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IEC 60580
Edition 3.0 2019-11
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment – Dose area product meters
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IEC 60580
Edition 3.0 2019-11
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment – Dose area product meters
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.50 ISBN 978-2-8322-7605-1
– 2 – IEC 60580:2019 RLV © IEC 2019
CONTENTS
FOREWORD . 4
INTRODUCTION . 2
1 Scope and object . 7
2 Normative references . 7
3 Terms and definitions . 8
4 General requirements . 15
4.1 Performance requirements . 15
4.2 Minimum EFFECTIVE RANGES of DOSE AREA PRODUCT and DOSE AREA PRODUCT
RATE . 15
4.3 Plane of measurement . 16
4.4 REFERENCE VALUES and STANDARD TEST CONDITIONS . 16
4.5 General test conditions . 16
4.5.1 STANDARD TEST CONDITIONS . 16
4.5.2 Test of components . 17
4.5.3 STABILIZATION TIME . 17
4.5.4 Adjustments during test . 17
4.5.5 Uniformity of RADIATION field . 17
4.6 Statistical fluctuations . 17
4.7 Uncertainty of measurement . 18
4.8 Constructional requirements as related to performance . 18
4.8.1 Display . 18
4.8.2 Indication of polarizing voltage failure . 19
4.8.3 Over-ranging . 19
4.8.4 Indication of reset or other inactive condition . 19
4.8.5 IONIZATION CHAMBER RADIATION DETECTOR . 19
4.9 STABILITY CHECK DEVICE . 20
4.10 Adjustment . 21
4.11 Electrical safety . 21
5 Limits of PERFORMANCE CHARACTERISTICS under STANDARD TEST CONDITIONS . 21
RELATIVE INTRINSIC ERROR .
5.1 Classification of DOSE AREA PRODUCT METERS according to LIMITS OF
VARIATION . 22
5.1.1 REFERENCE-CLASS DOSE AREA PRODUCT METERS . 22
5.1.2 FIELD-CLASS DOSE AREA PRODUCT METERS . 22
5.2 LINEARITY . 23
5.3 Warning function . 22
5.4 Repeatability . 23
5.5 RESOLUTION of reading . 24
5.6 STABILIZATION TIME . 24
5.7 Reset on DOSE AREA PRODUCT ranges . 24
5.8 Drift of INDICATED VALUES . 24
5.9 Long term stability . 25
5.10 RESPONSE TIME . 25
5.11 Spatial uniformity of RESPONSE . 26
6 LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES . 26
6.1 General . 26
6.2 Energy dependence of RESPONSE . 26
6.3 DOSE AREA PRODUCT RATE dependence of DOSE AREA PRODUCT measurements. 26
6.3.1 MEASURING ASSEMBLY . 26
6.3.2 IONIZATION CHAMBER – Recombination losses . 27
6.4 IRRADIATION TIME . 27
6.5 Field size . 27
6.6 Operating voltage . 27
6.7 Air pressure . 27
6.8 Temperature and humidity . 28
6.9 Air density fluctuation in the IONIZATION CHAMBER . 28
6.10 Electromagnetic compatibility . 28
6.10.1 General . 28
6.10.2 Electrostatic discharge . 29
6.10.3 Radiated electromagnetic fields . 29
6.10.4 Conducted disturbances induced by bursts and high frequencies . 29
6.10.5 Surges . 30
6.10.6 Voltage dips, short interruptions and voltage VARIATIONS . 30
6.11 COMBINED STANDARD UNCERTAINTY . 30
7 Marking . 32
7.1 MEASURING ASSEMBLY . 33
7.2 IONIZATION CHAMBER RADIATION DETECTOR . 34
8 ACCOMPANYING DOCUMENTS . 34
Bibliography . 36
INDEX OF DEFINED TERMS . 37
Table – RELATIVE INSTRINSIC ERROR, I .
Table 1 – Minimum EFFECTIVE RANGES – DOSE AREA PRODUCT . 16
Table 2 – Minimum effective ranges – DOSE AREA PRODUCT RATE . 16
Table 3 – REFERENCE VALUES and STANDARD TEST CONDITIONS . 16
Table 4 – Number of readings required to detect true differences ∆ (95 % confidence
level) between two sets of instrument readings . 18
Table 5 – LIMITS OF VARIATION for the effects of INFLUENCE QUANTITIES . 20
Table 6 – Maximum values for the COEFFICIENT OF VARIATION, V . 24
max
Table 7 – Climatic conditions . 28
Table – Example for assessment of the COMBINED STANDARD UNCERTAINTY .
Table 8 – Example for assessment of the COMBINED STANDARD UNCERTAINTY – FIELD-
CLASS DOSE AREA PRODUCT METER . 32
Table 9 – Example for assessment of the COMBINED STANDARD UNCERTAINTY –
REFERENCE-CLASS DOSE AREA PRODUCT METER . 33
– 4 – IEC 60580:2019 RLV © IEC 2019
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
DOSE AREA PRODUCT METERS
FOREWORD
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