1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 11073-10407:2011Health informatics Personalhealth device communicationPart 10407: Device specialization Blood pressure monitor (ISO/IEEE11073-10407:2010)BS EN ISO 11073
2、-10407:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 11073-10407:2011. It is identical to ISO/IEEE 11073-10407:2010.The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics.A list of organizations represe
3、nted 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 69162 1 ICS 35.240.80 Compliance with a British Standard cannot confe
4、r immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2011.Amendments issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11073-10407 March 2011 ICS
5、35.240.80 English Version Health informatics - Personal health device communication - Part 10407: Device specialization - Blood pressure monitor (ISO/IEEE 11073-10407:2010) Informatique de sant - Communication entre dispositifs de sant personnels - Partie 10407: Spcialisation des dispositifs - Monit
6、eur de pression sanguine (ISO/IEEE 11073-10407:2010) Medizinische Informatik - Kommunikation von Gerten fr die persnliche Gesundheit - Teil 10407: Gertespezifikation - Blutdruckmonitor (ISO/IEEE 11073-10407:2010) This European Standard was approved by CEN on 23 April 2010. CEN members are bound to c
7、omply 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-CENE
8、LEC 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
9、 same status 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
10、, Portugal, 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
11、 means reserved worldwide for CEN national Members. Ref. No. EN ISO 11073-10407:2011: EBS EN ISO 11073-10407:2011ISO/IEEE 11073-10407:2010(E) ISO 2010 All rights reserved IEEE 2010 All rights reserved vForeword ISO (the International Organization for Standardization) is a worldwide federation of nat
12、ional 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. Interna
13、tional 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 Socie
14、ties 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
15、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, o
16、r 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 S
17、tandard 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 existe
18、nce 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
19、 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 a
20、ny 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 11073-10407 was prepared by the 11073 Committee of the Engineering in Medicine and Biology Society of the IEEE
21、 (as IEEE Std 11073-10407-2008). 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 agreement between ISO and IEEE. Both p
22、arties 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-care medical device communication) Nom
23、enclature Part 10201: Domain information model Part 10404: Device specialization Pulse oximeter BS EN ISO 11073-10407:2011ISO/IEEE 11073-10407:2010(E) vi ISO 2010 All rights reserved IEEE 2010 All rights reserved Part 10407: Device specialization Blood pressure monitor Part 10408: (Point-of-care med
24、ical 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) Device Specialization Independant living
25、 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 communication) Transport profile Cable connecte
26、d Part 30300: (Point-of-care medical device communication) Transport profile Infrared wireless BS EN ISO 11073-10407:2011ISO/IEEE 11073-10407:2010(E) ISO 2010 All rights reserved IEEE 2010 All rights reserved viiIntroduction ISO/IEEE 11073 standards enable communication between medical devices and e
27、xternal computer systems. This document uses the optimized framework created in IEEE Std 11073-20601aand describes a specific, interoperable communication approach for blood pressure monitors. These standards align with and draw on the existing clinically focused standards to provide support for com
28、munication of data from personal health devices. aInformation on references can be found in Clause 2. BS EN ISO 11073-10407:2011BS EN ISO 11073-10407:2011INTERNATIONAL STANDARD ISO/IEEE 11073-10407:2010(E) ISO 2010 All rights reserved IEEE 2010 All rights reserved 1Health informatics Personal health
29、 device communication Part 10407: Device specialization Blood pressure monitor IMPORTANT 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, securi
30、ty, 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”
31、 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 est
32、ablishes a normative definition of communication between personal telehealth blood pressure monitor 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 por
33、tions of existing standards including ISO/IEEE 11073 terminology, information models, 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 interope
34、rability. This standard defines a common core of communication functionality for personal telehealth blood pressure monitors. 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 en
35、gines (e.g., cell phones, personal computers, personal health appliances, and set top boxes). Interoperability 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. 1.3 Context See IEEE Std 11073-2060
36、1TMfor an overview of the environment within which this standard is written. This document, IEEE Std 11073-10407, defines the device specialization for the blood pressure monitor, being a specific agent type, and provides a description of the device concepts, its capabilities, and its implementation
37、 according to this standard. BS EN ISO 11073-10407:2011ISO/IEEE 11073-10407:2010(E) 2 ISO 2010 All rights reserved IEEE 2010 All rights reservedThis standard is based on IEEE Std 11073-20601, which in turn draws information from both ISO/IEEE 11073-10201:2004 B51and ISO/IEEE 11073-20101:2004 B6. The
38、 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 B4 and adds new nomenclature codes for the purposes of this standard. Between this standard
39、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 collection of device specialization standards that utilize IEEE Std 11073-20601, where zz can be any number from 01 to 99, inclusive.22. Nor
40、mative references The following referenced documents are indispensable for the application of this document (i.e., they must be understood and used, so that each referenced document is cited in text and its relationship to this document is explained). For dated references, only the edition cited app
41、lies. For undated references, the latest edition of the referenced document (including any amendments or corrigenda) applies. IEEE Std 11073-20601TM-2008, Health informaticsPersonal health device communicationPart 20601: Application profileOptimized Exchange Protocol.3,4See Annex A for all informati
42、ve material referenced by this standard. 3. Definitions, acronyms, and abbreviations 3.1 Definitions For the purposes of this standard, the following terms and definitions apply. The Authoritative Dictionary of IEEE Standards Terms B2 should be referenced for terms not defined in this clause. 3.1.1
43、agent: A node that collects and transmits personal health data to an associated manager. 3.1.2 blood pressure: The cyclic pressure (i.e., amount of force applied over a given area divided by the size of this area) exerted by blood against the walls of blood vessels. Noninvasive blood pressure measur
44、ement is typically performed at the brachial artery (arm) or radial artery (wrist). There are usually two numbers reported for blood pressure, and with the home monitors, a third number is typically available. The first, and higher, number is produced by the contraction of the heart (See: systolic p
45、ressure). The second, lower number is produced by relaxation of the heart (See: diastolic pressure). The third number is the mean arterial pressure. 3.1.3 class: In object-oriented modeling, a class describes the attributes, methods, and events that objects instantiated from the class utilize. 3.1.4
46、 compute engine: See: manager. 3.1.5 device: A term used to refer to a physical apparatus implementing either an agent or a manager role. 3.1.6 diastolic pressure: This is minimum pressure achieved during the cardiac cycle. It is typically the second and the lower of the readings given as the blood
47、pressure. 1The numbers in brackets correspond to those of the bibliography in Annex A. 2Notes in text, tables, and figures are given for information only and do not contain requirements needed to implement the standard. 3The IEEE standards or products referred to in this clause are trademarks of the
48、 Institute of Electrical and Electronics Engineers, Inc. 4IEEE publications are available from the Institute of Electrical and Electronics Engineers, 445 Hoes Lane, Piscataway, NJ 08854, USA (http:/standards.ieee.org/). BS EN ISO 11073-10407:2011ISO/IEEE 11073-10407:2010(E) ISO 2010 All rights reser
49、ved IEEE 2010 All rights reserved 33.1.7 handle: An unsigned 16-bit number that is locally unique and identifies one of the object instances within an agent. 3.1.8 manager: A node receiving data from one or more agent systems. Some examples of managers include a cellular phone, health appliance, set top box, or a computer system. 3.1.9 mean arterial pressure: value of the integral of one cycle of the blood pressure curve divided by the period between successive heart b
