Iec 61223 3 2 2007

This second edition of the particular standard for the ACCEPTANCE TEST of mammographic X-RAY EQUIPMENT describes test methods for EQUIPMENT using RADIOGRAPHIC FILMS, EQUIPMENT using stor

Levels of compliance

Tests required by a higher level of compliance take precedence over similar tests with a lower level of compliance

Local regulatory requirements, including test procedures and acceptable values, shall take precedence over similar contractual requirements or corresponding items in this document

Individual contractual requirements, including test procedures and acceptable values, shall take precedence over similar corresponding items in this document

NOTE Requirements for status tests should be included in the contractual requirements

In the absence of specific regulatory or contractual requirements, the test procedures in this document shall be applicable

Values and acceptable tolerances shall be in accordance with the MANUFACTURER’s specifications for the EQUIPMENT

General conditions in test procedures

The aim of the ACCEPTANCE TEST is to demonstrate that the specified characteristics of the

EQUIPMENT lie within specified tolerances These tolerances are determined by regulatory or contractual requirements Prior to the ACCEPTANCE TEST procedures, an inventory of the

All X-ray equipment and its components must be clearly identified by type and serial number, and verified against the order contract This verification process should also include ensuring that all accompanying documents, records, and acceptance criteria are complete, confirming that the delivery is thorough, and that the documents correspond to the delivered equipment.

Before the acceptance test, the X-ray equipment must be calibrated to meet the specific requirements of the image receptor being utilized If a non-integrated image receptor is used, the system integrator is responsible for supplying the necessary specifications and usage conditions for the system.

The energy response of image receptors varies greatly due to differences in design, materials, and technology Adjusting the Automatic Exposure Control (AEC) allows for the fine-tuning of exposure parameters to achieve specific response values for the image receptor across various attenuation combinations.

Before conducting acceptance testing of mammographic X-ray equipment that utilizes radiographic films, it is essential to test the film processing This ensures that the radiographic cassettes with intensifying screens, the radiographic films, and the film processing meet specified performance criteria, including sensitivity, reproducibility, contrast, and the absence of artifacts Performance testing of these components must be completed prior to any acceptance test measurements involving radiography.

FILMS, for example by applying the methods described in ISO 4090, in Annex C of this standard, and the CONSTANCY TESTS according to IEC 61223-2-1

LICENSED TO MECON Limited - RANCHI/BANGALORE FOR INTERNAL USE AT THIS LOCATION ONLY, SUPPLIED BY BOOK SUPPLY BUREAU.

When digital images are quantitatively assessed, LINEARIZED DATA shall be used, and acquired with a RADIATION BEAM quality specified by the MANUFACTURER

No post-processing shall be applied on the ORIGINAL DATA used for purposes of quantitative image analysis

Before conducting acceptance testing on mammographic X-RAY EQUIPMENT that utilizes a storage phosphor system, it is essential to test the storage phosphor system to ensure it operates as intended Annex D provides examples of testing methods for evaluating the performance of the storage phosphor system.

The IMAGE DISPLAY DEVICES involved in the ACCEPTANCE TEST shall be tested prior to the

ACCEPTANCE TEST of the mammographic X-RAY EQUIPMENT It has to be assured that the IMAGE

DISPLAY DEVICES perform in the specified way, for example with respect to contrast and absence of ARTIFACTS

The HARD COPY CAMERAS involved in the ACCEPTANCE TEST shall be tested prior to the

ACCEPTANCE TEST of the mammographic X-RAY EQUIPMENT as recommended by the camera

It is essential to ensure that hard copy cameras operate effectively, particularly in terms of contrast and the elimination of artifacts that could negatively impact patient diagnoses.

Non-invasive measurements are favored for the acceptance test If invasive tests are included in the program, it must be demonstrated that the equipment has been returned to its original condition.

NOTE 1 In general, for mammography X - RAY EQUIPMENT with a non-integrated X- RAY IMAGE RECEPTOR , the X - RAY

EQUIPMENT may be tested before testing the system with the image receptor for those functions of the X - RAY

EQUIPMENT which does not involve the performance of the image receptor

The test procedures and methods are designed to verify the correct setup and functionality of the system, rather than to indicate performance in optimized clinical conditions Therefore, these specifications should not be utilized for comparing anticipated clinical performance across different systems, as additional measures are required for such evaluations.

Documents and data for the tests

Together with the mammographic X-RAY EQUIPMENT, the following documentation is required:

– statements of compliance with applicable parts of IEC 60601;

– list of EQUIPMENT/parts of EQUIPMENT ordered and actual delivery list (IEC 60601-1);

– list of applicable tests and acceptance criteria according to this standard as agreed upon between the USER and the supplier of the EQUIPMENT;

– results from tests performed earlier by the MANUFACTURER on the EQUIPMENT delivered as contracted;

– reports on previous quality assurance tests where applicable; and

– documentation of technical changes performed on the EQUIPMENT

The following documentation shall be present if applicable:

– test report on the film processing;

– report on RADIOGRAPHIC CASSETTE testing;

– test report on the viewing boxes;

– test report on HARD COPY CAMERAS and IMAGE DISPLAY DEVICES; and

– test report on storage phosphor system.

Test conditions

Different categories of tests can be identified:

The tests shall yield information reasonably necessary for a demonstration of performance over the full range of OPERATOR accessible variables

All pertinent information, including the identification of the tested mammographic X-ray equipment, the test equipment utilized, the geometrical setup, operating characteristics, correction factors, and results of the associated equipment (such as film, screen, and processing), must be documented alongside the test results This record should also capture the location, date, and names of the individuals conducting the tests.

In all tests requiring a TEST DEVICE, it must be positioned directly on the PATIENT SUPPORT and centered laterally on the PATIENT, unless stated otherwise.

SUPPORT, and the chest wall edges of the TEST DEVICE and the PATIENT SUPPORT shall be in line.

Scope of tests

The following items are subject to acceptance testing within this standard:

– X-RAY FIELD limitation and beam alignment (5.5);

– reproducibility of the AIR KERMA (5.8);

– ATTENUATION RATIO of material between the upper surface of the PATIENT SUPPORT and the

– Dynamic range of mammographic X-RAY EQUIPMENT using digital X-ray image receptors, including storage phosphor systems (5.12);

– entrance surface AIR KERMA (5.15);and

– Biopsy needle positioning accuracy of MAMMOGRAPHIC STEREOTACTIC DEVICES (5.16)

Test EQUIPMENT

The measurement EQUIPMENT used for the ACCEPTANCE TEST shall be certified as calibrated against a national or international standard where such a standard exists Details on the test

EQUIPMENT are specified in 4.6.2 to 4.6.8

Test EQUIPMENT required but not specified in 4.6.2 to 4.6.8:

– thermometer (as required for film processor);

– block of foam rubber as specified in 5.10.3.1;

– magnifying glass (magnifying at least × 4);

– test cassette and radio-opaque markers as specified in 5.5.2;

– 20 mm PMMA as specified in 5.11.3.1;

– Wire grid as specified in 5.11.3.3;

– lag effects TEST DEVICE as specified in 5.11.3.4.1;

– spatial resolution bar pattern as specified in 5.13.1.2;

– TEST DEVICE with low contrast structures as specified in 5.14;

– step wedge in PMMA as described as an example in Annex B;

– stereotactic TEST DEVICE as described as an example in Annex H;

– measurement EQUIPMENT used for determining the baseline values for CONSTANCY TESTS according to Cause 6

The high-voltage measuring instrument shall determine the X-RAY TUBE VOLTAGE within the specified range Instruments based on either direct or indirect measurements following

IEC 61676 (2002) may be used The OVERALL UNCERTAINTY shall be less than ±2 % or ±0,7 kV, whichever is the larger

NOTE Special features of mammographic X- RAY EQUIPMENT such as molybdenum TARGETS and possible K-edge

When calibrating devices for indirect measurements, it is essential to consider filters Achieving the stated uncertainty with non-invasive testing methods typically requires specialized calibration tailored to the specific type of X-ray used.

4.6.3 C URRENT TIME PRODUCT measuring instrument

The device's range for CURRENT TIME PRODUCT with the X-RAY EQUIPMENT typically spans from 0 mAs to 800 mAs The OVERALL UNCERTAINTY must not exceed ±5% or ±0.5 mAs, depending on which value is greater For the built-in CURRENT TIME PRODUCT measuring instrument to be utilized in the ACCEPTANCE TEST, it must be calibrated to ensure compliance with these specifications.

The LOADING TIME measuring instrument must determine LOADING TIME in accordance with IEC 60601-2-45, capable of measuring both the shortest and longest specified LOADING TIMES The OVERALL UNCERTAINTY should not exceed ±2% or ±1 ms, whichever is greater For the built-in LOADING TIME measuring instrument to be utilized in the ACCEPTANCE TEST, it must be calibrated to ensure compliance with these specifications.

The range of the integrating DOSIMETER for the measurement of the AIR KERMA shall be at least

10 àGy to 500 àGy for the measurements behind a PHANTOM , and at least 0,1 mGy to

For direct output measurements, a threshold of 100 mGy is established, ensuring an overall uncertainty of less than ±10% This consideration encompasses recombination losses at air kerma rates of up to 100 mGy/s, as well as uncertainties related to the dosimeter's energy response and the actual X-ray measurements.

SPECTRUM The DOSIMETER used for measurement of AIR KERMA shall conform to IEC 61674

4.6.6.1 TEST DEVICES for AUTOMATIC EXPOSURE CONTROL (AEC) system

The ATTENUATION layers will be constructed from PMMA, with a thickness designed to allow stacking for the creation of TEST DEVICES measuring 20 mm, 40 mm, 60 mm, and 70 mm.

The thickness tolerances must be maintained within ±1 mm, with a uniformity requirement of ±0.1 mm Additionally, the dimensions should be either semi-circular with a minimum radius of 100 mm or rectangular with minimum dimensions of 100 mm by 150 mm.

4.6.6.2 A TTENUATION layers for first HALF - VALUE LAYER measurements

The article specifies that a minimum of two distinct layers of aluminum foils is required, with a thickness ranging from 0.2 mm to 0.6 mm, selected based on the designated first half-value layers These foils must have a purity of 99.9%, and their thickness should be accurately measured within a tolerance of ±3%.

NOTE Information on the chemical composition of aluminium can be found in EN 573-3

The densitometer shall cover the optical density range 0 to 4,0 with an OVERALL UNCERTAINTY that meets the conditions:

A force scale with a range of at least 50 N to 300 N and an OVERALL UNCERTAINTY of less than ±5 N shall be used.

Evaluating the test results

Whenever specified limiting values or tolerances are exceeded, verify the results by making at least two additional measurements

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

5 Test methods for mammographic X-RAY EQUIPMENT

Initial test and inventory

The operation and functioning of the X-RAY EQUIPMENT shall comply with what is specified

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

The operation of the equipment under test requires a detailed description of all control devices, including knobs, switches, and touch panels, as well as indicators and displays Each symbol must be illustrated with its significance Additionally, the reproductions in the Instructions for Use must accurately reflect the actual X-ray equipment, ensuring consistency in position, labels, and symbols.

INSTRUCTIONS FOR USE shall be present in the language that has been agreed on

In the case of a non-integrated image receptor, the ACCEPTANCE TESTS should be performed against the specification provided by the system integrator

5.1.2.1 Visual inspection and functional check

The DIRECT FOCAL DISTANCE shall be checked by inspection of the ACCOMPANYING DOCUMENTS

The compatibility of the components in the system (e.g HARD COPY CAMERA) which are not an integral part of the mammographic X-RAY EQUIPMENT shall be assured by checking the

ACCOMPANYING DOCUMENTS and by functional tests as defined by the MANUFACTURER

The test is performed by visual inspection and functional check It comprises:

– presence of all documents according to 4.3;

– inventory of EQUIPMENT under test, including individual identification data for all components;

– visual inspection of the INSTRUCTIONS FOR USE (IEC 60601-1);

– functional check of the mechanical adjustment devices;

– functional check and identification of the control elements;

– visual inspection of the labelling of the control elements;

– visual inspection of the markings; and

– mechanical integrity of the EQUIPMENT

Check against acceptance criteria according to this standard as agreed upon between the

USER and the supplier of the EQUIPMENT, e.g movements, speeds, forces, interlocks.

X- RAY TUBE VOLTAGE

The MEASURED VALUES for the X-RAY TUBE VOLTAGE shall agree with the INDICATED VALUES on the X-ray generator control within the specified tolerances

The test must include a minimum of three X-ray tube voltage values that encompass the clinical application range for all focal spots, and, if relevant, for various X-ray tube current settings Testing is adequate if conducted for just one target.

NOTE Direct measurements for the reproducibility of the X- RAY TUBE VOLTAGE are not part of the ACCEPTANCE

TEST because the evaluation of the radiation output reproducibility (see 5.6) implies a statement on the X- RAY TUBE

H ALF VALUE LAYER (HVL)

The HVL shall comply with the MANUFACTURER’s specification and IEC 60601-2-45

Remove the breast compression plate for this test A narrow beam geometry with a large distance between absorber and detector is used according to Annex I Set the X- RAY TUBE

VOLTAGE to 28 kV and measure the HALF-VALUE LAYER for each TARGET FILTER combination

If an X-RAY TUBE VOLTAGE of 28 kV is not applicable to the system the test shall be performed according to the MANUFACTURER’s specification

Perform AIR KERMA measurements at a point located laterally over the PATIENT SUPPORT, specifically 6 cm from the chest wall edge Table 2 provides examples of typical HALF-VALUE LAYER values for different combinations of TARGET and FILTER materials.

Compare the HALF-VALUE LAYER measurements with the specified values to ensure accuracy For both automatically and manually interchangeable filters, verify through HALF-VALUE LAYER measurements that the correct filter is positioned as indicated.

Table 2 – Examples of typical HALF - VALUE LAYERS (HVL) in millimetres of aluminium

(mm Al) for mammographic X- RAY EQUIPMENT with different TARGET FILTER combinations operated at different X- RAY TUBE VOLTAGES

T ARGET and FILTER materials HVL at 25 kV mm Al

HVL at 28 kV mm Al

NOTE In a good approximation, the HALF VALUE LAYER (HVL) can be calculated by using the following equation:

If the thicknesses \(d_1\) and \(d_2\) of the aluminum foils differ by no more than 0.2 mm from the HALF VALUE LAYER, the relationship can be expressed as \(K = K_d \cdot (K_1 - K_2)\) Here, \(K_1\) and \(K_2\) represent the AIR KERMA values, while \(K_0\) denotes the AIR KERMA measured without any additional aluminum foil in the RADIATION BEAM All AIR KERMA values are based on the same CURRENT TIME PRODUCT.

N OMINAL FOCAL SPOT VALUE

The specification for the NOMINAL FOCAL SPOT VALUE stated in the ACCOMPANYING DOCUMENTS shall comply with IEC 60336

Compliance of the FOCAL SPOT size to the specified NOMINAL FOCAL SPOT VALUE according to

IEC 60336 shall be done by inspection of the ACCOMPANYING DOCUMENTS of the tube provided by the MANUFACTURER.

X- RAY FIELD limitation and beam alignment

The extent of the RADIATION BEAM shall comply with the tolerances specified in IEC 60601-2-45

In addition all those parts of an object placed on the PATIENT SUPPORT that are specified to be imaged shall be visible in the RADIOGRAM

Check the alignment of the RADIATION BEAM with the IMAGE RECEPTION AREA for all specified

DIRECT FOCAL DISTANCES, PATIENT SUPPORTS, TARGETS and FOCAL SPOTS, and for all available

Position the test cassette on top of the PATIENT SUPPORT, ensuring it overlaps all sides of the underlying image receptor with adequate margins The test cassette, which may contain film and screen or storage phosphor material, must be sufficiently large to cover the evaluated image receptor It can be rotated to achieve proper coverage Additionally, place radio-opaque markers, such as graduated rulers, on the test cassette Finally, create an image and process the film or read the storage phosphor plate accordingly.

The displacement between the radiation beam and the image receptor can be assessed using two images If film processing or computed radiography (CR) is not available on-site, alternative x-ray sensors, such as long persistence phosphors or instant processing films, should be utilized.

To evaluate the visibility of the sections of the PATIENT SUPPORT that contact the chest wall, an image of a TEST DEVICE with markers at a consistent distance from the edge should be utilized For image receptors that employ reloadable cassettes, such as screen film or CR, this measurement must be conducted multiple times to ensure the consistent insertion of the image receptor (film or plate) within the cassette.

NOTE 1 In the case of film screen systems, it may be desirable to specify a slight over-framing of the IMAGE

The reception area is essential as it allows users to eliminate transparent margins on the film This is particularly important for accurately reading diagnostic information from mammograms, especially when masking films for viewing is not feasible.

When evaluating results, it is essential to consider the tolerances of the film position within the cassette This can be achieved by manually positioning the film as close to the chest wall edge as possible and ensuring it is centered in the transverse direction.

Radiation output

The radiation output reproducibility must adhere to the manufacturer's specifications, ensuring that both the air kerma rate (measured in mGy/s) and the radiation output (expressed in μGy/mAs) meet the required standards set by the manufacturer.

The AIR KERMA shall be measured at a point located 40 mm over the PATIENT SUPPORT, centred laterally, and 6 cm off its chest wall edge a) Radiation output reproducibility

At least 5 measurements of the AIR KERMA shall be performed at a specific combination of

CURRENT TIME PRODUCT and X-RAY TUBE VOLTAGE b) Radiation output

For all combinations of TARGET and FILTER stated in the ACCOMPANYING DOCUMENTS, the AIR

The kerma rate, measured in mGy/s, and the specific radiation output, expressed in μGy/mAs, must be assessed at an X-ray tube voltage of 28 kV for all focal spots, without the use of a breast compression plate in the radiation beam.

5.6.3 Evaluation of the measurements a) Radiation output reproducibility

The evaluation of measurements will involve calculating the coefficient of variation and comparing it to the specified tolerance This coefficient is determined by dividing the standard deviation of the AIR KERMA values by their mean.

AIR KERMA values b) Radiation output

The measured AIR KERMA RATES (in mGy/s) shall be compared with the specified values

Values of specific radiation output (in μGy/mAs) shall be calculated from the MEASURED

VALUES by referencing them to a distance of 100 cm from the FOCAL SPOT The specific radiation output values shall be compared with the specified values

NOTE For measuring in the unattenuated RADIATION BEAM and for different TARGET FILTER combinations,

MANUFACTURERS of DOSIMETERS usually give calibration factors according to the DOSIMETER ’ S energy dependency.

A UTOMATIC EXPOSURE CONTROL (AEC)

5.7.1 AEC for film-screen systems

The performance of the AEC shall be evaluated by measuring the optical density of the film

The reproducibility of AIR KERMA must be assessed under consistent IRRADIATION conditions, while simultaneously recording the CURRENT TIME PRODUCT to evaluate consistency It is essential to maintain all settings constant throughout the testing process.

To ensure accurate results, the Automatic Exposure Control (AEC) must operate at a designated X-ray tube voltage and specific irradiations, producing optical densities within the required range for the chosen screen-film system Additionally, the optical densities should vary appropriately with the thickness of the test device and the X-ray tube voltage.

The use of ANTI-SCATTER GRID and no ANTI-SCATTER GRID techniques must adhere to defined tolerances Additionally, any adjacent correction steps should result in changes to optical density or LOADING FACTORS that remain within the specified tolerances.

When multiple operator-selectable AEC sensor configurations are available, only one reference configuration must be chosen and tested as per section 5.7.1.3.2 All other sensor configurations should be evaluated against this reference using identical settings for the reference radiogram The optical density of the resulting radiograms must fall within the specified limits If manual selection of AEC sensor configurations is not possible, testing should be conducted with the configuration automatically selected by the equipment.

5.7.1.3.2 Test method and setting for optical density

The TEST DEVICE must be made of PMMA material, ensuring that the active area of the AEC sensor remains consistently positioned and fully covered during tests Additionally, a breast compression plate should be included within the RADIATION BEAM, while maintaining a safe distance between the active area of the AEC sensor and the edges of the PATIENT SUPPORT or the chest wall.

TEST DEVICE to avoid effects, such as interfering scatter effects caused by the edge of the

For optimal results, utilize RADIOGRAPHIC FILM, INTENSIFYING SCREEN, and RADIOGRAPHIC CASSETTE specifically designed for PATIENTS Ensure that the same RADIOGRAPHIC CASSETTE is employed across all tests, and process the films under consistent, stable conditions It is essential to measure the optical densities or the differences in optical densities within the same designated areas of the film for accurate comparison.

To minimize the impact of unstable film processing conditions on measurement results, it is crucial to conduct tests without interruptions Additionally, maintaining a consistent time interval between irradiation and film processing is essential to reduce the effects of latent image fading.

The USER's preferred default technique involves creating a reference RADIOGRAM using an X-RAY TUBE VOLTAGE of 28 kV The selection of the TARGET, FILTER, and FOCAL SPOT must adhere to the INSTRUCTIONS FOR USE.

This reference RADIOGRAM shall be made using a TEST DEVICE of 40 mm thickness and the optical density D of the RADIOGRAM shall be in the range of 1,4 to 2,0

The optical density measured in this RADIOGRAM shall serve as reference value for the test in

5.7.1.3.4 Test method for the influence of layer thickness variation and X- RAY TUBE

VOLTAGE variation for ANTI - SCATTER GRID /no ANTI - SCATTER GRID techniques

With all settings of the AEC as used in 5.7.1.3.3, including the correction step, RADIOGRAMS are to be made for at least three different TEST DEVICE thicknesses (e.g 20 mm, 40 mm,

The article discusses the use of various combinations of X-ray tube voltage, target, and filter, with or without an anti-scatter grid, in accordance with the instructions for use It emphasizes that at least three different X-ray tube voltage values must be utilized Additionally, for each radiogram, the deviation of the optical density from the previously determined reference value must be assessed.

5.7.1.3.5 Step size and adjustable range of optical density

To evaluate optical density control, the correction step settings should be adjusted within ±0.5 of the reference RADIOGRAM's density, following the conditions outlined in section 5.7.1.3.3 The optical density differences between adjacent film steps will be assessed.

5.7.2 AEC for mammographic X - RAY EQUIPMENT using storage phosphor plates and for systems with an integrated digital X- RAY IMAGE RECEPTOR

Using the definition for AEC within this document, the AEC test for mammographic X-RAY

EQUIPMENT with storage phosphor plates and for systems with an integrated digital X - RAY

IMAGE RECEPTOR should include the test of following three items:

– AEC setting confirmation test; check that the storage phosphor plate sensitivity lies between the upper and lower limit for each AEC setting which will be used in clinical practice;

– reproducibility and accuracy test, as described in 5.8;

– LOW CONTRAST DETECTABILITY test, as described in 5.14.2

The AEC test for mammographic X-ray equipment utilizing storage phosphor plates and integrated digital X-ray image receptors involves confirming the AEC settings, as well as conducting tests for reproducibility and accuracy.

In contrast to film and screen imaging, where the performance of the image receptor is limited to a narrow range of exposure, the selection of irradiation parameters is not solely focused on maintaining constant doses The primary objective is to achieve consistent image quality and dose levels across different breast properties However, it is important to note that maintaining high image quality for all breast thicknesses at acceptable patient dose levels is not feasible Generally, image quality tends to be lower, and doses are higher for larger or denser breasts Therefore, strict consistency in image parameters or doses across varying breast properties and operating conditions is not pursued.

The evaluation of the AEC's performance involves a comprehensive assessment of image quality, determined by the Contrast to Noise Ratio under specific conditions, alongside the patient dose, represented by the Average Glandular Dose These metrics will be compared against the manufacturer's specifications to ensure compliance and effectiveness.

In addition, the reproducibility of AIR KERMA shall be tested with constant IRRADIATION conditions

Using AEC operation to produce RADIOGRAMS of each of a set of specified TEST DEVICES,

The contrast to noise ratio (CNR) values in radiograms must exceed the minimum thresholds set by the manufacturer and comply with the system image quality test outlined in section 5.14.2 Additionally, the dose value derived from the image quality, based on the CNR specific to the X-ray generator and receptor system combination, should also surpass the manufacturer's minimum requirements and adhere to the image quality standards specified in 5.14.2.

The signal to noise ratio (SNR) values in radiograms must exceed the minimum thresholds set by the manufacturer and comply with the image quality test outlined in section 5.14.2.

– the average glandular dose deduced in the same conditions shall be lower than the maximum values specified by the manufacturer;

– reproducibility and accuracy in each test condition shall be within the limit values specified by the manufacturer

The requirements shall be met for the various usable operating conditions present in the

EQUIPMENT (e.g pre-selected IRRADIATION programs or dose mode, magnification mode)

The test shall be performed using a TEST DEVICE according to the MANUFACTURER’s specifications and in compliance with 4.6.6.1

NOTE 1 It should be noted that the European guidelines require tests from 20 mm to 70 mm with 10 mm steps, plus 45 mm

Reproducibility of the AIR KERMA

Under constant test conditions the AIR KERMA shall remain within the specified tolerances

To measure AIR KERMA, use test objects with a total thickness of 40 mm placed on the PATIENT SUPPORT Position the detector for AIR KERMA measurement on top, ensuring it does not obstruct the chamber, the active area of the AEC sensor, or interfere with AEC functionality Conduct measurements at five consecutive LOADINGS with a constant X-RAY TUBE VOLTAGE Evaluate reproducibility by calculating the coefficient of variation, which is the ratio of the standard deviation to the mean of the measured AIR KERMA values.

A TTENUATION RATIO of material between the upper surface of the PATIENT

and the IMAGE RECEPTION PLANE

The ATTENUATION of the RADIATION BEAM for material between the upper surface of the PATIENT

SUPPORT and the IMAGE RECEPTION PLANE shall not exceed the specified values

The evidence of compliance with the specification shall be provided by the MANUFACTURER.

Breast COMPRESSION DEVICE

The following parameters shall be tested: a) indication of force, b) maximum compression force, and c) sustainability of the compression force applied

The value of the applied force displayed shall be within MANUFACTURER’s specification b) Maximum compression force

For a motorized breast COMPRESSION DEVICE, the maximum possible compression force shall be within MANUFACTURER’s specification c) Sustainability of the compression force applied

The applied compression force shall be maintained according to the specified values

The following test EQUIPMENT is required:

– a soft rubber block, 20 mm to 50 mm thick, and 100 mm to 120 mm long and wide

To obtain a cranio-caudal projection of the breast, position the X-ray tube and image receptor assembly accordingly Secure the scale on the patient support to prevent it from falling in any orientation, and place a soft rubber block on the sensitive area of the scale before proceeding with the breast operation.

COMPRESSION DEVICE, thus clamping the soft rubber block, and record the reading of the scale and the displayed value

The compression should also be tested at 90° and 180° of the X-RAY TUBE – image receptor assembly rotation, if the test instrument can be used at these angles

Conduct a minimum of five measurements of compression force within a one-minute interval, ensuring that the values are evenly distributed from zero compression to the maximum compression force specified in the accompanying documents.

5.10.4 Determination of compliance a) Indication of force

Compare the MEASURED VALUES with the displayed values, applying the above requirements of accuracy

LICENSED TO MECON Limited - RANCHI/BANGALORE FOR INTERNAL USE AT THIS LOCATION ONLY, SUPPLIED BY BOOK SUPPLY BUREAU. b) Maximum compression force

Compare the maximum MEASURED VALUE with the value stated in the ACCOMPANYING

DOCUMENTS c) Sustainability of the compression force applied

Check that the compression force is maintained (tolerance –10 N) over a period of 1 min.

Uniformity

This subclause does not apply to non-uniformities related to radiographic film, film processing, intensifying screens, storage phosphor plates, and radiographic cassettes Additionally, it excludes storage phosphor plate readers, hard copy cameras, and viewing boxes unless explicitly stated otherwise.

IMAGE DISPLAY DEVICES A discussion of ARTIFACTS and other non-uniformities is presented in

Mammographic images shall be free of such non-uniformities which could impact medical effectiveness

Grid lines shall be completely blurred in the specified range of ATTENUATION layer thickness or

The extent of lag effects shall comply with the specified tolerances

The intercepting layers in the RADIATION BEAM shall not generate ARTIFACTS in the radiographic image which could be detrimental to medical diagnostics

5.11.3.1 Basic test a) Insert a homogeneous ATTENUATION layer of 20 mm PMMA in the RADIATION BEAM, large enough so that no RADIATION can pass directly to the X-RAY IMAGE RECEPTOR For X- RAY

To ensure optimal imaging, maintain the focal spot to grid distance close to the anti-scatter grid's focusing distance When using AEC mode, set the X-ray tube voltage to 25 kV or the nearest available setting; if AEC is unavailable, apply a current-time product based on clinical values Follow standard procedures to obtain a visible image, aiming for an optical density of approximately 1.6 if radiographic film is utilized Finally, view the radiograms under consistent room illumination and using the same methods as in medical practice, ensuring that digital systems are adjusted for contrast and brightness in line with standard medical settings.

Visually inspect the RADIOGRAMS for any non-uniformities that may negatively impact medical diagnostics If scratches are observed on the RADIOGRAM, evaluate the PMMA ATTENUATION layer to identify whether the issue originates from the PMMA or the X-ray image receptor To confirm the source of the scratches, retake the exposure with the ATTENUATION layer repositioned.

All patient supports and breast compression plates associated with the X-ray equipment must undergo repeated testing to ensure compliance and safety.

NOTE Applying digital post processing algorithms to essentially uniform images can produce excessive contrast enhancement that will not be present in clinical images

5.11.3.2 Moving ANTI - SCATTER GRID blurring

If the X-RAY EQUIPMENT includes one or more moving ANTI-SCATTER GRIDS, perform the following test: a) Replace the 20 mm PMMA ATTENUATION layer with layers of specified thickness and repeat the procedure outlined in section 5.11.3.1 Alternatively, if the testing range is defined by LOADING TIME, use ATTENUATION layers of suitable thickness to cover the specified LOADING TIME range b) Display, view, and examine the RADIOGRAMS as detailed in section 5.11.3.1 c) Conduct the test for all ANTI-SCATTER GRIDS included in the X-RAY EQUIPMENT.

If the X-ray image receptor is not a screen-film system, conduct this test by adjusting the basic setup, which includes an attenuation layer of 20 mm PMMA Position a wire grid near the X-ray image receptor, ensuring it is large enough to cover the entire image reception area The wire grid can be placed between two thin plates.

To ensure optimal medical diagnostics, it is crucial to verify that PMMA is adequately flat Additionally, create an image following the same procedure as the basic test and carefully examine the RADIOGRAM for any distortions that may impact diagnostic accuracy If there are clinically relevant limits for line displacement, conduct the required measurements to assess compliance.

To conduct this test, ensure that the X-ray equipment includes a digital X-ray imaging device Follow the manufacturer's specifications for operating the device Begin by placing an attenuation plate, measuring at least 60 mm by 60 mm, on the patient support The attenuation plate must be made of tungsten.

For effective X-ray attenuation, materials such as lead (minimum thickness of 0.1 mm), stainless steel (minimum thickness of 0.2 mm), and aluminum (minimum thickness of 4.0 mm) should be utilized, or other equivalent materials may be considered It is essential to adhere to the manufacturer's recommended methods to produce accurate imaging results.

MANUFACTURER shall specify the X-ray exposure IRRADIATION values for this first image c) Follow the method(s) proposed by the MANUFACTURER for the treatment of the DIGITAL X-

To create a second image without additional irradiation of the X-ray image receptor, follow the manufacturer's specified method and time interval between the first and second images Additionally, measure the average pixel value within a rectangular region that includes at least 1,000 adjacent pixels, ensuring it does not overlap with the area of the image.

ATTENUATION plate (ROI 2, see Figure J.1 of Annex J)

To assess the additive lag effect performance within the manufacturer's specified tolerance, first measure the average pixel value of a rectangular region containing at least 1,000 pixels adjacent to the attenuation plate (ROI 2) Next, measure the average pixel value within the area covered by the attenuation plate (ROI 1) using the second image Finally, calculate the difference between these two measurements, divide it by the measurement obtained in step e), and compare the result to evaluate performance.

If your X-ray equipment includes a digital X-ray imaging device, ensure to operate it according to the manufacturer's specifications Adhere to the manufacturer's recommended method to create an image without any issues.

ATTENUATION plate The MANUFACTURER shall specify the X-ray exposure IRRADIATION values for this first image (Image1) b) Follow the method(s) proposed by the MANUFACTURER for the treatment of the DIGITAL X-

To create an image using the RAY IMAGING DEVICE between irradiations, place the specified ATTENUATION plate on the PATIENT SUPPORT as outlined in section 5.11.3.4.1 Adhere to the MANUFACTURER's guidelines and capture the image The MANUFACTURER will provide the X-ray exposure IRRADIATION values for this second image (Image2) Additionally, follow the MANUFACTURER's recommended methods for processing the DIGITAL X-ray.

To create an image using the RAY IMAGING DEVICE, first remove the ATTENUATION plate from the PATIENT SUPPORT, following the MANUFACTURER's guidelines The MANUFACTURER will provide the X-ray exposure IRRADIATION values for the third image (Image3) and the time interval between the second and third image acquisitions Next, measure the average pixel value of a rectangular region containing at least 1,000 pixels within the high-contrast ATTENUATION plate area (ROI 1) Additionally, measure the average pixel value of a rectangular region with at least 1,000 pixels that is adjacent to, but does not overlap with, the high-contrast ATTENUATION plate image (ROI 2).

− and compare the result with the tolerance specified by the MANUFACTURER.

Dynamic range of mammographic X- RAY EQUIPMENT using digital X-ray image receptors, including storage phosphor systems

receptors, including storage phosphor systems

The dynamic range of mammographic X-ray equipment indicates the maximum difference in breast thickness that can be effectively imaged at the same time, ensuring no loss of information from detector saturation This situation can arise when imaging larger breasts, where the overall thickness is significant, but the skin line area remains relatively thin.

The number of steps visible shall be superior or equal to the number specified by the

A specialized PMMA plate with a thickness of 40 mm will be utilized, featuring a step wedge design The thinnest section of the step wedge will measure 3 mm, and the wedge will consist of 12 steps, each increasing by 3 mm increments (refer to figure B-1 for illustration).

The dynamic range shall be measured as the smallest thickness of PMMA rendered without saturation when acquired in the conditions determined by the AEC for a 60 mm thickness TEST

Position the special plate outlined in section 5.12.3 on the PATIENT SUPPORT, placing a 20 mm attenuating plate on top Adjust the breast COMPRESSION DEVICE and all other operating parameters to match those used for testing the AEC with a 60 mm thickness of PMMA.

Acquire a RADIOGRAM in conditions allowing the determination of the dynamic range, in particular concerning the processing of the images

Follow the manufacturer's guidelines regarding display or measurement conditions, such as comparing to the maximum reachable level or standard deviation at zero, to ascertain the number of non-saturated steps This will allow for the determination of the thickness of the smallest non-saturated step.

Compare the results with the values specified by the MANUFACTURER.

Spatial resolution

5.13.1 Mammographic X- RAY EQUIPMENT using RADIOGRAPHIC FILM

The specified line groups shall be resolved when imaged in two orientations, parallel to the

Patient support involves ensuring that the chest wall edge is aligned perpendicularly A line group in a bar pattern is deemed resolved when its film image displays a consistent arrangement of distinct dark lines, matching the number of slits in the line group It is essential that the lines on the film appear continuous and unbroken.

This requirement does not apply to first order pseudo patterns, which are identified by having one dark line fewer than the correct bar pattern image Additionally, higher order pseudo patterns are not relevant for acceptance testing.

One or more PMMA blocks of 40 mm overall thickness shall be placed on the PATIENT

A high attenuation material with a specified thickness will be placed on top of PMMA blocks for testing The test will be conducted with line groups in both orientations as outlined in section 5.13.1.1 The test pattern should cover spatial frequencies ranging from 8 to 16 lp/mm, ideally in increments of 1 lp/mm The line group that corresponds to the limiting resolution must be positioned 6 cm from the chest wall edge.

– with all FOCAL SPOTS and TARGETS of the X-RAY TUBE in all combinations specified for

– with X-RAY TUBE VOLTAGES and imaging techniques (grid/non grid/magnification) as specified

The screen-film system and the optical density shall be chosen as for the reference RADIO -

GRAM taken in 5.7.1.3.3 when testing the performance of the AUTOMATIC EXPOSURE CONTROL

The line group images shall be evaluated with a magnifying glass in each RADIOGRAM

NOTE The distance of the bar patterns to the PATIENT SUPPORT and to its chest wall edge strongly influence the test results

– each of the geometric configurations (contact, geometric magnification),

– each of the relevant TARGET track/spectral FILTRATION combinations

Compare the results with the values specified by the MANUFACTURER

5.13.2 Mammographic X- RAY EQUIPMENT using digital X-ray image receptors and storage phosphor systems

A test for spatial resolution shall be provided by the manufacturer

Unless specified by the manufacturer, measurements of MODULATION TRANSFER F UNCTION

MTF (Modulation Transfer Function) is essential for verifying compliance with contractual specifications and assessing potential degradation over time through constancy testing However, it is important to recognize that MTF alone does not provide a complete assessment of absolute performance, as it does not account for detective quantum efficiency.

(DQE) should be used instead

NOTE Currently a set of IEC standards to describe DQE measurements is under development

In addition, care should be taken to differentiate the detector MTF, as described in

IEC 62220-1-2 mandates that measurements be conducted under highly controlled conditions, distinct from the system's setup, to assess the overall system Modulation Transfer Function (MTF), which includes factors such as the focal spot and geometry During acceptance testing, these effects are intentionally examined, leading to the preferred terminology of "system contrast transfer function (SCTF)."

The result of the test proposed will deviate from the MTF for detectors with high MTF below

The method selected, based on the research by Droege et al., may yield results that differ from those obtained through alternative methods, such as edge response techniques To prevent any confusion, the term "system contrast transfer function" will be used instead of MTF.

The system contrast transfer shall be determined for a finite number of spatial frequencies and compared to the minimum values specified by the MANUFACTURER

The System Contrast Transfer Function should be measured under relevant conditions as specified by the manufacturer This measurement is derived from the RMS value of a periodic square pattern placed on 40 mm thick attenuating plates, considering both contact and magnification conditions.

The test shall be performed for at least one combination of TARGET tracks and spectral

FILTRATIONS available, as specified by the MANUFACTURER

To minimize measurements and prevent moiré patterns, measurements should be conducted using a periodic resolution pattern oriented at 45° or according to the directions provided by the manufacturer.

Reproduce the configuration used to test the AEC with 40 mm object thickness, except the compression plate of the breast COMPRESSION DEVICE

Position a periodic resolution bar pattern made of thin, highly attenuating materials like lead or gold on top of the attenuating plates, ensuring the material thickness is 50 µm or less.

The required spatial frequencies of the pattern are respectively 2 lp/mm and 4 lp/mm for the

“contact” configuration, and 4 lp/mm and 8 lp/mm for the “magnification” configuration, within

5 % Each frequency pattern shall contain a minimum of 5 periods, a number of 8 or more being preferred The length of the bars constituting the pattern shall be larger than 10 periods

The bars shall be oriented at 45° ± 2° relative to the edge of the image receptor corresponding to the chest wall side or in the directions and locations recommended by the

The centres of the periodic bar patterns shall be placed at 60 mm from the edge of the

Patient support should be positioned on the chest wall side, ideally aligned as closely as possible to the axis, perpendicular to the chest wall, and within a maximum distance of 20 mm from that axis.

Zones with the same material and thickness as the attenuating and transparent parts of the periodic resolution patterns shall be placed immediately adjacent to the periodic pattern

The designated zones must be equal to or larger than the largest periodic pattern and strategically located to ensure that the average and standard deviation of pixel values within these zones accurately reflect those of the resolution bar patterns.

A sample configuration for the TEST DEVICE is provided in Annex F, but alternative configurations that meet the same requirements are acceptable In the absence of a dedicated TEST DEVICE, standard patterns can be utilized; however, this may necessitate a multi-step process to gather all necessary data.

NOTE 2 For certain EQUIPMENT it may be necessary to perform the test with the test pattern parallel and perpendicular to the centreline instead of the 45° angle

5.13.2.4 Test method a) Acquisition of the RADIOGRAMS

For each configuration, acquire a RADIOGRAM using the same technique factors as used for the determination of the CNR and AGD at 40 mm thickness

When different TARGET material/spectral FILTRATIONS are used, select the X-RAY TUBE

To achieve a detector element value in images within ± 25% of the target, it is essential to adjust the voltage according to the manufacturer's specifications and the tube loading (mAs), while utilizing the material and spectral filtration determined by the AEC.

The TEST DEVICE must be placed on the PATIENT SUPPORTS corresponding to each geometric configuration, specifically "contact" and "magnification," with the FOCAL SPOTS chosen appropriately Additionally, the region of interest should be sufficiently large to display the bar pattern clearly.

For each of the resolution bar patterns, measure the average and standard deviation in the images of

– the bar patterns at frequency f: m f and σf,

– the attenuating reference zone: m a and σa, and

– the transparent reference zones: m t and σt c) Computations

For each of the spatial frequencies f in each of the operating conditions, compute the system contrast transfer function M(f):

– each of the geometric configurations (contact, geometric magnification),

– each required spatial frequency, and

– each of the relevant TARGET track/spectral FILTRATION combinations

Compare the results with the values specified by the MANUFACTURER.

L OW CONTRAST DETECTABILITY

LOW CONTRAST DETECTABILITY requirements should be specified by the MANUFACTURER

For testing purposes, unless otherwise indicated by the manufacturer, a test device featuring low contrast structures is required This device should consist of holes drilled into a 40 mm thick layer of PMMA, with each hole measuring between 5 mm and 6 mm in diameter The depth of the holes must be either 0.1 mm or 0.15 mm.

0,2 mm, 0,25 mm, 0,3 mm, 0,35 mm, 0,4 mm with a tolerance of ± 0,02 mm

The TEST DEVICE shall be placed on the PATIENT SUPPORT RADIOGRAMS shall be made

– with all TARGETS and FILTERS of the X- RAY TUBE , in all combinations specified for NORMAL

– with X-RAY TUBE VOLTAGES and imaging techniques (grid/non grid/magnification) as specified

The screen-film system and the optical density shall be chosen as for the reference RADIO-

GRAM when testing the performance of the AUTOMATIC EXPOSURE CONTROL

The number of visible low contrast objects shall be determined for each RADIOGRAM

The outcomes of this test are heavily influenced by the screen-film system employed, while the focal spot has minimal impact due to the size of low contrast objects being several millimeters.

5.14.2 Mammographic X- RAY EQUIPMENT using an integrated digital X- RAY IMAGE

RECEPTOR or storage phosphor plates

LOW CONTRAST DETECTABILITY requirements should be specified by the MANUFACTURER An example is given in Annex G

LOW CONTRAST DETECTABILITY tests should be performed as specified by the MANUFACTURER

An example is given in Annex G.

Entrance surface AIR KERMA

The entrance surface AIR KERMA shall not exceed the specified value For mammographic

X-RAY EQUIPMENT using RADIOGRAPHIC FILM the entrance surface AIR KERMA shall be referred to an optical density of D = 1,6

Manufacturers typically recommend using a target filter combination of Mo/30 μm Mo or W/60 μm Mo for imaging medium breasts, depending on the design of the X-ray tube It is advised to maintain the same upper limit of entrance surface air kerma for both filter combinations.

Use the same IRRADIATION conditions as for the first reference RADIOGRAM when testing

The AIR KERMA will be measured at a height of 40 mm ± 1 mm above the patient support and at a distance of 6 cm from the edge of the chest wall, ensuring accurate performance assessment of the AEC while excluding any scattered radiation.

RADIATION from the TEST DEVICE shall contribute to the measurement For mammography

X-RAY EQUIPMENT using RADIOGRAPHIC FILM the entrance surface AIR KERMA K E shall be determined by using the measured AIR KERMA K and referring to the optical density D = 1,6 by calculation

If the dosimeter cannot measure without backscattered radiation, the air kerma (K) can be determined manually without the test device The air kerma can then be calculated for the same current time product used in the initial reference radiogram during the AEC performance testing.

The approximation \( K_E \approx K \times \frac{1.6}{D} \) yields a sufficiently accurate result for \( K_E \) when the measured optical density is near \( D = 1.6 \) For optical densities ranging from \( D = 1.4 \) to \( D = 1.8 \), the calculation error remains within ±5%.

5.15.2 Mammographic X- RAY EQUIPMENT using an integrated digital X- RAY IMAGE

RECEPTOR or storage phosphor plates

The entrance surface AIR KERMA shall not exceed the specified value of dose or signal level by the MANUFACTURER For mammographic X-RAY EQUIPMENT using integrated digital X- RAY IMAGE

RECEPTOR, the entrance surface AIR KERMA shall be referred to a signal level specified by the

Use IRRADIATION conditions specified by the MANUFACTURER for this test The AIR KERMA shall be determined at a height of 40 mm ± 1 mm over the PATIENT SUPPORT, and at a distance of

The measurement must be taken 6 cm from the edge of the chest wall, ensuring that no scattered radiation from the test device affects the results For mammographic X-ray equipment equipped with a digital detector, the entrance surface air kerma (K E) should be determined using the measured air kerma (K).

If the dosimeter cannot measure without backscattered radiation, the air kerma (K) can be determined through manual irradiation, bypassing the test device This method allows for accurate assessment of air kerma under specific conditions.

CURRENT TIME PRODUCT , as used for the first reference RADIOGRAM when testing performance of the AEC, can be calculated.

Biopsy needle positioning accuracy of MAMMOGRAPHIC STEREOTACTIC DEVICES

The accuracy of biopsy needle tip position in x, y, and z directions shall be within the specified range in the specified stereotactic biopsy volume

A mammographic stereotactic test device is essential for testing various biopsy needle directions This device features a perforated mounting plate that acts as a locator for the test needles It is designed to hold at least three steel needles of varying lengths, positioned perpendicularly to the plate's surface and aligned in the same direction An illustrative example of this arrangement can be found in Annex H.

The steel test needles are designed to serve as test objects, arranged in a specific pattern to ensure coverage of the designated stereotactic biopsy volume One needle must be positioned within ±5 mm of the center of this volume, while two additional needle tips should also be located within the specified biopsy volume, not exceeding 10 mm from the extreme x, y, and z points intended for reconstruction using the MAMMOGRAPHIC STEREOTACTIC DEVICE.

Measure the biopsy needle length and compare the result to the nominal biopsy needle length, or to the biopsy needle length value stored or programmed in the MAMMOGRAPHIC

STEREOTACTIC DEVICE The measured length shall agree with the nominal length to within ±0,3 mm Place the TEST DEVICE on the PATIENT SUPPORT of the MAMMOGRAPHIC STEREOTACTIC

To ensure accurate stereotactic biopsy, one test needle tip must be positioned within ±5 mm of the center of the designated biopsy volume, while two additional test needle tips should be placed within the specified volume and within 10 mm of the extreme x, y, z coordinates intended for reconstruction Utilizing an attenuating, homogeneous material is recommended for optimal results.

2 mm Al, may be attached close to the X-RAY SOURCE ASSEMBLY

Position the X-ray tube and image receptor assembly to obtain a cranio-caudal projection of the breast, followed by acquiring a pair of stereo views In each image, identify all projections of the test needle tips within the designated stereotactic biopsy volume and reconstruct their x, y, z coordinates For each test needle, align the biopsy needle tip according to the positions calculated by the mammographic stereotactic device Measure and document the differences in x, y, z positions between each test needle tip and the biopsy needle tip Repeat this process with the X-ray tube assembly and image receptor assembly rotated to the extremes of the angular deviation range specified by the manufacturer, including any intermediate deviations of 90 degrees or its multiples.

The MAMMOGRAPHIC STEREOTACTIC DEVICE is engineered to facilitate biopsies from multiple needle directions in relation to the X-RAY TUBE ASSEMBLY and image receptor assembly The procedure can be repeated in six distinct directions within the clinical range specified by the MANUFACTURER, ensuring that at least two of these directions are at the extremities of the defined range.

Compare the differences in the x, y, and z directions to the requirement above

6 Baseline values for CONSTANCY TESTS

After the mammographic X-ray equipment successfully passes the acceptance test, baseline values for future constancy tests will be established These baseline values will be determined using the appropriate measuring procedures and equipment designated for constancy testing.

