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• The Mission of the AERB is to ensure the use of ionising radiation
and nuclear energy in India does not cause undue risk to the
health of people and the environment.
• The Atomic Energy Regulatory Board (AERB) was constituted on
November 15, 1983 by the President of India by exercising the
powers conferred by Section 27 of the Atomic Energy Act, 1962
• AERB of india recommends and lays down guidelines regarding the Specifications of
medical x-ray equipment
• For the room layout of x-ray installation,
• Regarding the work practices in x-ray department , the protective devices and also the
responsibilities of the radiation personnel, employer and radiation safety officer (RSO).
• AERB is the authority in India which exercises a regulatory control on the approval of
new models of x-ray equipment and the layout of any new proposed x-ray installation.
• It also is the regulatory authority for registration and commissioning of new x-ray
equipment, inspection and decommissioning of x-ray installation, certification of a
RSO and of service engineers and also for imposing penalties on any person
contravening these rules
• The AERB implement the safety provisions by secondary legislation,viz, Atomic Energy
(Radiation Protection) Rules-2004, which provides necessary regulatory infrastructure
for effective implementation of radiation protection program in India
• Every medical diagnostic X-ray equipment shall meet the design safety
specifications stipulated in the AERB safety code
• The manufacturer/vendor shall obtain design certification from the
competent authority prior to manufacturing the X-ray equipment.
TYPE APPROVAL/NO OBJECTION CERTIFICATE
• Prior to marketing the X-ray equipment the manufacturer shall obtain a type approval
certificate from the competent authority for indigenously made equipment.
• For equipment of foreign make, the importing/vending agency shall obtain a No
Objection Certificate (NOC) from the competent authority, prior to marketing the
• Only type approved and NOC validated equipment shall be marketed in the country.
LAYOUT APPROVAL AND REGISTRATION
• Once the X-ray unit is installed, it should be registered with AERB along with lay out
• In the case of CT and cathlab, one has to get licensee for operation along with lay out
• For registration and license, quality assurance tests and nomination of RSO is
STEP- BY-STEP GUIDELINES FOR SUBMISSION OF
LAYOUT PLAN IN DIAGNOSTIC RADIOLOGY
1) Decide a suitable room for housing an X-ray unit to facilitate the easy movement
of staff and patient positioning.
2) Room should have preferably one entrance door and window if present, should be
above 2m from the finished floor level outside the x-ray room.
3) Door should have a hydraulic mechanism to ensure that door is closed during
procedure and should be provided with overlapping at the joints to avoid streaming.
4) Identify the walls as Wall A, Wall B, Wall C & Wall D (in any sequence)
5) Position the location of the equipment for each modality as follows:
a) Radiography and Fluoroscopy equipment:
• Couch, Control console and chest stand placed in such a way that chest stand is on
the opposite wall of the entrance door and the control console.
• Mobile protective barrier with lead equivalent glass viewing window should be
positioned in such a manner that the operator is completely shielded during the
• Control console should be positioned as far away as possible from the x-ray tube.
b) Computed Tomography and Interventional radiology equipment: Gantry
/ C-Arm, Couch, Separate control console room, viewing window, -
Position the gantry and couch such that the patient is completely visible
from the control console, during the scanning - The entrance door to the
gantry room from the control console shall have similar requirements as
the patient entrance door.
c) Mammography/ OPG/ CBCT: Control console, Equipment and
Protective barrier Positioning of equipment should be as far as possible
from the door and the control console.
6) Decide on the material and thickness of walls and door
7) Measure the distances of all the walls, doors, windows from the
centre of the couch
8) The required shielding of any material shall be provided at least up
to the height of 2m from external finished floor of x-ray room
ELORA REGISTRATION & RADIATION PROCUREMENT
APPROVAL FOR CT, DR & MAMMO EQUIPMENTS.
• Step 1: Creation of account in e-LORA for User ID & password
• The following documents are required to complete step1
• A) Proof of Identity and Date of Birth (of employer): Acceptable documents are as follows:
• Passport/Driving License/Photo identity document/card having serial number and date of
birth issued by Central/State Government or PSU (Residential Address should be mentioned)
• B) Proof of Employership:
• Example: (i) Appointment Letter of Employer, (ii) Board Resolution, (iv) Proprietor’s self
declaration on institute letter head affixed with institute seal
• C) Copy of any one of the document (in the relevant position) for the proof of existing of
• 1)PAN of Institute
• 2)TAN of Institute
• 3)Registration with State/Central/Local Government Authority
• D)Proof of Identity and Date of Birth : Passport/Driving License/Photo identity
document/card having serial number and date of birth issued by Central/State
Government or PSU (Residential Address should be mentioned)
• E)E-Mail id of Institute as well as Personal e-mail id.
• F)Employers Mobile No .............
• After Registration e-LORA will issue user ID & Password.
• Step 2: Radiation Procurement approval letter
• Remarks: Upload of AERB layout drawing signed by Hospital authorities &
Type approval certificate in AERB portal and getting Radiation Equipment
procurement approval certificate.
• Step 3: QA report for Applying for License
• Step 4: TLD Badges for Doctor/Operator
• Step 5: Qualified Technicians
• Step 6 : Approved RSO
• Step 7 : Radiation License Certificate
INSPECTION OF X-RAY INSTALLATIONS
• The diagnostic X-ray installations shall be made available by the
employer/ owner for inspection, at all reasonable times, to the
competent authority or its representative, to ensure compliance
with the safety code.
DECOMMISSIONING OF X-RAY INSTALLATIONS
• Decommissioning of X-ray equipment shall be registered
with the competent authority immediately by the
employer/owner of the equipment.
CERTIFICATION OF RSO
• Any person accepting assignment to discharge the duties and functions of
RSO in diagnostic X-ray installations shall do so only after obtaining
certification from the competent authority for the purpose.
• Such certification shall be granted on the basis of adequacy of the
person’s qualification, experience and testing/survey/dosimetry
CERTIFICATION OF SERVICE ENGINEERS
• Only persons holding valid certificate from the competent authority shall
undertake servicing of X-ray equipment.
• Certification shall be granted on the basis of qualifications, training, and
experience and safety record of such person and availability of servicing
RESPONSIBILITIES OF THE EMPLOYER(RULE 20)
• 1. Every employer shall:
• i. Ensure that provisions of these rules are implemented by the licensee, RSO and other
• ii. Provide facilities and equipment to the licensee, RSO and other worker to carry out their
• iii. Obtain dose records and health surveillance report of the workers from their former
• iv. Provide dose records and health surveillance reports of the worker to the new
• v. Furnish to each worker dose records and health surveillance reports of the worker
• vi. Inform the competent authority if the licensee or the RSO or any worker leaves the
• vii. Arrange for health surveillance of workers.
• 2. The employer shall be the custodian of radiation sources in his possession
and shall ensure physical security of the sources at all times.
• 3. The employer shall inform the competent authority, within twenty four
hours, of any accident involving a source or loss of source of which he is the
RESPONSIBILITIES OF THE LICENSEE (RULE 21)
• 1. The licensee is responsible for the implementation of terms and conditions of the
• 2. The licensee shall comply with the surveillance procedures, safety codes and safety
standards, specified by the competent authority.
• 3. Licensee shall establish written procedures and plans for controlling, monitoring and
assessment of exposure for ensuring adequate protection of workers, members of the
public and the environment and patients.
• 4. The licensee shall comply with the provision of rules for safe disposal of radioactive
• 5. The licensee shall:
• i. Maintain records of workers.
• ii. Arrange for preventive and remedial maintenance of radiation protection equipment,
and monitoring instruments.
• iii. Investigate excessive radiation exposure and maintain records of such investigations.
• iv. Inform competent authority about the occurrence, investigation and follow-up
actions, including steps to prevent future occurrences.
• v. Carry out physical verification of radioactive material periodically and maintain
• vi. Inform appropriate law enforcement agency in the locality of any loss of source.
• vii. Inform the employer and the competent authority of any loss of source.
• viii. Investigate and inform the competent authority of any accident involving source and
maintain record of investigations.
• ix. Verify the performance of radiation monitoring systems, safety
interlocks, protective devices and any other safety systems in the radiation installation.
• x. Prepare emergency plans in consultation with RSO.
• xi. Conduct quality assurance tests of structures, systems, components and sources and
• xii. Advise the employer about the modifications in working condition of a pregnant
• xiii. Inform the competent authority if the RSO or a worker leaves the employment.
• xiv. Inform the competent authority when he leaves the employment.
• 6. The licensee shall ensure that the workers are familiarized with
contents of the relevant surveillance procedures, safety standards,
safety codes, safety aides and safety manuals issued by the
competent authority and emergency response plans.
RESPONSIBILITY OF RADIOLOGICAL SAFETY OFFICER
• 1. Radiological Safety Officer (RSO) shall provide advice and assistance to the employer and
licensee on radiation safety.
• 2. RSO shall:
• i. Carry out measurements and analysis on radiation and radioactivity levels in the
controlled area, supervised area and maintain records of the same.
• ii. Investigate any situation that could lead to potential exposures.
• iii. Advise the employer to ensure regulatory constraints and the terms and conditions of
the license, safe storage and movement of radioactive material within the radiation
installation, to initiate suitable remedial measures in any situation that leads to potential
exposures, and regular measurements and analysis of radiation and radioactivity levels in
and around the installation.
• iv. Report all hazardous situations with details and remedial actions taken, to the
employer and licensee for reporting to the competent authority.
• v. Conduct quality assurance tests on structures, systems, components and sources.
• vi. Ensure periodic calibration of monitoring instruments.
• 3. RSO should assist the employer in
• (i) instructing the workers about hazards of radiation and safety and good work
• (ii) safe disposal of radioactive wastes,
• (iii) developing emergency response plans to deal with accidents and maintaining
• 4. RSO should advise the licensee on
• (i) modifications in working condition of a pregnant worker,
• (ii) the safety and security of radioactive sources.
• He should furnish to the licensee and the competent authority the periodic
reports on safety status of the radiation installation.
• He should inform the competent authority, whenever he leaves the employment.
RESPONSIBILITIES OF WORKER (RULE 23)
• 1. Every worker shall observe safety requirements and follow safety procedures and
instructions. He should not do any work that is harmful to him, co-workers, installation
• 2. Worker should inform the employer about his previous occupations. He should use
protective equipment, radiation monitors and personnel monitoring devices. He should
inform the licensee and the RSO, about accident or any potentially hazardous situation.
• 3. Female worker, once become pregnant, she should inform the same to the licensee
and Radiological Safety Officer
HEALTH SURVEILLANCE OF WORKERS (RULE 25)
• 1. Every employer shall provide the services of a physician with appropriate
qualifications to undertake occupational health surveillance of classified workers.
• 2. Every worker, initially on employment, and classified worker, thereafter at least
once in three years as long as the individual is employed, shall be subjected to the
following: (a) general medical examination, and (b) health surveillance to decide on
the fitness of each worker for the intended task.
• 3. The health surveillance shall include: (a) special tests or medical examinations as
specified by order by the competent authority, for workers who have received dose
in excess of regulatory constraints, and (b) counseling of pregnant workers.
• Room Size
• The room housing an X-ray unit shall be not less than 18 m2 for general
purpose radiography and conventional fluoroscopy equipment.
• The size of the room housing the gantry of the CT unit shall not be less than 25 m2.
• Also, not more than one unit of any type shall be installed in the same room, and no
single dimension of these X-ray rooms shall be less than 4 m.
• In the case of mammography, the room size shall be not less than 10 m2, and no
single dimension of the room shall be less than 3 m.
• If the X-ray installation is located in a residential complex, it shall be ensured that:
• 1. Walls of the X-ray rooms on which primary X-ray beam falls are not less than 35 cm or
14 inch thick brick or equivalent.
• 2. Walls of the X-ray room on which scattered X-ray fall are not less than 23 cm or 9 inch
thick brick or equivalent.
• 3. There is a shielding equivalent to at least 23 cm or 9 inch thick brick or 2 mm lead in
front of the door(s) and windows of the X-ray room to protect the adjacent areas, either
by general public or not under possession of the owner of the X-ray room. The density of
the normal masonary brick is considered as 1.6 g/cc.
• 4. The ceiling must have a thickness of concrete (density 2.35 g/cc), not less than 6 inch
or 13.5 cm.
OPTIONS IN SHIELDING MATERIALS
• X-ray equipment must be installed in adequately shielded rooms to ensure that
public in the vicinity of the x-ray installations are not unduly exposed to x-ray
• The adequacy of shielding depends on the material and thickness used for this
purpose. Different materials can be used for shielding.
• However, brick or concrete are considered the best materials, as they are easily
available, economical, and have good structural strength
• While lead is a suitable shielding option for energies encountered in diagnostic x-rays, it
is a weak structural material with tendency to lose uniformity and needs periodic
radiation survey to ensure its continued adequacy.
• Also, Lead poses a serious environmental hazard and the use of it is being discouraged
the world over. Recently, many new materials are being used/ developed as potential
shielding materials, as an alternate to Lead.
• AERB would like to promote use of these materials, on demonstration of shielding
REFERENCE DATA ON SHIELDING OF X-RAY INSTALLATION
• For equipment operating at 125 kV or above, should have a separate control room,
and provided with appropriate shielding, direct viewing (1.5 mm lead equivalence)
and oral communication facilities between the operator and the patient.
• The X-ray units operating below 125 kVp in diagnostic radiology are exempted from
the above class.
• In such a case, the control should be behind a mobile protective barrier of
• Doors are lined with 2 mm thick lead sheet with proper
overlapping at the joint and junction and wall of 9 inch thickness
of brick and ceiling of 6 inch of concrete
• Viewing Window
• Lead glass of suitable dimensions are provided as viewing windows with 1.5
mm thick lead equivalent.
• Mobile Protective Barrier
• Control panel should be kept behind the mobile protective barrier (MBP) of
thickness 2 mm lead equivalence
GENERAL RADIOGRAPHY INSTALLATION
• These X-ray units are operated in the range of 50–150 kVp.
• Walls that are irradiated directly by the X-ray beam are primary barriers.
• Hence, additional shielding must be provided for the wall behind the chest stand.
• Provisions are made to observe and communicate with the patient on the table.
• The mobile protective barrier with lead shield must be a permanent/mobile one with 2.1
• The viewing window at the mobile protective barrier must be 45 × 45 cm size and
• Fluoroscopic imaging systems are usually operated at potentials ranging from 60 to 120
• A primary barrier is incorporated into the fluoroscopic image receptor.
• Therefore, fluoroscopic unit room design considers only secondary protective barriers
against leakage and scattered radiations.
• Most fluoroscopic X-ray imaging systems also employ radiography.
• The shielding requirements for such a room are based on the combined workload of
both fluoroscopy and radiography
• Mammography units are typically operated between 25–30 kVp.
• The walls are constructed with bricks or gypsum wall board.
• Adequate protective barrier of lead acrylic or lead glass are incorporated into
dedicated mammography units.
• Gypsum wall board may contain voids and non uniform areas.
• Hence, higher thickness of gypsum wall board is recommended than that calculated.
COMPUTED TOMOGRAPHY INSTALLATION
• Computed tomography (CT) employs a collimated X-ray fan-beam that is intercepted by
the patient and by the detector array.
