2. These guidelines and requirements are applicable for
any of the Radiation Sources to be used in Radiation
Therapy which are
Source for Telecobalt unit
Medical Accelerator
Sources for Gamma Knife unit
Source(s) for Remote Afterloading Brachytherapy
unit
Sources for Manual Afterloading Brachytherapy
Simulator
Check source or any other new modality involving
ionizing radiation for therapeutic purposes.
3. Requirements includes :
Clearance of the unit by AERB
Approval of Room Layout Plan of Radiation Therapy
Installation
Appointment of Radiation Therapy Staff
Nomination and Approval of Radiological Safety
Officer
Procurement of Personnel Monitors
Measuring and Monitoring Instruments
Authorisation to procure Radiation Sources
4. Other Associated equipment/Accessories
Road Transport Approval
Receipt of Sources
Installation of the Unit
Loading of the source/Switching on Radiation in
case of Radiation Generating Equipment
Quality Assurance/Acceptance test
Commissioning Approval for Patient Treatment
Periodic Performance/ Quality Assurance test
Annual Status Report
5. Clearance of the unit by AERB
Verify from the supplier that the unit to be installed
is either type approved by Atomic Energy
Regulatory Board (AERB) or a NOC is issued.
The local supplier has to produce the copy of type
approval certificate or NOC (issued by AERB)
whenever its demanded.
Type approval : When a new model is to be
imported to INDIA for the first time, AERB issues
NOC to the local supplier to import only ONE unit .
6. This is based on the evaluation of specifications of
the unit, design standards and approval from the
competent authorities of other countries.
Once it is imported, AERB checks the performance
of the unit and check whether the unit meets the
required standards.
The type approval certificate is issued based on the
physical evaluation of the unit, to the local supplier.
Then the local supplier can market the same type of
unit with certain terms and conditions)
7. Approval of Room Layout Plan of Radiation
Therapy Installation
Prepare room layout and the site layout drawing in
consultation with Medical Physicists, Radiation
Oncologists, Architects and the supplier of the unit.
Submit two copies of the drawings along with the
application to the Head, Radiological Safety Division
(RSD), AERB.
It is recommended to commence the construction
of the Radiation Therapy facility only on receipt of
the approved plan from AERB.
8. The location of the teletherapy installation should
be away from unconnected facilities and should be
close to the associated facilities.
The associated facilities are Simulator room, Minor
Operation Theatre (for Brachytherapy), Mould
room, Treatment Planning System room, Physicist(s)
room, Radiation Oncologist(s) room, Patient waiting
area etc
Construct teletherapy/brachytherapy facility as per
the approved plan by AERB at the location shown in
the approved plan.
For further modifications in the approved layout
plan, concurrence must be obtained from RSD, AERB
prior to modification.
9. Appointment of Radiation Therapy Staff
Appoint adequate number of staffs as per the
qualification and experience stipulated in AERB
Safety Code.
Staffs includes Radiation Oncologists, Medical
Physicists and Radiation Therapy Technologists.
In case of existing setup for additional facility also
adequacy of staff should be checked.
In case of appointment of Medical Physicists, it is to
be ensured that at least one of them is eligible to
work as Radiological Safety Officer (RSO).
10. Procurement of Personnel Monitors and other
instruments
Procure Personnel Monitoring Badges from the
agency recognised by AERB for all the radiation
workers so that they are available during installation
of the unit.
Pocket dosimeters for the radiation workers and
appropriate measuring instruments for
measurement of output and other dosimetric
parameters should be procured.
Other measuring instruments includes Thimble
Ionisation Chamber, PPC, Well type Ionization
Chamber, Electrometer, Radiation Field Analyser etc.
11. Also appropriate monitoring instruments for area
monitoring ,Survey Meters, Contamination
Monitors, Gamma Zone Monitors etc should be
available in the facility.
Gamma Zone Monitor for Telecobalt unit and
Remote after loading Brachytherapy unit should be
of auto-reset type, whereas, that for manual
Brachytherapy must have manual-reset button.
The other associated equipments/accessories
includes Treatment Planning System (TPS), beam
modifiers, patient immobilisation devices such as
moulds, quality assurance test tools etc
12. Authorisation to procure Radiation Sources
Obtain authorisation from RSD, AERB by sending the
filled in form. The form must be filled in properly to
avoid undue delay.
