EN 61676-2002 en Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology (Incorporates Amendment A1 20.pdf

1、BRITISH STANDARDBS EN 61676:2002Medical electrical equipment Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiologyICS 11.040.50; 11.040.55g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g

2、55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58+A1:2009National forewordThis British Standard is the UK implementation of EN 61676:2002+A1:2009. It is identical with IEC 61676:2002 incorporating amendment 1:2008. It supersedes BS EN 61676:2002, which is withdr

3、awn.The UK participation in its preparation was entrusted by Technical Committee CH/62, Electromedical equipment in medical practice, to Subcommittee CH/62/3, Equipment for radiotherapy, nuclear medicine and radiation dosimetry.A list of organizations represented on this subcommittee can be obtained

4、 on request to its secretary. 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 cannot confer immunity from legal obligations. BS EN 61676:2002+A1:2009This British Standard was

5、 published under the authority of the Standards Policy and Strategy Committee on 21 January 2003 BSI 2009Amendments/corrigenda issued since publicationDate Comments 31 October 2009 Implementation of IEC amendment 1:2008 with CENELEC endorsement A1:2009. Table 2 replaced, Subclause 4.4.14 addedISBN 9

6、78 0 580 62578 7EUROPEAN STANDARD EN 61676NORME EUROPENNEEUROPISCHE NORM April 2009CENELECEuropean Committee for Electrotechnical StandardizationComit Europen de Normalisation ElectrotechniqueEuropisches Komitee fr Elektrotechnische NormungCentral Secretariat: rue de Stassart 35, B - 1050 Brussels 2

7、002 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.Ref. No. EN 61676:2002 EICS 11.040.50; 11.040.55English versionMedical electrical equipment -Dosimetric instruments used for non-invasive measurementof X-ray tube voltage in diagnostic radiol

8、ogy(IEC 61676:2002)Appareils lectromdicaux -Instruments de dosimtrie pour la mesurenon invasive de la tension du tube radiognedans la radiologie de diagnostic(CEI 61676:2002)Medizinische elektrische Gerte Gerte fr die nicht-invasive Messungder Rntgenrhrenspannungin der diagnostischen Radiologie(IEC

9、61676:2002)This European Standard was approved by CENELEC on 2002-11-01. CENELEC members are bound tocomply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration.Up-to-date lists and bibliogr

10、aphical references concerning such national standards may be obtained onapplication to the Central Secretariat or to any CENELEC member.This European Standard exists in three official versions (English, French, German). A version in any otherlanguage made by translation under the responsibility of a

11、 CENELEC member into its own language andnotified to the Central Secretariat has the same status as the official versions.CENELEC members are the national electrotechnical committees of Austria, Belgium, Czech Republic,Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxe

12、mbourg, Malta,Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United Kingdom.:2002+A1ForewordThe text of document 62C/340/FDIS, future edition 1 of IEC 61676, prepared by SC 62C, Equipment forradiotherapy, nuclear medicine and radiation dosimetry, of IEC TC 62, Electrical equ

13、ipment in medicalpractice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC asEN 61676 on 2002-11-01.The following dates were fixed: latest date by which the EN has to be implementedat national level by publication of an identicalnational standard or by endorsement (dop) 20

14、03-08-01 latest date by which the national standards conflictingwith the EN have to be withdrawn (dow) 2005-11-01Annexes designated “normative“ are part of the body of the standard.Annexes designated “informative“ are given for information only.In this standard, annex ZA is normative and annexes A,

15、B and C are informative.Annex ZA has been added by CENELEC.In this standard, the following print types are used: requirements, compliance with which can be tested, and definitions: roman type; notes, explanations, advice, general statements and exceptions: smaller roman type; test specifications: it

16、alic type; TERMS USED THROUGHOUT THIS STANDARD THAT HAVE BEEN DEFINED IN CLAUSE 3 OR IN EN 60601-1:SMALL CAPITALS._Endorsement noticeThe text of the International Standard IEC 61676:2002 was approved by CENELEC as a EuropeanStandard without any modification._Foreword to amendment A1 The text of docu

