1、BS EN ISO 11073-10419:2016Health informatics Personalhealth device communicationPart 10419: Device specialization Insulinpump (ISO/IEEE 11073-10419:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 11073-10419:2016 BRITISH STANDARDNational forewordThis B
2、ritish Standard is the UK implementation of EN ISO 11073-10419:2016.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 publication does not purp
3、ort 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 92556 6 ICS 35.240.80 Compliance with a British Standard cannot confer immunity from legal obliga
4、tions.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2016.Amendments/corrigenda issued since publicationDate Text affected2“ EN ISO 11073-10419 trsx uwtvrzr srvs ssryusrvstrsx srvs ssryusrvstrsx srvs ssryusrvstrsx tz trsx 22 “ o CEN-
5、CENELECManagement Centre: Avenue Marnix 17, B-1000 Brussels 9trsx ssryusrvstrsxBS EN ISO 11073-10419:2016EN ISO 11073-10419:2016 (E) 3 European foreword This document (EN ISO 11073-10419:2016) has been prepared by Technical Committee ISO/TC 215 “Health informatics” in collaboration with Technical Co
6、mmittee 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 December 2016, and conflicting national standards shall be withdraw
7、n 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 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, t
8、he 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 of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latv
9、ia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO/IEEE 11073-10419:2016 has been approved by CEN as EN ISO 11073-10419:2016 without any modification. BS E
10、N ISO 11073-10419:2016ISO/IEEE 11073-10419:2016(E) ISO 2016 All rights reserved IEEE 2015 All rights reserved iiiForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards
11、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 pa
12、rt 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)
13、 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
14、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
15、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
16、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
17、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
18、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 respo
19、nsibility. Further information may be obtained from ISO or the IEEE Standards Association.ISO/IEEE 11073-10419 was prepared by the IEEE 11073 Standards Comittee of the IEEE Engineering in Medicine and Biology Society (as IEEE Std 11073-10419-2015). It was adopted by Technical Committee ISO/TC 215, H
20、ealth 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
21、 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 10102: (Point-of-care medi
22、cal device communication) 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 Part 10404: Device specialization Pulse oximeter Part 10406: Devi
23、ce specialization Basic electrocardiograph (ECG) (1- to 3-lead ECG) BS EN ISO 11073-10419:2016ISO/IEEE 11073-10419:2016(E) iv ISO 2016 All rights reserved IEEE 2015 All rights reserved Part 10407: Device specialization Blood pressure monitor Part 10408: Device specialization Thermometer Part 10415:
24、Device specialization Weighing scale Part 10417: Device 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) P
25、art 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 med
26、ical 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
27、) Analytical instruments Point-of-care test Part 91064: (Standard communication protocol) Computer-assisted electrocardiography Part 92001: (Medical waveform format) Encoding rules Technical SpecificationBS EN ISO 11073-10419:2016Abstract: Within the context of the ISO/IEEE 11073 family of standards
28、 for device communication, a normative definition of communication between personal telehealth insulin pump devices and compute engines (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability, is establishedin this st
29、andard. Appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards are leveraged. The use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base framewo
30、rks in favor of interoperability are specified. A common core of communication functionality for personal telehealth insulin pump devices is defined. Keywords: IEEE 11073-10419, insulin pump, medical device communication, personal health devicesxThe Institute of Electrical and Electronics Engineers,
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