IEC 60580:2019

IEC 60580 ®
Edition 3.0 2019-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment – Dose area product meters

Appareils électromédicaux – Radiamètres de produit exposition-surface

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IEC 60580 ®
Edition 3.0 2019-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment – Dose area product meters

Appareils électromédicaux – Radiamètres de produit exposition-surface

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-7591-7

– 2 – IEC 60580:2019 © IEC 2019
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 8
4 General requirements . 14
4.1 Performance requirements . 14
4.2 Minimum EFFECTIVE RANGES of DOSE AREA PRODUCT and DOSE AREA PRODUCT
RATE . 14
4.3 Plane of measurement . 14
4.4 REFERENCE VALUES and STANDARD TEST CONDITIONS . 14
4.5 General test conditions . 15
4.5.1 STANDARD TEST CONDITIONS . 15
4.5.2 Test of components . 15
4.5.3 STABILIZATION TIME . 15
4.5.4 Adjustments during test . 16
4.5.5 Uniformity of RADIATION field . 16
4.6 Statistical fluctuations . 16
4.7 Uncertainty of measurement . 17
4.8 Constructional requirements as related to performance . 17
4.8.1 Display . 17
4.8.2 Indication of polarizing voltage failure . 17
4.8.3 Over-ranging . 17
4.8.4 Indication of reset or other inactive condition . 18
4.8.5 RADIATION DETECTOR . 18
4.9 STABILITY CHECK DEVICE . 18
4.10 Adjustment . 19
4.11 Electrical safety . 20
5 Limits of PERFORMANCE CHARACTERISTICS under STANDARD TEST CONDITIONS . 20
5.1 Classification of DOSE AREA PRODUCT METERS according to LIMITS OF
VARIATION . 20
5.1.1 REFERENCE-CLASS DOSE AREA PRODUCT METERS . 20
5.1.2 FIELD-CLASS DOSE AREA PRODUCT METERS . 20
5.2 LINEARITY . 20
5.3 Warning function . 20
5.4 Repeatability . 21
5.5 RESOLUTION of reading . 21
5.6 STABILIZATION TIME . 21
5.7 Reset on DOSE AREA PRODUCT ranges . 21
5.8 Drift of INDICATED VALUES . 21
5.9 Long term stability . 22
5.10 RESPONSE TIME . 22
5.11 Spatial uniformity of RESPONSE . 23
6 LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES . 23
6.1 General . 23
6.2 Energy dependence of RESPONSE . 23

6.3 DOSE AREA PRODUCT RATE dependence of DOSE AREA PRODUCT measurements. 23
6.3.1 MEASURING ASSEMBLY . 23
6.3.2 IONIZATION CHAMBER – Recombination losses . 24
6.4 IRRADIATION TIME . 24
6.5 Field size . 24
6.6 Operating voltage . 24
6.7 Air pressure . 25
6.8 Temperature and humidity . 25
6.9 Air density fluctuation in the IONIZATION CHAMBER . 25
6.10 Electromagnetic compatibility . 25
6.10.1 General . 25
6.10.2 Electrostatic discharge . 26
6.10.3 Radiated electromagnetic fields . 26
6.10.4 Conducted disturbances induced by bursts and high frequencies . 26
6.10.5 Surges . 27
6.10.6 Voltage dips, short interruptions and voltage VARIATIONS . 27
6.11 COMBINED STANDARD UNCERTAINTY . 27
7 Marking . 29
7.1 MEASURING ASSEMBLY . 29
7.2 RADIATION DETECTOR . 30
8 ACCOMPANYING DOCUMENTS . 30
Bibliography . 32
INDEX OF DEFINED TERMS . 33

Table 1 – Minimum EFFECTIVE RANGES – DOSE AREA PRODUCT . 14
Table 2 – Minimum EFFECTIVE RANGES – DOSE AREA PRODUCT RATE . 14
Table 3 – REFERENCE VALUES and STANDARD TEST CONDITIONS . 15
Table 4 – Number of readings required to detect true differences ∆ (95 % confidence
level) between two sets of instrument readings . 16
Table 5 – LIMITS OF VARIATION for the effects of INFLUENCE QUANTITIES . 19
Table 6 – Maximum values for the COEFFICIENT OF VARIATION, V . 21
max
Table 7 – Climatic conditions . 25
Table 8 – Example for assessment of the COMBINED STANDARD UNCERTAINTY – FIELD-
CLASS DOSE AREA PRODUCT METER . 28
Table 9 – Example for assessment of the COMBINED STANDARD UNCERTAINTY –
REFERENCE-CLASS DOSE AREA PRODUCT METER . 29

– 4 – IEC 60580:2019 © IEC 2019
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
DOSE AREA PRODUCT METERS
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
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
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Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
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with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
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3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
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6) All users should ensure that they have the latest edition of this publication.
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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 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 60850 has been prepared by subcommittee 62C: Equipment for
radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee 62:
Electrical equipment in medical practice.
This third edition cancels and replaces the second edition published 2000, and constitutes a
technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) a second class of devices is introduced with tighter uncertainty tolerances;
b) this document has been expanded to include detectors other than ionization chambers;
c) radiation qualities have been updated to the new definitions according to IEC 61267;
d) a requirement on the linearity of the dose area product rate measurement was added;
e) changed chamber light transmission requirement from 70 % to 60 %.

The text of this International Standard is based on the following documents:
FDIS Report on voting
62C/744/FDIS 62C/751/RVD
Full information on the voting for the approval of this International Standard can be found in
the report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: in roman type;
– explanations, advice, general statements, exceptions and references: small roman type;
– test specifications: italic type;
– TERMS USED THROUGHOUT THIS STANDARD WHICH HAVE BEEN DEFINED IN CLAUSE 3 OR LISTED IN
THE INDEX: SMALL CAPITALS.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
– 6 – IEC 60580:2019 © IEC 2019
INTRODUCTION
Diagnostic radiology is the largest contributor to man-made ionizing radiation to which the
public is exposed. The reduction in the exposure received by PATIENTS undergoing MEDICAL
RADIOLOGICAL EXAMINATIONS or procedures has therefore become a central issue in recent
years. The purpose of routine measurement of DOSE AREA PRODUCT is to help in achieving an
overall reduction in the radiation received by PATIENTS undergoing MEDICAL RADIOLOGICAL
EXAMINATIONS. Provided adequate records are kept, it is possible to determine PATIENT doses,
to compare different examination techniques, to establish a technique giving minimum
RADIATION to a PATIENT, and to ensure a maintenance of that technique; in this respect, such
measurements have a place of particular importance in training establishments. Examination
of records may also indicate a deterioration in the efficiency of the image-production system.

MEDICAL ELECTRICAL EQUIPMENT –
DOSE AREA PRODUCT METERS
1 Scope
This document specifies the performance and testing of DOSE AREA PRODUCT METERS intended
to measure DOSE AREA PRODUCT and/or DOSE AREA PRODUCT RATE to which the PATIENT is
during MEDICAL RADIOLOGICAL EXAMINATIONS.
exposed
This document is applicable to the following types of DOSE AREA PRODUCT METERS:
FIELD-CLASS DOSE AREA PRODUCT METERS normally used for the measurement of DOSE AREA
a)
PRODUCTS during MEDICAL RADIOLOGICAL EXAMINATIONS;
b) REFERENCE-CLASS DOSE AREA PRODUCT METERS normally used for the CALIBRATION of FIELD-
CLASS DOSIMETERS.
NOTE REFERENCE-CLASS DOSE AREA PRODUCT METERS can be used as FIELD-CLASS DOSE AREA PRODUCT
METERS.
The object of this document is
1) to establish requirements for a satisfactory level of performance for DOSE AREA PRODUCT
METERS, and
2) to standardize the methods for the determination of compliance with this level of
performance.
Two levels of performance are specified:
– a lower level of performance applying to FIELD-CLASS DOSE AREA PRODUCT METERS;
– a higher level of performance applying to REFERENCE-CLASS DOSE AREA PRODUCT METERS.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their
content constitutes requirements of this document. For dated references, only the edition
cited applies. For undated references, the latest edition of the referenced document (including
any amendments) applies.
IEC 60417, Graphical symbols for use on equipment (available at http://www.graphical-
symbols.info/equipment)
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1-2, Medical electrical equipment – Part 1-2: General requirements for basic safety
and essential performance – Collateral Standard: Electromagnetic disturbances –
Requirements and tests
IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms
IEC 62368-1, Audio/video, information and communication technology equipment – Part 1:
Safety requirements
– 8 – IEC 60580:2019 © IEC 2019
IEC 61000-4-2, Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurement
techniques – Electrostatic discharge immunity test
IEC 61000-4-3, Electromagnetic compatibility (EMC) – Part 4-3: Testing and measurement
techniques – Radiated, radio-frequency, electromagnetic field immunity test
IEC 61000-4-4, Electromagnetic compatibility (EMC) – Part 4-4: Testing and measurement
techniques – Electrical fast transient/burst immunity test
IEC 61000-4-5, Electromagnetic compatibility (EMC) – Part 4-5: Testing and measurement
techniques – Surge immunity test
IEC 61000-4-6, Electromagnetic compatibility (EMC) – Part 4-6: Testing and measurement
techniques – Immunity to conducted disturbances induced by radio-frequency fields
IEC 61000-4-11, Electromagnetic compatibility (EMC) – Part 4-11: Testing and measurement
techniques – Voltage dips, short interruptions and voltage variations immunity tests
IEC 61187, Electrical and electronic measuring equipment – Documentation
IEC 61267, Medical diagnostic X-ray equipment – Radiation conditions for use in the
determination of characteristics
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005, IEC
TR 60788:2004 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
NOTE 1 An index of defined terms is to be found at the end of the document.
NOTE 2 A searchable IEC Glossary can be found at std.iec.ch.
3.1
ACCOMPANYING DOCUMENT
document provided with an installation, equipment, associated equipment or accessory,
containing important information for the assembler, installer and user, particularly regarding
safety
3.2
AIR KERMA
K
quotient of dE by dm, where dE is the sum of the initial kinetic energies of all the charged
tr tr
particles in a mass dm of air, thus
dE
tr
K=
dm
–1
Note 1 to entry: Unit: J kg .
Note 2 to entry: The special name for the unit of AIR KERMA is gray (Gy) (ICRU 85A).

3.3
AIR KERMA RATE

K
quotient of dK by dt, where dK is the increment of AIR KERMA in the time interval dt, thus

dK
K
=
dt
–1 –1
Note 1 to entry: Unit: J kg s .
–1
Note 2 to entry: The special name for the unit of AIR KERMA rate is gray per second (Gy s ) (ICRU 85A).
3.4
COEFFICIENT OF VARIATION
standard deviation of a set of readings expressed as a percentage of the mean value of these
readings
3.5
CORRECTION FACTOR
INDICATED VALUE of an instrument from its value
dimensionless multiplier which corrects the
when operated under particular conditions to its value when operated under stated REFERENCE
CONDITIONS
[SOURCE: IEC 60731:2011, 3.6]
3.6
DOSE AREA PRODUCT
K·A
product of the area of the USEFUL BEAM and the AIR KERMA over the cross-section of the USEFUL
BEAM, both quantities being measured at the same distance from the FOCAL SPOT
Note 1 to entry: The unit of DOSE AREA PRODUCT is Gym .
3.7
DOSE AREA PRODUCT METER
equipment for the measurement of DOSE AREA PRODUCT or DOSE AREA PRODUCT RATE in the
beam of an X-ray machine used for diagnostic MEDICAL RADIOLOGICAL EXAMINATIONS
Note 1 to entry: A DOSE AREA PRODUCT METER contains the following components:
– RADIATION DETECTOR;
– MEASURING ASSEMBLY;
– STABILITY CHECK DEVICE.
3.8
DOSE AREA PRODUCT RATE

K ·A
quotient of an increment of DOSE AREA PRODUCT by the corresponding increment of time
Note 1 to entry: The unit of DOSE AREA PRODUCT RATE is Gym /s.
3.9
EFFECTIVE RANGE (of INDICATED VALUES)
range of INDICATED VALUES for which an instrument complies with a stated performance; the
maximum (minimum) EFFECTIVE INDICATED VALUE is the highest (lowest) in this range
Note 1 to entry: The concept of EFFECTIVE RANGE can, for example, also be applied to scale readings and to
related quantities that are not directly indicated by the instrument, e.g. input current. Its limits are the maximum
and MINIMUM RATED VALUES.
Note 2 to entry: The EFFECTIVE RANGE of INDICATED VALUES is referred to as EFFECTIVE RANGE in this document.

