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1、 IEC 61676 Edition 1.1 2009-01 INTERNATIONAL STANDARD Medical electrical equipment Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology IEC 61676:2002+A1:2008 Copyright International Electrotechnical Commission Provided by IHS under license with IECL
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9、sh to give us your feedback on this publication or need further assistance, please visit the Customer Service Centre FAQ or contact us: Email: csciec.ch Tel.: +41 22 919 02 11 Fax: +41 22 919 03 00 Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=HP
10、Monitoring/1111111164 Not for Resale, 02/02/2009 19:23:17 MSTNo reproduction or networking permitted without license from IHS -,-,- IEC 61676 Edition 1.1 2009-01 INTERNATIONAL STANDARD Medical electrical equipment Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diag
11、nostic radiology INTERNATIONAL ELECTROTECHNICAL COMMISSION CG ICS 11.040.50; 11.040.55 PRICE CODE ISBN 2-8318-1024-4 Registered trademark of the International Electrotechnical Commission Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=HP Monitoring/
12、1111111164 Not for Resale, 02/02/2009 19:23:17 MSTNo reproduction or networking permitted without license from IHS -,-,- 2 61676 IEC:2002+A1:2008(E) CONTENTS FOREWORD.3 INTRODUCTION.5 1 Scope and object6 2 Normative references .6 3 Terminology and definitions7 4 General performance requirements for
13、measurement of PRACTICAL PEAK VOLTAGE measurements10 4.1 Quantity to be measured .10 4.2 Limits of PERFORMANCE CHARACTERISTICs .10 4.3 LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES.13 4.4 Performance test procedures.15 5 Special instrumental requirements and marking22 5.1 Requirements for
14、the complete instruments.22 5.2 General.22 5.3 Display22 5.4 Range of measurement .22 5.5 Connectors and cables22 6 ACCOMPANYING DOCUMENTS.23 6.1 General.23 6.2 Information provided23 6.3 Instrument description.23 6.4 Detector 23 6.5 Delay time.23 6.6 Measurement window23 6.7 Data outlet 23 6.8 Tran
15、sport and storage .23 Annex A (informative) Recommended performance criteria for the invasive divider24 Annex B (informative) Additional information on PRACTICAL PEAK VOLTAGE25 Annex C (informative) Glossary of defined terms .32 Copyright International Electrotechnical Commission Provided by IHS und
16、er license with IECLicensee=HP Monitoring/1111111164 Not for Resale, 02/02/2009 19:23:17 MSTNo reproduction or networking permitted without license from IHS -,-,- 61676 IEC:2002+A1:2008 (E) 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION MEDICAL ELECTRICAL EQUIPMENT Dosimetric instruments used for non-i
17、nvasive measurement of X-ray tube voltage in diagnostic radiology 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 to promote internation
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24、al 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 including individual exp
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26、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 elements of this IEC
27、Publication may be the subject of patent rights. 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: Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC Technical Committe
28、e 62: Electrical equipment in medical practice. This consolidated version of IEC 61676 consists of the first edition (2002) documents 62C/340/FDIS and 62C/344/RVD and its amendment 1 (2008) documents 62C/445/CDV and 62C/452/RVC. The technical content is therefore identical to the base edition and it
29、s amendment and has been prepared for user convenience. It bears the edition number 1.1. A vertical line in the margin shows where the base publication has been modified by amendment 1. NOTE In the amendment, a new influence quantity “Additional tungsten filtration (tube aging)” has been introduced.