Also all the necessary documents mentioned in form for
procurement of sources to be used in Radiotherapy .
Procure radioactive sources, radiation generating
equipment (Accelerator or Simulator) as per the
specifications mentioned in the authorisation letter.
Road Transport Approval
Obtain road transport permission from RSD, AERB for
transporting the radioactive source from the
airport/port to the institution (not required in case of
Accelerator and Simulator).
13. Receipt of Sources
Intimate regarding the receipt of the source
(includes Accelerator and Simulator) to RSD, AERB
by filling in the form within 15 days of its receipt .
Install the teletherapy / brachytherapy unit as
per the approved plan.
Carryout the mechanical and electrical tests
thoroughly prior to source loading or switching
on the Radiation beam in case of Radiation
Generating Equipment.
Installation of the Unit
14. Loading of the source in case of Telecobalt
Equipment
Certified service engineer shall load the source
under supervision of the Medical Physicist/RSO.
RSO will be authorised by AERB for supervising the
source transfer operation.
For authorisation, RSO should submit the duly
filled in form prior to 15 days of actual date of
source transfer.
If the Physicist is not having prior experience in
source transfer operation of Telecobalt unit, the
institution may seek assistance of Medical Physicist
from any other Radiotherapy Centre following
instructions of AERB.
15. In cases like that, a consent letter from his/her employer
of the outside Medical Physicist must be attached along
with the filled in form.
The telecobalt source shall not be loaded if the
authorised Medical Physicist(s) are not present.
The source transfer report has to be submitted by the
Medical Physicist/RSO after loading the telecobalt
source.
Before loading of the source , RSO should ensure
that all the persons involved in the source loading,
operation and testing of the unit have personnel
monitoring badges.
16. After loading the source or switching the beam on,
RSO and the service engineer should carryout
radiation protection survey of the installation.
This should be done prior to any other radiation
tests.
In case the radiation levels around the installation
are not within the limit, all other tests must be
suspended and AERB shall be intimated promptly
with the recorded survey data.
17. Quality Assurance/Acceptance test
Perform thorough Quality assurance / acceptance
test of the tele therapy / brachy therapy unit.
(RP&AD guidelines can be taken as reference).
Report of whole tests must be kept in the hospital
records.
This reports are supposed to be produced while
inspection of Radiotherapy Department of your
institution by AERB personnel.
18. Commissioning Approval for Patient Treatment
Patient treatment should be started without
obtaining the commissioning approval from RSD,
AERB
In order to obtain commissioning approval for using
the unit for patient treatment from RSD, AERB
following documents must be submitted:
◦ Undertaking regarding the performance of the
unit in the prescribed format.
◦ Intimate regarding the availability personnel,
associated equipments etc.
19. Permission for commissioning shall be
granted only if :
◦ Adequate number of full-time staff in
Radiotherapy Department as mentioned are
there.
◦ Personnel monitoring badges for all the radiation
workers are available
◦ all the required associated instruments /
accessories like RFA, survey meters etc are
available
20. Periodic Performance/ Quality Assurance test
It is necessary to carry out :
Performance tests of the unit
Integrity check of the sources (barchytherapy)
Survey of the radiation installation periodically
Maintain all the records, and have to be produced
while inspection of Radiotherapy Department of your
institution by AERB personnel
21. Annual Status Report
Send Annual Report on Status of Radiation
Safety in Radiotherapy to RSD, AERB so that
it reaches by the end of each calendar year.
Please note that it is a mandatory
requirement to submit the report every
year.
23. The procedure for decommissioning the unit:
1) The Agency/Supplier of the unit should be
contacted during
◦ unloading the source (not required in case of
accelerator)
◦ dismantling of depleted uranium parts, if any.
◦ their transportation to the concerned agencies
◦ for safe disposal after obtaining approval from
AERB.
24. 2) To obtain their concurrence for accepting the
decayed source for disposal , the original supplier
of the existing decayed source/ Board of Radiation
& Isotope Technology (BRIT) should be contacted .
3) Consent has to be obtained from this Division for
decommissioning the radiotherapy unit from
AERB.
4) Medical Physicist-cum-Radiological Safety Officer
(RSO) may be authorised by this Division for
supervision of the source transfer operation in
case of telecobalt unit.
25. 5) In order to issue the above said authorisation,
application should reach this Division 15 days
before the actual date of source transfer
operation.
6) Source unloading should be done by a Certified
Service Engineer under the supervision of
authorised RSO.
7) If depleted uranium is present in any part of the
unit or used in the form of shielding blocks, all the
parts containing depleted uranium should be sent
to the concerned agency for safe disposal.
8) Supplier/manufacturer of the unit has to do this
and RSO has to ensure this.
26. 9) After unloading the source, the cavity in which
source moves should be checked for
contamination.
10) If found contaminated, a report should be sent to
this Division promptly for further advice regarding
packaging the contaminated parts and for sending
back to the concerned agency for safe disposal.
11) For accelerators also same should be done if
found contaminated. In case of accelerator after
dismantling target, collimators, flattening filters
etc., should be checked for contamination
27. 12) For transport of depleted uranium, contaminated
objects and decayed source to the concerned
agencies, permission has to be obtained from
AERB in separate forms.
13) If the source is purchased from a foreign country,
special permission is required for the export of
used sources.
14) Medical Physicist-cum-RSO of institution should
submit a report on the decommissioning of the
unit.
28. Licensee of the institute is always responsible in
fulfilling the regulatory requirements for ensuring
radiation safety while decommission the radiation
installation.
Licensee should check the credibility of agency
carrying out decommissioning.
It should have an
◦ an approved transport container, ii) complete
documentation of the concerned unit and the
transport container, iii) necessary tools and
gadgets for decommissioning, iv) appropriate
radiation survey meter, v) a written contingency
plan in case of emergency, and vi) BARC certified
Service Engineers
29. Finally
Dismantle the unit in such a way that the
unit can not be put again for use and
dispose them locally.
Monitor the area for any residual
radioactive contamination and declare it
to be free from radiation contamination.
30. The disposal agency for the radioactive
sources is
◦ Original supplier of the existing decayed source for
imported sources
◦ Board of Radiation & Isotope Technology (BRIT),
Mumbai for the locally supplied sources.
Whereas the disposal agencies for the
depleted uranium and contaminated parts
are
◦ Waste Management Division (WMD), BARC,
Mumbai and
◦ Centralised Waste Management Facility, IGCAR,
Kalpakkam
32. Disposal of a radiation sources from radiation
therapy facility includes:
◦ Sending back the radioactive source(s) to the
disposal agency for safe disposal complying with
the transport regulation
◦ Checking the objects, which were in contact with
the source(s) for contamination.
◦ In case of contamination, to separate out the
contaminated objects and send back to the
disposal agency for safe disposal complying with
the transport regulation.
◦ To monitor the area where the sources were kept
or used for any residual radioactive contamination
and declare it to be free from radiation
contamination.
33. Procedure for disposal of the sources:
The original supplier of the existing decayed
source/ BRIT should be contacted to obtain their
concurrence for accepting the decayed source
for disposal.
Consent has to be obtained from AERB Division
for disposing the sources.
Sources are to be checked for contamination. In
case the sources are found to be contaminated,
this Division should be contacted for specific
advice for packing the sources.
34. In case the sources are free from contamination,
they are to be packed, marked and labelled properly
as per the transport regulation.
This Division shall be contacted for obtaining
permission for transport of the above package to
the concerned disposal agency.
The Medical Physicist-cum-RSO of the institution
should submit a report on the decommissioning of
the unit
36. The telecobalt unit should not be used for
the clinical purposes if the output at the
normal treatment distance is below 50
cGy/min.
The source of a telecobalt unit needs to be
replaced, when the output of the unit
becomes low and is clinically not acceptable
because of the increase in treatment time.
37. Performance Evaluation of Telecobalt Unit
Performance evaluation is necessary to check
whether the machine is worth replacing the
telecobalt source or the unit needs to be
decommissioned.
In order to evaluate this thorough performance
check of telecobalt unit is required.
Once the source is replaced , the machine should
be able to function for at least one half life of the
source.
38. Authorisation to procure Telecobalt Source
Authorisation has to be obtained from RSD,
AERB.
Once the authorisation letter from AERB is
obtained, place order for procurement of
telecobalt source as per the specifications
mentioned in the authorisation letter.
In case of imported source undertaking need
to be obtained from the supplier of the
source to take back the source after its use.
39. Contact various Agencies
Contact the supplier of the telecobalt unit to assist
in replacement of the telecobalt source.
Concurrence need to be obtained from the supplier
of the old telecobalt source to take back the
decayed source .
Road Transport Approval
Road transport permission has to be obtained from
RSD, AERB for transporting the radioactive source
from the airport/port to the institution, in case of
imported source.
40. Receipt of Sources
Once the source is received, intimate receipt of the
source to RSD, AERB within 15 days.
The certified service engineer shall load the
telecobalt source.
Loading the Source
Source loading should be under supervision of the
Medical Physicist/RSO, who has been authorised by
AERB for supervising the source transfer operation.
To obtain the authorisation ,Medical Physicist/RSO
should submit application prior to 15 days of actual
date of source transfer
41. Before Loading of the source ensure that all the
persons involved in the source loading, operation
and testing of the unit have personnel monitoring
badges.
After loading the telecobalt source, the source
transfer report has to be submitted by the Medical
Physicist/RSO.
After loading the source, it is the responsibility of
the RSO to carryout radiation protection survey of
the installation prior to any other radiation tests
42. Quality Assurance Tests
Thorough Quality Assurance Tests of the telecobalt
unit has to be done and records has to be
maintained .
This has to be produced while inspection of
Radiotherapy Department of your institution by
AERB personnel.
Commissioning Approval for Patient Treatment
after replacement of telecobalt source
Commissioning approval for restarting the unit for
patient treatment has to be obtained from RSD,
AERB
For commissioning approval undertaking regarding
the performance of the unit has to be submitted
43. Intimating regarding the availability of personnel ,
associated equipments etc also should be submitted
for commissioning approval.
Adequate number of full-time staff in Radiotherapy
Department, personnel monitoring badges for all
the radiation workers and all the required
associated instruments/accessories.
Patient treatment should not be started without
obtaining the commissioning approval from RSD,
AERB.
44. Periodic Performance/ Quality Assurance test
Performance tests of the unit and survey of the
radiation installation has to be carried out
periodically .
Maintain all the records, which has to be produced
while inspection of Radiotherapy Department of
your institution by AERB personnel.
Annual Status Report
Annual Report on Status of Radiation Safety in
Radiotherapy Department has to be sent to RSD,
AERB so that it reaches by the end of each calendar
year
46. Classified worker:- The employer shall designate as
classified workers, those of his employees, who are
likely to receive an effective dose in excess of three-
tenths of the average annual dose limits notified by
the competent authority and shall forthwith inform
those employees that they have been so designated.
Radiological Safety Officer:- Every employer shall
designate, with the written approval of the
competent authority, a person having appropriate
qualifications as Radiological Safety Officer.
47. Responsibilities of the employer
(1) Every employer shall
◦ Ensure that provisions of these rules are
implemented by the licensee, Radiological Safety
Officer and other worker(s).
◦ Provide facilities and equipment to the
Radiological Safety Officer ,licensee and other
worker(s) to carry out their functions effectively
in conformity with regulatory constraint.
◦ Prior to employment of a worker, procure from his
former employer, where applicable, the dose
records and health surveillance reports
48. ◦ Upon termination of service of worker provide to
his new employer on request his dose records and
health surveillance reports.
◦ Furnish to each worker dose records and health
surveillance reports of the worker in his
employment annually, as and when requested by
the worker and at the termination of his service.
◦ Inform the competent authority if the licensee or
the Radiological Safety Officer or any worker
leaves the employment.
◦ Arrange for health surveillance of workers as
specified under rule 25.
49. The employer shall be the custodian of
radiation sources in his possession and shall
ensure physical security of the sources at all
times.
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 custodian
50. Responsibilities of the licensee
The responsibility for implementing the terms and
conditions of the licence shall rest with the
licensee
The licensee shall comply with the surveillance
procedures, safety codes and safety standards
specified by the competent authority.
