1、 g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58communication Part 20101: Application profiles Base standardThe European Standard EN ISO 11073-2010
2、1:2005 has the status of a British StandardICS 35.240.80Health informatics Point-of-care medical device BRITISH STANDARDBS EN ISO 11073-20101: 2005BS 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 3The 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” facility of the BSI Electron
4、ic 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 obligations.Summary of pagesThis do
5、cument 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 document was las
6、t issued.Amendments issued since publicationAmd. No. Date CommentsA list of organizations represented on this committee can be obtained on request to its secretary.Cross-referencesenquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international
7、and European developments and promulgate them in the UK.National 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, Heal
8、th informatics, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any EUROPEAN 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 baseblankEN ISO/IEEE 11073-20101:2005Health informatics Point-of-care medical device comm
20、unication Part 20101:Application profiles Base standardSponsorIEEE 1073 Standard Committeeof theIEEE Engineering in Medicine and Biology SocietyApproved 24 June 2004IEEE-SA Standards BoardiiEN ISO/IEEE 11073-20101:2005EN ISO/IEEE 11073-20101:2005IEEE Standards documents are developed within the IEEE
21、 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 Standards Institute, which brings together volunteers representing varied view
22、points and interests to achieve the final product. Volunteers are not necessarily members of the Institute and serve with-out compensation. While the IEEE administers the process and establishes rules to promote fairness in the consensus devel-opment process, the IEEE does not independently evaluate
23、, test, or verify the accuracy of any of the information contained in its standards.Use of an IEEE Standard is wholly voluntary. The IEEE disclaims liability for any personal injury, property or other dam-age, of any nature whatsoever, whether special, indirect, consequential, or compensatory, direc
24、tly or indirectly resulting from the publication, use of, or reliance upon this, or any other IEEE Standard document.The IEEE does not warrant or represent the accuracy or content of the material contained herein, and expressly disclaims any express or implied warranty, including any implied warrant
25、y of merchantability or fitness for a specific purpose, or that the use of the material contained herein is free from patent infringement. IEEE Standards documents are supplied “AS IS.”The existence of an IEEE Standard does not imply that there are no other ways to produce, test, measure, purchase,
26、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.
27、Every IEEE Standard is subjected to review at least every five years for revi-sion or reaffirmation. When a document is more than five years old and has not been reaffirmed, it is reasonable to conclude that its contents, although still of some value, do not wholly reflect the present state of the a
28、rt. Users are cautioned to check to determine that they have the latest edition of any IEEE Standard.In publishing and making this document available, the IEEE is not suggesting or rendering professional or other services for, or on behalf of, any person or entity. Nor is the IEEE undertaking to per
29、form any duty owed by any other person or entity to another. Any person utilizing this, and any other IEEE Standards document, should rely upon the advice of a com-petent professional in determining the exercise of reasonable care in any given circumstances.Interpretations: Occasionally questions ma
30、y arise regarding the meaning of portions of standards as they relate to specific applications. When the need for interpretations is brought to the attention of IEEE, the Institute will initiate action to prepare appropriate responses. Since IEEE Standards represent a consensus of concerned interest
31、s, it is important to ensure that any interpretation has also received the concurrence of a balance of interests. For this reason, IEEE and the members of its soci-eties and Standards Coordinating Committees are not able to provide an instant response to interpretation requests except in those cases
32、 where the matter has previously received formal consideration. At lectures, symposia, seminars, or educational courses, an individual presenting information on IEEE standards shall make it clear that his or her views should be considered the personal views of that individual rather than the formal
33、position, explanation, or interpretation of the IEEE.Comments for revision of IEEE Standards are welcome from any interested party, regardless of membership affiliation with IEEE. Suggestions for changes in documents should be in the form of a proposed change of text, together with appropriate suppo
34、rting comments. Comments on standards and requests for interpretations should be addressed to:Secretary, IEEE-SA Standards Board445 Hoes LanePiscataway, NJ 08854 USAAuthorization to photocopy portions of any individual standard for internal or personal use is granted by the Institute of Electrical a
35、nd Electronics Engineers, Inc., provided that the appropriate fee is paid to Copyright Clearance Center. To arrange for payment of licensing fee, please contact Copyright Clearance Center, Customer Service, 222 Rosewood Drive, Danvers, MA 01923 USA; +1 978 750 8400. Permission to photocopy portions
36、of any individual standard for educational classroom use can also be obtained through the Copyright Clearance Center. NOTE 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 posit
37、ion 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 license may be required by an IEEE standard or for conducting inquiries into the legal valid-ity or scope of those patents that
38、are brought to its attention.iiiivEN ISO/IEEE 11073-20101:2005EN ISO/IEEE 11073-20101:2005ISO 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
39、 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 take part in the work. ISO
40、 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. Publication as an International Standard requires approv
41、al 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 pilot project, IEEE is responsible for the devel
42、opment 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 shall be held responsible for identifying any or
43、 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.vEN ISO/IEEE 11073-20101:2005IEEE IntroductionThis introduction is not part of ISO/IEEE 11073-20101:2004(E), Health informatics Point-of-care medical devic
44、e communication Part 20101: 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
45、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 “Real-time” means that data from multiple devices can be retri
46、eved, 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” mean
47、s 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 needless loss of information. The standards are especially targete
48、d 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 being interfaced. Notice to usersPatents Attention is called to
49、 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 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 it
