Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology

IEC 61676:2023 is available as IEC 61676:2023 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 61676:2023 specifies the performance requirements of instruments as used in the non-invasive measurement of X-RAY tube voltage up to 150 kV and the relevant compliance tests. This document also describes the method for calibration and gives guidance for estimating the uncertainty in measurements performed under conditions different from those during calibration. Applications for such measurement are found in diagnostic radiology including mammography, computed tomography (CT), dental radiology and radioscopy. This document is not concerned with the safety aspect of such instruments. The requirements for electrical safety applying to them are contained in IEC 61010-1. IEC 61676:2023 cancels and replaces first edition published in 2002, Amendment 1:2008. This edition constitutes a technical revision. It includes an assessment of the combined standard uncertainty for the performance of a hypothetical instrument for the non-invasive measurement of the tube high voltage (in Annex A) which replaces Annex A of the edition 1.1 titled "Recommended performance criteria for the invasive divider".

Medizinische elektrische Geräte - Geräte für die nicht-invasive Messung der Röntgenröhrenspannung in der diagnostischen Radiologie

Appareils électromédicaux - Instruments de dosimétrie pour la mesure non invasive de la tension du tube radiogène dans la radiologie de diagnostic

IEC 61676:2023 est disponible sous forme de IEC 61676:2023 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L'IEC 61676:2023 spécifie les exigences de performance des appareils utilisés dans le mesurage non invasif de la tension du tube radiogène jusqu’à 150 kV et les essais de conformité applicables. Le présent document décrit également la méthode d’étalonnage et donne des recommandations pour l’estimation de l’incertitude des mesurages réalisés dans des conditions différentes de celles rencontrées au cours de l’étalonnage. Les applications pour un tel mesurage se rencontrent dans la radiologie de diagnostic y compris la mammographie, la tomodensitométrie, la radiologie dentaire et la radioscopie. Le présent document ne traite pas des aspects sécurité de tels appareils. Les exigences pour la sécurité électrique s’appliquant à ceux-ci figurent dans l’IEC 61010-1. L'IEC 61676:2023 annule et remplace la première édition parue en 2002 et l'Amendement 1:2008. Cette édition constitue une révision technique. Elle comprend une évaluation de l’incertitude type composée pour les performances d’un appareil hypothétique pour le mesurage non invasif de la haute tension du tube (à l’Annexe A) qui remplace l’Annexe A de l’édition 1.1 intitulée "Critères de performances recommandés pour le diviseur invasif".

Medicinska električna oprema - Dozimetrijska oprema za posredno merjenje napetosti rentgenske elektronke v diagnostični radiologiji

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Status
Not Published
Publication Date
27-Apr-2023
Current Stage
4060 - Enquiry results established and sent to TC, SR, BTTF - Enquiry
Start Date
15-Apr-2022
Completion Date
15-Apr-2022

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SLOVENSKI STANDARD
oSIST prEN IEC 61676:2022
01-marec-2022
Medicinska električna oprema - Dozimetrijska oprema za posredno merjenje
napetosti rentgenske elektronke v diagnostični radiologiji
Medical electrical equipment - Dosimetric instruments used for non-invasive
measurement of X-ray tube voltage in diagnostic radiology
Medizinische elektrische Geräte - Geräte für die nicht-invasive Messung der
Röntgenröhrenspannung in der diagnostischen Radiologie

Appareils électromédicaux - Instruments de dosimétrie pour la mesure non invasive de la

tension du tube radiogène dans la radiologie de diagnostic
Ta slovenski standard je istoveten z: prEN IEC 61676:2022
ICS:
11.040.50 Radiografska oprema Radiographic equipment
11.040.55 Diagnostična oprema Diagnostic equipment
17.240 Merjenje sevanja Radiation measurements
oSIST prEN IEC 61676:2022 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN IEC 61676:2022
62C/830/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 61676 ED2
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-01-21 2022-04-15
SUPERSEDES DOCUMENTS:
62C/796A/CD, 62C/808A/CC

IEC SC 62C : EQUIPMENT FOR RADIOTHERAPY, NUCLEAR MEDICINE AND RADIATION DOSIMETRY

SECRETARIAT: SECRETARY:
Germany Ms Regina Geierhofer
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
SC 62B
Other TC/SCs are requested to indicate their interest, if any,
in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY

SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING

Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.

This document is still under study and subject to change. It should not be used for reference purposes.

Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which

they are aware and to provide supporting documentation.
TITLE:

Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray

tube voltage in diagnostic radiology
PROPOSED STABILITY DATE: 2026
NOTE FROM TC/SC OFFICERS:

Copyright © 2021 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download

this electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee

positions. You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other

purpose without permission in writing from IEC.
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62C/830/CDV – 2 – IEC CDV 61676 © IEC 2021
1 CONTENTS

2 FOREWORD ........................................................................................................................... 4

3 INTRODUCTION ..................................................................................................................... 6

4 1 Scope and object .............................................................................................................. 7

5 2 Normative references ....................................................................................................... 7

6 3 Terminology and definitions .............................................................................................. 8

7 4 General performance requirements for measurement of PRACTICAL PEAK VOLTAGE

8 measurements ................................................................................................................ 10

9 4.1 Quantity to be measured ....................................................................................... 10

10 4.2 Limits of PERFORMANCE CHARACTERISTICs ............................................................... 11

11 4.3 LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES ......................................... 13

12 4.4 Performance test procedures ................................................................................. 15

13 5 Special instrumental requirements and marking .............................................................. 22

14 5.1 Requirements for the complete instruments ........................................................... 22

15 5.2 General ................................................................................................................. 22

16 5.3 Display .................................................................................................................. 22

17 5.4 Range of measurement ......................................................................................... 22

18 5.5 Connectors and cables .......................................................................................... 22

19 6 ACCOMPANYING DOCUMENTS ............................................................................................. 22

20 6.1 General ................................................................................................................. 22

21 6.2 Information provided .............................................................................................. 22

22 6.3 Instrument description ........................................................................................... 22

23 6.4 Detector ................................................................................................................ 23

24 6.5 Delay time ............................................................................................................. 23

25 6.6 Measurement window ............................................................................................ 23

26 6.7 Data outlet ............................................................................................................ 23

27 6.8 Transport and storage ........................................................................................... 23

28 Annex A (informative) COMBINED STANDARD UNCERTAINTY ..................................................... 24

29 Annex B (informative) Additional information on PRACTICAL PEAK VOLTAGE ............................ 25

30 INDEX OF DEFINED TERMS ................................................................................................ 31

32 Figure B.1 – Example of a waveform of a two-pulse generator .............................................. 27

33 Figure B.2 – Example of a waveform of a constant-voltage generator ................................... 27

34 Figure B.3 – Example of falling load waveform ...................................................................... 28

36 Table 1 – MINIMUM EFFECTIVE RANGES .................................................................................... 11

37 Table 2 – Minimum RATED RANGE OF USE, REFERENCE CONDITIONS, STANDARD TEST

38 CONDITIONS, LIMITS OF VARIATION ( L) and INTRINSIC ERROR (E) over the EFFECTIVE

39 RANGE of use, for the pertaining INFLUENCE QUANTITY ............................................................. 14

40 Table 3 – Minimum test points and test values of PRACTICAL PEAK VOLTAGE for

41 INFLUENCE QUANTITIES ............................................................................................................ 15

42 Table 4 – Maximum HALF-VALUE LAYER (HVL) depending on anode angle ............................... 21

43 Table B.1 – Values of 20 samples of the falling load waveform in figure B.3 ......................... 28

44 Table B.2 – Voltage bins, probability and weighting factors for the 20 samples of the

45 falling load waveform in figure B.3 ........................................................................................ 29

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46 Table B.3 – Weighting factors for the 20 equally spaced samples of the falling load

47 waveform in figure B.3 .......................................................................................................... 30

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49 INTERNATIONAL ELECTROTECHNICAL COMMISSION
50 ⎯⎯⎯⎯⎯
51 MEDICAL ELECTRICAL EQUIPMENT –
53 Dosimetric instruments used for non-invasive measurement
54 of X-ray tube voltage in diagnostic radiology
57 FOREWORD

58 1) The International Electrotechnical Commission (IEC) is a worldwide organization for st andardization comprising

59 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote

60 international co-operation on all questions concerning standardization in the electrical and electronic fields. To

61 this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,

62 Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC

63 Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested

64 in the subject dealt with may participate in this preparatory work. International, governmental and non-

65 governmental organizations liaising with the IEC also participate in this preparation. IEC collabora tes closely

66 with the International Organization for Standardization (ISO) in accordance with conditions determined by

67 agreement between the two organizations.

68 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

69 consensus of opinion on the relevant subjects since each technical committee has re presentation from all

70 interested IEC National Committees.

71 3) IEC Publications have the form of recommendations for international use and are accepted by I EC National

72 Committees in that sense. While all reasonable efforts are made to ensure that the techni cal content of IEC

73 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

74 misinterpretation by any end user.

75 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Pub lications

76 transparently to the maximum extent possible in their national and regional publications. Any divergence

77 between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

78 the latter.

79 5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any

80 equipment declared to be in conformity with an IEC Publication.

81 6) All users should ensure that they have the latest edition of this publication.

82 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

83 members of its technical committees and IEC National Committees for any personal injury, property damage or

84 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

85 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

86 Publications.

87 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

88 indispensable for the correct application of this publication.

89 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

90 patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

91 International Standard IEC 61676 has been prepared by subcommittee SC 62C: Equipment

92 for radiotherapy, nuclear medicine and radiation dosimetry, of IEC Technical Committee 62:

93 Electrical equipment in medical practice.

94 This second edition of IEC 61676 cancels and replaces the edition 1.1, published in 2009. It

95 includes an assessment of the COMBINED STANDARD UNCERTAINTY for the performance of a

96 hypothetical instrument for the non-invasive measurement of the tube high voltage (in

97 Annex A) which replaces Annex A of the edition 1.1 titled “Recommended performance criteria

98 for the invasive divider”.
100
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101 In this standard the following print types are used:

102 − requirements, compliance with which can be tested, and definitions: in roman type;

103 − notes, explanations, advice, general statements and exceptions: in small roman type;

104 − test specifications: in italic type;

105 − TERMS USED THROUGHOUT THIS STANDARD THAT HAVE BEEN DEFINED IN CLAUSE 3 OR IN IEC

106 60601-1 AND ITS COLLATERAL STANDARDS: IN SMALL CAPITALS.

107 The committee has decided that the contents of the base publication and its amendments will

108 remain unchanged until the maintenance result date indicated on the IEC web site under

109 "http://webstore.iec.ch" in the data related to the specific publication. At this date,

110 the publication will be
111 • reconfirmed,
112 • withdrawn,
113 • replaced by a revised edition, or
114 • amended.
115 A bilingual version of this publication may be issued at a later date.

116 NOTE The committee knows this second edition of the standard does still not address all problems associated

117 with non-invasive high voltage measurements. For mammography only molybdenum filtration is considered in

118 conjunction with a molybdenum anode although in addition tungsten and rhodium anodes with other filtrations are

119 in use like rhodium, aluminium, copper, silver or titanium. At the time when this document was drafted there were

120 not enough data available in the literature to define realistic limits of variation for these types of INFLUENCE

121 QUANTITIES. On the other hand, the committee was informed that several international projects were started to

122 examine the general behaviour of non-invasive X-ray multimeters of the main manufacturers. Results from these

123 studies were to be expected within about 5 years. Therefore, the committee decided to set a short stability time for

124 the second edition and update the standard as soon as the results from these new examinations will be available.

