BS EN ISO 11073-10101-2006 Health informatics - Point-of-care medical device communications - Nomenclature《健康信息学 床旁检测医疗设备通信 术语》.pdf

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

20、rds 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 compensation. While the IEEE administers the process and establishes rules to promote fairness in the

21、 consensus devel- opment process, the IEEE does not independently evaluate, 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

22、whatsoever, whether special, indirect, consequential, or compensatory, directly 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 expre

23、ssly disclaims any express or implied warranty, including any implied warranty 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 doe

24、s not imply that there are no other ways to produce, test, measure, purchase, 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 developme

25、nts in the state of the art and comments received from users of the standard. 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,

26、 although still of some value, do not wholly reflect the present state of the art. 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 service

27、s for, or on behalf of, any person or entity. Nor is the IEEE undertaking to perform 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 reas

28、onable care in any given circumstances. Interpretations: Occasionally questions may 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 appro

29、priate responses. Since IEEE Standards represent a consensus of concerned interests, 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 a

30、ble to provide an instant response to interpretation requests except in those cases 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

31、 should be considered the personal views of that individual rather than the formal 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

32、 should be in the form of a proposed change of text, together with appropriate supporting comments. Comments on standards and requests for interpretations should be addressed to: Secretary, IEEE-SA Standards Board 445 Hoes Lane Piscataway, NJ 08854 USA Authorization to photocopy portions of any indi

33、vidual standard for internal or personal use is granted by the Institute of Electrical and 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 R

34、osewood Drive, Danvers, MA 01923 USA; +1 978 750 8400. Permission to photocopy portions 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 u

35、se 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 license may be required by an IEEE stan

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