1、BS EN ISO 11073-20601:2016Health informatics Personalhealth device communication Part 20601: Application profile Optimized exchange protocol (ISO/IEEE 11073-20601:2016, including Cor 1:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 11073-20601:2016 BR
2、ITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 11073-20601:2016. It is identical to ISO/IEEE 11073-20601:2016,incorporating corrigendum June 2016. It supersedes BS EN ISO 11073-20601:2011 which is withdrawn.The start and finish of text introduced or altered b
3、y corrigendum isindicated in the text by tags. Text altered by ISO/IEEE corrigendumJune 2016 is indicated in the text by .The UK participation in its preparation was entrusted to TechnicalCommittee IST/35, Health informatics.A list of organizations represented on this committee can be obtainedon req
4、uest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 88581 5ICS 35.240.80Compliance with a British
5、Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the StandardsPolicy and Strategy Committee on 31 October 2016.Amendments/corrigenda issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 110
6、73-20601 August 2016 ICS 35.240.80 Supersedes EN ISO 11073-20601:2011English Version Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol (ISO/IEEE 11073-20601:2016, including Cor 1:2016) Informatique de sant - Communication entre
7、dispositifs de sant personnels - Partie 20601: Profil dapplication - Protocole dchange optimis (ISO/IEEE 11073-20601:2016, y compris Cor 1:2016) Medizinische Informatik - Kommunikation von Gerten fr die persnliche Gesundheit - Teil 20601: Anwendungsprofil - Optimiertes Datenbertragungsprotokoll (ISO
8、/IEEE 11073-20601:2016, einschlielich Cor 1:2016) This European Standard was approved by CEN on 21 February 2016. 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 a
9、lteration. 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 official versions (English, French, German). A version in any other language
10、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 of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Es
11、tonia, 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, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR ST
12、ANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11073-20601:2016 EBS EN ISO 11073
13、-20601:2016EN ISO 11073-20601:2016 (E) 3 European foreword This document (EN ISO 11073-20601:2016 including Cor 1:2016) has been prepared by Technical Committee ISO/TC 215 “Health informatics” in collaboration with Technical Committee CEN/TC 251 “Health informatics” the secretariat of which is held
14、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 February 2017, and conflicting national standards shall be withdrawn at the latest by February 2017. Attention is drawn to the possibility t
15、hat 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. This document supersedes EN ISO 11073-20601:2011. According to the CEN-CENELEC Internal Regulations, the national standards o
16、rganizations of the following 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, Luxembou
17、rg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO/IEEE 11073-20601:2016 including Cor 1:2016 has been approved by CEN as EN ISO 11073-20601:2016 without any modification. BS EN
18、ISO 11073-20601:2016EN ISO 11073-20601:2016 (E) 3 European foreword This document (EN ISO 11073-20601:2016 including Cor 1:2016) has been prepared by Technical Committee ISO/TC 215 “Health informatics” in collaboration with Technical Committee CEN/TC 251 “Health informatics” the secretariat of which
19、 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 February 2017, and conflicting national standards shall be withdrawn at the latest by February 2017. Attention is drawn to the poss
20、ibility 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. This document supersedes EN ISO 11073-20601:2011. According to the CEN-CENELEC Internal Regulations, the national st
21、andards organizations of the following 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,
22、 Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO/IEEE 11073-20601:2016 including Cor 1:2016 has been approved by CEN as EN ISO 11073-20601:2016 without any modificatio
23、n. BS EN ISO 11073-20601:2016ISO/IEEE 11073-20601:2016(E) ISO 2016 All rights reserved IEEE 2014 All rights reserved iiiForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Sta
24、ndards 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. International organizations, governmental and non-governmental, in liaison with ISO, also
25、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 Societies and the Standards Coordinating Committees of the IEEE Standards Association (I
26、EEE-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 and interests to achieve the final product. Volunteers are not necessarily members
27、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, or verify the accuracy of any of the information contained in its standards. The mai
28、n 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 Standard requires approval by at least 75 % of the member bodies casting a vote. Att
29、ention 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 existence or validity of any patent rights in connection therewith. ISO/IEEE is not respo
30、nsible 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 terms or conditions provided in connection with submission of a Letter of Assuranc
