Iec 61223 3 1 1999

23 6.8 *AIR KERMA RATE at the ENTRANCE PLANE of the X-RAY IMAGE INTENSIFIER for RADIOSCOPY.... 4.4 Test parameters – X-RAY TUBE VOLTAGE;– CURRENT TIME PRODUCT;– LOADING TIME; – FOCAL SPO

Evaluation and routine testing

in medical imaging departments –

Part 3-1:

Acceptance tests –

Imaging performance of X-ray equipment

for radiographic and radioscopic systems

Essais d'évaluation et de routine

dans les services d'imagerie médicale –

Partie 3-1:

Essais d'acceptation –

Performance d'imagerie des appareils

à rayonnement X pour systèmes radiographiques

et radioscopiques

Reference number IEC 61223-3-1:1999(E)

base publication, the base publication incorporating amendment 1 and the base

publication incorporating amendments 1 and 2.

Validity of this publication

The technical content of IEC publications is kept under constant review by the IEC,

thus ensuring that the content reflects current technology.

Information relating to the date of the reconfirmation of the publication is available

in the IEC catalogue.

Information on the subjects under consideration and work in progress undertaken

by the technical committee which has prepared this publication, as well as the list

of publications issued, is to be found at the following IEC sources:

• IEC web site*

• Catalogue of IEC publications

Published yearly with regular updates

(On-line catalogue)*

• IEC Bulletin

Available both at the IEC web site* and as a printed periodical

Terminology, graphical and letter symbols

For general terminology, readers are referred to IEC 60050: International

Electrotechnical Vocabulary (IEV)

For graphical symbols, and letter symbols and signs approved by the IEC for

general use, readers are referred to publications IEC 60027: Letter symbols to be

used in electrical technology, IEC 60417: Graphical symbols for use on equipment.

Index, survey and compilation of the single sheets and IEC 60617: Graphical symbols

for diagrams.

* See web site address on title page.

Evaluation and routine testing

in medical imaging departments –

Part 3-1:

Acceptance tests –

Imaging performance of X-ray equipment

for radiographic and radioscopic systems

Essais d'évaluation et de routine

dans les services d'imagerie médicale –

Partie 3-1:

Essais d'acceptation –

Performance d'imagerie des appareils

à rayonnement X pour systèmes radiographiques

et radioscopiques

PRICE CODE

 IEC 1999  Copyright - all rights reserved

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mechanical, including photocopying and microfilm, without permission in writing from the publisher.

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Telefax: +41 22 919 0300 e-mail: inmail@iec.ch IEC web site http://www.iec.ch

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For price, see current catalogue

Commission Electrotechnique Internationale

International Electrotechnical Commission

FOREWORD 4

INTRODUCTION 5

Clause 1 Scope and object 6

1.1 Scope 6

1.2 Object 6

2 Normative references 7

3 Terminology 8

3.1 Degree of requirements 8

3.2 Use of terms 8

3.3 Defined terms 8

4 General aspects of ACCEPTANCE TESTS 9

4.1 General conditions to be considered in test procedures 9

4.2 Documents and data for the tests 9

4.3 Test conditions 9

4.4 Test parameters 10

4.5 Test equipment including PHANTOMS (ATTENUATION devices) and TEST DEVICES 11

4.6 Evaluating the test results 12

5 Test methods for RADIOGRAPHY EQUIPMENT 13

5.1 Visual and functional tests 13

5.2 *X-RAY TUBE VOLTAGE 13

5.3 *TOTAL FILTRATION 14

5.4 *FOCAL SPOT of the X-RAY TUBE 14

5.5 *Limitation and indication of the extent of the X-RAY BEAM 15

5.6 *Linearity and reproducibility of TRANSMISSION KERMA or RADIATION OUTPUT 17

5.7 *ATTENUATION RATIO of material between the PATIENT and the X-RAY IMAGE RECEPTOR 18

5.8 *AUTOMATIC EXPOSURE CONTROL (AEC) 18

5.9 LINE PAIR RESOLUTION for DIRECT RADIOGRAPHY 20

5.10 * AIR KERMA area product indicator 20

6 Test methods for RADIOSCOPY EQUIPMENT 20

6.1 Visual and functional tests 20

6.2 X-RAY TUBE VOLTAGE 21

6.3 TOTAL FILTRATION 21

6.4 FOCAL SPOT of theX-RAY TUBE 21

6.5 Functioning of the AUTOMATIC EXPOSURE RATE CONTROL (AERC) 21

6.6 Limitation of the extent of the X-RAY BEAM 22

Clause Page

6.7 ATTENUATION RATIO of material between the PATIENT and the X-RAY

IMAGE RECEPTOR 23

6.8 *AIR KERMA RATE at the ENTRANCE PLANE of the X-RAY IMAGE INTENSIFIER for RADIOSCOPY 23

6.9 *Entrance AIR KERMA RATE for RADIOSCOPY with X-RAY IMAGE INTENSIFIER 24

6.10 AIR KERMA at the ENTRANCE PLANE of the X-RAY IMAGE INTENSIFIER for CINERADIOGRAPHY or other INDIRECT RADIOGRAPHY systems (excluding digital systems) 25

6.11 Entrance AIR KERMA for CINERADIOGRAPHY or other INDIRECT RADIOGRAPHY systems (excluding digital systems) 25

6.12 *LINE PAIR RESOLUTION for RADIOSCOPY with X-RAY IMAGE INTENSIFIER and for CINERADIOGRAPHY or other INDIRECT RADIOGRAPHY systems (excluding digital systems) 26

6.13 *LOW CONTRAST RESOLUTION for RADIOSCOPY with X-RAY IMAGE INTENSIFIER and for CINERADIOGRAPHY or other INDIRECT RADIOGRAPHY systems (excluding digital systems) 27

6.14 AIR KERMA area product indicator 28

7 Additional tests required for TOMOGRAPHY EQUIPMENT 28

7.1 *Requirements 28

7.2 Test method 29

8 Test report and statement of compliance 29

Annex A (normative) Terminology – Index of defined terms 36

Annex B (informative) Test parameters, symbols and units 39

Annex C (informative) Examples of low contrast TEST DEVICES 40

Annex D (informative) Examples of requirements (accuracy, tolerances, discrepancies) according to actual IEC standards or state of the art 42

Annex E (informative) Bibliography 46

Tables B.1 Test parameters, symbols and units 39

D.1 Typical values of FOCAL SPOT dimensions for NOMINAL FOCAL SPOT VALUES 42

D.2 Values for the discrepancy parameters X, Y and Z according to IEC 60601-1-3 43

D.3 Typical values for the TRANSMISSION KERMA index 43

D.4 Typical values for the ATTENUATION RATIO of material between the PATIENT and the X-RAY IMAGE RECEPTOR 44

Figures 1 Measuring arrangement for RADIOGRAPHY and RADIOSCOPY EQUIPMENT for AIR KERMA measurements 31

2 Measuring arrangement for RADIOGRAPHY and RADIOSCOPY EQUIPMENT to test geometry and resolutions 32

3 LINE PAIR RESOLUTION TEST DEVICE 33

4 TOMOGRAPHY LINE PAIR RESOLUTION TEST DEVICE 34

5 Discrepancies in visual indication of the X-RAY FIELD 35

6 Discrepancies in covering the IMAGE RECEPTION AREA 35

INTERNATIONAL ELECTROTECHNICAL COMMISSION

_

EVALUATION AND ROUTINE TESTING

IN MEDICAL IMAGING DEPARTMENTS – Part 3-1: Acceptance tests –

Imaging performance of X-ray equipment for radiographic and radioscopic systems

FOREWORD

1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees) The object of the 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, the IEC publishes International Standards Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation The IEC collaborates closely 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 the 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 interested National Committees.

3) The documents produced have the form of recommendations for international use and are published in the form

of standards, technical reports or guides and they are accepted by the National Committees in that sense.

4) In order to promote international unification, IEC National Committees undertake to apply IEC International Standards transparently to the maximum extent possible in their national and regional standards Any divergence between the IEC Standard and the corresponding national or regional standard shall be clearly indicated in the latter.

5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with one of its standards.

6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject

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

International Standard IEC 61223-3-1 has been prepared by subcommittee 62B: Diagnosticimaging equipment, of IEC technical committee 62: Electrical equipment in medical practice

The text of this standard is based on the following documents:

FDIS Report on voting 62B/361/FDIS 62B/365/RVD

Full information on the voting for the approval of this standard can be found in the report onvoting indicated in the above table

Annex A forms an integral part of this standard

Annexes B, C, D and E are for information only

In this standard, the following print types are used:

– explanations, advice, notes, general statements, exceptions and references: smaller roman type;

– TERMS DEFINED IN IEC 60788, IN IEC 60601-1 OR IN THE IEC 61223 SERIES: SMALL CAPITALS (SEE ANNEX A)

A bilingual version of this standard may be issued at a later date

This standard is part of a series of International Standards which give methods of acceptance

EQUIPMENT), including film processing, used in medical imaging departments

Some provisions or statements in this standard require additional information Such information

is presented in annex D An asterisk in the left margin of a clause or subclause indicates thepresence of such additional information

EVALUATION AND ROUTINE TESTING

IN MEDICAL IMAGING DEPARTMENTS – Part 3-1: Acceptance tests –

Imaging performance of X-ray equipment for radiographic and radioscopic systems

1 Scope and object

1.1 Scope

imaging systems

• TOMOGRAPHY EQUIPMENT – excluding COMPUTED TOMOGRAPHY;

• CINERADIOGRAPHY equipment;

– RADIOSCOPY EQUIPMENT, including:

does not apply to any digital image acquisition or image processing parts of the above

NOTE – Since the characterization of digital detectors and image processing is still under development, this will be included in a later edition of this standard.

1.2 Object

This standard defines:

b) methods of testing whether measured quantities related to those parameters comply withthe specified tolerances

These methods rely mainly on non-invasive measurements, using appropriate test equipment,performed during or after the installation is completed Signed statements covering steps of

part of the acceptance testing

The aim is to verify compliance of the installation with specifications relating to the image

of applying the most recent editions of the normative documents indicated below For undatedreferences, the latest edition of the normative document referred to applies Members of IECand ISO maintain registers of currently valid International Standards

IEC 60336:1993, X-ray tube assemblies for medical diagnosis – Characteristics of focal spotsIEC 60417-1:1998, Graphical symbols for use on equipment – Part 1: Overview and applicationIEC 60522:1976, Inherent filtration of an X-ray tube assembly

IEC 60580:1977, Area exposure product meterIEC 60601-1:1988, Medical electrical equipment – Part 1: General requirements for safety

3 Collateral standard: General requirements for radiation protection in diagnostic X-rayequipment

safety of high-voltage generators of diagnostic X-ray generatorsIEC 60601-2-28:1993, Medical electrical equipment – Part 2: Particular requirements for thesafety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis

IEC 60788:1984, Medical radiology – TerminologyIEC 60878:1988, Graphical symbols for electrical equipment in medical practice

IEC 61223-1:1993, Evaluation and routine testing in medical imaging departments – Part 1:

General aspects

IEC 61267:1994, Medical diagnostic X-ray equipment – Radiation conditions for use in thedetermination of characteristics

ISO 2092:1981, Light metals and their alloys – Code of designation based on chemical symbols

3 Terminology

3.1 Degree of requirements

meanings, as follows:

the need to comply;

in other standards, usually concerning particular operating conditions, testarrangements or values connected with compliance;

ACCOMPANYING DOCUMENTS or in other documentation relating to the EQUIPMENT

under consideration, usually concerning its intended purposes, or theparameters or conditions associated with its use or with testing to determinecompliance

3.2 Use of terms

IEC 60788, IEC 61223-1 and in 3.3 of this standard (see annex A)

NOTE – Attention is drawn to the fact, that, in cases where the concept addressed is not strongly confined to the definition given in one of the publications listed above, a corresponding term is printed in lower case letters.

3.3 Defined terms 3.3.1

ARTIFACT

apparent structure visible in the image which does not represent a structure within the object

3.3.2

LINE PAIR RESOLUTION

highest spatial frequency of the specified line-group test pattern imaged under specifiedconditions which is distinguishable in the image The unit is lp/mm

NOTE – L INE PAIR RESOLUTION is used here as a practical substitute for spatial resolution.

3.3.3

LOW CONTRAST RESOLUTION

lowest contrast detail object of a specified shape and area that can be resolved from anuniform background

3.3.4

RADIATION OUTPUT

AIR KERMA per CURRENT TIME PRODUCT (mGy/mAs) at a given distance from the FOCAL SPOT in

3.3.5

TRANSMISSION KERMA ( TRANSMISSION KERMA RATE )

AIR KERMA (AIR KERMA RATE) in the central X-RAY BEAM behind the specified attenuating layer

4 General aspects of ACCEPTANCE TESTS

4.1 General conditions to be considered in test procedures

equipment lie within the specified tolerances Some requirements are enforced by legislation

Other requirements and specifications may be in the order contract, in the supplier's brochure

or in other standards, for example in the IEC 60601 series

installed and put into service according to the set-up procedure as given in the

MANUFACTURER's documentation

contract

RADIOGRAPHIC CASSETTES with INTENSIFYING SCREENS, RADIOGRAPHIC FILMS and film processing

of RADIOGRAPHIC FILMS and INTENSIFYING SCREENS, for example with respect to sensitivity,

condition after the test

4.2 Documents and data for the tests

The following documentation is required:

– INSTRUCTIONS FOR USE, including guidance for the operation of the EQUIPMENT;

medical practice and whether this results in a limitation of the scope of the tests or of the

tested;

The measuring arrangements which may be used for performing tests are illustrated infigures 1 and 2.

