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1、BRITISH STANDARD BS EN ISO 11073-20101: 2005 Health informatics Point-of-care medical device communication Part 20101: Application profiles Base standard The European Standard EN ISO 11073-20101:2005 has the status of a British Standard ICS 35.240.80 ? Licensed Copy: sheffieldun sheffieldun, na, Fri
2、 Nov 17 09:56:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 11073-20101:2005 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 5 December 2005 BSI 5 December 2005 ISBN 0 580 46540 3 National foreword This British Standard is the offic
3、ial English language version of EN ISO 11073-20101:2005. It is identical with ISO/IEEE 11073-20101:2004. The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics, which has the responsibility to: A list of organizations represented on this committee can
4、 be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” f
5、acility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligat
6、ions. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of page
7、s This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO/IEEE title pages, pages ii to ix, a blank page, pages 1 to 78, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the docume
8、nt was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11073-20101 August 2005 ICS 35.240.80 English Version Heal
9、th informatics - Point-of-care medical device communication - Part 20101: Application profiles - Base standard (ISO/IEEE 11073-20101:2004) Informatique de sant - Communication entre dispositifs mdicaux sur le site des soins - Partie 20101: Profils dapplications - Norme de base (ISO/IEEE 11073- 20101
10、:2004) Medizinische Informatik - Kommunikation patientennaher medizinischer Gerte - Teil 20101: Anwendungsprofil - Basisnorm This European Standard was approved by CEN on 16 August 2005. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for givi
11、ng 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 Central Secretariat or to any CEN member. This European Standard exists in three official versi
12、ons (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 Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, C
13、yprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EU
14、ROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2005 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11073-20101:2005: E Licensed Copy: sheffieldun sheffieldun, na, Fr
15、i Nov 17 09:56:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 2 Foreword The text of ISO/IEEE 11073-20101:2004 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 11073-20101:2005 by Tec
16、hnical 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 February 2006, and conflicting national standards shall b
17、e withdrawn at the latest by February 2006. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,
18、Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO/IEEE 11073-20101:2004 has been approved by CEN as EN ISO 11073- 20101:2005 without any
19、modifications. EN ISO/IEEE 11073-20101:2005 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI INTERNATIONAL STANDARD ISO/IEEE 11073-20101 First edition 2004-12-15 Reference number ISO/IEEE 11073-20101:2004(E) Health informatics Point-of-care m
20、edical device communication Part 20101: Application profiles Base standard Informatique de sant Communication entre dispositifs mdicaux sur le site des soins Partie 20101: Profils dapplications Norme de base Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:56 GMT+00:00 2006, Uncontrolled
21、 Copy, (c) BSI blank Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Health informatics Point-of-care medical device communication Part 20101: Application profiles Base standard Sponsor IEEE 1073 Standard Committee of the IEEE Engineering in
22、 Medicine and Biology Society Approved 24 June 2004 IEEE-SA Standards Board EN ISO/IEEE 11073-20101:2005 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii EN ISO/IEEE 11073-20101:2005 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 0
23、9:56:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii IEEE Standards documents 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 develop- ment process, ap
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39、ntation of this standard may require use of subject matter covered by patent rights. By publication of this standard, no position is taken with respect to the exist- ence or validity of any patent rights in connection therewith. The IEEE shall not be responsible for identifying patents for which a l
40、icense may be required by an IEEE standard or for conducting inquiries into the legal valid- ity or scope of those patents that are brought to its attention. EN ISO/IEEE 11073-20101:2005 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv EN
41、ISO/IEEE 11073-20101:2005 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI v ISO Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of prepari
42、ng 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. International organizations, governmental and non-governmental, in lia
43、ison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publicati
44、on as an International Standard requires approval by at least 75% of the member bodies casting a vote. A pilot project between ISO and the IEEE has been formed to develop and maintain a group of ISO/IEEE standards in the field of medical devices as approved by Council resolution 43/2000. Under this
45、pilot project, IEEE is responsible for the development and maintenance of these standards with participation and input from ISO member bodies. Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of patent rights. Neither ISO nor the IEEE
46、shall be held responsible for identifying any or all such patent rights. ISO/IEEE 11073-20101:2004(E) was prepared by IEEE 1073 Committee of the IEEE Engineering in Medicine and Biology Society. EN ISO/IEEE 11073-20101:2005 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:56 GMT+00:00 20
47、06, Uncontrolled Copy, (c) BSI vi IEEE Introduction This introduction is not part of ISO/IEEE 11073-20101:2004(E), Health informatics Point-of-care medical device communication Part 20101: Application profiles Base standard. ISO/IEEE 11073 standards enable communication between medical devices and e
48、xternal computer systems. They provide automatic and detailed electronic data capture of patient vital signs information and device operational data. The primary goals are to: Provide real-time plug-and-play interoperability for patient-connected medical devices Facilitate the efficient exchange of
49、vital signs and medical device data, acquired at the point-of-care, in all health care environments “Real-time” means that data from multiple devices can be retrieved, time correlated, and displayed or processed in fractions of a second. “Plug-and-play” means that all the clinician has to do is make the connection the systems automatically detect, configure, and communicate without any other human interaction. “Efficient exchange of medical device data” means that i