IEC TR 60788-2004 Medical electrical equipment - Glossary of defined terms《医疗电气设备.定义的术语汇编》.pdf

1、TECHNICAL REPORT IECTR 60788Second edition 2004-02Medical electrical equipment Glossary of defined terms Reference number IEC/TR 60788:2004(E) Publication numbering As from 1 January 1997 all IEC publications are issued with a designation in the 60000 series. For example, IEC 34-1 is now referred to

2、 as IEC 60034-1. Consolidated editions The IEC is now publishing consolidated versions of its publications. For example, edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the base publication, the base publication incorporating amendment 1 and the base publication incorporating amendments 1 a

3、nd 2. Further information on IEC publications The technical content of IEC publications is kept under constant review by the IEC, thus ensuring that the content reflects current technology. Information relating to this publication, including its validity, is available in the IEC Catalogue of publica

4、tions (see below) in addition to new editions, amendments and corrigenda. Information on the subjects under consideration and work in progress undertaken by the technical committee which has prepared this publication, as well as the list of publications issued, is also available from the following:

5、IEC Web Site (www.iec.ch) Catalogue of IEC publications The on-line catalogue on the IEC web site (www.iec.ch/searchpub) enables you to search by a variety of criteria including text searches, technical committees and date of publication. On-line information is also available on recently issued publ

6、ications, withdrawn and replaced publications, as well as corrigenda. IEC Just Published This summary of recently issued publications (www.iec.ch/online_news/ justpub) is also available by email. Please contact the Customer Service Centre (see below) for further information. Customer Service Centre

7、If you have any questions regarding this publication or need further assistance, please contact the Customer Service Centre: Email: custserviec.ch Tel: +41 22 919 02 11 Fax: +41 22 919 03 00 TECHNICAL REPORT IEC TR 60788Second edition 2004-02Medical electrical equipment Glossary of defined terms PRI

8、CE CODE IEC 2004 Copyright - all rights reserved No part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher. International Electrotechnical Commission, 3, rue

9、de Varemb, PO Box 131, CH-1211 Geneva 20, Switzerland Telephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmailiec.ch Web: www.iec.ch XJ For price, see current catalogue Commission Electrotechnique Internationale International Electrotechnical Commission 2 TR 60788 IEC:2004(E) INTERNATION

10、AL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT GLOSSARY OF DEFINED TERMS FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is

11、to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and

12、Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non- governmental organizations liaising with the

13、IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly a

14、s possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sen

15、se. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees und

16、ertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC provides no marking procedure

17、to indicate its approval and cannot be rendered responsible for any EQUIPMENT declared to be in conformity with an IEC Publication. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents in

18、cluding individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or re

19、liance upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the

20、 elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. The main task of IEC technical committees is to prepare International Standards. However, a technical committee may propose the publication of a tec

21、hnical report when it has collected data of a different kind from that which is normally published as an International Standard, for example “state of the art“. IEC 60788, which is a technical report, has been prepared by IEC TC 62: Electrical EQUIPMENT in medical practice. This second edition cance

22、ls and replaces the first edition of IEC 60788 published in 1984. This second edition constitutes a technical revision. The text of this technical report is based on the following documents: Enquiry draft Report on voting 62/137/DTR 62/140/RVC Full information on the voting for the approval of this

23、technical report can be found in the report on voting indicated in the above table. This publication does not follow the rules for structuring International Standards as given in Part 2 of the ISO/IEC Directives.TR 60788 IEC:2004(E) 3 The committee has decided that the contents of this publication w

24、ill remain unchanged until 2005. At this date, the publication will be reconfirmed; w i t h d r a w n ; replaced by a revised edition, or amended. 4 TR 60788 IEC:2004(E) INTRODUCTION Purpose To provide an actual mirror of defined terms for all steps in the development of IEC standards under the scop

25、e of “MEDICAL ELECTRICAL EQUIPMENT”, IEC TC 62. To give guidance for harmonisation of the defined terms used in the IEC standards on “MEDICAL ELECTRICAL EQUIPMENT”. Contents All DEFINED TERMS used in the General, Particular and Collateral Standards, recorded in the project files of the IEC for TC 62

26、, SC 62A, 62B, 62C and 62D are mirrored. Recommendations to avoid existing redundancy are added as red text in the column “Definitions” in the table. Maintenance An annual maintenance cycle for this TR is introduced. Closing date for the editorial input is the middle of December of a year. The annua

27、l editorial maintenance is done by the Secretaries of the IEC technical committee 62 and its subcommittees 62A, 62B, 62C and 62D. The compilation (addition of new terms and deletion of obsolete terms) is done by the Secretary of IEC TC 62. Targets Represent the state-of-the-art in the definitions Ha