TRANSMISSION KERMA RATE, KT, and the X-RAY IMAGE RECEPTOR AIR KERMA, KB, or the X-RAY

IMAGERECEPTOR AIR KERMA RATE, KB, and the test parameters derived from them.

Figure 2 includes the measuring arrangement to test geometry and resolutions

The arrangements in figures 1 and 2 are indicative only The test may be carried out in the

every component in the figures is needed in every test

(KERMA RATEMETER) shall be not less than 250 mm

NOTE – For the effects of SCATTERED RADIATION , see 4.5.4.

The tests shall yield information reasonably necessary for a demonstration of performance over

the test equipment used, geometrical set-up, operating characteristics, correction factors and

recorded with the test results The record shall include the identification of the location, thedate and the names of the persons performing the tests

4.4 Test parameters

– X-RAY TUBE VOLTAGE;– CURRENT TIME PRODUCT;– LOADING TIME;

– FOCAL SPOT;– TOTAL FILTRATION;– RADIATION OUTPUT;– TRANSMISSION KERMA (TRANSMISSION KERMA RATE);

– ATTENUATION RATIO;– AIR KERMA (AIR KERMA RATE);

– AIR KERMA (AIR KERMA RATE) at the ENTRANCE PLANE of the X-RAY IMAGE INTENSIFIER;– LINE PAIR RESOLUTION;

– LOW CONTRAST RESOLUTION;

Annex B lists symbols and units for some of the above items

4.5 Test equipment including PHANTOMS ( ATTENUATION devices) and TEST DEVICES

4.5.1 General

according to national or international regulations, if applicable)

The uncertainty of measuring instruments shall be less than one-third of the specifiedtolerances for the quantities being measured

4.5.2 High-voltage measuring instrument

the specified range Instruments based on either direct or indirect measurements may be used

4.5.3 K ERMAMETER

The KERMAMETER (KERMA RATEMETER) shall have a range sufficient to measure the AIR KERMA

(AIR KERMA RATE) within the required accuracy for the system under test and shall be calibratedfor the applied beam qualities

If legal regulations require the use of other dosimetric quantities, they may be applied

4.5.4 P HANTOMS ( ATTENUATION devices) and TEST DEVICES

PHANTOMS and TEST DEVICES may consist of attenuating layers (PHANTOM part of the object)

combination or separately

The following requirements apply:

a) External dimensions

PHANTOM dimensions shall be at least large enough to intercept the entire RADIATION BEAM

for all test conditions applicable; see figures 1 and 2

b) ATTENUATION and hardening

(Al 99,5 according to ISO 2092) and a material thickness of 25 mm ± 0,5 mm; seeIEC 61267

Some, but not all, tests will need an additional homogeneous attenuating layer of about1,5 mm copper

A PHANTOM of low atomic number material (for example TISSUE EQUIVALENT MATERIAL) is

20 cm of water

For some tests lead layers (1 mm to 2 mm thick) are needed to make lead masks or for the

shall be determined and used in calculating the results

These structural elements should be of such material and arranged in such a way that the

e) LINE PAIR RESOLUTION TEST DEVICE

The TEST DEVICE shall comprise line-group test patterns with a lead thickness of 0,05 mmand grid groups with local frequencies of 0,6 lp/mm to 5,0 lp/mm with a gradation ofless than or equal to 20 % from group to group The outer dimensions are for example

f) LOW CONTRAST RESOLUTION TEST DEVICE

parameter is measured, the results should be recorded together with the description of the

TEST DEVICE used

The detail diameters shall be such that their resolution is neither enhanced nor degraded by

For examples, see annex C

4.5.5 Lens

4.5.6 Densitometer

The densitometer shall cover the optical density range 0 to 3,5

4.5.7 Additional inspection and TEST DEVICES for TOMOGRAPHY X- RAY EQUIPMENT

– TEST DEVICE to test the layer height adjustment:

above with additional holes; see figure 4) with an inclination of the short axis of the test

pattern shall be at such intervals as to give an interval of 1 mm in the direction of height;

– TOMOGRAPHY movement TEST DEVICE:

– TOMOGRAPHY LINE PAIR RESOLUTION TEST DEVICE:

A line-group test pattern with a lead thickness of between 0,05 mm and 0,10 mm and gridgroups with local frequencies of 0,5 lp/mm to 4 lp/mm with a gradation of less than or equal

figure 4

4.6 Evaluating the test results

Whenever specified limiting values or tolerances are not met, verify the results by making atleast two additional measurements

