1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 11073-10421:2012Health informatics Personalhealth device communicationPart 10421: Device specialization Peakexpiratory flow monitor (peak flow) (ISO11073-10421:2012)BS
2、EN ISO 11073-10421:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO11073-10421:2012.The UK participation in its preparation was entrusted to TechnicalCommittee IST/35, Health informatics.A list of organizations represented on this committee can beobtaine
3、d on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2012. Published by BSI StandardsLimited 2012ISBN 978 0 580 79086 7ICS 35.240.80Compliance with a B
4、ritish Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 November 2012.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11073-1
5、0421 November 2012 ICS 35.240.80 English Version Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow) (ISO 11073-10421:2012) Informatique de sant - Communication entre dispositifs de sant personnels - Partie 10421: S
6、pcialisation des dispositifs - Moniteur de surveillance du dbit expiratoire de pointe (dbit de pointe) (ISO 11073-10421:2012) 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 gi
7、ving 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 of
8、ficial 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
9、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
10、, 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 nati
11、onal Members. Ref. No. EN ISO 11073-10421:2012: EBS EN ISO 11073-10421:2012EN ISO 11073-10421:2012 (E) 3 Foreword This document (EN ISO 11073-10421:2012) has been prepared by Technical Committee ISO/TC 215 “Health informatics“ in collaboration with Technical Committee CEN/TC 251 “Health informatics”
12、 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 dr
13、awn 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 follow
14、ing 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, No
15、rway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11073-10421:2012 has been approved by CEN as a EN ISO 11073-10421:2012 without any modification. BS EN ISO 11073-10421:2012ISO/IEEE 11073-10421:2012(E) I
16、SO 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 heal
17、th devices 4 4.1 General 4 4.2 Introduction to ISO/IEEE 11073-20601 modeling constructs . 4 5. Peak expiratory flow monitor device concepts and modalities. 5 5.1 General 5 5.2 PEF 5 6. Peak expiratory flow monitor domain information model . 7 6.1 Overview . 7 6.2 Class extensions . 7 6.3 Object inst
18、ance diagram 7 6.4 Types of configuration . 9 6.5 Medical device system object 9 6.6 Numeric objects . 13 6.7 Real-time sample array objects 20 6.8 Enumeration objects 20 6.9 PM-store objects 22 6.10 Scanner objects 22 6.11 Class extension objects 22 6.12 Peak expiratory flow monitor information mod
19、el extensibility rules 22 7. Peak expiratory flow monitor service model 22 7.1 General 22 7.2 Object access services 22 7.3 Object access event report services . 23 BS EN ISO 11073-10421:2012ISO/IEEE 11073-10421:2012(E) iv ISO 2012 All rights reserved IEEE 2012 All rights reserved8. Peak expiratory
20、flow monitor communication model 24 8.1 Overview . 24 8.2 Communications characteristics 24 8.3 Association procedure . 24 8.4 Configuring procedure . 26 8.5 Operating procedure 28 8.6 Time synchronization 29 9. Test associations . 29 9.1 Behavior with standard configuration 29 9.2 Behavior with ext
21、ended configurations . 30 10. Conformance 30 10.1 Applicability 30 10.2 Conformance specification 30 10.3 Levels of conformance 30 10.4 Implementation conformance statements 31 Annex A (informative) Bibliography . 36 Annex B (normative) Any additional ASN.1 definitions . 37 Annex C (normative) Alloc
22、ation of identifiers . 38 Annex D (informative) Message sequence examples . 39 Annex E (informative) Protocol data unit examples 41 Annex F (informative) IEEE list of participants 52 BS EN ISO 11073-10421:2012ISO/IEEE 11073-10421:2012(E) ISO 2012 All rights reserved IEEE 2012 All rights reserved vFo
23、reword 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 tec
24、hnical 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 o
25、f 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 America
26、n 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
27、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 techni
28、cal 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
29、 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 i
30、nto 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-disc
31、riminatory. 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 11073-10421 wa
32、s prepared by the IEEE 11073 Standards Comittee of the IEEE Engineering in Medicine and Biology Society (as IEEE Std 11073-10421-2010). 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” defin
33、ed 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 Pe
34、rsonal 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: D
35、evice specialization Blood pressure monitor Part 10408: Device specialization Thermometer Part 10415: Device specialization Weighing scale BS EN ISO 11073-10421:2012ISO/IEEE 11073-10421:2012(E) vi ISO 2012 All rights reserved IEEE 2012 All rights reserved Part 10417: Device specialization Glucose me
36、ter 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
37、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 3
38、0400: (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 fo
39、rmat) Encoding rules BS EN ISO 11073-10421:2012ISO/IEEE 11073-10421:2012(E) ISO 2012 All rights reserved IEEE 2012 All rights reserved viiIntroduction This introduction is not part of IEEE Std 11073-10421-2010, Health informaticsPersonal health device communicationPart 10421: Device specializationPe
40、ak expiratory flow monitor (peak flow). ISO/IEEE 11073 standards enable communication between medical devices and external computer systems. This document uses the optimized framework created in IEEE Std 11073-20601-2008aand describes a specific, interoperable communication approach for weighing sca
41、les. These standards align with, and draw upon, the existing clinically focused standards to provide support for communication of data from clinical or personal health devices aFor information on references, see Clause 2. BS EN ISO 11073-10421:2012BS EN ISO 11073-10421:2012IMPORTANT NOTICE: This sta
42、ndard is not intended to ensure safety, security, health, or environmental protection. 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 im
43、portant 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
44、 http:/standards.ieee.org/IPR/disclaimers.html. 1 Overview 1.1 Scope The scope of this standard is to establish a normative definition of communication between personal telehealth peak flow monitoring devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, a
45、nd set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and
46、behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of functionality of a peak-flow monitoring device. The use case is restricted to personal respiratory monitoring and therefore does not include hospital-b
47、ased spirometry. Continuous and high-acuity monitoring (e.g., for emergency response) are outside the scope of the use case. In the context of personal health devices, a peak flow meter is a device used to measure the respiratory function of those managing respiratory conditions such as asthma and c
48、hronic obstructive pulmonary disease. The ability to identify declining respiratory status prior to the need for acute intervention improves the quality of life for the individual while reducing the overall costs of care. Respiratory status data are collected by a personal respiratory monitoring dev
49、ice and forwarded to a central data repository for review and action by a health care provider. The data are episodic in nature and are forwarded at designated intervals or when the person is symptomatic. ISO/IEEE 11073-10421:2012(E) ISO 2012 All rights reserved IEEE 2012 All rights reserved 1Health informatics Personal health device communication Part 10421: Device specialization Peak expiratory flow monitor (peak flow) ISO/IEEE 11073-10421:2012(E
