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The Federal Democratic Republic of Ethiopia
Ethiopian Radiation Protection Authority
Radiation Sources and Practices Notification and Authorization Directorate

Mandatory Regulatory Requirements to Practice Conventional Diagnostic Radiology

and for Issuance of a License

I - Introduction

Background

The number of radiation sources in Ethiopia is mainly in medical applications. Medical exposure
control has been therefore one of the important activities of the ERPA almost for a decade. Some
good progress in the quality of radiological services and safety of medical institutions in the
country has been recorded. This can be justified by the increased number of licensed medical
applications, as licenses are issued when set regulatory requirements are fulfilled and it can be
considered as a good indicator of the level of radiation protection and overall standard of a
radiological facility. Besides, Situational Analysis conducted by the ERPA for the last 7 years (four
in number between 2000 and 2007) can serve as an indicator on the level of progress in
radiological diagnostic services in the country. However, due to its very nature quality of service
and safety issues can go backwards unless an efficient and continuous compliance monitoring
system is implemented.

The ERPA 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.

Purpose

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

General Diagnostic Radiology 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 ERPA by
proclamation No. 571/2008. This mandatory 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.

Scope

This procedure applies to all General Diagnostic Radiology facilities practicing diagnostic imaging
application with x-ray machine for the purposes of obtaining diagnostic information of patients as
prescribed by appropriate medical personnel.

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II - Safety Provisions, X- Ray Premise and Safety Control System III - Safety of the X- ray Premise V. X-ray Machine VII - Personnel
(Radiological protection survey) Performance Requirements
A. Lead apron, G. Area of the The X-ray department must be Equipment of diagnostic A Radiation Safety Officer
Lead aprons of 0.50 mm of lead (or lead Darkroom safe from radiological point of radiology shall conform to (RSO) has to be officially
equivalent) are indispensable for the view at every location (maximum applicable national or assigned by the
Area of the darkroom of 1 µSv/hr at all locations
examiner and the radiographer and other shall not be less than occupied by a member of public
international standards such as organization applying for
staff involved as necessary during 6m2. and 6.5 µSv/hr in the control the International Electro Authorization and the
fluoroscopic procedures. Comforters, cubicle and any occupationally technical Commission (IEC) or following management
However, there is no
children, and pregnant women should be accessed location by radiation International Standards responsibilities have to be
strictly provided with lead aprons under mandatory of workers). Organization (ISO). respected in recruiting
any exposure circumstances. darkroom area Such equipment should satisfy radiation workers and
However, it is possible for machines with requirements for Lead glass window shall be the technical requirements of assignment of an RSO:
maximum voltage of up to 100 kV peak digital film processing provided to the control verification of machine A. Fixed Radiography
to have lead aprons not less than 0.25 system or similar IT cubicle, and it should have a parameters, and Quality where there is no
mm lead and 0.35mm lead above 100 kV nominal value of 2 mm lead Assurance tests at large. Under special procedures
technologies. or its equivalent. The lead
peak. Interventional radiology staff H. Wall thickness all circumstances, the like I.V.P., Barium
should always use 0.5 mm lead glass shall be fitted at proper equipment should be meal etc
Wall thickness of at location to provide a clear
equivalent wrap-around aprons accompanied with the • At least one formally
least 17 cm concrete view (to the radiographer) of necessary documents including trained Junior
Lead apron(s) integrity (Physical or its equivalent (with a patient undergoing the service and operating Radiographer has to
conditions for holes, cracks, etc) shall be no radiation leakage radiological examination. manuals, results of acceptance be available. If there
checked properly. to the surroundings, The wall of the X-ray room tests, and calibration certificate is a higher workload
B. Gonad shields i.e. maximum of 1 (exposure room) should be for the required machine above 150 Patients
Gonad shields of different sizes and thick enough to attenuate parameters of the x-ray per week (~ 50 mA-
µSv/hr at all locations
shielding capacity at least for standing (contain) leakage of machine. min/week) then an
occupied by a radiation. The wall thickness 1. Deviation of kVp Accuracy ≤
positions shall be made available to be additional
used by patients and pregnant women.
member of the public is generally suggested to be ±10% radiographer has to
and 6.5 µSv/hr to the 17 cm of concrete (pure) or 2. Deviation of the X-ray timer ≤
be provided
control cubicle and equivalent, as an alternative ±10%
However, it is advisable the provision of 3. Out put inconsistency ≤ 5% • At least one
gonad shields for lying positions (here, it any occupationally to the description on the lay 4. Collimator accuracy (light & Darkroom technician
is assumed that gonad shields available accessed location by out of the X-ray premise. A 3 radiation field congruency) ≤ ± has to be assigned
for standing positions will also be used radiation workers). layers of brick (standard 2% B. Fixed Radiography
for lying). I. Warning light & brick density) is proposed as 5. Beam alignment accuracy where there is special
the thickness of the wall in (perpendicularity of radiation
signs beam) ≤ 30
procedures like I.V.P.,
Gonad shields integrity (Physical the direction of the primary Barium meal, etc
A warning red light beam. All other sides can 6. Tube and collimator Leakage ≤
conditions for holes, cracks, etc) shall be
coupled/synchronized 100mR • At least one formally
checked properly. have a thickness of 2 layers 7. Evaluation of total filtration, trained Senior
C. Lead glass goggle with the machine of brick. Doors adjacent to i.e. HVL (Half Value Layer) test Radiographer has to
Lead glass goggles have to be provided power shall be the exposure room shall be acceptable for a given kVp be available. If there
for protection of the eye of the patient, provided at properly shielded/ lead-lined Malfunction of collimator light is a higher workload
helpers or radiation workers for appropriate with lead of 2 mm or its and other series mechanical above 120 patients
fluoroscopic and other special location(s). equivalent material. Lead defects shall also be seriously per week (~ 40 mA-
procedures. overlap shall be made to considered: min/week), then
D. Lead gloves avoid radiation leakage at additional Senior
Placards containing edges, hinges and these includes; looking for
Lead gloves shall be provided for Radiographer has to
international radiation connections. loose screw; indicators & meter
operators during fluoroscopy procedures be provided.
hazard sign (Trefoil IV. Dark room Accessories check; stability, stiffness of
and by comforters in supporting the
The following darkroom • At least one
patient. symbol) and notices tube hanger, chest stand, etc; Darkroom technician
accessories shall be provided:
in English and 1. Film hopper (Light tight) conditions of movements of has to be assigned.
Glove integrity (Physical conditions for Amharic (or/and other (A film hopper with a pull-back or locks of tubes; checks for C. For facilities with one
holes, cracks, etc) shall be checked local languages) shutter has to be provided and control-panel switches and or more of such
properly. the film hopper shall be light movement of collimators.
should be available tight.)
practices with
E. Personal Monitoring Service for VI. Documentation Fluoroscopic
and posted at suitable 2. Film dryer (that could Requirements
radiation workers machines,
Personal monitoring service for all locations. Local rules provide uniform drying of
Full documentation shall be
radiographs) Mammography
radiation workers (such as radiologists, should also be presented with the application
3. Film processor (with all machines,
radiographers and darkroom technicians; presented describing necessary items, such as for Authorization to the Angiography
besides to all medical personnel involved working procedures 4. Hatch box with an inter Authority such as: machines and CT
in the operation and delivery of radiation and safety rules. lock system • Machine specifications (including scanners:
to patients depending on the diagnostic [A hatch box with an interlock manufacturer’s information,
J. Patient system, and internal maximum and minimum
• At least one formally
procedures for example interventional Identification System trained Radiologist
dimensions that could parameters that could be set,
radiology) shall be provided. Adequate (such as Film Printer) and a Senior
accommodate the largest size date of manufacture, etc) and
level of dose recording system shall be Radiographer has to
Proper patient film cassettes in sufficient shipping certificate as
provided that can serve as the number, must be available. be available. If there
identification system, necessary.
radiological profile of an individual
like film printer shall Besides, if one side of the • License from MoH/Health is a higher workload
radiation worker. hatch box is along the Bureau 120 patients per week
F. Area of the exposure room be provided and exposure room it shall be • Trade license (~40 mA-min/week)
Area of the exposure room shall not be routinely used. properly shielded (lead-lined) • Tax payer identification number and more than two of
less than 24 m2 for conducting general K. Auxiliary rooms to avoid radiation exposure of • Floor layout of the facility, these practices are
radiography and not less than 28 m2 for Dressing cubicles and the films placed in the box]. • Copies of educational performed then
special procedures such as fluoroscopy, toilet adjacent to the 5. Light tight film cassettes qualifications of workers, additional Senior
CT-scan, etc. exposure room shall be with intensifying screen • Properly signed and completed Radiographer has to
N.B. The exposure room shall have provided. If special adequate to the application protocols AP-NT-01
diagnostic radiological
be provided.
sufficient ventilation (such as a procedures like barium and AP-DR-01. At least one Darkroom
ventilation window with a height above meal is practiced a practice. Operating and maintenance
2m from outside ground level and 6. Radiation level in the instruction shall also be submitted
technician has to be
barium kitchen with
position in such a way that backscatter required provisions (like,
darkroom shall be very but it can be made later. assigned.
small and usually in the
radiation will not fall on windows of cabinet, sink, etc) shall level of background to
opposite building, verandah, etc). be provided adjacent to ensure the quality of
the exposure room. films.

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