43 10. Conformance 43 10.1 Applicability 43 10.2 Conformance specification 43 10.3 Levels of conformance 44 10.4 Implementation conformance statements 44 Annex A informative Bibliography 50 Annex B normative Any additional ASN.1 definitions . 51 Annex C normative Allocation of identifiers. 52 Annex D informative Message sequence examples. 53 Annex E informative Protocol data unit examples 55 E.1 General 55 E.2 Association information exchange 55 E.3 Configuration information exchange. 58 E.4 GET MDS attributes service . 61 E.5 Data reporting 62 E.6 Disassociation . 63 Annex F informative IEEE list of participants 64 BS EN ISO 11073-104722012 ISO/IEEE 11073-104722012E ISO 2012 – All rights reserved IEEE 2012 – All rights reserved vForeword ISO 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 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 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 Standards Board. The IEEE develops its standards through a consensus development process, approved by the American 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 promote 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 technical 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 covered 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 inquiries 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-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 11073-10472 was prepared by the IEEE 11073 Standards Comittee of the IEEE Engineering in Medicine and Biology Society as IEEE Std 11073-10472-2010. 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 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 communication text in parentheses gives a variant of subtitle  Part 10101 Point-of-care medical device communication Nomenclature  Part 10201 Point-of-care medical device communication Domain information model  Part 10404 Device specialization Pulse oximeter  Part 10407 Device specialization Blood pressure monitor  Part 10408 Device specialization Thermometer  Part 10415 Device specialization Weighing scale BS EN ISO 11073-104722012 ISO/IEEE 11073-104722012E vi ISO 2012 – All rights reserved IEEE 2012 – All rights reserved Part 10417 Device specialization Glucose meter  Part 10420 Device specialization Body composition analyzer  Part 10421 Device specialization Peak expiratory flow monitor peak flow  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  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 communication 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 rulesBS EN ISO 11073-104722012 ISO/IEEE 11073-104722012E ISO 2012 – All rights reserved IEEE 2012 – All rights reserved viiIntroduction This introduction is not part of IEEE Std 11073-10472-2012, Health InformaticsPersonal health device communicationPart 10472 Device specializationMedication monitor. ISO/IEEE 11073 standards enable communication between medical devices and external computer systems. Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between medication monitoring devices and managers e.g., cell phones, personal computers, personal health appliances, set top boxes in a manner that enables plug-and-play interoperability. It leverages 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 ambiguity in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for medication monitors. In this context, medication monitors are defined as devices that have the ability to determine and communicate to a manager measures of a user’s adherence to a medication regime. BS EN ISO 11073-104722012BS EN ISO 11073-104722012IMPORTANT NOTICE This standard is not intended to ensure safety, security, health, or environmental protection in all circumstances. Implementers of the standard are responsible for determining appropriate safety, security, environmental, and health practices or regulatory requirements. This IEEE document is made available for use subject to important notices and legal disclaimers. These notices and disclaimers appear in all publications containing this document and may be found under the heading “Important Notice” or “Important Notices and Disclaimers Concerning IEEE Documents.” They can also be obtained on request from IEEE or viewed at http//standards.ieee.org/IPR/disclaimers.html. 1 Overview 1.1 Scope Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between medication monitoring devices and managers e.g., cell phones, personal computers, personal health appliances, set top boxes in a manner that enables plug-and-play interoperability. It leverages 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 ambiguity in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for medication monitors. In this context, medication monitors are defined as devices that have the ability to determine and communicate to a manager measures of a user’s adherence to a medication regime. ISO/IEEE 11073-104722012E ISO 2012 – All rights reserved IEEE 2012 – All rights reserved 1 Health informatics Personal health device communication Part 10472 Device specialization Medication monitor BS EN I

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