1、BRITISH STANDARDBS EN ISO 11073-10201: 2005Health informatics Point-of-care medical device communication Part 10201: Domain information modelThe European Standard EN ISO 11073-10201:2005 has the status of a British StandardICS 35.240.80g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g
2、3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 11073-10201:2005ISBN 0 580 46539 XNational forewordThis British Standard is the official English language version of EN ISO 11073-10201:2005. It is identi
3、cal with ISO/IEEE 11073-10201:2004.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 be obtained on request to its secretary.Cross-referencesThe British S
4、tandards 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” facility of the BSI Electronic Catalogue or of British Standards Online.T
5、his 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 obligations. aid enquirers to understand the text; present to the responsible in
6、ternational/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 pagesThis document comprises a front cover, an inside front cover, the EN ISO
7、title page, the EN ISO foreword page, the ISO/IEEE title pages, pages ii to xi, a blank page, pages 1 to 167 and a back cover.The BSI copyright notice displayed in this document indicates when the document was last issued.Amendments issued since publicationAmd. No. Date CommentsThis British Standard
8、 was published under the authority of the Standards Policy and Strategy Committee on 28 April 2006 BSI 2006EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 11073-10201August 2005ICS 35.240.80English VersionHealth informatics - Point-of-care medical device communication- Part 10201: Domain infor
9、mation model (ISO/IEEE 11073-10201:2004)Informatique de sant - Communication entre dispositifsmdicaux sur le site des soins - Partie 10201: Modledinformation du domaine (ISO/IEEE 11073-10201:2004)Medizinische Informatik - Kommunikation patientennahermedizinischer Gerte - Teil 10201: Bereichs-Informa
10、tionsmodellThis 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 giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliograph
11、ical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN me
12、mber into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithu
13、ania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2005 CEN All right
14、s of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 11073-10201:2005: EForeword The text of ISO/IEEE 11073-10201:2004 has been prepared by Technical Committee ISO/TC 215 “Health informatics” of the International Organization for Standardization (
15、ISO) and has been taken over as EN ISO 11073-10201:2005 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 endorsement, at the lates
16、t by February 2006, and conflicting national standards shall be 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
17、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. Endorsement notice The text of ISO/IEEE 11073-10201:2004 has
18、 been approved by CEN as EN ISO 11073-10201:2005 without any modifications. EN ISO 11073-10201:2005INTERNATIONALSTANDARDISO/IEEE11073-10201First edition2004-12-15Reference numberISO/IEEE 11073-10201:2004(E)Health informatics Point-of-caremedical device communication Part 10201:Domain information mod
19、el Informatique de sant Communication entre dispositifs mdicaux sur lesite des soins Partie 10201: Modle dinformation du domaineEN ISO 11073-10201:2005blankHealth informatics Point-of-care medical device communication Part 10201: Domain information modelSponsor IEEE 1073 Standard Committee of the IE
20、EE Engineering in Medicine and Biology SocietyApproved 24 June 2004 IEEE-SA Standards BoardEN ISO 11073-10201:2005iiiiiIEEE Standards documents are developed within the IEEE Societies and the Standards Coordinating Committees of the IEEE Standards Association (IEEE-SA) Standards Board. The IEEE deve
21、lops its standards through a consensus develop-ment 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 serve with-out c
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36、ntion is called to the possibility that implementation 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 res
37、ponsible for identifying patents for which a license 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 11073-10201:2005ivvISO ForewordISO (the International Organization for Standardization) is
38、a worldwide federation 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 represent
39、ed on that committee. 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.Draft International Standards ad
40、opted 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.A pilot project between ISO and the IEEE has been formed to develop and maintain a group of ISO/IEEE standa
41、rds in the field of medical devices as approved by Council resolution 43/2000. Under this 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
42、this International Standard may be the subject of patent rights. Neither ISO nor the IEEE shall be held responsible for identifying any or all such patent rights.ISO/IEEE 11073-10201:2004(E) was prepared by IEEE 1073 Committee of the IEEE Engineering in Medicine and Biology Society.EN ISO 11073-1020
43、1:2005viIEEE IntroductionThis introduction is not part of ISO/IEEE 11073-10201:2004(E), Health informatics Point-of-care medical device communication Part 10201: Domain information model.ISO/IEEE 11073 standards enable communication between medical devices and external computer systems. They provide
44、 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 vital signs and medical device data, a
45、cquired 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 automatica
46、lly detect, configure, and communicate without any other human interaction. “Efficient exchange of medical device data” means that information that is captured at the point-of-care (e.g., patient vital signs data) can be archived, retrieved, and processed by many different types of applications with
47、out extensive software and equipment support, and without needless loss of information. The standards are especially targeted at acute and continuing care devices, such as patient monitors, ventilators, infusion pumps, ECG devices, etc. They comprise a family of standards that can be layered togethe
48、r to provide connectivity optimized for the specific devices being interfaced. Notice to usersPatents Attention is called to the possibility that implementation of this standard may require use of subject matter covered by patent rights. By publication of this standard, no position is taken with res
49、pect to the existence or validity of any patent rights in connection therewith. The IEEE shall not be responsible for identifying patents or patent applications for which a license may be required by to implement an IEEE standard or for conducting inquiries into the legal validity or scope of those patents that are brought to its attention.ErrataErrata, if any, for this and all other standards can be accessed at the following URL: http:/standards.ieee.org/reading/ieee/updates/errata/index.html. Users are encouraged to check this URL for errata pe
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