– 10 – IEC 60580:2019 © IEC 2019
3.10
FIELD-CLASS DOSE AREA PRODUCT METER
DOSE AREA PRODUCT METER whose performance and stability are sufficient for it to be used to
make routine measurements
Note 1 to entry: DOSE AREA PRODUCT METERS built in or permanently connected to the diagnostic X-ray unit are
normally field-class instruments, but can also be reference-class instruments.
3.11
FILTRATION
modification of characteristics of ionizing RADIATION on passing through matter
Note 1 to entry: FILTRATION includes:
– modification of the energy spectrum of ionizing RADIATION by preferential absorption of components;
– modification of the spatial distribution of RADIATION intensity over the cross section of a RADIATION beam,
by differential ATTENUATION.
3.12
HALF-VALUE LAYER
thickness of a specified material which under NARROW BEAM CONDITIONS attenuates photon
RADIATION according to its energy spectrum to an extent such that the AIR KERMA RATE is
reduced to one half of the value that is measured without the material
3.13
INDICATED VALUE
value of a quantity derived from the scale reading of an instrument together with any scale
factors indicated on the control panel of the instrument
[SOURCE: IEC 60731:2011, 3.2]
3.14
INFLUENCE QUANTITY
any external quantity that may affect the performance of an instrument (e.g. ambient
temperature, RADIATION QUALITY etc.)
[SOURCE: IEC 60731:2011, 3.7, modified – addition of the parenthesis]
3.15
INSTRUMENT PARAMETER
any internal property of an instrument that may affect the performance of this instrument
[SOURCE: IEC 60731:2011, 3.8]
3.16
IONIZATION CHAMBER
detector consisting of a chamber filled with a suitable medium, usually gaseous, in which an
electric field, insufficient to induce charge multiplication, is provided for the collection at the
electrodes of charges associated with ions and the electrons produced in the SENSITIVE
VOLUME of the detector by ionizing RADIATION
3.17
IRRADIATION TIME
duration of irradiation determined according to specific methods, usually the time during which
the rate of a RADIATION quantity exceeds a specified level
3.18
LIMITS OF VARIATION
maximum VARIATION of a PERFORMANCE CHARACTERISTIC, y, permitted by this document

Note 1 to entry: If LIMITS OF VARIATION are stated as ±L %, the VARIATION, ∆y/y, expressed as a percentage,
remain in the range from –L % to +L %.
[SOURCE: IEC 60731:2011, 3.13, modified – addition of " y, permitted by this document".]
3.19
LINEARITY
maximum VARIATION of the RESPONSE of an instrument within the EFFECTIVE RANGE of
measurement quantity, permitted by this document
3.20
MANUFACTURER
organization or individual who produces an equipment
3.21
MEASURED VALUE
value of a physical quantity derived by applying all relevant corrections to an INDICATED VALUE
3.22
MEASURING ASSEMBLY
device to convert the output from the RADIATION DETECTOR into a form suitable for the display
of the value(s) of DOSE AREA PRODUCT or DOSE AREA PRODUCT RATE
3.23
MEDICAL RADIOLOGICAL EXAMINATION
medical examination using ionizing RADIATION
3.24
MINIMUM RATED RANGE
least range of an INFLUENCE QUANTITY or INSTRUMENT PARAMETER within which the instrument
shall operate within the specified LIMITS OF VARIATION in order to comply with this document
[SOURCE: IEC 60731:2011, 3.15.1, modified – addition of "in order to comply with this
document".]
3.25
PATIENT
living being (person or animal) undergoing medical investigation or treatment
[SOURCE: IEC 60601-1:2005, 3.76, modified – replacement of "a medical, surgical or dental
procedure" by "medical investigation or treatment"]
3.26
PERFORMANCE CHARACTERISTIC
one of the quantities used to define the performance of an instrument (e.g. RESPONSE,
RADIATION DETECTOR LEAKAGE CURRENT)
[SOURCE: IEC 60731:2011, 3.11, modified – modification of the example]
3.27
QUALITY EQUIVALENT FILTRATION
quantitative indication of the FILTRATION effected by one or several layer(s) of reference
material(s) which, if substituted in a beam of specified RADIATION QUALITY under NARROW BEAM
CONDITION for the material or an object under consideration, give(s) the same RADIATION
QUALITY as for the material under consideration

