IEC 61676-2002 Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology《医用电气设备.在放射诊断中X射线管电压的无伤害性测量用剂量测定仪器》.pdf

1、INTERNATIONALSTANDARDIEC61676First edition2002-09Medical electrical equipment Dosimetric instruments used fornon-invasive measurement of X-raytube voltage in diagnostic radiologyAppareils lectromdicaux Instruments de dosimtrie pour la mesurenon invasive de la tension du tube radiognedans la radiolog

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9、l Electrotechnical Commission Provided by IHS under license with IECNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-INTERNATIONALSTANDARDIEC61676First edition2002-09Medical electrical equipment Dosimetric instruments used fornon-invasive measurement of X-raytube vo

10、ltage in diagnostic radiologyAppareils lectromdicaux Instruments de dosimtrie pour la mesurenon invasive de la tension du tube radiognedans la radiologie de diagnostic IEC 2002 Copyright - all rights reservedNo part of this publication may be reproduced or utilized in any form or by any means, elect

11、ronic ormechanical, including photocopying and microfilm, without permission in writing from the publisher.International Electrotechnical Commission, 3, rue de Varemb, PO Box 131, CH-1211 Geneva 20, SwitzerlandTelephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmailiec.ch Web: www.iec.ch

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13、 2 61676 IEC:2002(E)CONTENTSFOREWORD 3INTRODUCTION 51 Scope and object . 62 Normative references. 63 Terminology and definitions . 74 General performance requirements for measurement of PRACTICAL PEAK VOLTAGEmeasurements 104.1 Quantity to be measured104.2 Limits of PERFORMANCE CHARACTERISTICs .104.3

14、 LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES .134.4 Performance test procedures.155 Special instrumental requirements and marking 215.1 Requirements for the complete instruments .215.2 General .215.3 Display 225.4 Range of measurement225.5 Connectors and cables 226ACCOMPANYING DOCUMENTS

15、226.1 General .226.2 Information provided226.3 Instrument description .226.4 Detector.226.5 Delay time .226.6 Measurement window 226.7 Data outlet.236.8 Transport and storage .23Annex A (informative) Recommended performance criteria for the invasive divider 24Annex B (informative) Additional inform

16、ation on PRACTICAL PEAK VOLTAGE 25Annex C (informative) Glossary of defined terms32Copyright International Electrotechnical Commission Provided by IHS under license with IECNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-61676 IEC:2002(E) 3 INTERNATIONAL ELECTROTEC

17、HNICAL COMMISSIONMEDICAL ELECTRICAL EQUIPMENT Dosimetric instruments used for non-invasive measurementof X-ray tube voltage in diagnostic radiologyFOREWORD1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprisingall national electrotechnical co

18、mmittees (IEC National Committees). The object of the IEC is to promoteinternational co-operation on all questions concerning standardization in the electrical and electronic fields. Tothis end and in addition to other activities, the IEC publishes International Standards. Their preparation isentrus

19、ted to technical committees; any IEC National Committee interested in the subject dealt with mayparticipate in this preparatory work. International, governmental and non-governmental organizations liaisingwith the IEC also participate in this preparation. The IEC collaborates closely with the Intern

20、ationalOrganization for Standardization (ISO) in accordance with conditions determined by agreement between thetwo organizations.2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, aninternational consensus of opinion on the relevant subjects since e

21、ach technical committee has representationfrom all interested National Committees.3) The documents produced have the form of recommendations for international use and are published in the formof standards, technical specifications, technical reports or guides and they are accepted by the NationalCom

22、mittees in that sense.4) In order to promote international unification, IEC National Committees undertake to apply IEC InternationalStandards transparently to the maximum extent possible in their national and regional standards. Anydivergence between the IEC Standard and the corresponding national o

23、r regional standard shall be clearlyindicated in the latter.5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for anyequipment declared to be in conformity with one of its standards.6) Attention is drawn to the possibility that some of the elements

24、of this International Standard may be the subjectof patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.International Standard IEC 61676 has been prepared by subcommittee SC 62C: Equipmentfor radiotherapy, nuclear medicine and radiation dosimetry, of IE

25、C Technical Committee 62:Electrical equipment in medical practice.The text of this standard is based on the following documents:FDIS Report on voting62C/340/FDIS 62C/344/RVDFull information on the voting for the approval of this standard can be found in the report onvoting indicated in the above tab

26、le.This publication has been drafted in accordance with the ISO/IEC Directives, Part 3.Annexes A, B and C are for information only.In this standard the following print types are used: requirements, compliance with which can be tested, and definitions: in roman type; notes, explanations, advice, gene

27、ral statements and exceptions: in small roman type; test specifications: in italic type; TERMS USED THROUGHOUT THIS STANDARD THAT HAVE BEEN DEFINED IN CLAUSE 3 OR IN IEC60601-1 AND ITS COLLATERAL STANDARDS: IN SMALL CAPITALS.Copyright International Electrotechnical Commission Provided by IHS under l

28、icense with IECNot for ResaleNo reproduction or networking permitted without license from IHS-,-,- 4 61676 IEC:2002(E)The committee has decided that the contents of this publication will remain unchanged until2004. At this date, the publication will be reconfirmed; withdrawn; replaced by a revised e

29、dition, or amended.A bilingual version of this publication may be issued at a later date.NOTE The committee is aware of the fact that this standard does not address all problems associated with non-invasive high voltage measurements. In particular one influence quantity concerning the target conditi

30、on is notdealt with at all. Before this can be done, a substantial amount of measurements is still necessary to improve thephysical understanding of this influence quantity. On the other hand, for the reasons described in the introductionthere is an urgent need to publish this standard in order to a

