BS EN ISO 11073-10404-2011 Health informatics Personal health device communication Device specialization Pulse oximeter《健康信息学 个人健康设备通信 专门化设备 脉冲光电血氧计》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 11073-10404:2011Health informatics Personalhealth device communicationPart 10404: Device specialization Pulseoximeter (ISO/IEEE 11073-10404:2010)BS EN ISO 11073-10404:2

2、011 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 11073-10404:2011. It is identical to ISO/IEEE 11073-10404:2010.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

3、 list 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 69161 4 ICS 35.240.80Compliance with a

4、British 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 I

5、SO 11073-10404 March 2011 ICS 35.240.80 English Version Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter (ISO/IEEE 11073-10404:2010) Informatique de sant - Communication entre dispositifs de sant personnels - Partie 10404: Spcialisation d

6、es disposititfs - Oxymtre de pouls (ISO/IEEE 11073-10404:2010) Medizinische Informatik - Kommunikation von Gerten fr die persnliche Gesundheit - Teil 10404: Gertespezifikation - Pulsoximeter (ISO/IEEE 11073-10404:2010) This European Standard was approved by CEN on 23 April 2010. CEN members are boun

7、d to comply 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 CE

8、N-CENELEC 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 h

9、as the 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,

10、Poland, 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

11、by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11073-10404:2011: EBS EN ISO 11073-10404:2011 EN ISO 11073-10404:2011 (E) 3 Foreword The text of ISO/IEEE 11073-10404:2010 has been prepared by Technical Committee ISO/TC 215 “Health informatics“ of the International Organizat

12、ion for Standardization (ISO) and has been taken over as EN ISO 11073-10404:2011 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 e

13、ndorsement, at 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 f

14、or identifying 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, Fran

15、ce, Germany, 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 11073-10404:2010 has been approved by CEN as a E

16、N ISO 11073-10404:2011 without any modification. BS EN ISO 11073-10404:2011ISO/IEEE 11073-10404:2010(E) ISO 2010 All rights reserved IEEE 2010 All rights reserved iiiContents Page Foreword. v Introduction.vii 1. Overview. 1 1.1 Scope 1 1.2 Purpose. 1 1.3 Context. 2 2. Normative references 2 3. Defin

17、itions, acronyms, and abbreviations. 2 3.1 Definitions 2 3.2 Acronyms and abbreviations 3 4. Introduction to ISO/IEEE 11073 personal health devices. 3 4.1 General. 3 4.2 Introduction to IEEE 11073-20601 modeling constructs. 4 5. Pulse oximeter device concepts and modalities 4 5.1 General. 4 5.2 Devi

18、ce types. 5 5.3 General concepts 5 5.4 Collected data. 6 5.5 Derived data. 8 5.6 Stored data . 8 5.7 Device configurations 8 6. Pulse oximeter DIM 9 6.1 Overview 9 6.2 Class extensions . 9 6.3 Object instance diagram. 9 6.4 Types of configuration . 10 6.5 MDS object 11 6.6 Numeric objects . 14 6.7 R

19、eal-time sample array (RT-SA) objects . 24 6.8 Enumeration objects. 25 6.9 PM-store objects 29 6.10 Scanner objects 33 6.11 Class extension objects 37 6.12 Pulse oximeter information model extensibility rules 37 BS EN ISO 11073-10404:2011ISO/IEEE 11073-10404:2010(E) iv ISO 2010 All rights reserved I

20、EEE 2010 All rights reserved7. Pulse oximeter service model . 37 7.1 General. 37 7.2 Object access services 37 7.3 Object access EVENT REPORT services 40 8. Pulse oximeter communication model 41 8.1 Overview 41 8.2 Communications characteristics. 41 8.3 Association procedure 42 8.4 Configuring proce

21、dure . 43 8.5 Operating procedure. 45 8.6 Time synchronization. 46 9. Test associations . 46 9.1 Behavior with standard configuration 46 9.2 Behavior with extended configurations 46 10. Conformance. 46 10.1 Applicability. 46 10.2 Conformance specification. 47 10.3 Levels of conformance. 47 10.4 Impl

