1、BRITISH STANDARD BS EN ISO 11073-10101: 2005 Health informatics Point-of-care medical device communication Part 10101: Nomenclature The European Standard EN ISO 11073-10101:2005 has the status of a British Standard ICS 01.040.35; 35.240.80 BS EN ISO 11073-10101:2005 ISBN 0 580 46538 1 National forew
2、ord This British Standard is the official English language version of EN ISO 11073-10101:2005. It is identical with ISO/IEEE 11073-10101:2004. The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics, which has the responsibility to: A list of organizat
3、ions represented on this committee can 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 Corresponde
4、nce 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 with a British Standard does not of its
5、elf 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 international and European developments and prom
6、ulgate them in the UK. Summary of pages 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 x, pages 1 to 490, an inside back cover and a back cover. The BSI copyright notice displayed in this document i
7、ndicates when the document was last issued. Amendments issued since publication Amd. No. Date Comments This British Standard was published under the authority of the Standards Policy and Strategy Committee on 20 January 2006 BSI 20 January 2006EUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO1107
8、310101 August2005 ICS35.240.80;01.040.35 EnglishVersion HealthinformaticsPointofcaremedicaldevicecommunication Part10101:Nomenclature(ISO/IEEE1107310101:2004) InformatiquedesantCommunicationentredispositifs mdicauxsurlesitedessoinsPartie10101: Nomenclature(ISO/IEEE1107310101:2004) MedizinischeInform
9、atikKommunikationpatientennaher medizinischerGerteTeil10101:Nomenklatur ThisEuropeanStandardwasapprovedbyCENon16August2005. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropean Standardthestatusofanationalstandardwithoutanyalteration.Uptodat
10、elistsandbibliographicalreferencesconcerningsuchnational standardsmaybeobtainedonapplicationtotheCentralSecretariatortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytranslation undertheresponsibilityofaCENmemberintoitsownlangua
11、geandnotifiedtotheCentralSecretariathasthesamestatusastheofficial versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France, Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,
12、Slovakia, Slovenia,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2005CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No
13、.ENISO1107310101:2005:E EN ISO 11073-10101:2005Foreword The text of ISO/IEEE 11073-10101:2004 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 11073-10101:2005 by Technical Committee
14、 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 be withdrawn at t
15、he 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, Hungary, Iceland
16、, 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 11073-10101:2004 has been approved by CEN as EN ISO 11073- 10101:2005 without any modifications. I
17、NTERNATIONAL STANDARD ISO/IEEE 11073-10101 First edition2004-12-15 Reference number ISO/IEEE 11073-10101:2004(E) Health informatics Point-of-care medical device communication Part 10101: Nomenclature Informatique de sant Communication entre dispositifs mdicaux sur le site des soins Partie 10101: Nom
18、enclatureEN ISO 11073-10101:2005blank Health informatics Point-of-care medical device communication Part 10101: Nomenclature Sponsor IEEE 1073 Standard Committee of the IEEE Engineering in Medicine and Biology Society Approved 24 June 2004 IEEE-SA Standards Board EN ISO 11073-10101:2005ii EN ISO 110
19、73-10101:2005iii 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, approved by the American National Standa
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36、dard or for conducting inquiries into the legal valid- ity or scope of those patents that are brought to its attention. EN ISO 11073-10101:2005EN ISO 11073-10101:2005 ivv ISO Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO
37、 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. International organizations, gover
38、nmental 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 adopted by the technical committees are circulated to the
39、 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 standards in the field of medical devices as approved by Cou
40、ncil 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 this International Standard may be the subject of pate
41、nt rights. Neither ISO nor the IEEE shall be held responsible for identifying any or all such patent rights. ISO/IEEE 11073-10101:2004(E) was prepared by IEEE 1073 Committee of the IEEE Engineering in Medicine and Biology Society. EN ISO 11073-10101:2005vi IEEE Introduction This introduction is not
42、part of ISO/IEEE 11073-10101:2004(E), Health informatics Point-of-care medical device communication Part 10101: Nomenclature. ISO/IEEE 11073 standards enable communication between medical devices and external computer systems. They provide automatic and detailed electronic data capture of patient vi
43、tal 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, acquired at the point-of-care, in all health care environments
44、 “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 huma
45、n 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 without extensive software and equipment support, and without nee
46、dless 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 together to provide connectivity optimized for the specific devices
47、being interfaced. Notice to users Patents 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 respect to the existence or validity of any patent rights in co
48、nnection 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. Errata Errata, 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 periodically. Interpretati