31、ssure that non-invasive measurements are comparableto each other within tolerable uncertainties, regardless of differences in X-RAY GENERATOR, waveform or otherinfluence quantities (except target condition), which is not the case for the time being. The committee has decidedto revise this standard a

32、s soon as sufficient knowledge on the outstanding items is available.Copyright International Electrotechnical Commission Provided by IHS under license with IECNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-61676 IEC:2002(E) 5 INTRODUCTIONThe result of a measuremen

33、t of the X-RAY TUBE VOLTAGE by means of invasive or non-invasiveinstruments is normally expressed in the form of one single number for the value of the tubevoltage, irrespective of whether the tube voltage is constant potential or shows a timedependent waveform. Non-invasive instruments for the meas

34、urement of the X-RAY TUBEVOLTAGE on the market usually indicate the mean peak voltage. But the quantity mean peakvoltage is not unambiguously defined and may be any mean of all voltage peaks. It isimpossible to establish test procedures for the performance requirements of non-invasiveinstruments for

35、 the measurement of the X-RAY TUBE VOLTAGE without the definition of thequantity under consideration. Therefore, this Standard is based on a quantity recentlyproposed in the literature1to be called “PRACTICAL PEAK VOLTAGE“. The PRACTICAL PEAKVOLTAGE is unambiguously defined and applicable to any wav

36、eform. This quantity is related tothe spectral distribution of the emitted X-RADIATION and the image properties. X-RAYGENERATORS operating at the same value of the PRACTICAL PEAK VOLTAGE will produce thesame low level contrast in the RADIOGRAMS, even when the waveforms of the tube voltagesare differ

37、ent. Detailed information on this concept is provided in Annex B. An example for thecalculation of the PRACTICAL PEAK VOLTAGE in the case of a “falling load” waveform is alsogiven in Annex B.As a result of introducing a new quantity, the problem arises that this standard has beenwritten for instrume

38、nts which were not explicitly designed for the measurement of thePRACTICAL PEAK VOLTAGE. However, from preliminary results of a trial type test of a non-invasive instrument currently on the market, it can be expected that future instruments andmost instruments on the market will be able to fulfil th

39、e requirements stated in this standardwithout insurmountable difficulties. For the most critical requirements on voltage waveformand frequency dependence of the RESPONSE, it turned out from these investigations that it iseven easier to comply with the standard by using the PRACTICAL PEAK VOLTAGE as

40、themeasurement quantity.The calibration and adjustment of the X-RAY TUBE VOLTAGE of an X-RAY GENERATOR is generallyperformed by the MANUFACTURER using a direct INVASIVE MEASUREMENT. Instruments utilisingNON-INVASIVE MEASUREMENTS can also be used to check the calibration or to adjust THE X-RAYTUBE VO

41、LTAGE. These instruments are required to have uncertainties of the voltagemeasurement comparable with the INVASIVE MEASUREMENT. One of the most importantparameters of diagnostic X-RAY EQUIPMENT is the voltage applied to the X-RAY TUBE, becauseboth the image quality in diagnostic radiology and the DO

42、SE received by the PATIENTundergoing radiological examinations are dependent on the X-RAY TUBE VOLTAGE. An overalluncertainty below 5 % is required, and this value serves as a guide for the LIMITS OFVARIATION for the effects of INFLUENCE QUANTITIES.1See annex B.Copyright International Electrotechnic

43、al Commission Provided by IHS under license with IECNot for ResaleNo reproduction or networking permitted without license from IHS-,-,- 6 61676 IEC:2002(E)MEDICAL ELECTRICAL EQUIPMENT Dosimetric instruments used for non-invasive measurementof X-ray tube voltage in diagnostic radiology1 Scope and obj

44、ectThis International Standard specifies the performance requirements of instruments as used inthe NON-INVASIVE MEASUREMENT of X-RAY TUBE VOLTAGE up to 150 kV and the relevantcompliance tests. This standard also describes the method for calibration and gives guidancefor estimating the uncertainty in

45、 measurements performed under conditions different fromthose during calibration.Applications for such measurement are found in diagnostic RADIOLOGY includingmammography, COMPUTED TOMOGRAPHY (CT), dental radiology and RADIOSCOPY. This standardis not concerned with the safety aspect of such instrument

46、s. The requirements for electricalsafety applying to them are contained in IEC 61010-1.2 Normative referencesThe following referenced documents are indispensable for the application of this document.For dated references, only the edition cited applies. For undated references, the latest editionof th

47、e referenced document (including any amendments) applies.IEC 60417 (all parts), Graphical symbols for use on equipmentIEC 60788:1984, Medical radiology TerminologyIEC 61000-4-2:1995, Electromagnetic compatibility (EMC) Part 4: Testing and measurementtechniques Section 2: Electrostatic discharge immu

48、nity test. Basic EMC PublicationIEC 61000-4-3:2000, Electromagnetic compatibility (EMC) Part 4-3: Testing and measure-ment techniques Radiated, radio-frequency, electromagnetic field immunity test. Basic EMCPublicationIEC 61000-4-4:1995, Electromagnetic compatibility (EMC) Part 4: Testing and measur

49、ementtechniques Section 4: Electrical fast transient/burst immunity test. Basic EMC PublicationIEC 61000-4-5:1995, Electromagnetic compatibility (EMC) Part 4: Testing and measurementtechniques Section 5: Surge immunity test. Basic EMC PublicationIEC 61000-4-6:1996, Electromagnetic compatibility (EMC) Part 4: