Logo Company Name: Document No.

: Effective Date:

የኢትዮጵያ ቴክኖሎጂ ባለስልጣን WI/ETA/023 30/01/2016E.C

ETHIOPIAN TECHNOLOGY AUTHORITY 11/10/2023G.C

Title: Issue No. Page No.:

የፍሎሮስኮፒ ራጅ መሳሪያ የሬጉላቶሪ ቁጥጥር መስፈርት 2 1 of 20

Fluoroscopy X-Ray Equipment Regulatory Requirement

Issue History
Issue No. Description Originator Approved By Date
of Change Name Signature
2 Fassika Abebe

For Document Control Use Only

Copy Number Copy Controlling Stamp

PLEASE MAKE SURE THAT THIS IS THE CORRECT ISSUE BEFORE USE
Logo Company Name: Document No.: Effective Date:

የኢትዮጵያ ቴክኖሎጂ ባለስልጣን WI/ETA/023 30/01/2016E.C

ETHIOPIAN TECHNOLOGY AUTHORITY 11/10/2023G.C

Title: Issue No. Page No.:

የፍሎሮስኮፒ ራጅ መሳሪያ የሬጉላቶሪ ቁጥጥር መስፈርት 2 2 of 20

Fluoroscopy X-Ray Equipment Regulatory Requirement

Contents
1. Purpose...................................................................................................................................3
2. Scope......................................................................................................................................3
3. Responsible Person.................................................................................................................3
4. Definitions and Abbreviations................................................................................................3
4.1 Abbreviations........................................................................................................................3
4.2 Definitions.............................................................................................................................4
5. Regulatory Requirements........................................................................................................6
5.1 Safety Provisions, X- Ray Premise and Safety Control System............................................7
5.2 Operator controls and indicators...........................................................................................9
5.3 Test Compliance, Test Criteria for Passing the Test Initiation and termination of loading. 10
5.4 Safety of the X- ray Premise (Radiological protection survey)...........................................11
5.5 X-ray Machine Performance...............................................................................................11
5.6 Test Compliance, Test Criteria for Passing the Test...........................................................12
5.7 Test Compliance, Test Criteria for Passing the Test Automatic exposure control systems. 14
5.8 Beam quality – half value layer...........................................................................................14
5.9 Test Compliance, Test Criteria for Passing the Test...........................................................16
5.10 Test Compliance, Test Criteria for Passing the Test.........................................................18
5.11 Test Compliance, Test Criteria for Passing the Test.........................................................19
5.12 Documentation Requirements...........................................................................................19
5.13 Personnel Requirements....................................................................................................20
6. Records.................................................................................................................................20
7. Reference documents............................................................................................................20

PLEASE MAKE SURE THAT THIS IS THE CORRECT ISSUE BEFORE USE
Logo Company Name: Document No.: Effective Date:

የኢትዮጵያ ቴክኖሎጂ ባለስልጣን WI/ETA/023 30/01/2016E.C

ETHIOPIAN TECHNOLOGY AUTHORITY 11/10/2023G.C

Title: Issue No. Page No.:

የፍሎሮስኮፒ ራጅ መሳሪያ የሬጉላቶሪ ቁጥጥር መስፈርት 2 3 of 20

Fluoroscopy X-Ray Equipment Regulatory Requirement

1. Purpose

This procedure is intended to establish basic/mandatory requirements required for license

in fluoroscopy and to assist inspectors to decide uniformly whether a radiological facility
should be licensed, not begin or stop its services by the power vested to the ETA by
proclamation No. 1025/2017. This regulatory requirement will be available and
distributed to users beforehand so as to guide and inform them about the license process
to get authorization to practice diagnostic radiological services.
2. Scope

This radiation safety requirement sets out the minimum requirements for ionizing
radiation apparatus that is used for fluoroscopy involving the irradiation of humans.
3. Responsible Person

DG, DDG, QMR, R/N/T/NAC, R/N/T/RC, N/R/R/T/C

4. Definitions and Abbreviations

4.1 Abbreviations
ETA: Ethiopian Technology Authority
DG: Director General
DDG: Deputy Director General
R/N/T/NAC: Radiation and Nuclear Technology Notification and
Authorization Chief Executive Officer
R/N/T/RC: Nuclear and Radiation Technology Regulatory Control Chief
Executive officer
N/R/R/T/C: Nuclear and Radiation Technology Research Chief Executive
Officer

PLEASE MAKE SURE THAT THIS IS THE CORRECT ISSUE BEFORE USE
Logo Company Name: Document No.: Effective Date:

የኢትዮጵያ ቴክኖሎጂ ባለስልጣን WI/ETA/023 30/01/2016E.C

ETHIOPIAN TECHNOLOGY AUTHORITY 11/10/2023G.C

Title: Issue No. Page No.:

የፍሎሮስኮፒ ራጅ መሳሪያ የሬጉላቶሪ ቁጥጥር መስፈርት 2 4 of 20

Fluoroscopy X-Ray Equipment Regulatory Requirement

QMS: Quality Management System

MM: Management Manual
QMR: Quality Manager
WI: Work Instruction
ISO: International Organization for Standardization
4.2 Definitions
 Baseline value: means the reference value provided by the manufacturer or the
value
 Coefficient of variation: means the ratio of the sample standard deviation to the
mean value of a series of measurements.
 Continuous mode: means, for an X-ray generator, mode of loading an X-ray tube
continuously as in radiotherapy or in radioscopy or fluoroscopy.
 Effective focal spot size: means the size of the perpendicular projection of the
actual focal spot on the reference plane.
 Equivalent dimensions: means dimensions as determined by the star pattern
measurement method according to:
 F = N/57.3 x D/(M-1) where M is the magnification (diameter of the image of the
star pattern divided by the diameter of the star phantom)
 D is diameter of blur region
 N is angle of pattern lines in degrees
 Focal spot to image receptor distance: means the distance from the focal spot to
the point at which the reference axis intersects with the image receptor plane.
 High level or boost mode: means a mode where the air kerma entrance rate, as
measured in Appendix B, may exceed 100 mgy in one minute.
 Image acquisition: means the acquisition of intermittent image sequences where
the image presentation is not primarily intended for simultaneous and immediate

PLEASE MAKE SURE THAT THIS IS THE CORRECT ISSUE BEFORE USE
Logo Company Name: Document No.: Effective Date:

የኢትዮጵያ ቴክኖሎጂ ባለስልጣን WI/ETA/023 30/01/2016E.C

ETHIOPIAN TECHNOLOGY AUTHORITY 11/10/2023G.C

Title: Issue No. Page No.:

የፍሎሮስኮፒ ራጅ መሳሪያ የሬጉላቶሪ ቁጥጥር መስፈርት 2 5 of 20

Fluoroscopy X-Ray Equipment Regulatory Requirement

observation and the acquired images are automatically captured and stored for
later clinical or diagnostic reference.
 Image reception area: means the active surface of the image receptor at the time
an X-ray pattern is received.
 Intermittent mode: means, for an X-ray generator, mode of loading an X-ray
tube where the electric energy is supplied to the tube in single, intermittent or
pulsed loadings, as for example in radiography, cineradiography.
 Irradiation time: : means the duration of an irradiation determined by:
a. For single phase units, the irradiation time is determined by counting the total
number of pulses in the radiation waveform and multiplying by a factor of 0.02 if
half rectified or a factor of 0.01 if full wave rectified.
b. For other units, the irradiation time is determined from the time that the
kilovoltage has risen the first time to a value above 65%, but not higher than 85%
of the peak kilovoltage value, until the time at which it finally drops below the
same value.
 kvp (X-ray tube voltage): means the potential difference, applied to an X-ray
tube between the anode and the cathode, which is expressed by its peak value in
kilovolts (kvp).
 Leakage air kerma: means air kerma produced by ionising radiation which has
passed through the protective shielding of a radiation source as well as that which,
for some types of X-ray generators, has passed through the radiation aperture
before and after loading (e.g. one containing a grid controlled X-ray tube).
Leakage air kerma is usually expressed in milligray (mgy) or microgray (μgy).
 Loading: means the act of supplying electrical energy to the anode of an X-ray
tube.

PLEASE MAKE SURE THAT THIS IS THE CORRECT ISSUE BEFORE USE
Logo Company Name: Document No.: Effective Date:

የኢትዮጵያ ቴክኖሎጂ ባለስልጣን WI/ETA/023 30/01/2016E.C

ETHIOPIAN TECHNOLOGY AUTHORITY 11/10/2023G.C

Title: Issue No. Page No.:

የፍሎሮስኮፒ ራጅ መሳሪያ የሬጉላቶሪ ቁጥጥር መስፈርት 2 6 of 20

Fluoroscopy X-Ray Equipment Regulatory Requirement

 “ma” (X-ray tube current): means the electric current of the electron beam
incident on the target of an X-ray tube, which is expressed by its mean value in
milliamperes (ma).
 “mas” (current time product): means the electric charge resulting from the
loading of an X-ray tube, expressed in milliampere seconds (mas), as the product
of the mean X-ray tube current in milliamperes and the duration of the loading in
seconds.
 Optical density: means the common logarithm of the ratio of the amount of light
striking one side of the film to the amount of light that passes through the film.
 Total permanent filtration: means inherent filtration and other filtration not
removable without the use of tools.
5. Regulatory Requirements

Fluoroscopy is the method that provides real-time X ray imaging that is especially useful
for guiding a variety of diagnostic and interventional procedures. The ability of
fluoroscopy to display motion is provided by a continuous series of images produced at a
maximum rate of 25-30 complete images per second. This is similar to the way
conventional television or video transmits images.

While the X-ray exposure needed to produce one fluoroscopic image is low (compared to
radiography), high exposures to patients can result from the large series of images that
are encountered in fluoroscopic procedures. Therefore, the total fluoroscopic time is one
of the major factors that determine the exposure to the patient from fluoroscopy.

Because the X ray beam is usually moved over different areas of the body during a
procedure, there are two very different aspects that must be considered. One is the area
most exposed by the beam, which results in the highest absorbed dose to that specific part
of the skin and to specific organs. The other is the total radiation energy imparted to the

PLEASE MAKE SURE THAT THIS IS THE CORRECT ISSUE BEFORE USE
Logo Company Name: Document No.: Effective Date:

የኢትዮጵያ ቴክኖሎጂ ባለስልጣን WI/ETA/023 30/01/2016E.C

ETHIOPIAN TECHNOLOGY AUTHORITY 11/10/2023G.C

Title: Issue No. Page No.:

የፍሎሮስኮፒ ራጅ መሳሪያ የሬጉላቶሪ ቁጥጥር መስፈርት 2 7 of 20

Fluoroscopy X-Ray Equipment Regulatory Requirement

patient’s body, which is related to the Kerma Area Product (KAP or PAK), a quantity
that is easily measurable.

The absorbed dose to a specific part of the skin and other tissues is of concern in
fluoroscopy for two reasons: one is the need for minimizing the dose to sensitive organs,
such as the gonads and breast, by careful positioning of the X ray beam and using
shielding when appropriate. The second is the possible incidence of the radiation beam to
an area of the skin for a long time that can result in radiation injuries in cases of very high
exposure.

In fluoroscopy, as in all types of X ray imaging, the minimum exposure required to form
an image depends on the specific image information requirements. An important
characteristic of a fluoroscopic system is its sensitivity, i.e. the amount of exposure
required to produce images. The use of intensifier tubes and more modern digital flat
panel receptors make it possible to optimize the balance of patient exposure with image
quality so as not to expose the patient to unnecessary radiation. Non-intensified
fluoroscopy with just a fluorescent screen for a receptor should not be used because of
the excessive exposure to the patient.

This regulatory requirement sets the minimum safety criteria for used to carry out
fluoroscopy. Compliance with this requirement will assist in ensuring that patent, public
and occupational exposure to radiation is minimized.

The ETA has adapted and established the regulatory control systems from the beginning
in which a continuous and an effective linked system of Notification, Authorization,
Inspection and Enforcement are used for effective control of sources in the country.
5.1 Safety Provisions, X- Ray Premise and Safety Control System
A. Lead apron,
Lead aprons of 0.50 mm of lead (or lead equivalent) are indispensable for the
examiner and the radiographer and other staff involved as necessary. Lead

PLEASE MAKE SURE THAT THIS IS THE CORRECT ISSUE BEFORE USE
Logo Company Name: Document No.: Effective Date:

የኢትዮጵያ ቴክኖሎጂ ባለስልጣን WI/ETA/023 30/01/2016E.C

ETHIOPIAN TECHNOLOGY AUTHORITY 11/10/2023G.C

Title: Issue No. Page No.:

የፍሎሮስኮፒ ራጅ መሳሪያ የሬጉላቶሪ ቁጥጥር መስፈርት 2 8 of 20

Fluoroscopy X-Ray Equipment Regulatory Requirement

apron(s) integrity (Physical conditions for holes, cracks, etc) shall be checked
properly.
B. Lead glass goggle
Lead glass goggles have to be provided for protection of the eye of the patient.
C. X-ray protective surgical gloves
X-ray protective surgical gloves shall be provided for protection of the hands of
the patient. Glove integrity (Physical conditions for holes, cracks, etc) shall be
checked properly.

D. Ring dosimeter
Is designed to monitor exposure and serve as a tool to alert an individual if
radiation dose readings exceed unhealthy levels of radiation exposure
E. Thyroid shields
Thyroid shields shall be provided. Thyroid shields integrity (Physical conditions
for holes, cracks, etc) shall be checked properly.
F. Film Viewing Box
Film viewing screen with uniform light intensity and color should be available
G. Area of the exposure room
Area of the exposure room shall not be less than 28 m2 for fluoroscopy.
N.B. The exposure room shall have sufficient ventilation (such as a ventilation
window with a height above 2m from outside ground level and position in such a
way that backscatter radiation will not fall on windows of opposite building,
verandah, etc.)
H. Wall thickness
Wall thickness of at least 17 cm concrete or its equivalent (with no radiation
leakage to the surroundings, i.e. maximum of 1 µSv/hr at all locations occupied

PLEASE MAKE SURE THAT THIS IS THE CORRECT ISSUE BEFORE USE
Logo Company Name: Document No.: Effective Date:

የኢትዮጵያ ቴክኖሎጂ ባለስልጣን WI/ETA/023 30/01/2016E.C

ETHIOPIAN TECHNOLOGY AUTHORITY 11/10/2023G.C

Title: Issue No. Page No.:

የፍሎሮስኮፒ ራጅ መሳሪያ የሬጉላቶሪ ቁጥጥር መስፈርት 2 9 of 20

Fluoroscopy X-Ray Equipment Regulatory Requirement

by a member of the public and 7.5 µSv/hr to the control cubicle and any
occupationally accessed location by radiation workers).
I. Warning light & signs
A warning red light coupled/synchronized with the machine power shall be
provided at appropriate location(s).
Placards containing international radiation hazard sign (Trefoil symbol) and
notices in English and Amharic (or/and other local languages) should be available
and posted at suitable locations. Local rules should also be presented describing
working procedures and safety rules.
J. Auxiliary rooms
Dressing room and toilet that keep the privacy and safety of the patients adjacent
to the exposure room shall be provided.
Note 1. The test must be performed using an optimized combination of imaging
mode, image acquisition and image processing parameters.
The following image receptor input air kerma rates:

Field size Air Kerma rates (mm) (μGy.min-1)

< 140 120
140 to < 230 80
≥ 230 60

X-ray tube housing stability

The X-ray tube housing must remain stationary during loading unless it is intended to
move.
5.2 Operator controls and indicators
Irradiation switch on mobile radiation apparatus

PLEASE MAKE SURE THAT THIS IS THE CORRECT ISSUE BEFORE USE
Logo Company Name: Document No.: Effective Date:

የኢትዮጵያ ቴክኖሎጂ ባለስልጣን WI/ETA/023 30/01/2016E.C

ETHIOPIAN TECHNOLOGY AUTHORITY 11/10/2023G.C

Title: Issue No. Page No.:

የፍሎሮስኮፒ ራጅ መሳሪያ የሬጉላቶሪ ቁጥጥር መስፈርት 2 10 of 20

Fluoroscopy X-Ray Equipment Regulatory Requirement

There must be an irradiation switch fitted to a mobile radiation apparatus which

will allow the operator to be positioned at least 2m from the X-ray tube.
Note: This test does not apply to radiation apparatus if it can be shown that the air
kerma rate will not exceed 10μGy/min at the operator’s and foot position.
5.3 Test Compliance, Test Criteria for Passing the Test Initiation and
termination of loading
Each loading must be initiated and maintained by means of a control requiring
continuous actuation by the operator. Means shall be provided for the operator to
terminate each loading at any time before its intended completion, except during
serial radiography or for single loadings with a loading time of 0.5 seconds or less.
Loading indication
There must be a specific and conspicuous audible signal indicating loading in the
high level or boost mode.
Supply indication when the apparatus is energized, this status must be clearly
indicated. The supply indicator and the load indicator must be clearly labeled or
otherwise easily distinguishable from each other.
Indication if more than one X-ray tube If there is more than one X-ray tube
incorporated in the apparatus, the selected tube must be clearly indicated.
Indication of fluoroscopy time
The system must have a radioscopy or fluoroscopy timer, and:
a. the timer must provide an audible signal at intervals not exceeding 5
minutes; and
b. Means must be provided for the timer to be reset to zero.
Loading indication –intermittent mode

Loading in the intermittent mode must be indicated by a visible signal.

Additionally, an audible signal must be provided which indicates either the
duration or the instant of termination of loading.

PLEASE MAKE SURE THAT THIS IS THE CORRECT ISSUE BEFORE USE
Logo Company Name: Document No.: Effective Date:

የኢትዮጵያ ቴክኖሎጂ ባለስልጣን WI/ETA/023 30/01/2016E.C

ETHIOPIAN TECHNOLOGY AUTHORITY 11/10/2023G.C

Title: Issue No. Page No.:

የፍሎሮስኮፒ ራጅ መሳሪያ የሬጉላቶሪ ቁጥጥር መስፈርት 2 11 of 20

Fluoroscopy X-Ray Equipment Regulatory Requirement

Loading indication –continuous mode

Loading in the continuous mode must be indicated by a specific visible signal.
Loading factors
Loading factors must be continuously displayed.
Focal spot marking
The position of the focal spot must be clearly and visibly indicated.
5.4 Safety of the X- ray Premise (Radiological protection survey)
The X-ray department must be safe from radiological point of view at every
location (maximum of 1 µSv/hr at all locations occupied by a member of public and
7.5 µSv/hr in the control cubicle and any occupationally accessed location by
radiation workers).

Lead glass window shall be provided to the control cubicle, and it should have a
nominal value of 2 mm lead or its equivalent. The lead glass shall be fitted at proper
location to provide a clear view (to the radiographer) of a patient undergoing
radiological examination.

The wall of the X-ray room (exposure room) should be thick enough to attenuate
(contain) leakage of radiation. The wall thickness is generally suggested to be 17
cm of concrete (pure) or equivalent, as an alternative to the description on the lay
out of the X-ray premise. All doors adjacent to the exposure room shall be properly
shielded /lead-lined with lead of 2 mm or its equivalent material. Lead overlap shall
be made to avoid radiation leakage at edges, hinges and connections.
5.5 X-ray Machine Performance
Equipment of diagnostic radiology shall conform to applicable national or
international standards such as the International Electro technical Commission
(IEC) or International Standards Organization (ISO). Such equipment should satisfy
the technical requirements of verification of machine parameters, and Quality

PLEASE MAKE SURE THAT THIS IS THE CORRECT ISSUE BEFORE USE
Logo Company Name: Document No.: Effective Date:

የኢትዮጵያ ቴክኖሎጂ ባለስልጣን WI/ETA/023 30/01/2016E.C

ETHIOPIAN TECHNOLOGY AUTHORITY 11/10/2023G.C

Title: Issue No. Page No.:

የፍሎሮስኮፒ ራጅ መሳሪያ የሬጉላቶሪ ቁጥጥር መስፈርት 2 12 of 20

Fluoroscopy X-Ray Equipment Regulatory Requirement

Assurance tests at large. Under all circumstances, the equipment should be

accompanied with the necessary documents including the service and operating
manuals, results of acceptance tests, and calibration certificate for the required
machine parameters of the x-ray machine.
1. Deviation of kVp Accuracy ≤ ±10%

2. Deviation of the X-ray timer ≤ ±10%

3. Output inconsistency ≤ 5%

4. The first half value layer in the X-ray beam incident to the Patient must be
greater than or equal to:

i. 3.8 millimeters of aluminum at 120kVp; or

ii. 4.2 millimeters of aluminum at 130kVp
Entrance skin air kerma At 70 kVp, the air kerma rate, at 1 metre from the focal
spot,must not be less than 15 μGy per mAs.
Linearity
The following conditions must be met using a kVp value of approximately 70 kVp
and, if the equipment provides for such adjustments to be made, at least 4 pairs of
mA (or mAs) stations including the lowest and the highest available. The test must
be performed for each focal spot size.
Field indication, limitation and alignment Light field intensity
If a light beam diaphragm is fitted to the radiation apparatus, the illuminance of the
light field indicator must not be less than 100 lux at 1m from the focal spot of the
X-ray tube.
5.6 Test Compliance, Test Criteria for Passing the Test
X-ray/light field alignment
If a light beam diaphragm is fitted to the radiation apparatus:

PLEASE MAKE SURE THAT THIS IS THE CORRECT ISSUE BEFORE USE
Logo Company Name: Document No.: Effective Date:

የኢትዮጵያ ቴክኖሎጂ ባለስልጣን WI/ETA/023 30/01/2016E.C

ETHIOPIAN TECHNOLOGY AUTHORITY 11/10/2023G.C

Title: Issue No. Page No.:

የፍሎሮስኮፒ ራጅ መሳሪያ የሬጉላቶሪ ቁጥጥር መስፈርት 2 13 of 20

Fluoroscopy X-Ray Equipment Regulatory Requirement

a. The extent of misalignment between any boundary of the light field and the
equivalent boundary of the X-ray field in the plane of the image receptor must not
exceed 1 percent of the focus to image receptor distance; and
b. The central axis of the X-ray beam must coincide with the central axis of the light
field to within ±1.4 degrees (e.g. For a 20 cm high field alignment test tool, the
top test object must be within 5mm of the bottom test object).
X-ray field/image receptor – fluoroscopy
If the X-ray beam is rectangular, and the image receptor is circular, the length and
width of the X-ray beam must fall within the image receptor area. For X-ray
beams that are not rectangular, the discrepancy between any edge of the X-ray
beam axis and the corresponding visible edge of the image on the television
monitor must not exceed 1.5 percent of the focal spot to image receptor distance.
X-ray field/image receptor – radiography
For systems with fixed or automatic alignment of the X-ray tube assembly and the
image receptor assembly, in modes of operation where a light field indicator is not
fitted or cannot be used:
a. Any boundary of the X-ray beam must not fall more than 1.5 percent of the focus
to image receptor distance outside of the equivalent boundary of the image
reception area; and
b. For spot film imaging, the boundaries of adjacent segmental images must not
overlap.
However, if the X-ray beam is rectangular, and the image receptor is circular, the
length and width of the X-ray beam must fall within the image receptor.
For all other systems where a light field is not fitted or cannot be used, the size
and position of the X-ray beam must comply with manufacturer’s specifications.
Note: A representative sample of the clinically used combinations of focal spot to
image receptor distance and image receptors must be tested.

PLEASE MAKE SURE THAT THIS IS THE CORRECT ISSUE BEFORE USE
Logo Company Name: Document No.: Effective Date:

የኢትዮጵያ ቴክኖሎጂ ባለስልጣን WI/ETA/023 30/01/2016E.C

ETHIOPIAN TECHNOLOGY AUTHORITY 11/10/2023G.C

Title: Issue No. Page No.:

የፍሎሮስኮፒ ራጅ መሳሪያ የሬጉላቶሪ ቁጥጥር መስፈርት 2 14 of 20

Fluoroscopy X-Ray Equipment Regulatory Requirement

5.7 Test Compliance, Test Criteria for Passing the Test Automatic exposure
control systems
Reproducibility (a) Using the centre detector, the air kerma from 5 consecutive
loadings at 80 kVp with a patient equivalent phantom must be within ±10 percent of
the mean; and

For values of and

where

; and/or

For values of and where

Where:
are the measured values of air kerma.

and are the indicated current time products.

and are the indicated x-ray tube currents.

and are the indicated irradiation times.

PLEASE MAKE SURE THAT THIS IS THE CORRECT ISSUE BEFORE USE
Logo Company Name: Document No.: Effective Date:

የኢትዮጵያ ቴክኖሎጂ ባለስልጣን WI/ETA/023 30/01/2016E.C

ETHIOPIAN TECHNOLOGY AUTHORITY 11/10/2023G.C

Title: Issue No. Page No.:

የፍሎሮስኮፒ ራጅ መሳሪያ የሬጉላቶሪ ቁጥጥር መስፈርት 2 15 of 20

Fluoroscopy X-Ray Equipment Regulatory Requirement

5.8 Beam quality – half value layer

The total permanent filtration must be such that the measured first half-value layer
is not less than 2.3 millimeters of aluminum at an indicated value of 80 kVp.
X-ray source assembly leakage: The leakage air kerma averaged over any area of 100
square centimeters at one meter from the focal spot must not exceed 1 mGy in one hour
with the X-ray tube operating at the maximum rated voltage and the maximum rated
continuous current.
Maximum air kerma rate:
The maximum air kerma rate during fluoroscopy must not exceed the following values
when measured under the test conditions.
 Systems with manual dose control only 50 mGy.min-1
 Systems with automatic dose control (automatic and manual mode)
 100 mGy.min-1
 High level or boost mode
 150 mGy.min-1
 Typical air kerma rates For systems capable of operation in automatic dose
control mode:
a. the air kerma rate during radioscopy or fluoroscopy (other than high level or boost
mode) must not exceed 50 mGy.min -1 and should not exceed 20 mGy.min-1 when
measured under the test conditions given in Appendix C; and
b. if the air kerma during radioscopy or fluoroscopy (other than high level or boost
mode) does exceed 20 mGy.min-1, then the air kerma rate (other than high level or
boost mode) at the input surface of the image receptor must not exceed the
following values: contrast resolution as displayed on a clinical reference monitor
during radioscopy or fluoroscopy, the air kerma from irradiations to the lateral
detectors must be within 10 percent of each other.

PLEASE MAKE SURE THAT THIS IS THE CORRECT ISSUE BEFORE USE
Logo Company Name: Document No.: Effective Date:

የኢትዮጵያ ቴክኖሎጂ ባለስልጣን WI/ETA/023 30/01/2016E.C

ETHIOPIAN TECHNOLOGY AUTHORITY 11/10/2023G.C

Title: Issue No. Page No.:

የፍሎሮስኮፒ ራጅ መሳሪያ የሬጉላቶሪ ቁጥጥር መስፈርት 2 16 of 20

Fluoroscopy X-Ray Equipment Regulatory Requirement

Note: For this test, phantoms constructed of 2 mm of copper or 15 cm of acrylic are

suitable substitutes for a patient equivalent phantom. 32 kVp compensation For
systems utilizing a film-screen image receptor system the optical density of the
images of a patient equivalent phantom using 60, 80, 100 and 120 kVp must not
differ by more than 0.20 from the mean optical density. The mean optical density
must be in the range 0.5 to 2.0.
Note: where the equipment is designated for a specific clinical application an alternative
range of kVp settings consistent with the clinical application must be used for testing.
Thickness compensation
The optical density of four pairs of exposures made at the following parameters must not
differ by more than 0.2 from the other value in the pair.
a. 60kVp with 10 and 15 cm acrylic phantoms; and
b. 80kVp with 15 and 20 cm acrylic phantoms; and
c. 100kVp with 15 and 20 cm acrylic phantoms; and
d. 120kVp with 10 and 15 cm acrylic phantoms.
Minimum response time
The minimum response time of the automatic exposure control to radiation must not
exceed 10 milliseconds, except for single phase systems where it must not exceed 20
milliseconds.
Indication of automatic exposure control
There must be a visible indication when the automatic exposure control function is
selected.
5.9 Test Compliance, Test Criteria for Passing the Test
Indication of detector(s) selected
There must be a visible indication of the image receptor selected and the automatic
exposure control detector(s) active.

PLEASE MAKE SURE THAT THIS IS THE CORRECT ISSUE BEFORE USE
Logo Company Name: Document No.: Effective Date:

የኢትዮጵያ ቴክኖሎጂ ባለስልጣን WI/ETA/023 30/01/2016E.C

ETHIOPIAN TECHNOLOGY AUTHORITY 11/10/2023G.C

Title: Issue No. Page No.:

የፍሎሮስኮፒ ራጅ መሳሪያ የሬጉላቶሪ ቁጥጥር መስፈርት 2 17 of 20

Fluoroscopy X-Ray Equipment Regulatory Requirement

For clarification, the automatic exposure control must only be able to be operated if the
image receptor selected is equipped with an automatic exposure control detector.
Density control
Where the operator can alter the sensitivity of the detectors, this adjustment must cause a
change in air kerma consistent with Manufacturer’s instructions for use.
Failsafe timer – 600mA operation
A failsafe timer must be provided and must limit any loading to not more than 60
kilojoules or the current time product to no more than 600 mAs.
Failsafe timer – 600mAs Indication
A visible indication must be provided whenever a loading has been terminated by the
failsafe timer.
Failsafe timer – 600mAs reset
When a loading has been terminated
Field size (millimetre) Air kerma rate (μGy.min-1)
< 140 120
140 to < 230 80
≥ 230 60
Minimum focus to skin distance: The minimum focus to skin distance must not be able
to be less than 200 millimeters.
Image receptor in place: It must not be possible to initiate fluoroscopic loading without
an Image receptor in place to fully intercept the X-ray beam.
Image quality: The equivalent dimensions of focal spot sizes:
a. Should not exceed the relevant values specified in Appendix A for the
nominal focal spot size; and
b. Must not exceed equivalent dimensions of 2.6 millimeters width and 3.7
millimeters length.

PLEASE MAKE SURE THAT THIS IS THE CORRECT ISSUE BEFORE USE
Logo Company Name: Document No.: Effective Date:

የኢትዮጵያ ቴክኖሎጂ ባለስልጣን WI/ETA/023 30/01/2016E.C

ETHIOPIAN TECHNOLOGY AUTHORITY 11/10/2023G.C

Title: Issue No. Page No.:

የፍሎሮስኮፒ ራጅ መሳሪያ የሬጉላቶሪ ቁጥጥር መስፈርት 2 18 of 20

Fluoroscopy X-Ray Equipment Regulatory Requirement

Note: If the equipment does not meet the requirements of part (a), but does satisfy the
requirements of part (b), a comment to this effect must be made on the Assessment
Report.
Image uniformity: An image of grids in-situ within their image receptor must be
spatially uniform and free from clinically significant artifacts.
The image must be obtained using a clinically representative air kerma at the image
receptor and loading factors of approximately 70 kVp and at least 100 milliseconds using
a focus to image receptor distance within the focal range of the grid. High contrast
resolution Using a Westmead or similar test object attached to the face of the image
receptor, the high contrast resolution as displayed on a clinical reference monitor during
fluoroscopy must be greater than or equal to:

Field size (millimeter) Line pairs (millimeter)

< 140 1.6

140 to < 230 1.2

≥ 230 0.8

Note: This test must be performed using an optimized combination of imaging mode,
image acquisition and image processing parameters.
5.10 Test Compliance, Test Criteria for Passing the Test
Low contrast resolution Using a Westmead or similar test object attached to the face of
the image receptor, and 2 millimeters of copper in the beam positioned as close as
practicable to the collimator, the low must be greater than or equal to:
a. 5 percent for 10 millimeter diameter detail (for a Westmead test object, at least 9
of the 10 millimeter diameter circles must be detectable); and