– 12 – IEC 60580:2019 © IEC 2019
3.28
RADIATION DETECTOR
equipment, generally sub-assembly, or substance which, in the presence of RADIATION,
provides by either direct or indirect means a signal or other indication suitable for use in
measuring one or more quantities of the incident RADIATION
3.29
RADIATION DETECTOR LEAKAGE CURRENT
any current in the signal path arising in the RADIATION DETECTOR system which is not produced
by ionizing RADIATION in the measuring volume
3.30
RADIATION QUALITY
for a specific type of RADIATION, the description of any characteristic that depends on its
energy spectrum
Note 1 to entry: For the purposes of this document, a practical approximation of RADIATION QUALITY is expressed
as the quotient of the first HALF-VALUE LAYER and the second HALF-VALUE LAYER.
3.31
RATED FIELD SIZE
size of the USEFUL BEAM at the RADIATION DETECTOR within which the RADIATION DETECTOR
performs to its specification
3.32
RATED RANGE (of use)
range of values of an INFLUENCE QUANTITY or INSTRUMENT PARAMETER within which the
instrument will operate within the LIMITS OF VARIATION
Note 1 to entry: Its limits are the maximum and MINIMUM RATED VALUES.
Note 2 to entry: The EFFECTIVE RANGE of use is referred to as RATED RANGE in this document.
[SOURCE: IEC 60731:2011, 3.15, modified – Addition of the Note 2 to entry.]
3.33
REFERENCE CONDITIONS
conditions under which all INFLUENCE QUANTITIES and INSTRUMENT PARAMETERS have their
REFERENCE VALUES
[SOURCE: IEC 60731:2011, 3.9.1]
3.34
REFERENCE-CLASS DOSE AREA PRODUCT METER
DOSE AREA PRODUCT METER whose performance and stability are sufficient for it to be used to
calibrate other DOSE AREA PRODUCT METERs or for higher-precision field use requirements
3.35
REFERENCE VALUE
particular value of an INFLUENCE QUANTITY (or INSTRUMENT PARAMETER) chosen for the purpose
of reference
Note 1 to entry: I.e. the value of an INFLUENCE QUANTITY (or INSTRUMENT PARAMETER) at which the CORRECTION
FACTOR for dependence on that INFLUENCE QUANTITY (or INSTRUMENT PARAMETER) is unity.
[SOURCE: IEC 60731:2011, 3.9]
3.36
RESPONSE
quotient of the INDICATED VALUE divided by the CONVENTIONAL TRUE VALUE

[SOURCE: IEC 60731:2011, 3.11.1, modified – "ionization charge or current" was replaced by
"indicated value".]
3.37
RESPONSE TIME
the time taken for a scale reading to reach and remain within a specified deviation from its
final steady value, after a sudden change in the quantity being measured
[SOURCE: IEC 60731:2011, 3.11.4, modified – "scale" was added to the definition.]
3.38
RESOLUTION OF THE DISPLAY
smallest change of scale reading to which a numerical value can be assigned without further
interpolation
Note 1 to entry: For an analogue display, the RESOLUTION is the smallest fraction of a scale interval that can be
determined by an observer under specified conditions.
Note 2 to entry: For a digital display, the RESOLUTION is the smallest significant increment of the reading.
[SOURCE: IEC 60731:2011, 3.11.2, modified – Addition of new notes to entry.]
3.39
STABILITY CHECK DEVICE
device, either separate or integral part of the DOSE AREA PRODUCT METER, which enables the
stability of the RESPONSE of the RADIATION DETECTOR and/or MEASURING ASSEMBLY to be
checked
Note 1 to entry: The STABILITY CHECK DEVICE can be a purely electrical device.
3.40
STABILIZATION TIME
time taken for a stated PERFORMANCE CHARACTERISTIC to reach and remain within a specified
deviation from its final steady value, after the DOSE AREA PRODUCT METER has been switched
on and after the polarizing voltage, if needed, has been applied to the RADIATION DETECTOR
3.41
STANDARD TEST CONDITIONS
conditions under which all INFLUENCE QUANTITIES and INSTRUMENT PARAMETERS have their
STANDARD TEST VALUES
[SOURCE: IEC 60731:2011, 3.10.1]
3.42
STANDARD TEST VALUES
value, values or range of values of an INFLUENCE QUANTITY or INSTRUMENT PARAMETER which
are permitted when carrying out calibrations or tests on another INFLUENCE QUANTITY or
INSTRUMENT PARAMETER
[SOURCE: IEC 60731:2011, 3.10]
3.43
USEFUL BEAM
all X-rays which emerge through a cone defined by the focus point and the specified aperture
of its PROTECTIVE SHIELDING or of its BEAM-LIMITING DEVICE