31、e 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 any patent rights, and the risk of infringement of such rights, is entirely their ow
32、n responsibility. Further information may be obtained from ISO or the IEEE Standards Association.ISO/IEEE 11073-20601 was prepared by the IEEE 11073 Standards Comittee of the IEEE Engineering in Medicine and Biology Society (as IEEE Std 11073-20601-2014). It was adopted by Technical Committee ISO/TC
33、 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. IEEE is responsible for the maintenance of this document with participation and inp
34、ut from ISO member bodies. BS EN ISO 11073-20601:2016Abstract: Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard defines a common framework for making an abstract model of personal health data available in transport-independent transfer syntax requi
35、red to establish logical connections between systems and to provide presentation capabilities and services needed to perform communication tasks. The protocol is optimized to personal health usage requirements and leverages commonly used methods and tools wherever possible.Keywords: IEEE 11073-20601
36、, medical device communication, personal health devicesThe Institute of Electrical and Electronics Engineers, Inc. 3 Park Avenue, New York, NY 10016-5997, USA Copyright 2014 by The Institute of Electrical and Electronics Engineers, Inc. All rights reserved. Published 10 October 2014. Printed in the
37、United States of America.IEEE and IEEE 802 are registered trademarks in the U.S. Patent fitness for a particular purpose; non-infringement; and quality, accuracy, effectiveness, currency, or completeness of material. In addition, IEEE disclaims any and all conditions relating to: results; and workma
38、nlike effort. IEEE standards documents are supplied “AS IS” and “WITH ALL FAULTS.”Use of an IEEE standard is wholly voluntary. The existence of an IEEE standard does not imply that there are no other ways to produce, test, measure, purchase, market, or provide other goods and services related to the
39、 scope of the IEEE standard. Furthermore, the viewpoint expressed at the time a standard is approved and issued is subject to change brought about through developments in the state of the art and comments received from users of the standard. In publishing and making its standards available, IEEE is
40、not suggesting or rendering professional or other services for, or on behalf of, any person or entity nor is IEEE undertaking to perform any duty owed by any other person or entity to another. Any person utilizing any IEEE Standards document, should rely upon his or her own independent judgment in t
41、he exercise of reasonable care in any given circumstances or, as appropriate, seek the advice of a competent professional in determining the appropriateness of a given IEEE standard.IN NO EVENT SHALL IEEE BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (I
42、NCLUDING, BUT NOT LIMITED TO: PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE PUBLICAT
43、ION, USE OF, OR RELIANCE UPON ANY STANDARD, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE AND REGARDLESS OF WHETHER SUCH DAMAGE WAS FORESEEABLE.Translations The IEEE consensus development process involves the review of documents in English only. In the event that an IEEE standard is translated,
44、only the English version published by IEEE should be considered the approved IEEE standard.ISO/IEEE 11073-20601:2016(E) ISO 2016 All rights reserved IEEE 2014 All rights reserved BS EN ISO 11073-20601:2016Abstract: Within the context of the ISO/IEEE 11073 family of standards for device communication
45、, this standard defines a common framework for making an abstract model of personal health data available in transport-independent transfer syntax required to establish logical connections between systems and to provide presentation capabilities and services needed to perform communication tasks. Th
46、e protocol is optimized to personal health usage requirements and leverages commonly used methods and tools wherever possible.Keywords: IEEE 11073-20601, medical device communication, personal health devicesThe Institute of Electrical and Electronics Engineers, Inc. 3 Park Avenue, New York, NY 10016
47、-5997, USA Copyright 2014 by The Institute of Electrical and Electronics Engineers, Inc. All rights reserved. Published 10 October 2014. Printed in the United States of America.IEEE and IEEE 802 are registered trademarks in the U.S. Patent fitness for a particular purpose; non-infringement; and qual
48、ity, accuracy, effectiveness, currency, or completeness of material. In addition, IEEE disclaims any and all conditions relating to: results; and workmanlike effort. IEEE standards documents are supplied “AS IS” and “WITH ALL FAULTS.”Use of an IEEE standard is wholly voluntary. The existence of an I
49、EEE standard does not imply that there are no other ways to produce, test, measure, purchase, market, or provide other goods and services related to the scope of the IEEE standard. Furthermore, the viewpoint expressed at the time a standard is approved and issued is subject to change brought about through developments in the state of the art and comments received from users of the standard. In publishing and making its standards available, IEEE is not suggesting or rendering professional or other services for, or on behalf of, any person or
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