PLEASE MAKE SURE THAT THIS IS THE CORRECT ISSUE BEFORE USE
Logo Company Name: Document No.: Effective Date:

የኢትዮጵያ ቴክኖሎጂ ባለስልጣን WI/ETA/023 30/01/2016E.C

ETHIOPIAN TECHNOLOGY AUTHORITY 11/10/2023G.C

Title: Issue No. Page No.:

የፍሎሮስኮፒ ራጅ መሳሪያ የሬጉላቶሪ ቁጥጥር መስፈርት 2 19 of 20

Fluoroscopy X-Ray Equipment Regulatory Requirement

b. 15 percent for a 1 mm diameter detail (for a Westmead test object, 1.5 mm on the
low contrast detestability section which is 10 percent is acceptable). By the
failsafe timer it must not be possible to initiate another loading without first
operating a manual reset.
Preset exposure limit indication
A visible or audible signal must be provided whenever a loading has been terminated by
a preset exposure limit.
Tomography performance
The system must resolve a 40 mesh (1.6 holes/mm) screen pattern or better section
thickness. The section thickness must comply with manufacturer's specifications or
instructions for use.
Section levels Agreement between the indicated and measured section levels must be
within ±5 mm.
Irradiation uniformity and pattern
The density of the image of the hole in the lead sheet of a phantom must be nearly
uniform or must vary in uniformity according to the pattern expected. The image
must reveal no unexpected overlaps, inconsistencies of irradiation or asymmetry
in motion.
5.11 Test Compliance, Test Criteria for Passing the Test
Radiation warning sign
The radiation apparatus must be marked with a sign or label incorporating the following
information:
 Radiation warning symbol (trefoil)
 The words “caution” or “warning”
 Words to the general form of “x-rays produced when energized”
 The symbol and lettering must be black on a yellow background.

PLEASE MAKE SURE THAT THIS IS THE CORRECT ISSUE BEFORE USE
Logo Company Name: Document No.: Effective Date:

የኢትዮጵያ ቴክኖሎጂ ባለስልጣን WI/ETA/023 30/01/2016E.C

ETHIOPIAN TECHNOLOGY AUTHORITY 11/10/2023G.C

Title: Issue No. Page No.:

የፍሎሮስኮፒ ራጅ መሳሪያ የሬጉላቶሪ ቁጥጥር መስፈርት 2 20 of 20

Fluoroscopy X-Ray Equipment Regulatory Requirement

5.12 Documentation Requirements

Full documentation shall be presented with the application for Authorization to the
Authority such as:
 Machine specifications (including manufacturer’s information, maximum and
minimum parameters that could be set, date of manufacture, etc) and shipping
certificate as necessary.
 Floor layout of the facility,
 Copies of educational qualifications of workers,
 Properly signed and sealed completed notification & application protocols AP-
NT-01 and AP-DR-01.
 License Certificate from appropriate health and trade bureaus, and Certificate that
assures the institution is the registrant of TIN number shall be submitted to ETA
5.13 Personnel Requirements
A Radiation Safety Officer (RSO) has to be officially assigned by the
organization applying for Authorization.
At least one formally trained radiologist has to be available. If there is a higher
workload 120 patients per week (~ 40 mA-min/weeks) and more than two of
these practices are performed then additional Senior Radiographer has to be
provided.
6. Records

Sample Holding Time Form OF/ETA/103

Bach Chain of Custody Meter List Form OF/ETA/104
Sample Preparation Log Book Form OF/ETA/105
Office Inter Memo OF/ETA/042

PLEASE MAKE SURE THAT THIS IS THE CORRECT ISSUE BEFORE USE
Logo Company Name: Document No.: Effective Date:

የኢትዮጵያ ቴክኖሎጂ ባለስልጣን WI/ETA/023 30/01/2016E.C

ETHIOPIAN TECHNOLOGY AUTHORITY 11/10/2023G.C

Title: Issue No. Page No.:

የፍሎሮስኮፒ ራጅ መሳሪያ የሬጉላቶሪ ቁጥጥር መስፈርት 2 21 of 20

Fluoroscopy X-Ray Equipment Regulatory Requirement

7. Reference documents

ISO 9001: 2015 Quality Management System - Requirements,

ISO 9000: 2015 Quality Management Systems-Fundamentals & Vocabulary.
QM/ETA/001 ETA Management Manual.

PLEASE MAKE SURE THAT THIS IS THE CORRECT ISSUE BEFORE USE