1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 11073-20601:2011Health informatics Personal health device communicationPart 20601: Application profile Optimized exchange protocol (ISO/IEEE 11073-20601:2010)Copyright
2、European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11073-20601:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 11073-20601:2011. It is
3、 identical to ISO/IEEE 11073-20601:2010.The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the neces
4、sary provisions of a contract. Users are responsible for its correct application. BSI 2011 ISBN 978 0 580 68055 7 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 Strateg
5、y Committee on 30 April 2011.Amendments issued since publicationDate Text affectedCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NOR
6、M EN ISO 11073-20601 March 2011 ICS 35.240.80 English Version Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol (ISO/IEEE 11073-20601:2010) Informatique de sant - Communication entre dispositifs de sant personnels - Partie 20601
7、: Profil dapplication - Protocole dchange optimis (ISO/IEEE 11073-20601:2010) Medizinische Informatik - Kommunikation von Gerten fr die persnliche Gesundheit - Teil 20601: Anwendungsprofil - Optimiertes Datenbertragungsprotokoll (ISO/IEEE 11073-20601:2010) This European Standard was approved by CEN
8、on 23 April 2010. 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 standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards ma
9、y 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 in any other language made by translation under the responsibility of a CEN member into its own language and notified
10、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, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Lu
11、xembourg, Malta, Netherlands, Norway, 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 r
12、ights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11073-20601:2011: ECopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,
13、-BS EN ISO 11073-20601:2011 EN ISO 11073-20601:2011 (E) 3 Foreword The text of ISO/IEEE 11073-20601:2010 has been prepared by Technical Committee ISO/TC 215 “Health informatics” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 11073-20601:2011 by Technica
14、l 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, at the latest by September 2011, and conflicting national standards shall be wit
15、hdrawn 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 identifying any or all such patent rights. According to the CEN/CENELEC Internal Regulati
16、ons, 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, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
17、 Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO/IEEE 11073-20601:2010 has been approved by CEN as a EN ISO 11073-20601:2011 without any modification. Copyright European Committee for Standardiz
18、ation Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11073-20601:2011ISO/IEEE 11073-20601:2010(E) ISO 2010 All rights reserved IEEE 2010 All rights reserved iiiContents Page Foreword vi Introduction viii 1. Overview.
19、 1 1.1 Scope 1 1.2 Purpose. 1 1.3 Context. 2 2. Normative references 5 3. Definitions, acronyms, and abbreviations. 5 3.1 Definitions 5 3.2 Acronyms and abbreviations 5 4. Guiding principles. 6 5. Introduction to IEEE 11073 personal health devices 7 5.1 General. 7 5.2 Domain information model (DIM).
20、 8 5.3 Service model. 8 5.4 Communication model. 8 6. Personal health device DIM 8 6.1 General. 8 6.2 Nomenclature usage. 9 6.3 Personal health object class definitions 10 6.3.1 General . 10 6.3.2 MDS class 12 6.3.3 Metric class. 18 6.3.4 Numeric class . 23 6.3.5 RT-SA class 26 6.3.6 Enumeration cla
21、ss. 27 6.3.7 PM-store class 30 6.3.8 PM-segment class. 34 6.3.9 Scanner classes . 37 6.4 Information model extensibility rules 45 7. Personal health device service model . 45 7.1 General. 45 7.2 Association service 46 7.3 Object access services 46 7.4 Specific application of object access EVENT REPO
22、RT services for personal health devices 47 7.4.1 General . 47 7.4.2 Confirmed and unconfirmed event reports. 47 Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11073-20
23、601:2011ISO/IEEE 11073-20601:2010(E) iv ISO 2010 All rights reserved IEEE 2010 All rights reserved7.4.3 Configuration event report . 47 7.4.4 Agent- and manager-initiated measurement data transmission 49 7.4.5 Variable, fixed, and grouped format event reports . 50 7.4.6 Single-person and multiple-pe
