BS EN ISO 11073-10406-2013 Health informatics Personal health device communication Device specialization Basic electrocardiograph (ECG) (1- to 3-lead ECG)《健康信息学 个人健康装置通信 装置专门化 基本心电.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 11073-10406:2012Health informatics Personal health device communicationPart 10406: Device specialization Basic electrocardiograph (ECG) (1- to 3-lead ECG) BS EN ISO 110

2、73-10406:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 11073-10406:2012. It is identical to ISO/IEEE 11073-10406:2012.The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics.A list of organizations repre

3、sented 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 2012ISBN 978 0 5

4、80 79444 5 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 31 January 2013.Amendments issued since publicationDate T e x t a f f e c t e dEUROPEAN

5、STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11073-10406 January 2013 ICS 35.240.80 English Version Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012) Informatique de sant -

6、Communication entre dispositifs de sant personnels - Partie 10406: Spcialisation des dispositifs - lectrocardiographe de base (ECG) (ECG 1 3) (ISO/IEEE 11073-10406:2012) Medizinische Informatik - Kommunikation von Gerten fr die persnliche Gesundheit - Teil 10406: Gertespezifikation - Basiselektrokar

7、diogramm (EKG) (EKG mit 1 bis 3 Ableitungen) (ISO/IEEE 11073-10406:2012) This European Standard was approved by CEN on 30 November 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

8、 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

9、 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, Czec

10、h 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. EU

11、ROPEAN 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 11073-10406:2012: EBS

12、EN ISO 11073-10406:2012EN ISO 11073-10406:2012 (E) 3 Foreword This document (EN ISO 11073-10406:2012) 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 Europ

13、ean Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2013, and conflicting national standards shall be withdrawn at the latest by June 2013. Attention is drawn to the possibility that some of the elements o

14、f 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

15、 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, Sloveni

16、a, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO/IEEE 11073-10406:2012 has been approved by CEN as a EN ISO 11073-10406:2012 without any modification. ISO/IEEE 11073-10406:2012(E) IEEE 2012 All rights reserved iiiContents 1. Overview 1 1.1 Scope . 1 1.

17、2 Purpose 1 1.3 Context 2 2. Normative references 2 3. Definitions, acronyms, and abbreviations 3 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 ISO/IEEE 11073-20601 modeling constructs. 4 4.3 Compl

18、iance with other standards. 5 5. Basic ECG (1- to 3-lead ECG) device concepts and modalities. 6 5.1 General 6 5.2 ECG waveform 6 5.3 R-R interval . 6 5.4 Heart rate . 7 6. Basic ECG (1- to 3-lead ECG) domain information model 7 6.1 Overview . 7 6.2 Class extensions. 7 6.3 Object instance diagram 7 6

19、.4 Types of configuration. 8 6.5 Profiles. 9 6.6 Medical device system object 11 6.7 Numeric objects. 15 6.8 Real-time sample array objects 18 6.9 Enumeration objects 19 6.10 PM-store objects 22 6.11 Scanner objects 29 6.12 Class extension objects 32 6.13 Basic ECG (1- to 3-lead ECG) information mod

20、el extensibility rules 32 7. Basic ECG (1- to 3-lead ECG) service model 32 7.1 General 32 7.2 Object access services 32 7.3 Object access event report services . 35 8. Basic ECG (1- to 3-lead ECG) communication model. 35 8.1 Overview . 35 8.2 Communications characteristics 36 8.3 Association procedu

21、re . 36 8.4 Configuring procedure. 38 8.5 Operating procedure 39 8.6 Time synchronization 40 BS EN ISO 11073-10406:2012ISO/IEEE 11073-10406:2012(E) iv IEEE 2012 All rights reserved9. Test associations. 40 9.1 Behavior with standard configuration 40 9.2 Behavior with extended configurations . 41 10.

22、Conformance 41 10.1 Applicability 41 10.2 Conformance specification 41 10.3 Levels of conformance 42 10.4 Implementation conformance statements 42 Annex A (informative) Bibliography . 47 Annex B (normative) Any additional ASN.1 definitions . 48 Annex C (normative) Allocation of identifiers. 49 Annex

23、 D (informative) Message sequence examples. 50 Annex E (informative) Protocol data unit examples 52 BS EN ISO 11073-10406:2012ISO/IEEE 11073-10406:2012(E) IEEE 2012 All rights reserved vForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards

24、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 organizat

25、ions, 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 Sta

26、ndards 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

27、 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 acc

28、uracy of any of the information or the soundness of any judgments 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

29、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 res

30、pect 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 whe

31、ther 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

32、 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 11073-10406 was prepared by the IEEE 11073 Standards Comittee of the IEEE Engineering in Med

33、icine and Biology Society (as IEEE Std 11073-10406-2011). 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 bet

34、ween 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 sub

35、title): 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 10406: Device specialization Basic electrocardiograph (ECG) (1- to 3-lead ECG) Part 10

36、407: Device specialization Blood pressure monitor Part 10408: Device specialization Thermometer BS EN ISO 11073-10406:2012ISO/IEEE 11073-10406:2012(E) vi IEEE 2012 All rights reserved Part 10415: Device specialization Weighing scale Part 10417: Device specialization Glucose meter Part 10420: Device

37、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) Applicat

38、ion 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 me

39、dical 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 rules Te

40、chnical Specification BS EN ISO 11073-10406:2012ISO/IEEE 11073-10406:2012(E) IEEE 2012 All rights reserved viiIntroduction This introduction is not part of IEEE Std 11073-10406-2011, Health informaticsPersonal health device communicationPart 10406: Device specializationBasic electrocardiograph (ECG)

41、 (1- to 3-lead ECG). Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between personal basic electrocardiograph (ECG) devices and managers (e.g., cell phones, personal computers, personal heal

42、th appliances, and 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 IEEE 11073-20601 information models. It specifies the use of specific term codes, formats, and behaviors in tele

43、health environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth basic ECG (1- to 3-lead ECG) devices. Monitoring ECG devices are distinguished from diagnostic ECG equipment with re

44、spect to including support for wearable ECG devices, limiting the number of leads supported by the equipment to three, and not requiring the capability of annotating or analyzing the detected electrical activity to determine known cardiac phenomena. This standard is consistent with the base framewor

45、k and allows multifunction implementations by following multiple device specializations (e.g., ECG and respiration rate). BS EN ISO 11073-10406:2012IMPORTANT NOTICE: This standard is not intended to ensure safety, security, health, or environmental protection. Implementers of the standard are respon

46、sible 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 m

47、ay 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 stand

48、ards for device communication, this standard establishes a normative definition of the communication between personal basic electrocardiograph (ECG) devices and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play inte

49、roperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology and IEEE Std 11073-20601 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 common core of communication functionality for personal telehealth basic ECG (1- to 3-lead ECG) devices. Monitoring ECG devices a