In the evaluation of the results concerning limit values (upper or lower), the uncertainty in themeasurement shall be taken into consideration

5 Test methods for RADIOGRAPHY EQUIPMENT

5.1 Visual and functional tests 5.1.1 Requirements

All OPERATOR accessible controls shall be labelled with a graphical symbol, for exampleIEC 60417-1 or IEC 60878, and/or in plain language The colour of indicator lamps shall comply

ambient illumination

The INSTRUCTIONS FOR USE shall describe comprehensively how the X-RAY EQUIPMENT under

shall be described and all symbols shall be illustrated with their significance Reproductions inthe INSTRUCTIONS FOR USE shall be in agreement with the actual X-RAY EQUIPMENT, with respect

is required locally or specified in the order contract

5.1.2 Test methods

The tests are performed by visual inspection and functional check They comprise:

where this parameter is variable);

5.2 *X -RAY TUBE VOLTAGE

At least three standard X-RAY TUBE VOLTAGE measurements shall normally be performed, at

60 kV, 80 kV and 100 kV or at voltages close to these values, at 50 % or more of the highest

CURRENT settings

NOTE 1 – The suggested LOADING FACTORS given above are a minimum recommendation The choice of LOADING FACTORS should be made considering the nature of the EQUIPMENT under test and its clinical application, so as to explore enough of the X- RAY TUBE VOLTAGE / LOADING TIME /X- RAY TUBE CURRENT relationship to establish the conformance of the EQUIPMENT to its specification and the needs of the USER

NOTE 2 – At no time during testing should the maximum ratings of the X- RAY TUBE ASSEMBLY be exceeded.

control panel and the specified tolerances

NOTE – The LOADING FACTORS should be recorded because the X- RAY TUBE VOLTAGE measured may vary with the

SOURCE ASSEMBLY and by examination of the ACCOMPANYING DOCUMENTS The QUALITY EQUIVALENT FILTRATION may be determined according to clauses 3 and 4 of IEC 60522, ifnecessary

NOTE – This requires measuring the HALF - VALUE LAYER under NARROW BEAM CONDITIONS with the X- RAY EQUIPMENT

operating at appropriate values of X- RAY TUBE VOLTAGE and corresponding LOADING FACTORS , and to compare with the HALF - VALUE LAYER from an X- RAY TUBE with the same TARGET material and TARGET ANGLE

EQUIPMENT operating at appropriate values of X-RAY TUBE VOLTAGE with suitable LOADING FACTORS in the range of NORMAL USE This test gives only an approximate estimate of the TOTAL FILTRATION because these test conditions do not fully comply with IEC 60522

5.4 *F OCAL SPOT of the X- RAY TUBE

5.4.1 Requirements

the dimensions specified in IEC 60336 Additional specifications, for example concerning

the scope of this standard only if these specifications also state the test method

5.4.2 Test method

VALUES with IEC 60336 shall be confirmed by the MANUFACTURER

NOTE – F OCAL SPOT measuring procedures by SLIT CAMERA , PINHOLE CAMERA , star pattern evaluation and Fourier transform of images of TEST DEVICES all give different results concerning size and resolution The standard

FOCAL SPOT measurement is specified according to IEC 60336 by SLIT CAMERA under specified projection conditions and optical density.

5.5 *Limitation and indication of the extent of the X- RAY BEAM

5.5.1 Accuracy of marked and written indications of the X- RAY FIELD size 5.5.1.1 Requirements

the specified tolerances

5.5.1.2 Test methods

ACCOMPANYING DOCUMENTS Where appropriate, measure the dimensions of the X-RAY FIELD

FOCAL SPOT TO IMAGE RECEPTOR DISTANCE, as available for NORMAL USE and at the commonly

Other test procedures than those described here may be used if they lead to comparableresults

the PATIENT SUPPORT in the centre of the X-RAY FIELD and using the arrangement in figure 2,without the attenuating layer

CASSETTES had been exposed on the top of the PATIENT SUPPORT, this field size must becorrected to correspond to that at the cassette tray

within the specified tolerances

5.5.2 Accuracy of indication of the LIGHT FIELD - INDICATOR

5.5.2.1 Requirements

tolerances specified

5.5.2.2 Test methods

RADIOGRAPHIC FILM

In figure 5, the measured discrepancies are represented by a1 and a2 on one axis, and by b1

compliance, the following relationships are true:

L 2

1 a X r

L 2

1 b X r

where

X is the tolerance specified

5.5.3 Correspondence between the X- RAY FIELD and IMAGE RECEPTION AREA with

automatic adjustment of the RADIATION APERTURE

5.5.3.1 Requirements

IMAGE RECEPTION AREA shall comply with the tolerances specified

5.5.3.2 Test methods

appropriate

Allow a period of at least 5 s for the automatic mechanism to complete any adjustmentoccurring during the tests

CASSETTE or a RADIOGRAPHIC FILM in a light-proof envelope on the PATIENT SUPPORT Then

DEVICE will automatically adjust the X-RAY FIELD size to the format of the RADIOGRAPHIC CASSETTE used Choose LOADING FACTORS so as to give an optical density D in the range 0,5 to

relationships are true:

B 2

1 c Y r

B 2

1 d Y r

B 2

1 2

1 c d d Z r

where

Y and Z are the tolerances specified

NOTE – If the above requirements are fulfilled, the X- RAY EQUIPMENT complies with the X- RAY FIELD centring requirements.

5.6 *Linearity and reproducibility of TRANSMISSION KERMA or RADIATION OUTPUT

5.6.1 Requirements

OUTPUT) according to the regional requirements

shall comply with the tolerances or values specified

The RADIATION OUTPUT and the TRANSMISSION KERMA per CURRENT TIME PRODUCT at a given

CURRENT selection for each FOCAL SPOT

comply with the values and tolerances specified

The RADIATION OUTPUT shall comply with the values and tolerances specified

5.6.2 Test method

Carry out the measurements using the arrangement in figure 1, with the attenuating layer in

TIME PRODUCT (AIR KERMA per CURRENT TIME PRODUCT) for a specific value of the X-RAY TUBE VOLTAGES The detector of the KERMAMETER is to be placed in the RADIATION BEAM behind theattenuating layer at a sufficient distance

X-RAY TUBE CURRENT for the lowest and the highest available value of LOADING TIME;

the attenuating layer

NOTE 1 – The combinations of LOADING FACTORS specified for the tests are limited in number but chosen from experience as being appropriate in most cases.

NOTE 2 – At no time during testing should the maximum ratings of the X- RAY TUBE ASSEMBLY be exceeded.

Evaluate the results as follows:

Compare the results with the specified values and tolerances

5.7 *A TTENUATION RATIO of material between the PATIENT and the X- RAY IMAGE RECEPTOR

5.7.1 Requirements

The ATTENUATION RATIO, TR, of material between the PATIENT and the X-RAY IMAGE RECEPTOR

shall not exceed the specified values

5.7.2 Test method

CONDITION

RECEPTOR AIR KERMA (AIR KERMA RATE), KB ( KB), if accessible.

K

rr

B T B

= × 22

where

Compare the results of these measurements with the specified values

5.8 *A UTOMATIC EXPOSURE CONTROL ( AEC ) 5.8.1 N OMINAL SHORTEST IRRADIATION TIME with AUTOMATIC EXPOSURE CONTROL

5.8.1.1 Requirements

The NOMINAL SHORTEST IRRADIATION TIME (see IEC 60601-2-7) shall be specified in the

ACCOMPANYING DOCUMENTS together with the test conditions

5.8.2 * Performance of the AEC

5.8.2.1 Requirements

INTENSIFYING SCREENS and film processing

compliance

If this statement of compliance cannot be provided, the following tests are applicable

a) IRRADIATIONS using AEC at specified X-RAY TUBE VOLTAGES, with a specified PHANTOM, for

systems, shall give optical densities within the specified range;

b) specified variations of PHANTOM thickness and X-RAY TUBE VOLTAGE shall lead to opticaldensities within the specified range for a specified film-screen system and a specified

optical densities for the specified film-screen system within the tolerances specified

5.8.2.2 Test methods 5.8.2.2.1 Constancy of the optical density with variation of X- RAY TUBE VOLTAGE and

PHANTOM thickness ( RADIOGRAPHIC FILM method)

PATIENT SUPPORT Use a PHANTOM of 15 cm of water as reference thickness, see 4.5.4 For

system used in the test shall be the same as that used in medical practice A test of theperformance of the film processing shall precede any of these tests; see 4.1 The filmprocessing shall be carried out under normal and stable conditions, for example with respect to

the RADIOGRAPHIC FILM with a densitometer If the optical density is in accordance with the

10 cm and 20 cm of water

The constancy of the optical densities D for combinations of measuring fields may be checked

NOTE 1 – If the AEC has more than one sensor area (measuring field), not all sensor areas may have the same sensitivity and produce the same optical density This depends on the specified anatomical REGION OF INTEREST for the RADIOGRAMS ; see the INSTRUCTIONS FOR USE