24、rson event reports . 50 7.4.7 Temporarily stored measurements 51 8. Communication model 52 8.1 General. 52 8.2 System context . 52 8.3 Communications characteristics. 53 8.3.1 General . 53 8.3.2 Common communications characteristics 55 8.3.3 Reliable communications characteristics 55 8.3.4 Best-effo
25、rt communications characteristics 56 8.4 State machines 56 8.4.1 Agent state machine . 56 8.4.2 Manager state machine . 59 8.4.3 Timeout variables . 60 8.5 Connected procedure 61 8.5.1 General . 61 8.5.2 Entry conditions . 61 8.5.3 Normal procedures . 61 8.5.4 Exit conditions 61 8.5.5 Error conditio
26、ns 62 8.6 Unassociated procedure . 62 8.6.1 General . 62 8.6.2 Entry conditions . 62 8.6.3 Normal procedures . 62 8.6.4 Exit conditions 62 8.6.5 Error conditions 62 8.7 Associating procedure 63 8.7.1 General . 63 8.7.2 Entry conditions . 63 8.7.3 Normal procedures . 63 8.7.4 Exit conditions 67 8.7.5
27、 Error conditions 67 8.7.6 Test association 67 8.8 Configuring procedure . 69 8.8.1 General . 69 8.8.2 Entry conditions . 69 8.8.3 Normal procedures . 69 8.8.4 Exit conditions 71 8.8.5 Error conditions 71 8.9 Operating procedure. 72 8.9.1 General . 72 8.9.2 Entry conditions . 72 8.9.3 Normal procedu
28、res . 72 8.9.4 Exit conditions 83 8.9.5 Error conditions 83 8.10 Disassociating procedure . 85 8.10.1 General . 85 8.10.2 Entry conditions . 85 8.10.3 Normal procedures . 85 8.10.4 Exit conditions 85 8.10.5 Error conditions 86 8.11 Message encoding 86 8.12 Time coordination 86 Copyright European Com
29、mittee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11073-20601:2011ISO/IEEE 11073-20601:2010(E) ISO 2010 All rights reserved IEEE 2010 All rights reserved v8.12.1 General . 86 8.12.2 Absolute t
30、ime . 86 8.12.3 Relative time. 88 8.12.4 High-resolution relative time 89 9. Conformance model 89 9.1 Applicability 89 9.2 Conformance specification. 90 9.3 Implementation conformance statements (ICSs) . 90 9.4 General conformance . 90 9.4.1 General ICS 91 9.4.2 Minimum requirements ICS . 92 9.4.3 S
31、ervice support ICS 93 9.5 Device additions/extensions ICS 94 9.5.1 General additions/extensions ICS. 94 9.5.2 Personal health device DIM object and class (POC) ICS. 95 9.5.3 POC attribute ICS. 95 9.5.4 POC behavior ICS 96 9.5.5 POC notification ICS 96 9.5.6 POC nomenclature ICS 97 Annex A (normative
32、) ASN.1 definitions 98 Annex B (informative) Scale and range specification example 130 Annex C (informative) The PM-store concept 132 Annex D (informative) Transport profile types 137 Annex E (normative) State tables . 140 Annex F (normative) Medical device encoding rules (MDER) 151 Annex G (informa
33、tive) Encoded data type definitions . 163 Annex H (informative) Examples. 182 Annex I (normative) Nomenclature codes 190 Annex J (informative) Derivation and modification history. 194 Annex K (informative) Bibliography 197 Copyright European Committee for Standardization Provided by IHS under licens
34、e with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11073-20601:2011ISO/IEEE 11073-20601:2010(E) vi ISO 2010 All rights reserved IEEE 2010 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation
35、 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 represented on that committee.
36、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 documents are developed within the IEE
37、E 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 volunteers representing varied view
38、points 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,
39、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 voting. Publication as an Internat
40、ional 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 respect to the
41、 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 whether any li
42、censing 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 validi
43、ty 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 11073-20601 was prepared by the 11073 Committee of the Engineering in Medicine and Biology Society of t
44、he IEEE (as IEEE Std 11073-20601-2008). 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.
45、 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-care medical device communicati
46、on) Nomenclature Part 10201: Domain information model Part 10404: Device specialization Pulse oximeter Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11073-20601:2011I
47、SO/IEEE 11073-20601:2010(E) ISO 2010 All rights reserved IEEE 2010 All rights reserved vii Part 10407: Device specialization Blood pressure monitor Part 10408: (Point-of-care medical device communication) Device specialization Thermometer Part 10415: (Point-of-care medical device communication) Devi
48、ce 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 Part 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
