AERB Guidelines

Radiological Safety Division (RSD)

• The Atomic Energy Regulatory Board was constituted on November 15, 1983 by the President of
India by exercising the powers conferred by the Atomic Energy Act to carry out certain regulatory
and safety functions under the Act. The regulatory authority of AERB is derived from the rules
and notifications promulgated under the Atomic Energy Act and the Environment (Protection)
Act, 1986.

Mission

• The Mission of the AERB is to ensure the use of ionizing radiation and nuclear energy in India
does not cause unacceptable impact on workers, members of the public and to the environment.

MEDICAL X-RAY EQUIPMENT INSTALLATION

PURPOSE

 This Code is intended to govern radiation safety in design, installation and operation of X-ray
generating equipment for medical diagnostic purposes in order to:

(a) ensure that radiation workers and members of the public are not exposed to radiation in excess of
limits specified by the competent authority under the Radiation Protection Rules, 1971.

(b) reduce radiation exposures below these limits to levels as low as reasonably achievable.

(c) ensure availability of appropriate equipment, personnel and expertise for safe use of the equipment
and for patient protection;

(d) ensure timely detection and prompt rectification of radiation safety-related defects or
malfunctioning of the equipment.

ROOM LAYOUT FOR AN X-RAY INSTALLATION

Location :

 Shall be located as far away as feasible from areas of high occupancy places/departments.

 In case the installation is located in a residential complex, it shall be ensured that:-

A. Walls of the x-ray rooms on which primary x-ray beam falls are not less than 35 cm thick brick or
equivalent.

B. Walls of the x-ray room on which scattered x-ray fall are not less than 23 cm thick brick
C. There is a shielding equivalent to at least 23 cm thick brick or 1.7 mm lead in front of the door(s)
and windows of the

X-ray room.

Layout:

 The room housing an x-ray unit shall have an appropriate area to facilitate easy movement of
staff, patient positioning.

 Appropriate structural shielding shall be provided for walls, doors, ceiling and floor of the room
housing the X-ray.

 Appropriate shielding shall also be provided for the dark room to ensure that the undeveloped
X-ray films are not exposed to more than 10μGy per week.

Room Size:

• The room housing an X-ray unit shall be not less than 18 m square for general purpose
radiography and conventional fluoroscopy.

• The size of room housing the gantry of the CT unit shall not be less than 25 m square.

• 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.

Control Panel:

• The control panel of diagnostic X-ray equipment operating at 125 kVp or above shall be installed
in a separate with direct viewing and oral communication facilities.

• In case of X-ray equipment operating up to 125 kVp, the control panel can be located in the X-
ray room.

• The distance between control panel and X-ray unit/chest stand shall be not less than 3 m for
general purpose fixed X-ray equipment.

Warning Light and Placard:

Red light shall be provided outside the X-ray room and kept “ON” when the unit is in use.

An appropriate warning placard as indicated in Appendix-II shall also be posted outside the X-ray room.

Openings and Ventilation:

DOSE LIMITS

Workers

 cumulative effective dose over a block of five years shall not exceed 100 mSv.

 effective dose in any calendar year during a five-year block shall not exceed 30 mSv.

 (a) equivalent dose in any calendar year to lens of the eye shall not exceed 150 mSv;

(b) equivalent dose in any calendar year to the skin shall not exceed 500 mSv.

 In case of a woman worker of reproductive age, once pregnancy has been estabilished, the
conceptus shall be protected by applying a supplementary equivalent dose limit to the surface
of the woman's abdomen (lower trunk) of 2 mSv for the remainder of the pregnancy.

Trainees

 The effective dose in any calendar year shall not exceed 6 mSv.

Public

 effective dose in any calendar year shall not exceed 1 mSv.

 In special circumstances, a higher value of effective dose is allowed in a single year, provided
that the effective dose averaged over a five year period does not exceed 1 mSv/y.

APPENDIX-III

MINIMUM QUALIFICATION AND EXPERIENCE REQUIRED

1. Radiologist

 An M.B.B.S. degree from a recognized university or an equivalent qualification;

 A post-graduate degree/diploma in radio-diagnosis from a recognized university.

 10+2 or equivalent examination passed with science from a recognized board

 Radiographer's/X-ray technologist's course of minimum two years duration (including in-field

3. Radiological Safety Officer

 A certification from the competent authority to the effect that the RSO designate is capable of
fulfilling the duties and functions of an RSO as laid down.

4. Service Engineer

 A degree/diploma in electrical/electronic engineering or in an-associated discipline.

 A certification from the competent University.

SAFETY SPECIFICATIONS FOR MEDICAL DIAGNOSTIC X-RAY EQUIPMENT

Tube Housing:

 Every housing for medical diagnostic x-ray equipment shall be so constructed that leakage
radiation through the protective tube housing in any direction, averaged over an area not larger
than 100 cm2 with no linear dimension greater than 20 cm

 Shall not exceed an air kerma of 1 mGy in one hour at a distance of 1.0 m from the x-ray target.

 Filtration

 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.

Exposure Switch:
  Control panel shall have provision to terminate X-ray exposure automatically after a pre-set
time or manually at any moment

 When mechanical timers are provided, repeated exposures shall not be possible without
resetting the timer.

 The timer shall be capable of accurately reproducing short exposure of 0.05 second and its
maximum range of exposure shall not exceed 5 second.

 Radiation Leakage from Transformer:

 Radiation levels at 5 cm from the transformer surface of the X-ray unit shall not exceed 5 mGy in
any one hour.

Dental X-Ray Equipment

Focus-to-Skin Distance

 In case of orthopan tomography (OPG) equipment for dental panoramic tomography, the focus-
to-skin distance shall be not less than 15 cm.

Dental X-Ray Cones:

Cones that will limit the beam diameter to less than 7.5 cm at the distance specified at the cone end.

Mammography X-Ray Equipment

Tube Housing:

 Tube housing shall be so constructed that leakage radiation averaged over an area of 100 cm2,
with no linear dimension greater than 20 cm and located at 5 cm from any point on the external
surface of X-ray tube housing, does not exceed 0.02 mGy in any one hour.
Beam Filtration:

 The total filtration in the useful beam shall be not less than 0.03 mm of molybdenum for screen-
film mammography for Mo-W alloy target type

 0.5 mm of aluminium for xero-mammography for W-target X-ray tubes.

 Breast Compression Device:

 The degree of 8 compression shall be smoothly adjustable and shall remain at the set level
during exposure.

 The compression plate shall not attenuate the beam by more than

 2 mm tissue equivalent material.

Computed Tomography

Beam-Limiting Devices:

 The tube housing shall be provided with beam-limiting devices so that un-attenuated primary
beam at the plane of detector shall not exceed the useful dimension of detector by more than
20%.

Beam Filtration:

 Tube housing shall be provided with filter for both beam-hardening and beam-flattening (bow-
tie filter).

Scan Plane Visualiser:

A scan plane visualization device shall be provided to indicate directly or indirectly the position of slice
plane(s) (tomographic plane or a reference plane offset from the tomographic plane) on the patient
within ± 2 mm.
 Fluoroscopy
Table-Top Exposure:

 The air kerma rate measured at table top for the minimum focus-to-table top distance shall be
as low as possible, and in any case shall not exceed 5 cGy per min.

Entrance Exposure:

• For photofluorographic spot film cameras, the entrance kerma at image intensifier for maximum
tube potential and current shall not be greater than 3.0 mGy per exposure.

• For cine-fluorography, the entrance kerma to the image intensifier shall not be more than 0.3
mGy per frame.

Video Camera:

• Video camera shall have a signal-to-noise ratio equal to or greater than 500 : 1 and shall employ
a progressive read-out.

RADIATION PROTECTION & WORK PRACTISE

 TLD

Survey Meters:

 Gas Ionization dosimeter

 Scintillation Dosimeter

Protective Aprons:

• Protective aprons shall have a minimum lead equivalence of 0.25 mm and their size/design shall
ensure adequate protection to the torso and gonads.

• Gonad shields shall have a minimum lead equivalence of 0.5 mm.

Protective Gloves:

• Protective gloves shall have a minimum lead equivalence of 0.25 mm and the design shall
ensure adequate protection against scattered radiation reaching the hands and wrists and shall
permit easy movements of hands/ fingers.

Radiological Safety Officer (RSO):

 Assist the employer in meeting the relevant regulatory requirements applicable to his/her X-ray
installation.

 Assist implement all radiation surveillance measures, conduct periodic radiation protection
surveys, maintain proper records of periodic quality assurance tests, and personnel doses,
instruct all workers on relevant safety measures, educate and train new entrants, and take local
measures, including issues of clear administrative instructions in writing, to deal with radiation
emergencies.

 (Appendix I)

REGULATORY CONTROLS

 Design Certification

 Type Approval / No Objection Certificate

 Approval of Layout
 Registration of X-ray Equipment

 Commissioning of X-ray Equipment

 Inspection of X-ray Installations

 Decommissioning of X-ray Installations

 Certification of RSO

 Certification of Service Engineers

 Penalties

APPENDIX – IV

NOC / Type approval of medical radiography / fluoroscopy/ct / x ray equipment

APPENDIX – V

Application for approval of x ray installation layout

APPENDIX – VI

Approval of nomination of radiology safety officer level 1

APPENDIX VII

Approval of service engineer