28、rmonize the language of the IEC publications Ease translations of the IEC publications Enable self-control by the experts working in projects for MEDICAL ELECTRICAL EQUIPMENT. Coded reference of the DEFINED TERMS In all cases as appropriate the reference codes “IEV xxx-xx-xx” of the International El

29、ectronic Vocabulary (IEV) are added in the “Reference” column of the table. F o r DEFINED TERMS used in RADIOLOGY the reference codes “rm-xx-xx” remain unchanged as initiated by IEC 60788 Ed.1. For main fields other than RADIOLOGY, the coded references will be generated in future annual editions. Re

30、placement This technical report replaces IEC 60788 Ed.1, Medical radiology Terminology.TR 60788 IEC:2004(E) 5 MEDICAL ELECTRICAL EQUIPMENT GLOSSARY OF DEFINED TERMS 1 Scope This Technical report comprises all defined terms used in the IEC standards and technical reports which fall under the scope of

31、 MEDICAL ELECTRICAL EQUIPMENT, and are on the list of publications as stated in May 2003. 2 Normative references The documents referenced in 2.2 are forming the sources for the defined terms in this document. 2.1 General The defined terms listed in this glossary are mirrored as presented in the stan

32、dards and technical reports. Only the recommendations are added for further harmonisation of multiple defined terms. The glossary is prepared to ease the use of the electronic version by two search functions: Search in the alphabetic order, and Search by the technical and physical chapters in case o

33、f ionising radiation (rm-xx-xx). 2.2 List of the IEC publications mirrored in this edition 2004 The list of IEC Standards below comprises the defined terms as used in the latest consolidated version, comprising the amendments as applicable. 6 TR 60788 IEC:2004(E) 1 60336 1993-07 2 60522 1999-02 3 60

34、526 1978-01 4 60580 2000-01 5 60601-1/A1+ A2 1988-12/ 1991-11/ 1995-03 6 60601-1-2 2001-09 7 60601-1-3 1994-07 8 60601-1-4 Ed.1.1 2000-04 9 60601-2-1 /A1 1998-06/ 2002-05 10 60601-2-2 1998-09 11 60601-2-3/A1 1991-06/ 1998-09 12 60601-2-4 2002-08 13 60601-2-5 2000-07 14 60601-2-6 1984-01 15 60601-2-7

35、 1998-02 16 60601-2-8 Ed.1.1 1999-04 17 60601-2-9 1996-10 18 60601-2-10/A1 1987-12/ 2001-09 19 60601-2-11 1997-08 20 60601-2-12 2001-10 21 60601-2-13 2003-05 22 60601-2-16 1998-02 23 60601-2-17/A1 1989-09/ 1996-03 24 60601-2-18/A1 1996-08/ 2000-07 25 60601-2-19/A1 1990-12/ 1996-10 26 60601-2-20/A1 1

36、990-12/ 1996-10 27 60601-2-21/A1 1994-02/ 1996-10 28 60601-2-23 1999-12 29 60601-2-24 1998-02 30 60601-2-25/A1 1993-03/ 1999-05 31 60601-2-26 2002-11 32 60601-2-27 1994-04 33 60601-2-28 1993-04 34 60601-2-29, 1999-01 35 60601-2-30 1999-12 36 60601-2-31/A1 1994-10/ 1998-01 37 60601-2-32 1994-03 38 60

37、601-2-33 2002-05 39 60601-2-34 2000-10 40 60601-2-35 1996-11 41 60601-2-36 1997-03 42 60601-2-37 2001-07 43 60601-2-38/A1 1996-10/ 1999-12 44 60601-2-39 1999-06 45 60601-2-40 1998-02 46 60601-2-41 2000-02 47 60601-2-43 2000-06 48 60601-2-44 Ed.2.1 2002-11 49 60601-2-45 2001-05 50 60601-2-46 1998-06

38、51 60601-2-47 2001-07 52 60601-2-49 2001-07 53 60601-2-50 2000-07 54 60601-2-51 2003-02 55 60601-2-55 To be published 56 60601-3-1 1996-08 57 60613 1989-05 58 60627 2001-08 59 60731/A1 1997-07/ 2002-06 60 60789 1992-02 61 60806 1984-01 62 60976/A1 1989-06/ 2000-07 63 60977/A1 1989-10/ 2000-04 64 611

39、68 1993-12 65 61170 1993-12 66 61217 Ed.1.1 2002-03 67 61223-1 1993-07 68 61223-2-1 1993-07 69 61223-2-4 1994-03 70 61223-2-5 1994-03 71 61223-2-6 1994-04 72 61223-2-7 1999-09 73 61223-2-9 1999-09 74 61223-2-10 1999-09 75 61223-2-11 1999-09 76 61223-3-1 1999-03 77 61223-3-2 1996-11 78 61223-3-3 1996