• Consequently only secondary radiation is incident on protective barriers.
• The operating potential, typically in the range of 80–140 kVp, as well as the workload
are much higher than for general radiography or fluoroscopy.
• Due to large amount of secondary radiation, floors, walls and ceilings need special
• Additionally, scattered and leakage radiations from CT systems are not isotropic.
• The radiation levels in the direction of the gantry are much less than the radiation levels
along the axis of the patient table.
• TUBE HOUSING
• Leakage radiation through the protective tube housing in any direction, shall not
exceed an air kerma of 1 mGy in one hour at a distance of 1.0 m from the X-ray target
when the tube is operating at the maximum rated kVp and for the maximum rated
current at that kVp. There shall be a distinctly visible mark on the tube housing to
indicate the plane of focus.
• Beam Limiting Devices
• Tube housing for stationary and mobile diagnostic X-ray units shall be provided with
light beam collimators. These collimators shall comply with the leakage radiation level
prescribed for tube housing
• Beam Filtration
• (a) The minimum total filtration in useful beam for maximum rated operating tube
potential shall be as given in the following table:
• (b) Total filtration shall be indicated on the tube housing. The total permanent filtration in
the tube shall be not less than 1.5 mm Al.
• Tube Positioning
• X-ray unit shall have facilities for tube positioning, target-to-film distance selection, useful
beam centring and angulation, positioning of the patient and the X-ray film for exposure in
the desired manner, and appropriate features to display the same.
• Bucky Alignment
• X-ray table shall have provisions for correct positioning of the grid, the bucky tray and the
film cassette in proper alignment with the useful beam and for their locking in the desired
• Cable Length
• X-ray unit shall be provided with electrical cables of sufficient length so that the control
panel/operation switch can be located and operated from a minimum distance of 3 m
from the nearest position of the X-ray tube. For mobile/portable X-ray equipment the
cable length shall be not less than 2 m.
• Control Panel
• Control panel shall be provided with means to indicate and control exposure
parameters, including tube potential, time of exposure, tube current, and integral
exposure in milliampere-seconds (mAs). It shall also provide facilities for technique
selection and the engagement of the bucky mechanism. A clearly marked and
identifiable indicator shall be provided at the control panel to show whether the X-
ray beam is 'ON' or 'OFF'. For portable/mobile units appropriate indication of
exposure parameters shall be provided.
• Tabletop should be made of radioparent substances which allow to pass
radiation without much attenuation. But as well as they should be strong
enough to carry patient weight
• Carbon fibres are commonly used .
DOSE LIMITS BY AERB
The limits on effective dose apply to the sum of effective doses from external
as well as internal sources. The limits exclude the exposures due to natural
background radiation and medical exposures.
Calendar year shall be used for all prescribed dose limits
1. An effective dose of 20 mSv/yr averaged over five consecutive years (calculated
on a sliding scale of five years);
2. An effective dose of 30 mSv in any year;
3. An equivalent dose to the lens of the eye of 150 mSv in a year;
4. An equivalent dose to the extremities (hands and feet) of 500 mSv in a year and
5. An equivalent dose to the skin of 500 mSv in a year;
6. Limits given above apply to female workers also. However, once pregnancy is
declared the equivalent dose limit to embryo/fetus shall be 1 mSv for the remainder of
Apprentices and Trainees
The occupational exposure of apprentices and trainees between 16 and 18 years of
age shall be so controlled that the following limits are not exceeded:
1. An effective dose of 6 mSv in a year;
2. An equivalent dose to the lens of the eye of 50 mSv in a year;
3. An equivalent dose to the extremities (hands and feet) of 150 mSv in a year
4. An equivalent dose to the skin of 150 mSv in a year.
Dose Limits for Members of the Public
1. An effective dose of 1 mSv in a year;
2. An equivalent dose to the lens of the eye of 15 mSv in a year; and
3. An equivalent dose to the skin of 50 mSv in a year.