– 14 – IEC 60580:2019 © IEC 2019
3.44
USEFUL FIELD
cross section of the USEFUL BEAM, perpendicular to its specified direction at a specified
distance from the FOCAL SPOT or at a specified plane of measurement
3.45
VARIATION
relative difference, ∆y/y, between the values of a PERFORMANCE CHARACTERISTIC, y, when one
INFLUENCE QUANTITY (or INSTRUMENT PARAMETER) successively assumes two specified values,
the other INFLUENCE QUANTITIES (and INSTRUMENT PARAMETERS) being kept constant at the
STANDARD TEST VALUES (unless other values are specified)
[SOURCE: IEC 60731:2011, 3.12]
4 General requirements
4.1 Performance requirements
In Clauses 5 and 6 the performance requirements are stated for a complete DOSE AREA
PRODUCT METER including both the RADIATION DETECTOR and MEASURING ASSEMBLY. For a DOSE
AREA PRODUCT METER designed to operate with one or more RADIATION DETECTORS, each
combination of the MEASURING ASSEMBLY and RADIATION DETECTOR shall comply with the
requirements in 4.6, and in Clauses 5 and 6 relevant to this combination.
4.2 Minimum EFFECTIVE RANGES of DOSE AREA PRODUCT and DOSE AREA PRODUCT RATE
The minimum EFFECTIVE RANGES of DOSE AREA PRODUCT and DOSE AREA PRODUCT RATE are
listed in Tables 1 and 2.
Table 1 – Minimum EFFECTIVE RANGES – DOSE AREA PRODUCT
Application Minimum EFFECTIVE RANGE
5 2
Standard procedures (1,0 – 1,0 × 10 ) µGym
1 6 2
Long time fluoro (1,0 × 10 – 1,0 × 10 ) µGym
–1 4 2
Paediatric procedures (1,0 × 10 – 1,0 × 10 ) µGym

Table 2 – Minimum EFFECTIVE RANGES – DOSE AREA PRODUCT RATE
Application Minimum EFFECTIVE RANGE
–1 3 2
Standard procedures (1,0 × 10 – 1,0 × 10 ) µGym /s
–1 3 2 a
Paediatric procedures (1,0 × 10 – 1,0 × 10 ) µGym /s
a –2 3 2
(1,0 × 10 – 1,0 × 10 ) µGym /s recommended

4.3 Plane of measurement
The instrument shall be designed so as to indicate the DOSE AREA PRODUCT and/or the DOSE
AREA PRODUCT RATE in the USEFUL BEAM for the plane in which the RADIATION is incident on the
PATIENT, excluding, as far as practicable, the contribution of back-scattering to the MEASURED
VALUE.
4.4 REFERENCE VALUES and STANDARD TEST CONDITIONS
These values are as given in Table 3.

Table 3 – REFERENCE VALUES and STANDARD TEST CONDITIONS
INFLUENCE QUANTITY REFERENCE VALUES STANDARD TEST CONDITIONS
Temperature +20 °C +15 °C to +25 °C
Relative humidity 50 % 30 % to 75 %
Air pressure 101,3 kPa Atmospheric pressure
a
DOSE AREA PRODUCT RATE As at CALIBRATION REFERENCE VALUE ±10 %
RADIATION QUALITY 100 kV (RQR 8, IEC 61267) REFERENCE VALUE
IRRADIATION TIME As at CALIBRATION REFERENCE VALUE ±10 %
Field size As at CALIBRATION REFERENCE VALUE
b
Electromagnetic fields Zero Insignificant
a
DOSE AREA PRODUCT RATE is only an INFLUENCE QUANTITY for DOSE AREA PRODUCT MEASUREMENTS.
b
Insignificant means that the field is sufficiently small not to have any determinable effect on the RESPONSE of the

DOSE AREA PRODUCT METER, e.g. as exists in a normal laboratory environment without special shielding.