30、 Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=HP Monitoring/1111111164 Not for Resale, 02/02/2009 19:23:17 MSTNo reproduction or networking permitted without license from IHS -,-,- 4 61676 IEC:2002+A1:2008(E) Annexes A, B and C are for informatio
31、n 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, general statements and exceptions: in small roman type; test specifications: in italic type; TERMS USED THROUGHOUT THIS STANDAR
32、D THAT HAVE BEEN DEFINED IN CLAUSE 3 OR IN IEC 60601-1 AND ITS COLLATERAL STANDARDS: IN SMALL CAPITALS. The committee has decided that the contents of the base publication and its amendments will remain unchanged until the maintenance result date indicated on the IEC web site under “http:/webstore.i
33、ec.ch“ in the data related to the specific publication. At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, 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
34、address all problems associated with non- invasive high voltage measurements. In particular one influence quantity concerning the target condition is not dealt with at all. Before this can be done, a substantial amount of measurements is still necessary to improve the physical understanding of this
35、influence quantity. On the other hand, for the reasons described in the introduction there is an urgent need to publish this standard in order to assure that non-invasive measurements are comparable to each other within tolerable uncertainties, regardless of differences in X-RAY GENERATOR, waveform
36、or other influence quantities (except target condition), which is not the case for the time being. The committee has decided to revise this standard as soon as sufficient knowledge on the outstanding items is available. Copyright International Electrotechnical Commission Provided by IHS under licens
37、e with IECLicensee=HP Monitoring/1111111164 Not for Resale, 02/02/2009 19:23:17 MSTNo reproduction or networking permitted without license from IHS -,-,- 61676 IEC:2002+A1:2008 (E) 5 INTRODUCTION The result of a measurement of the X-RAY TUBE VOLTAGE by means of invasive or non-invasive instruments i
38、s normally expressed in the form of one single number for the value of the tube voltage, irrespective of whether the tube voltage is constant potential or shows a time dependent waveform. Non-invasive instruments for the measurement of the X-RAY TUBE VOLTAGE on the market usually indicate the mean p
39、eak voltage. But the quantity mean peak voltage is not unambiguously defined and may be any mean of all voltage peaks. It is impossible to establish test procedures for the performance requirements of non-invasive instruments for the measurement of the X-RAY TUBE VOLTAGE without the definition of th
40、e quantity under consideration. Therefore, this Standard is based on a quantity recently proposed in the literature1 to be called “PRACTICAL PEAK VOLTAGE“. The PRACTICAL PEAK VOLTAGE is unambiguously defined and applicable to any waveform. This quantity is related to the spectral distribution of the
41、 emitted X-RADIATION and the image properties. X-RAY GENERATORS operating at the same value of the PRACTICAL PEAK VOLTAGE will produce the same low level contrast in the RADIOGRAMS, even when the waveforms of the tube voltages are different. Detailed information on this concept is provided in Annex
42、B. An example for the calculation of the PRACTICAL PEAK VOLTAGE in the case of a “falling load” waveform is also given in Annex B. As a result of introducing a new quantity, the problem arises that this standard has been written for instruments which were not explicitly designed for the measurement
43、of the PRACTICAL 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 and most instruments on the market will be able to fulfil the requirements stated in this standard without insurmoun
44、table difficulties. For the most critical requirements on voltage waveform and frequency dependence of the RESPONSE, it turned out from these investigations that it is even easier to comply with the standard by using the PRACTICAL PEAK VOLTAGE as the measurement quantity. The calibration and adjustm
45、ent of the X-RAY TUBE VOLTAGE of an X-RAY GENERATOR is generally performed by the MANUFACTURER using a direct INVASIVE MEASUREMENT. Instruments utilising NON-INVASIVE MEASUREMENTS can also be used to check the calibration or to adjust THE X-RAY TUBE VOLTAGE. These instruments are required to have un
46、certainties of the voltage measurement comparable with the INVASIVE MEASUREMENT. One of the most important parameters of diagnostic X-RAY EQUIPMENT is the voltage applied to the X-RAY TUBE, because both the image quality in diagnostic radiology and the DOSE received by the PATIENT undergoing radiolo
47、gical examinations are dependent on the X-RAY TUBE VOLTAGE. An overall uncertainty below 5 % is required, and this value serves as a guide for the LIMITS OF VARIATION for the effects of INFLUENCE QUANTITIES. 1 See annex B. Copyright International Electrotechnical Commission Provided by IHS under lic
48、ense with IECLicensee=HP Monitoring/1111111164 Not for Resale, 02/02/2009 19:23:17 MSTNo reproduction or networking permitted without license from IHS -,-,- 6 61676 IEC:2002+A1:2008(E) MEDICAL ELECTRICAL EQUIPMENT Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology 1 Scope and object This International Standard specifies the performance requirements of instruments as used in the NON-INVASIVE MEASUREMENT of X-RAY TUBE VOLTAGE