1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 11073-10408:2011Health informatics Personalhealth device communicationPart 10408: Device specialization Thermometer (ISO/IEEE 11073-10408:2010)BS EN ISO 11073-10408:201
2、1 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 11073-10408:2011. It is identical to ISO/IEEE 11073-10408:2010.The UK participation in its preparation was entrusted to T e c h n i c a l C o m m i t t e e I S T / 3 5 , H e a l t h i n f o r m a t i c s .A l
3、ist 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. BSI 2011 ISBN 978 0 580 68052 6 ICS 35.240.80Compliance with a Br
4、itish Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2011.Amendments issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO
5、 11073-10408 March 2011 ICS 35.240.80 English Version Health informatics - Personal health device communication - Part 10408: Device specialization - Thermometer (ISO/IEEE 11073-10408:2010) Informatique de sant - Communication entre dispositifs de sant personnels - Partie 10408: Spcialisation des di
6、spositifs - Thermomtre (ISO/IEEE 11073-10408:2010) Medizinische Informatik - Kommunikation von Gerten fr die persnliche Gesundheit - Teil 10408: Gertespezifikation - Thermometer (ISO/IEEE 11073-10408:2010) This European Standard was approved by CEN on 23 April 2010. CEN members are bound to comply w
7、ith 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 Man
8、agement 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 s
9、tatus as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portu
10、gal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means
11、reserved worldwide for CEN national Members. Ref. No. EN ISO 11073-10408:2011: EBS EN ISO 11073-10408:2011 EN ISO 11073-10408:2011 (E) 3 Foreword The text of ISO/IEEE 11073-10408:2010 has been prepared by Technical Committee ISO/TC 215 “Health informatics” of the International Organization for Stand
12、ardization (ISO) and has been taken over as EN ISO 11073-10408:2011 by 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, a
13、t the latest by September 2011, and conflicting national standards shall be withdrawn at the latest by September 2011. 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 identifyin
14、g any or all such patent rights. 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, Estonia, Finland, France, Germany,
15、Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO/IEEE 11073-10408:2010 has been approved by CEN as a EN ISO 11073-1
16、0408:2011 without any modification. BS EN ISO 11073-10408:2011ISO/IEEE 11073-10408:2010(E) ISO 2010 All rights reserved IEEE 2010 All rights reserved iiiContents Page Forewordv Introductionvii 1. Overview1 1.1 Scope.1 1.2 Purpose1 1.3 Context2 2. Normative references .2 3. Definitions, acronyms, and
17、 abbreviations2 3.1 Definitions.2 3.2 Acronyms and abbreviations.3 4. Introduction to ISO/IEEE 11073 personal health devices3 4.1 General3 4.2 Introduction to IEEE 11073-20601 modeling constructs4 5. Thermometer device concepts and modalities .4 5.1 General4 5.2 Body temperature5 6. Thermometer doma
18、in information model 5 6.1 Overview.5 6.2 Class extensions 5 6.3 Object instance diagram5 6.4 Types of configuration 6 6.5 Medical device system object .7 6.6 Numeric objects 10 6.7 Real-time sample array objects .12 6.8 Enumeration objects12 6.9 PM store objects12 6.10 Scanner objects .12 6.11 Clas
19、s extension objects .12 6.12 Thermometer information model extensibility rules.13 7. Thermometer service model.13 7.1 General13 7.2 Object access services.13 7.3 Object access event report services.14 8. Thermometer communication model .15 8.1 Overview.15 8.2 Communications characteristics15 8.3 Ass
20、ociation procedure.15 8.4 Configuring procedure 17 8.5 Operating procedure18 8.6 Time synchronization19 BS EN ISO 11073-10408:2011ISO/IEEE 11073-10408:2010(E) iv ISO 2010 All rights reserved IEEE 2010 All rights reserved9. Test associations 19 9.1 Behavior with standard configuration .19 9.2 Behavio
21、r with extended configurations.19 10. Conformance19 10.1 Applicability19 10.2 Conformance specification20 10.3 Levels of conformance20 10.4 Implementation conformance statements21 Annex A (informative) Bibliography26 Annex B (normative) Any additional ASN.1 definitions.27 Annex C (normative) Allocat
22、ion of identifiers 28 Annex D (informative) Message sequence examples 29 Annex E (informative) Protocol data unit examples31 BS EN ISO 11073-10408:2011ISO/IEEE 11073-10408:2010(E) ISO 2010 All rights reserved IEEE 2010 All rights reserved vForeword ISO (the International Organization for Standardiza
23、tion) 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
24、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 documen
25、ts 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 volu