4.5 General test conditions
4.5.1 STANDARD TEST CONDITIONS
STANDARD TEST CONDITIONS listed in Table 3 shall be met during the test procedure except
The
a) for the INFLUENCE QUANTITY under investigation;
b) where local conditions of temperature and relative humidity are outside the STANDARD TEST
CONDITIONS. In this case the tester shall demonstrate the validity of the test results.
4.5.2 Test of components
The preferred procedure for verifying that the performance requirements are met is to test the
components separately, in which case:
– tests on the RADIATION DETECTOR shall be performed using a "high-precision" MEASURING
ASSEMBLY;
– tests on the MEASURING ASSEMBLY shall be carried out using a "high-precision" current or
charge source, as required, connected to the input.
In this context, "high precision" means that the PERFORMANCE CHARACTERISTICS of the test
equipment shall be such that they perturb the value of the particular PERFORMANCE
CHARACTERISTIC being measured by less than one-quarter of the LIMITS OF VARIATION.
Any tests may be carried out using the complete DOSE AREA PRODUCT METER; in particular, this
is the preferred method for investigating the effects of high-frequency electromagnetic fields
and electrostatic discharges on a cable-connected RADIATION DETECTOR supplied with a
MEASURING ASSEMBLY as a system. Some tests performed with the whole system cannot give
information as to whether the origin of the VARIATION lies in the RADIATION DETECTOR or in the
MEASURING ASSEMBLY (e.g. RADIATION DETECTOR LEAKAGE CURRENT and ZERO DRIFT). If a
complete system is tested and the relevant INFLUENCE QUANTITY affects both parts, the
quadratic sum of the separate LIMITS OF VARIATION may be taken as an overall LIMIT OF
VARIATION.
4.5.3 STABILIZATION TIME
The instrument shall be switched on for at least the STABILIZATION TIME quoted by the
MANUFACTURER, before the start of the compliance test.

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In addition, the RADIATION DETECTOR should be allowed to attain thermal equilibrium with the
environment and it should have the polarizing voltage, if needed, applied for a period of time
equal to or greater than the specified STABILIZATION TIME.
4.5.4 Adjustments during test
Compliance tests shall be performed with the instrument ready for use, after the STABILIZATION
TIME and after making any necessary preliminary adjustments. During the tests, adjustments
may be repeated at intervals as long as they do not interfere with the effect to be verified. For
example, zero setting is not permitted during tests for measuring the RADIATION DETECTOR
LEAKAGE CURRENT.
4.5.5 Uniformity of RADIATION field
The uniformity over the part of the USEFUL FIELD used for the compliance test shall be checked,
for example, by scanning the RADIATION field with a small RADIATION DETECTOR compared with
the size of the USEFUL FIELD. Appropriate corrections shall be made to ensure an uncertainty
of the test results of not more than one-fifth of the LIMITS OF VARIATION under test.
NOTE The field uniformity of any X-RAY TUBE is subject to deterioration in use; regular checks are made.
4.6 Statistical fluctuations
At low DOSE AREA PRODUCT and DOSE AREA PRODUCT RATES the magnitude of the statistical
fluctuations of the instrument’s reading due to the random nature of the RADIATION alone may
be a significant fraction of the VARIATION of the mean reading permitted in the test. A sufficient
number of readings shall be taken to ensure that the mean value of such readings may be
estimated with sufficient precision to demonstrate compliance or non-compliance with the test
requirements. Table 4 provides guidance on the number of readings required to determine
true differences between two sets of instrument readings at the 95 % confidence level. The
number of readings, n, and the COEFFICIENT OF VARIATION, v, of the sets of readings (assumed
to be equal for each set) is listed.
Table 4 – Number of readings required to detect true differences ∆
(95 % confidence level) between two sets of instrument readings
Number of readings required, n
COEFFICIENT OF VARIATION, v
< 0,5 % 0,5 % 1 % 2 % 3 % 4 % 5 % 10 %
∆
1 %
...