22、ementation conformance statements (ICSs) . 48 Annex A (informative) Bibliography 52 Annex B (normative) Additional ASN.1 definitions 53 Annex C (normative) Allocation of identifiers . 55 Annex D (informative) Message sequence examples . 57 Annex E (informative) PDU examples . 59 BS EN ISO 11073-1040

23、4:2011ISO/IEEE 11073-10404:2010(E) ISO 2010 All rights reserved IEEE 2010 All rights reserved vForeword 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 carri

24、ed 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 part in the work. I

25、SO 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) Standards Board.

26、 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 Institute and ser

27、ve 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 of technical comm

28、ittees 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 is called to the

29、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 for identifying e

30、ssential 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 Patent Statement

31、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 responsibility. Furthe

32、r information may be obtained from ISO or the IEEE Standards Association. ISO/IEEE 11073-10404 was prepared by the 11073 Committee of the Engineering in Medicine and Biology Society of the IEEE (as IEEE Std 11073-10404-2008). It was adopted by Technical Committee ISO/TC 215, Health informatics, in p

33、arallel 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 parties are responsible for the maintenance of this document. ISO/IEEE 11073 consists of the following parts

34、, 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 10201: Domain information model Part 10404: Device specialization Pulse oximeter Part 10407:

35、 Device specialization Blood pressure monitor BS EN ISO 11073-10404:2011ISO/IEEE 11073-10404:2010(E) vi ISO 2010 All rights reserved IEEE 2010 All rights reserved Part 10408: (Point-of-care medical device communication) Device specialization Thermometer Part 10415: (Point-of-care medical device comm

36、unication) Device specialization Weighing scale Part 10417: Device specialization Glucose meter Part 10471: (Point-of-care medical device communication) Device specialization Independant living activity hub Part 20101: (Point-of-care medical device communication) Application profiles Base standard P

37、art 20601: (Point-of-care medical device communication) 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 BS EN ISO 11

38、073-10404:2011ISO/IEEE 11073-10404:2010(E) ISO 2010 All rights reserved IEEE 2010 All rights reserved viiIntroduction ISO/IEEE 11073 standards enable communication between medical devices and external computer systems. This standard uses the optimized framework created in IEEE Std 11073-20601-2008aa

39、nd describes a specific, interoperable communication approach for pulse oximeters. 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.

40、 BS EN ISO 11073-10404:2011BS EN ISO 11073-10404:2011INTERNATIONAL STANDARD ISO/IEEE 11073-10404:2010(E) ISO 2010 All rights reserved IEEE 2010 All rights reserved 1Health informaticsPersonal health device communication Part 10404: Device specializationPulse oximeter IMPORTANT NOTICE: This standard

41、is not intended to ensure 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 IEEE document is made available for us

42、e 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 can also be obtained on request from IE

43、EE 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 telehealth pulse oximeter devices and compute

44、 engines (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play (PnP) interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards,

45、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 personal telehealth pulse oximeters.

46、 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, set top boxes). Interoperability is key to growing

47、the potential market for these devices and enabling people to be better informed participants in the management of their health. BS EN ISO 11073-10404:2011ISO/IEEE 11073-10404:2010(E) 2 ISO 2010 All rights reserved IEEE 2010 All rights reserved1.3 Context See IEEE Std 11073-20601-20081for an overvie

48、w of the environment within which this standard is written. This standard, IEEE Std 11073-10404-2008, defines the device specialization for the pulse oximeter, being a specific agent type, and provides a description of the device concepts, its capabilities, and its implementation according to this s

49、tandard. This standard is based on IEEE Std 11073-20601-2008, which in turn draws information from both ISO/IEEE 11073-10201:2004 B32and ISO/IEEE 11073-20101:2004 B4. The medical device encoding rules (MDER) used within this standard are fully described in IEEE Std 11073-20601-2008. 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 t