1、BRITISH STANDARDBS EN ISO 11073-20101: 2005Health informatics Point-of-care medical device communication Part 20101: Application profiles Base standardThe European Standard EN ISO 11073-20101:2005 has the status of a British StandardICS 35.240.80g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3
2、g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 11073-20101:2005This British Standard was published under the authority of the Standards Policy and Strategy Committee on 5 December 2005 BSI 5
3、December 2005ISBN 0 580 46540 3National forewordThis British Standard is the official 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
4、 the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary.Cross-referencesThe British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section enti
5、tled “International Standards Correspondence Index”, or by using the “Search” facility 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
6、 with a British Standard does not of itself confer immunity from legal obligations. 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 internat
7、ional and European developments and promulgate them in the UK.Summary of pagesThis 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.Th
8、e BSI copyright notice displayed in this document indicates when the document was last issued.Amendments issued since publicationAmd. No. Date CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 11073-20101August 2005ICS 35.240.80English VersionHealth informatics - Point-of-care medical de
9、vice communication- Part 20101: Application profiles - Base standard (ISO/IEEE11073-20101:2004)Informatique de sant - Communication entre dispositifsmdicaux sur le site des soins - Partie 20101: Profilsdapplications - Norme de base (ISO/IEEE 11073-20101:2004)Medizinische Informatik - Kommunikation p
10、atientennahermedizinischer Gerte - Teil 20101: Anwendungsprofil -BasisnormThis 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 st
11、andard without any alteration. Up-to-date lists and bibliographical 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 l
12、anguage made by translationunder the responsibility of a CEN member 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,G
13、ermany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement
14、 Centre: rue de Stassart, 36 B-1050 Brussels 2005 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 11073-20101:2005: E2 Foreword The text of ISO/IEEE 11073-20101:2004 has been prepared by Technical Committee ISO/TC 215 “Health inf
15、ormatics” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 11073-20101:2005 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
16、 publication of an identical text or by endorsement, at the latest 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 i
17、mplement this European Standard: Austria, Belgium, Cyprus, 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 King
18、dom. Endorsement notice The text of ISO/IEEE 11073-20101:2004 has been approved by CEN as EN ISO 11073-20101:2005 without any modifications. EN ISO/IEEE 11073-20101:2005INTERNATIONALSTANDARDISO/IEEE11073-20101First edition2004-12-15Reference numberISO/IEEE 11073-20101:2004(E)Health informatics Point
19、-of-care medical device communication Part 20101: Application profiles Base standardInformatique de sant Communication entre dispositifs mdicaux sur lesite des soins Partie 20101: Profils dapplications Norme de baseblankHealth informatics Point-of-care medical device communication Part 20101:Applica
20、tion profiles Base standardSponsorIEEE 1073 Standard Committeeof theIEEE Engineering in Medicine and Biology SocietyApproved 24 June 2004IEEE-SA Standards BoardEN ISO/IEEE 11073-20101:2005iiEN ISO/IEEE 11073-20101:2005iiiIEEE Standards documents are developed within the IEEE Societies and the Standa
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38、ion.EN ISO/IEEE 11073-20101:2005ivEN ISO/IEEE 11073-20101:2005vISO ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical
39、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. ISO collaborates closely with
40、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. Publication as an International Standard requires approval by at least 75% of the m
41、ember 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 pilot project, IEEE is responsible for the development and maintenance of t
42、hese 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 shall be held responsible for identifying any or all such patent rights.ISO
43、/IEEE 11073-20101:2004(E) was prepared by IEEE 1073 Committee of the IEEE Engineering in Medicine and Biology Society.EN ISO/IEEE 11073-20101:2005viIEEE IntroductionThis introduction is not part of ISO/IEEE 11073-20101:2004(E), Health informatics Point-of-care medical device communication Part 20101
44、: Application profiles Base standard.ISO/IEEE 11073 standards enable communication between medical devices and external 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
45、-time plug-and-play interoperability for patient-connected medical devices Facilitate the efficient exchange of 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
46、 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 information that is
47、 captured at the point-of-care (e.g., patient vital signs data) can be archived, retrieved, and processed by many different types of applications without extensive software and equipment support, and without needless loss of information. The standards are especially targeted at acute and continuing
48、care devices, such as patient monitors, ventilators, infusion pumps, ECG devices, etc. They comprise a family of standards that can be layered together to provide connectivity optimized for the specific devices being interfaced. Notice to usersPatents Attention is called to the possibility that impl
49、ementation 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 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