NOTE 2 – If using PHANTOM material other than water, for example polymethyl-methacrylate (PMMA), the absolute values of the optical density and the AIR KERMA can be different from the values with a water PHANTOM

5.8.2.2.2 Reproducibility test of the AEC ( KERMAMETER method)

reference conditions, for example standard position of available range of density correctionsteps and dose steps as appropriate to the film-screen system

Select one sensor (usually the centre sensor) Make five measurements and calculate thereproducibility

Compare the results of these measurements with the values specified

5.8.3 Back-up timer and security cut-out 5.8.3.1 Requirements

LOADING TIME has been reached In the presence of a security cut-out, no separate test of theback-up timer shall be carried out

5.8.3.2 Test methods

values specified

NOTE – A malfunctioning back-up timer may lead to excess X- RAY TUBE LOAD resulting in the damage of the X- RAY TUBE The OPERATOR should be aware of this possibility.

5.9 L INE PAIR RESOLUTION for DIRECT RADIOGRAPHY

NOTE – There is no requirement and no test included here because the LINE PAIR RESOLUTION is either determined

by the FOCAL SPOT size (see 5.4) and the measuring arrangement, or limited by the characteristic for the film-screen system used.

5.10 * A IR KERMA area product indicator 5.10.1 Requirements

5.10.2 Test method

Carry out the measurement using the arrangement in figure 1

FIELD Make the collimated field size about 15 cm × 15 cm Choose LOADING FACTORS so as togive an optical density in the range 0,5 to 2,0 Measure the field size on the processed

RADIOGRAPHIC FILM

6.1 Visual and functional tests 6.1.1 Requirements

The requirements are given in 5.1.1, if applicable

6.1.2 Test methods

The test methods are given in 5.1.2, if applicable

6.2 X- RAY TUBE VOLTAGE

6.2.1 Requirements

CONTROL (AERC) when the attenuating layer/PHANTOM is placed in the X-RAY BEAM This

specified tolerance

6.2.2 Test methods

recorded These values are stored with the "lock-in" button If there is no "lock-in" button, and ifthere is no possibility to select these values manually, the order contract shall specify the testprocedure

Compare the results of the measurements with the values indicated at the control panel

NOTE – Modern radioscopic systems with X- RAY IMAGE INTENSIFIER -television systems are equipped with an AERC This control system consists of a kV or mA control or a combined kV/mA control Separate measurement of the individual LOADING FACTORS is only possible with invasive measurements.

6.3 T OTAL FILTRATION

6.3.1 Requirements

The requirements given in 5.3.1 are applicable

6.3.2 Test method

The test method given in 5.3.2 is applicable

6.4 F OCAL SPOT of the X- RAY TUBE

6.4.1 Requirements

The requirements given in 5.4.1 are applicable

6.4.2 Test method

The test method given in 5.4.2 is applicable

6.5 Functioning of the AUTOMATIC EXPOSURE RATE CONTROL ( AERC ) 6.5.1 Requirements

NOTE – An AUTOMATIC EXPOSURE RATE CONTROL ( AERC ) is intended to maintain constant average image brightness independent of the X-ray absorption of the objects being examined by adjusting the LOADING FACTORS This function may be linked with that of an automatic brightness control (ABC) or an automatic gain control (AGC) of the television chain.

6.5.2 Test method

ATTENUATION of a test object is varied, use the procedure specified in the MANUFACTURER'sinstallation instructions

6.6 Limitation of the extent of the X- RAY BEAM

described in this subclause may be used if they lead to comparable results

6.6.1 Correspondence between the X- RAY FIELD , the IMAGE RECEPTION AREA of X- RAY IMAGE

INTENSIFIERS and the image display 6.6.1.1 Requirements

X-RAY IMAGE INTENSIFIER and the displayed image shall comply with the tolerances specified

6.6.1.2 Test methods

FOR USE and by measurement of the X-RAY FIELDS, where appropriate

measurements, allow a period of at least 5 s for the automatic mechanism to complete anyadjustments

When determining compliance with the requirements, carry out the measurements with the

REFERENCE AXIS normal to the IMAGE RECEPTOR PLANE within ± 3 °.Carry out the measurements using the arrangement of figure 2, without the attenuating layer

BEAM LIMITING DEVICE is visible on the video display unit (VDU), both in vertical and horizontaldirection

If not all four blades are visible, perform the following test steps

NOTE – The test film IRRADIATION will not affect the test results.