17、ment 62C/445/CDV, future amendment 1 to IEC 61676:2002, prepared by SC 62C, Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as amendment A1 to EN 6

18、1676:2002 on 2009-03-01. The following dates were fixed: latest date by which the amendment has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2009-12-01 latest date by which the national standards conflicting with the amendment have to b

19、e withdrawn (dow) 2012-03-01 _ Endorsement notice The text of amendment 1:2008 to the International Standard IEC 61676:2002 was approved by CENELEC as an amendment to the European Standard without any modification. _ BS EN 61676:2002+A1:2009EN 61676:2002Page 2CONTENTSINTRODUCTION.41 Scope and object

20、52 Normative references .53 Terminology and definitions64 General performance requirements for measurement of PRACTICAL PEAK VOLTAGEmeasurements94.1 Quantity to be measured .94.2 Limits of PERFORMANCE CHARACTERISTICs .94.3 LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES.124.4 Performance tes

21、t procedures.145 Special instrumental requirements and marking5.1 Requirements for the complete instruments.5.2 General .5.3 Display215.4 Range of measurement .215.5 Connectors and cables216ACCOMPANYING DOCUMENTS.226.1 General .226.2 Information provided226.3 Instrument description .226.4 Detector 2

22、26.5 Delay time.226.6 Measurement window226.7 Data outlet 226.8 Transport and storage .22Annex A (informative) Recommended performance criteria for the invasive divider 23Annex B (informative) Additional information on PRACTICAL PEAK VOLTAGE 24Annex C (informative) Glossary of defined terms .31Annex

23、 ZA (normative) Normative references to international publications with theircorresponding European publications .32BS EN 61676:2002+A1:2009EN 61676:2002Page 3212121 4 67616 g211 EI2:C200(E)INTRODUCTIONThe result of a measurement of the X-RAY TUBE VOLTAGE by means of invasive or non-invasiveinstrume

24、nts 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 measurement of the X-RAY TUBEVOLTAGE on the market usually indicate the mean

25、 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 the measurement of the X-RAY TUBE VOLTAGE without the definition of the

26、quantity 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 waveform. This quantity is related tothe spectral distribution of the emitt

27、ed 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 different. Detailed information on this concept is provided in Annex B. An exa

28、mple 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 instruments which were not explicitly designed for the measurement of thePRACTIC

29、AL 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 the requirements stated in this standardwithout insurmountable difficultie

30、s. 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 themeasurement quantity.The calibration and adjustment of the X-RAY TUBE

31、 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 VOLTAGE. These instruments are required to have uncertainties of the volta

32、gemeasurement 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 DOSE received by the PATIENTundergoing radiological examinations are depen

33、dent on the X-RAY TUBE VOLTAGE. An overalluncertainty below g1775 % is required, and this value serves as a guide for the LIMITS OFVARIATION for the effects of INFLUENCE QUANTITIES.1See annex B.BS EN 61676:2002+A1:2009EN 61676:2002Page 467616 g211 EI2:C200(E) 5 MEDICAL ELECTRICAL EQUIPMENT Dosimetri

34、c instruments used for non-invasive measurementof X-ray tube voltage in diagnostic radiology1 Scope and objectThis 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.