125
126
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127 INTRODUCTION

128 The result of a measurement of the X-RAY TUBE VOLTAGE by means of invasive or non-invasive

129 instruments is normally expressed in the form of one single number for the value of the tube

130 voltage, irrespective of whether the tube voltage is constant potential or shows a time

131 dependent waveform. Non-invasive instruments for the measurement of the X-RAY TUBE

132 VOLTAGE on the market usually indicate the “mean peak voltage”. But the quantity “mean peak

133 voltage” is not unambiguously defined and may be any mean of all voltage peaks. It is

134 impossible to establish test procedures for the performance requirements of non-invasive

135 instruments for the measurement of the X-RAY TUBE VOLTAGE without the definition of the

136 quantity under consideration. Therefore, this standard is based on a quantity called

137 "PRACTICAL PEAK VOLTAGE". The PRACTICAL PEAK VOLTAGE is unambiguously defined and

138 applicable to any waveform. This quantity is related to the spectral distribution of the emitted

139 X-RADIATION and the image properties. X-RAY GENERATORS operating at the same value of the

140 PRACTICAL PEAK VOLTAGE will produce the same low-level contrast in the RADIOGRAMS, even

141 when the waveforms of the tube voltages are different. Detailed information on this concept is

142 provided in Annex B. An example for the calculation of the PRACTICAL PEAK VOLTAGE in the

143 case of a “falling load” waveform is also given in Annex B.

144 The calibration and adjustment of the X-RAY TUBE VOLTAGE of an X-RAY GENERATOR is

145 generally performed by the MANUFACTURER using a direct INVASIVE MEASUREMENT. Instruments

146 utilising NON-INVASIVE MEASUREMENTS can also be used to check the calibration or to adjust

147 the X-RAY TUBE VOLTAGE. These instruments are required to have uncertainties of the voltage

148 measurement comparable with the INVASIVE MEASUREMENT. One of the most important

149 parameters of diagnostic X-RAY EQUIPMENT is the voltage applied to the X-RAY TUBE, because

150 both the image quality in diagnostic radiology and the DOSE received by the PATIENT

151 undergoing radiological examinations are dependent on the X-RAY TUBE VOLTAGE. An overall

152 uncertainty below ±5 % is required, and this value serves as a guide for the LIMITS OF

153 VARIATION for the effects of INFLUENCE QUANTITIES.
154
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155 MEDICAL ELECTRICAL EQUIPMENT –
156
157 Dosimetric instruments used for non-invasive measurement
158 of X-ray tube voltage in diagnostic radiology
159
160
161
162 1 Scope and object

163 This International Standard specifies the performance requirements of instruments as used in

164 the NON-INVASIVE MEASUREMENT of X-RAY TUBE VOLTAGE up to 150 kV and the relevant

165 compliance tests. This standard also describes the method for calibration and gives guidance

166 for estimating the uncertainty in measurements performed under conditions different from

167 those during calibration.

168 Applications for such measurement are found in diagnostic RADIOLOGY including

169 mammography, COMPUTED TOMOGRAPHY (CT), dental radiology and RADIOSCOPY. This standard

170 is not concerned with the safety aspect of such instruments. The requirements for electrical

171 safety applying to them are contained in IEC 61010-1.
172 2 Normative references

173 The following documents are referred to in the text in such a way that some or all of their

174 content constitutes requirements of this document. For dated references, only the edition

175 cited applies. For undated references, the latest edition of the referenced document (including

176 any amendments) applies.