26、nteers 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 do
27、es 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 vot
28、ing. 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 positi
29、on 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 claim
30、s 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 t
31、hat 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 11073-10408 was prepared by the 11073 Committee of the Engineering in Me
32、dicine and Biology Society of the IEEE (as IEEE Std 11073-10408-2008). 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
33、agreement between ISO and IEEE. Both parties are responsible for the maintenance of this document. 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-
34、care medical device communication) Nomenclature Part 10201: Domain information model Part 10404: Device specialization Pulse oximeter BS EN ISO 11073-10408:2011ISO/IEEE 11073-10408:2010(E) vi ISO 2010 All rights reserved IEEE 2010 All rights reserved Part 10407: Device specialization Blood pressure
35、monitor Part 10408: (Point-of-care medical device communication) Device specialization Thermometer Part 10415: (Point-of-care medical device communication) Device specialization Weighing scale Part 10417: Device specialization Glucose meter Part 10471: (Point-of-care medical device communication) De
36、vice specialization Independant living activity hub Part 20101: (Point-of-care medical device communication) Application profiles Base standard Part 20601: (Point-of-care medical device communication) Application profile Optimized exchange protocol Part 30200: (Point-of-care medical device communica
37、tion) Transport profile Cable connected Part 30300: (Point-of-care medical device communication) Transport profile Infrared wireless BS EN ISO 11073-10408:2011ISO/IEEE 11073-10408:2010(E) ISO 2010 All rights reserved IEEE 2010 All rights reserved viiIntroduction ISO/IEEE 11073 standards enable commu
38、nication between medical devices and external computer systems. This document uses the optimized framework created in IEEE Std 11073-20601aand describes a specific, interoperable communication approach for weighing scales. These standards align with, and draw upon, the existing clinically focused st
39、andards to provide support for communication of data from clinical or personal health devices. aFor information on references, see Clause 2. BS EN ISO 11073-10408:2011BS EN ISO 11073-10408:2011INTERNATIONAL STANDARD ISO/IEEE 11073-10408:2010(E) ISO 2010 All rights reserved IEEE 2010 All rights reser
40、ved 1IMPORTANT NOTICE: This standard is not intended to assure 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 I
41、EEE 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 ca
42、n 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 communication between personal teleheal
43、th thermometer devices and compute engines (e.g., cell phones, personal computers, personal health 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, information models
44、, application profile standards, and transport standards. 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 per
45、sonal telehealth thermometers. 1.2 Purpose This standard addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and compute engines (e.g., cell phones, personal computers, personal health appliances, and set top boxes). I
46、nteroperability is the key to growing the potential market for these devices and to enabling people to be better informed participants in the management of their health. Health informatics Personal health device communication Part 10408: Device specialization Thermometer BS EN ISO 11073-10408:2011IS
47、O/IEEE 11073-10408:2010(E) 2 ISO 2010 All rights reserved IEEE 2010 All rights reserved1.3 Context See IEEE Std 11073-20601TMfor an overview of the environment within which this standard is written. This document, IEEE Std 11073-10408, defines the device specialization for the thermometer, being a s
48、pecific agent type, and it provides a description of the device concepts, its capabilities, and its implementation according to this standard. This standard is based on IEEE Std 11073-20601, which in turn draws information from both ISO/IEEE 11073-10201:2004 B31and ISO/IEEE 11073-20101:2004 B4. The
49、medical device encoding rules (MDERs) used within this standard are fully described in IEEE Std 11073-20601. This standard reproduces relevant portions of the nomenclature found in ISO/IEEE 11073-10101:2004 B2 and adds new nomenclature codes for the purposes of this standard. Between this standard and IEEE Std 11073-20601, all required nomenclature codes for implementation are documented. NOTEIn this standard, IEEE Std 11073-104zz is used to refer to the
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