40、-11 79 61223-3-4 2000-03 80 61262-1 1994-07 81 61262-2 1994-07 82 61262-3 1994-07 83 61262-4 1994-07 84 61262-5 1994-08 85 61262-6 1994-07 86 61262-7 1995-09 87 61267 1994-10 88 61303 1994-10 89 61331-1 1994-10 90 61331-2 1994-10 91 61331-3 1998-11 92 61674/A1 1997-10/ 2002-06 93 61675-1 1998-02 94

41、61675-2 1998-01 95 61675-3 1998-02 96 61676 2002-09 97 61852 1998-04 98 61859 1997-05 99 61948-1, TR 2001-02 100 61948-2, TR 2001-02 101 62083 2000-11 102 62266, TR 2002-03 103 ISO 14971 2000-11TR 60788 IEC:2004(E) 7 Glossary of DEFINED TERMS used for MEDICAL ELECTRICAL EQUIPMENT Edition 2004 Search

42、. .via chapters .by alphabetic index A B-C D E-F G-I K-M N-O P-Q R S T-V W-Z for imaging EQUIPMENT for all medical EQUIPMENT Physics General Ionizing RADIATION Interactions Quantities, units and related concepts Generation and emission of ionizing RADIATION General HIGH VOLTAGE generators X-RAY TUBE

43、 assemblies PARTICLE ACCELERATORS Beam therapy, RADIONUCLIDE sources Therapy EQUIPMENT with SEALED RADIOACTIVE SOURCES RADIOLOGICAL EQUIPMENT using ionizing RADIATION General EQUIPMENT for medical diagnostics Images: Reception, transfer, recording EQUIPMENT for RADIOTHERAPY EQUIPMENT for nuclear med

44、icine Accessories Operation of EQUIPMENT Geometry of RADIATION BEAM Medical RADIOLOGICAL techniques General Diagnosis using beams Therapy using beams Nuclear medicine Dosimetry General RADIATION DETECTORS PHANTOMS Protection against ionizing RADIATION General Limits and factors Groups of persons Are

45、as Means of protection Testing of RADIOLOGICAL EQUIPMENT General Test EQUIPMENT VERIFICATION of characteristics Concepts in mathematics, metrics, statistics Obligation & statement of compliance Technology General Docu- mentation EQUIPMENT Operation of EQUIPMENT Persons Magnetic resonance EQUIPMENT G

46、eneral ULTRASOUND EQUIPMENT General 8 TR 60788 IEC:2004(E) PHYSICS General rm-10 RADIATION TYPE PHYSICS Ionizing RADIATION rm-11 DOSE PROFILE EXTRA-FOCAL RADIATION FOCAL RADIATION INTRINSIC ENERGY RESOLUTION INTRINSIC ENERGY SPECTRUM IONIZING RADIATION LEAKAGE RADIATION MAXIMUM ENERGY NEUTRON PHOTON

47、 PRIMARY RADIATION RADIATION RADIONUCLIDE RESIDUAL RADIATION SCATTERED RADIATION STRAY RADIATION PHYSICS Interactions rm-12 ABSORPTION BACK-SCATTERING BUILD UP FILTRATION INDUCED RADIOACTIVITY IRRADIATION RADIOACTIVITY TRANSMISSION PHYSICS Quantities, units and related concepts rm-13 ABSORBED DOSE A

48、BSORBED DOSE RATE ABSORBED DOSE RATE TO WATER ABSORBED DOSE TO WATER ACTIVITY ADDITIONAL FILTRATION AIR KERMA AIR KERMA LENGTH AIR KERMA RATE ATTENUATION ATTENUATION COEFFICIENT ATTENUATION EQUIVALENT ATTENUATION RATIO AUTOMATIC CONTROL SYSTEM AUTOMATIC EXPOSURE CONTROL AUTOMATIC EXPOSURE RATE CONTR

49、OL AUTOMATIC INTENSITY CONTROL BUILD UP FACTOR DEPTH DOSE DOSE AREA PRODUCT DOSE AREA PRODUCT RATE DOSE EQUIVALENT DOSE MONITOR UNIT ELECTRON ENERGY FLUENCE RATE ENERGY RESOLUTION EXPOSURE EXPOSURE RATE HALF-VALUE LAYER INHERENT FILTRATION KERMA KERMA RATE LEAD EQUIVALENT NOMINAL ENERGY QUALITY EQUIVALENT FILTRATION RADIATION SPECTRUM RADIATION CONDITION RADIATION ENERGY RADIATION OUTPUT RADIATION QUALITY RADIATION QUANTITIE