177 IEC 60417, Graphical symbols for use on equipment (available at http://www.graphical-

178 symbols.info/equipment)
179 IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms

180 IEC 61000-4-2, Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurement

181 techniques – Electrostatic discharge immunity test

182 IEC 61000-4-3, Electromagnetic compatibility (EMC) – Part 4-3: Testing and measurement

183 techniques – Radiated, radio-frequency, electromagnetic field immunity test

184 IEC 61000-4-4, Electromagnetic compatibility (EMC) – Part 4-4: Testing and measurement

185 techniques – Electrical fast transient/burst immunity test

186 IEC 61000-4-5, Electromagnetic compatibility (EMC) – Part 4-5: Testing and measurement

187 techniques – Surge immunity test

188 IEC 61000-4-6, Electromagnetic compatibility (EMC) – Part 4-6: Testing and measurement

189 techniques – Immunity to conducted disturbances induced by radio-frequency fields

190 IEC 61000-4-11, Electromagnetic compatibility (EMC) – Part 4-11: Testing and measurement

191 techniques – Voltage dips, short interruptions and voltage variations immunity tests

192 IEC 61010-1, Safety requirements for electrical equipment for measurement, control, and

193 laboratory use – Part 1: General requirements
194 IEC 61187, Electrical and electronic measuring equipment – Documentation
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195 ISO 7000:1989, Graphical symbols for use on equipment – Index and synopsis
196 3 Terminology and definitions

197 For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,

198 IEC TR 60788:2004 and the following apply.

199 ISO and IEC maintain terminological databases for use in standardization at the following

200 addresses:
201 • IEC Electropedia: available at http://www.electropedia.org/
202 • ISO Online browsing platform: available at http://www.iso.org/obp
203 NOTE 1 An index of defined terms is to be found at the end of the document.
204 NOTE 2 A searchable IEC Glossary can be found at std.iec.ch
205 3.1
206 CORRECTION FACTOR

207 dimensionless multiplier which corrects the INDICATED VALUE of an instrument from its value

208 when operated under particular conditions to its value when operated under stated REFERENCE

209 CONDITIONS
210 3.2
211 EFFECTIVE RANGE

212 range of INDICATED VALUES for which an instrument complies with a stated performance. The

213 maximum (minimum) effective INDICATED VALUE is the highest (lowest) in this range

214 3.3
215 INDICATED VALUE

216 value of quantity derived from the scale reading of an instrument together with any scale

217 factors indicated on the control panel of the instrument
218 3.4
219 INFLUENCE QUANTITY

220 any external quantity that may affect the performance of an instrument (e.g., ambient

221 temperature etc.) and any property of the X-RAY EQUIPMENT under test that needs to be taken

222 into account in using the instrument for NON-INVASIVE MEASUREMENT of X-RAY TUBE VOLTAGE

223 (e.g., range of X-RAY TUBE VOLTAGE, ANODE ANGLE, anode material, TOTAL FILTRATION etc.)

224 3.5
225 INSTRUMENT PARAMETER

226 any internal property of an instrument that may affect the performance of the instrument

227 3.6
228 INTRINSIC ERROR

229 deviation of the MEASURED VALUE (i.e., the INDICATED VALUE, corrected to REFERENCE

230 CONDITIONS) from the CONVENTIONAL TRUE VALUE under STANDARD TEST CONDITIONS
231 3.7
232 INVASIVE MEASUREMENT

233 measurement of the X-RAY TUBE VOLTAGE by external connection of a suitable meter or a high

234 resistance divider
235 3.8
236 LIMITS OF VARIATION

237 maximum VARIATION of a PERFORMANCE CHARACTERISTIC y, permitted by this standard. If the

238 LIMITS OF VARIATION are stated as ±L % the VARIATION y / y, expressed as a percentage, shall

239 remain in the range from −L % to +L %
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240 3.9
241 MAXIMUM PEAK VOLTAGE

242 maximum value of the X-RAY TUBE VOLTAGE in a specified time interval. The unit of this

243 quantity is the volt (V)
244 3.10
245 MEAN PEAK VOLTAGE

246 mean value of all X-RAY TUBE VOLTAGE peaks during a specified time interval. The unit of this