7 Test report and statement of compliance

A test report shall be drawn up with the following items:

– description of the mammographic X-RAY EQUIPMENT tested, including individual identification data for all components;

– compilation of relevant performance and functioning specifications;

– description of the test EQUIPMENT, including film and processing data;

– statement whether the tested mammographic X-RAY EQUIPMENT complies with the requirements of this standard and with the specified parameters; and

– the location, the date and the names of the persons performing the tests

The test report shall be headed:

Test report on ACCEPTANCE TEST of mammographic X-RAY EQUIPMENT according to IEC 61223-

If compliance with this standard is to be stated, this shall be done as follows:

Imaging performance of mammographic X-RAY EQUIPMENT, * ) complies with IEC 61223-3-

NOTE *) Identification (for example name of EQUIPMENT , model or type reference)

T EST DEVICES and arrangements for testing the automatic exposure control system with a digital X- RAY IMAGE RECEPTOR

Increase the coverage by the attenuating plate on chest wall side to increase robustness to positioning vs scatter and possible influence of raw beam

The curved contour and the chamfered edge mimick a real breast shape for the compression plate

The pegs allow an accurate positioning of the plates

Figure A.2 – Alternative design for the top attenuating plate

Hole allowing registration with pegs of other plates

Figure A.3 – Alternative design for the two additional attenuating plates

Figure A.4a – Step1: with Al foil

Al foil 99,9 % purity Thickness: (0,20 ± 0,01) mm

Region of interest, square or circular

(20 ± 1) mm size or (400 ± 40) mm² area

Figure A.4 – Measurement of CNR: 2-step methods

T EST DEVICE for testing the dynamic range of systems with a digital X- RAY IMAGE RECEPTOR

Hole allowing registration with pegs of other plates

Same as in Figure A.2 + 5 mm

Figure B.1 – Test object for the dynamic range (to be used together with a 20 mm PMMA plate placed on top)

Test methods for screen-film X-ray image receptor

For assuring the performance of the X-RAY IMAGE RECEPTORS it is informative to check whether the nominal AIR KERMA K N stays below a specified maximum value

If no maximum value for K N has been specified then it can be useful to compare K N and the

The AIR KERMA K s, as specified by the manufacturer of the screen-film system, should be verified to ensure that it falls within an acceptable range For a mammographic screen-film system, the AIR KERMA K s corresponds to the AIR KERMA that produces a net optical density D n = 1.0, based on laboratory measurements conducted in accordance with ISO 9236-3.

For screen-film systems designed for patient use, the AIR KERMA K B values must be measured at an X-RAY TUBE VOLTAGE of 28 kV The selection of the TARGET and FILTER should follow the INSTRUCTIONS FOR USE specific to a medium breast.

For the test procedure, a TEST DEVICE with a thickness of 40 mm, as detailed in Annex A, must be placed on the PATIENT SUPPORT The AIR KERMA will be measured in the plane of the RADIOGRAPHIC CASSETTE, specifically over the sensitive area of the AEC detector Additionally, the optical density of the RADIOGRAPHIC FILM, exposed under identical settings in a RADIOGRAPHIC CASSETTE, will be assessed in the corresponding region.

When replacing the RADIOGRAPHIC CASSETTE by the detector of the DOSIMETER the AEC will switch off at a significantly different AIR KERMA It can be necessary then, for determining the

AIR KERMA K B in the IMAGE RECEPTION PLANE, to use a second DOSIMETER as a monitor, or to calculate the AIR KERMA K B by using the built-in CURRENT TIME PRODUCT measuring instrument.

Subsequently the nominal AIR KERMA K N that results in a net density D 0 = 1,0 shall be calculated using the formula

D n is the actual net density of the RADIOGRAPHIC FILM,and

G is the average gradient of the screen-film system as determined with methods of X-ray sensitometry, referred to the actual net density and to the net density D n = 1

The approximation \( K_N \approx K_B \times \frac{1.2}{D} \) allows for a sufficiently accurate calculation of \( K_N \) when only the values of \( K_B \) and \( D \) are known, especially if the measured optical density \( D \) is near 1.2 Optical densities in the range of 1.1 to 1.3 result in deviations of no more than ±5%, while those in the range of 1.0 to 1.4 yield deviations of up to ±10%.

For assuring the performance of the X-RAY IMAGE RECEPTORS it is informative to check the variation in INTENSIFYING SCREEN sensitivity and X-ray ATTENUATION for the RADIOGRAPHIC

Cassettes and intensifying screens must be compatible for effective use in mammographic techniques, as variations in their properties should be minimized This consistency is essential to ensure stable dose delivery and optical density in Automatic Exposure Control (AEC) modes.

All radiographic cassettes used with patients must undergo testing If the user supplies a different type of radiographic cassette for specific procedures, such as magnification techniques, these cassettes should be evaluated independently.

Each of these RADIOGRAPHIC CASSETTES shall be inspected visually before it is exposed In case of a suspected defect a test for light-tightness according to ISO 4090 is recommended

The RADIOGRAPHIC CASSETTES shall be irradiated one after the other, with the same

IRRADIATION conditions and settings as for the first reference RADIOGRAM when testing the performance of the AEC All IRRADIATIONS performed with the same types of RADIOGRAPHIC

CASSETTE and INTENSIFYING SCREENS shall be made using RADIOGRAPHIC FILMS from the same package For each RADIOGRAPHIC CASSETTE tested a relative dose value or the CURRENT TIME

The PRODUCT will be documented, and the variations from the average value will be assessed Additionally, the optical density of the RADIOGRAPHIC FILMS will be measured consistently at the same location.

RADIOGRAM, and shall also be recorded The difference between the highest and lowest value of optical density shall be compared with the MANUFACTURER’s specification or recommendation

Optimum spatial resolution can only be achieved if the INTENSIFYING SCREENS and the

RADIOGRAPHIC FILMS are in close contact in all RADIOGRAPHIC CASSETTES

All RADIOGRAPHIC CASSETTES intended to be used with PATIENTS are to be tested according to the method and requirement described in ISO 4090

Test methods for storage phosphor system

The following may be tested as part of the acceptance testing of the storage phosphor system for mammographic X-RAY EQUIPMENT

This test is to confirm that the gain of the storage phosphor system is adequate and meets the

MANUFACTURER’s specifications, or the regulatory or contractual requirements

The EQUIPMENT needed to perform the test are a DOSIMETER and a software program to provide a digital value of a specific pixel or ROI

Under defined loading and testing conditions, the storage phosphor plate is exposed to X-rays, allowing for the measurement of the entrance dose The storage phosphor system, operating in automatic sensitivity mode, reads the plate The average digital value of a specific region of interest (ROI) in the image is then measured, and the sensitivity value must be adjusted based on the measured dose.

This test is done to all storage phosphor plates and cassettes to confirm the variation of the sensitivity of storage phosphor plates is within specified range

This test is to confirm that the accuracy of measurement of storage phosphor system is adequate and meet the MANUFACTURER’s specifications, or the regulatory or contractual requirements

The EQUIPMENT needed to perform the test are a PHANTOM specified for evaluating geometric distortion and a software program to provide a digital value of a specific pixel or ROI

The PHANTOM is positioned on the PATIENT SUPPORT, and under defined loading and testing conditions, the storage phosphor plate is exposed to X-rays Subsequently, the storage phosphor system reads the plate in automatic sensitivity mode.

Tiêu đề	Part 3-2: Acceptance Tests – Imaging Performance of Mammographic X-ray Equipment
Chuyên ngành	Electrical Engineering
Thể loại	standard
Năm xuất bản	2007
Thành phố	Geneva

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Số trang	128
Dung lượng	1,02 MB