c) Adjust the BEAM LIMITING DEVICE to maximum field size Measure the visible X-RAY FIELD SIZE

under radioscopic conditions by noting the matrix intervals in all four directions displayed onthe VDU

density D in the range 0,5 to 2,0

directions and define the discrepancies to the noted matrix intervals

36 cm/25 cm/17 cm

For compliance, the requirements given in 5.5.3 are applicable

6.6.2 Correspondence between the X- RAY FIELD and the IMAGE RECEPTION AREA using a

SPOTFILM DEVICE

6.6.2.1 Requirements

6.6.2.2 Test methods

The test method given in 5.5.3.2 is applicable

6.7 A TTENUATION RATIO of material between the PATIENT and the X- RAY IMAGE RECEPTOR

6.7.1 Requirements

The requirements given in 5.7.1 are applicable

6.7.2 Test method

The test method given in 5.7.2 is applicable

6.8 *A IR KERMA RATE at the ENTRANCE PLANE of the X- RAY IMAGE INTENSIFIER for RADIOSCOPY

6.8.1 Requirements

The AIR KERMA RATE at the ENTRANCE PLANE of the X-RAY IMAGE INTENSIFIER shall comply withthe values specified The measurements shall be made under the conditions specified by theoperating modes provided

give different absolute values In each case, compliance is tested against the values specified

6.8.2 Test method

Carry out the measurements using the arrangement in figure 1, with the attenuating layer, for

ENTRANCE PLANE of the X-RAY IMAGE INTENSIFIER; see 4.5.4

Select an X-RAY TUBE VOLTAGE of 70 kV to 80 kV If the X-RAY TUBE VOLTAGE selection is

VOLTAGE to within this range

TRANSMISSION KERMA RATE, KT, and calculate KB from the relationship:

2 B

2 T R

T B

r

rT

K

X-RAY IMAGE INTENSIFIER format

Compare the results of this measurement with the specified values

6.9 *Entrance AIR KERMA RATE for RADIOSCOPY with X- RAY IMAGE INTENSIFIER

6.9.1 Requirements

The measurements shall be carried out under the conditions specified in the operating modesprovided

NOTE – These measurements give an indication of the effectiveness of additional X- RAY BEAM filtering devices and

of the PATIENT SURFACE AIR KERMA This is especially important for cardiac radioscopic systems using high dose rate RADIOSCOPY

has to be proved

6.9.2 Test method

PHANTOM.Select a voltage of 70 kV to 80 kV

If the voltage selection is automatic, further attenuating layers may be needed to drive theoperating voltage to within this range

Compare the results with the specified values

6.9.3 Test method for maximum entrance AIR KERMA RATE

INTENSIFIER shall be covered by a high absorbing layer, for example by 2 mm of lead The

AUTOMATIC EXPOSURE RATE CONTROL will increase the AIR KERMA RATE to the maximum value

Measure the maximum entrance AIR KERMA RATE at the reference point as defined for the X-RAY EQUIPMENT under test by the MANUFACTURER.

NOTE – International Standards and some regional regulations define as reference point:

> 30 cm above the PATIENT SUPPORT for C-arm units and overtable tube equipment;

> 1 cm above PATIENT SUPPORT for undertable tube equipment.

Compare the results with the specified values

6.10 A IR KERMA at the ENTRANCE PLANE of the X- RAY IMAGE INTENSIFIER for CINERADIOGRAPHY

or other INDIRECT RADIOGRAPHY systems (excluding digital systems) 6.10.1 Requirements

The AIR KERMA per image, under the specified conditions, shall be as specified

6.10.2 Test method

Carry out the measurements using the same conditions as in 6.8.2

PLANE of the X-RAY IMAGE INTENSIFIER is not directly accessible, measure the TRANSMISSION KERMA, KT, and calculate KB from the relationship:

T

rr

R T B

= × 22

If a film is used, the optical density D shall be 1,0 ± 0,2, unless some other figure is specified

For AUTOMATIC EXPOSURE CONTROL (kV/mA control), for example with CINERADIOGRAPHY

layer in addition to the 25 mm of aluminium used in the arrangement of figure 1, to achieve anX-RAY TUBE VOLTAGE of about 70 kV

cine-runs) divided by the number of irradiated images Make the measurement in the stablephase

Compare the results of these measurements with the specified values

6.11 Entrance AIR KERMA for CINERADIOGRAPHY or other INDIRECT RADIOGRAPHY systems (excluding digital systems)

6.11.1 Requirements

Measurements shall be carried out under the conditions specified in the operating modesprovided

NOTE – These measurements give an indication of the effectiveness of additional X- RAY BEAM filtering devices and

of the PATIENT SURFACE AIR KERMA This is especially important for cardiac radioscopic systems using high power RADIOSCOPY