35、This standard also describes the method for calibration and gives guidancefor estimating the uncertainty in measurements performed under conditions different fromthose during calibration.Applications for such measurement are found in diagnostic RADIOLOGY includingmammography, COMPUTED TOMOGRAPHY (CT

36、), dental radiology and RADIOSCOPY. This standardis not concerned with the safety aspect of such instruments. 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 doc

37、ument.For dated references, only the edition cited applies. For undated references, the latest editionof the 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, Electromag

38、netic compatibility (EMC) Part 4: Testing and measurementtechniques Section 2: Electrostatic discharge immunity 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 t

39、est. Basic EMCPublicationIEC 61000-4-4:1995, Electromagnetic compatibility (EMC) Part 4: Testing and measurementtechniques Section 4: Electrical fast transient/burst immunity test. Basic EMC PublicationIEC 61000-4-5:1995, Electromagnetic compatibility (EMC) Part 4: Testing and measurementtechniques

40、Section 5: Surge immunity test. Basic EMC PublicationIEC 61000-4-6:1996, Electromagnetic compatibility (EMC) Part 4: Testing and measurementtechniques Section 6: Immunity to conducted disturbances, induced by radio frequencyfields. Basic EMC PublicationIEC 61000-4-11:1994, Electromagnetic compatibil

41、ity (EMC) Part 4: Testing and measure-ment techniques Section 11: Voltage dips, short interruptions and voltage variationsimmunity tests. Basic EMC PublicationIEC 61010-1:2001, Safety requirements for electrical equipment for measurement, control,and laboratory use Part 1:General RequirementsBS EN 6

42、1676:2002+A1:2009EN 61676:2002Page 5 6 67616 g211 EI2:C200(E)IEC 61187:1993, Electrical and electronic measuring equipment DocumentationISO:1993, International vocabulary of basic and general terms in metrology(ISBN 92-67-01075-1)ISO 7000:1989, Graphical symbols for use on equipment Index and synops

43、is3 Terminology and definitionsFor the purposes of this standard the following definitions apply.The definitions given in this standard are generally in agreement with those in IEC 60788 andthe ISO International vocabulary of basic and general terms in metrology. Any terms notdefined in this subclau

44、se have the meanings defined in the above publications or areassumed to be in general scientific usage.3.1CORRECTION FACTORdimensionless multiplier which corrects the INDICATED VALUE of an instrument from its valuewhen operated under particular conditions to its value when operated under stated REFE

45、RENCECONDITIONS3.2EFFECTIVE RANGErange of INDICATED VALUES for which an instrument complies with a stated performance. Themaximum (minimum) effective INDICATED VALUE is the highest (lowest) in this range3.3INDICATED VALUEthe value of quantity derived from the scale reading of an instrument together

46、with any scalefactors indicated on the control panel of the instrument3.4INFLUENCE QUANTITYany external quantity that may affect the performance of an instrument (e.g. ambienttemperature etc.) and any property of the X-RAY EQUIPMENT under test that needs to be takeninto account in using the instrume

47、nt for NON-INVASIVE MEASUREMENT of X-RAY TUBE VOLTAGE(e.g. range of X-RAY TUBE VOLTAGE, ANODE ANGLE, anode material, TOTAL FILTRATION etc.)3.5INSTRUMENT PARAMETERany internal property of an instrument that may affect the performance of the instrument3.6INTRINSIC ERRORdeviation of the MEASURED VALUE

48、(i.e. the INDICATED VALUE, corrected to REFERENCECONDITIONS) from the CONVENTIONAL TRUE VALUE under STANDARD TEST CONDITIONS3.7INVASIVE MEASUREMENTmeasurement of the X-RAY TUBE VOLTAGE by external connection of a suitable meter or a highresistance dividerBS EN 61676:2002+A1:2009EN 61676:2002Page 667

49、616 g211 EI2:C200(E) 7 3.8LIMITS OF VARIATIONthe maximum VARIATION of a PERFORMANCE CHARACTERISTIC y, permitted by this standard. Ifthe LIMITS OF VARIATION are stated as g177L % the VARIATION g68y / y, expressed as a percentage,shall remain in the range from g45L % to +L %3.9MAXIMUM PEAK VOLTAGEmaximum value of the X-RAY TUBE VOLTAGE in a specified time interval. The unit of thisquantity is the volt (V)3.10MEAN PEAK VOLTAGEmean value of all X-RAY TUBE VOLTAGE peaks durin