247 quantity is the volt (V)
248 3.11
249 MEASURED VALUE

250 best estimate of the CONVENTIONAL TRUE VALUE of a quantity, being derived from the INDICATED

251 VALUE of an instrument together with the application of all relevant CORRECTION FACTORS

252 NOTE The CONVENTIONAL TRUE VALUE will usually be the value determined by the working standard with which the

253 instrument under test is being compared.
254 3.12
255 MINIMUM EFFECTIVE RANGE

256 smallest permitted range of INDICATED VALUES for which an instrument complies with a stated

257 performance
258 3.13
259 NON-INVASIVE MEASUREMENT
260 measurement of X-RAY TUBE VOLTAGE by analysis of the emitted RADIATION
261 3.14
262 PERFORMANCE CHARACTERISTIC

263 one of the quantities used to define the performance of an instrument (e.g., RESPONSE)

264 3.15
265 VOLTAGE RIPPLE

266 VOLTAGE RIPPLE at the X-RAY TUBE, r, is expressed as a percentage of the peak voltage, U ,

max
267 over a specified time interval. This is expressed by the formula:
U − U
max min
268 r =  100%
max

269 where U is the highest voltage in the interval, and U is the lowest voltage in the interval

max min
270 3.16
271 PRACTICAL PEAK VOLTAGE (PPV)
272 PRACTICAL PEAK VOLTAGE is defined as:
max
p(U)  w(U)  U dU
max
ˆ min
273 U = with p(U) dU = 1
max
min
p(U)  w(U) dU
min

274 where p(U) is the distribution function for the voltage U and w(U) is a weighting function. Umax

275 is the highest voltage in the interval, and U is the lowest voltage in the interval. The unit of

min
276 the quantity PRACTICAL PEAK VOLTAGE is the volt (V)

277 NOTE Additional information on the PRACTICAL PEAK VOLTAGE, the weighting function w(U) and the distribution

278 function p(U) is provided in Annex C. Using this weighting function w(U) the PRACTICAL PEAK VOLTAGE will be

279 defined as the constant potential which produces the same AIR KERMA contrast behind a specified PHANTOM as the

280 non-dc voltage under test.
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281 3.17
282 RATED RANGE (of use)

283 range of values of an INFLUENCE QUANTITY or INSTRUMENT PARAMETER within which the

284 instrument will operate within the LIMITS OF VARIATION. Its limits are the maximum and

285 minimum RATED values.

286 The MINIMUM RATED RANGE is the least range of an INFLUENCE QUANTITY or INSTRUMENT

287 PARAMETER within which the instrument shall operate within the specified LIMITS OF VARIATION

288 in order to comply with this standard
289 3.18
290 REFERENCE CONDITIONS

291 conditions under which all INFLUENCE QUANTITIES and INSTRUMENT PARAMETERS have their

292 REFERENCE VALUES
293 3.19
294 REFERENCE VALUE

295 particular value of an INFLUENCE QUANTITY (or INSTRUMENT PARAMETER) chosen for the

296 purposes of reference i.e., the value of an INFLUENCE QUANTITY (or INSTRUMENT PARAMETER) at

297 which the CORRECTION FACTOR for dependence on that INFLUENCE QUANTITY (or INSTRUMENT

298 PARAMETER) is unity
299 3.20
300 RELATIVE INTRINSIC ERROR
301 ratio of the INTRINSIC ERROR to the CONVENTIONAL TRUE VALUE
302 3.21
303 RESPONSE
304 quotient of the INDICATED VALUE divided by the CONVENTIONAL TRUE VALUE
305 3.22
306 STANDARD TEST CONDITIONS

307 conditions under which all INFLUENCE QUANTITIES and INSTRUMENT PARAMETERS have their

308 STANDARD TEST VALUES
309 3.23
310 STANDARD TEST VALUES

311 value, values, or a range of values of an INFLUENCE QUANTITY or INSTRUMENT PARAMETER,

312 which is/are permitted when carrying out calibrations or tests on another INFLUENCE QUANTITY

313 or INSTRUMENT PARAMETER
314 3.24
315 VARIATION

316 relative difference y / y, between the values of a PERFORMANCE CHARACTERISTIC y, when one

317 INFLUENCE QUANTITY (or INSTRUMENT PARAMETER) assumes successively two specified values,

318 the other INFLUENCE QUANTITIES (and INSTRUMENT PARAMETERS) being kept constant at the

319 STANDARD TEST VALUES (unless other values are specified)
320 3.25
321 X-RAY TUBE VOLTAGE

322 potential difference applied to an X-RAY TUBE between the anode and the cathode. The unit of

323 this quantity is the volt (V)
324 4 General performance requirements for measurement of PRACTICAL PEAK
325 VOLTAGE measurements
326 4.1 Quantity to be measured
327 The quantity to be measured is the PRACTICAL PEAK VOLTAGE.
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328 NOTE Additional quantities may be displayed.

329 The MINIMUM EFFECTIVE RANGES of PRACTICAL PEAK VOLTAGE shall be as listed in table 1 for the

330 relevant X-RAY applications.
331 Table 1 – MINIMUM EFFECTIVE RANGES
Application Nominal anode material MINIMUM EFFECTIVE RANGE
Mammography
a)
24 kV to 35 kV
(20 kV to 50 kV)
Diagnostic
W 60 kV to 120 kV
(40 kV to 150 kV)
W 80 kV to 140 kV
(70 kV to 150 kV)
Dental
W 60 kV to 90 kV
(40 kV to 110 kV)
Fluoroscopic
W 60 kV to 120 kV
(40 kV to 130 kV)

For mammography anode materials other than Mo, the MINIMUM EFFECTIVE RANGE of PPV shall be at least 10 kV.

332
333 4.2 Limits of PERFORMANCE CHARACTERISTICs
334 4.2.1 Limits

335 All values of the limits of PERFORMANCE CHARACTERISTICS stated in this subclause do not

336 contain the uncertainty of the test equipment.
337 4.2.2 Maximum error
338 4.2.2.1 Maximum RELATIVE INTRINSIC ERROR for voltages above 50 kV

339 The RELATIVE INTRINSIC ERROR, l, of PRACTICAL PEAK VOLTAGE, , measurements made under

340 STANDARD TEST CONDITIONS, shall not be greater than ±2 % over the EFFECTIVE RANGE of

341 voltages. This is expressed by the formula:
ˆ ˆ
U − U
meas true
342 I =  0,02
true
ˆ ˆ

343 where U is the MEASURED VALUE of PRACTICAL PEAK VOLTAGE and U is the true value of

meas true

344 the PRACTICAL PEAK VOLTAGE. The voltages for the MINIMUM EFFECTIVE RANGE are listed in

345 table 1.

346 The compliance test for performance requirement 4.2.2.1 is listed under 4.2.2.2.

347 4.2.2.2 Maximum INTRINSIC ERROR for voltages below 50 kV

348 The maximum INTRINSIC ERROR, E, of PRACTICAL PEAK VOLTAGE, , measurements made under

349 STANDARD TEST CONDITIONS shall not be greater than ±1 kV over the EFFECTIVE RANGE of

350 voltages. This is expressed by the formula:
ˆ ˆ
351
E = U − U  1,0 kV
meas true
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oSIST prEN IEC 61676:2022
62C/830/CDV – 12 – IEC CDV 61676 © IEC 2021
ˆ ˆ

352 where is the MEASURED VALUE of PRACTICAL PEAK VOLTAGE and is the conventional

U U
meas true

353 true value of the PRACTICAL PEAK VOLTAGE. The voltages for the MINIMUM EFFECTIVE RANGE are

354 listed in table 1.
355 C
...

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