Every 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, wherever
applicable.
51. The licensee shall comply with the provision of rules
for safe disposal of radioactive waste issued under
the Act.
Without prejudice to the generality of the above,
the licensee shall
◦ not allow workers, other than those specified in
sub-clause (ii) of clause of sub-rule (2) of rule 7
and already dealt with under rule 17.
◦ maintain records of workers as specified under
rule 24.
◦ arrange for preventive and remedial maintenance
of radiation protection equipment, and
monitoring instruments
52. ◦ in consultation with the Radiological Safety
Officer, investigate any case of exposure in excess
of regulatory constraints received by individual
workers and maintain records of such
investigations.
◦ inform competent authority promptly of the
occurrence, investigation and follow-up actions in
cases of exposure in excess of regulatory
constraints, including steps to prevent recurrence
of such incidents.
◦ carry out physical verification of radioactive
material periodically and maintain inventory.
53. ◦ inform appropriate law enforcement agency in the
locality of any loss of source.
◦ inform the employer and the competent authority
of any loss of source
◦ investigate and inform the competent authority of
any accident involving source and maintain record
of investigations
◦ verify the performance of radiation monitoring
systems, safety interlocks, protective devices and
any other safety systems in the radiation
installation
54. ◦ in consultation with Radiological Safety Officer,
prepare emergency plans, for responding to
accident to mitigate their consequences and
ensure emergency preparedness measures.
◦ conduct or arrange for quality assurance tests of
structures, systems, components and sources and
related equipment.
◦ advise the employer about the modifications in
working condition of a pregnant worker.
55. ◦ inform the competent authority if the Radiological
Safety Officer or a worker leaves the employment;
and
◦ inform the competent authority when he leaves
the employment
• The licensee shall ensure that the workers are
familiarised with contents of the relevant
surveillance procedures, safety standards, safety
codes, safety guides and safety manuals issued by
the competent authority and emergency response
plans.
56. Responsibilities of the Radiological Safety
Officer (RSO)
The Radiological Safety Officer shall be responsible
for advising and assisting the employer and licensee
on safety aspects aimed at ensuring that the
provisions of these rules are complied with.
The Radiological Safety Officer shall:
◦ carry out routine measurements and analysis on
radiation and radioactivity levels in the controlled
area, supervised area of the radiation installation
and maintain records of the results thereof
57. ◦ investigate any situation that could lead to
potential exposures.
• Advise the employer regarding
o the necessary steps aimed at ensuring that the
regulatory constraints and the terms and
conditions of the licence are adhered to.
o the safe storage and movement of radioactive
material within the radiation installation.
o initiation of suitable remedial measures in
respect of any situation that could lead to
potential exposures; and
58. o routine measurements and analysis on radiation
and radioactivity levels in the off-site environment
of the radiation installation and maintenance of the
results thereof.
ensure that
◦ reports on all hazardous situations along with
details of any immediate remedial actions taken
are made available to the employer and licensee
for reporting to the competent authority and a
copy endorsed to the competent authority.
◦ QA tests of structures, systems, components and
sources, as applicable are conducted.
◦ monitoring instruments are calibrated periodically.
59. assist the employer in
◦ instructing the workers on hazards of radiation
and on suitable safety measures and work
practices aimed at optimising exposures to
radiation sources.
◦ the safe disposal of radioactive wastes.
◦ developing suitable emergency response plans to
deal with accidents and maintaining emergency
preparedness.
60. advise the licensee on
◦ the modifications in working condition of a
pregnant worker.
◦ the safety and security of radioactive sources.
furnish to the licensee and the competent authority
the periodic reports on safety status of the radiation
installation.
inform the competent authority when he leaves the
employment
61. Responsibilities of worker
Every worker shall observe the safety requirements
and follow safety procedures and instructions and
shall refrain from any wilful act that could be
detrimental to self, co-workers, the radiation
installation and public.
The worker shall
◦ provide to the employer information about his
previous occupations including radiation work, if
any.
◦ make proper use of such protective equipment,
radiation monitors and Personnel monitoring
devices as provided
62. ◦ inform the licensee and the Radiological Safety
Officer, of any accident or potentially hazardous
situation that may come to his notice
A female worker shall, on becoming aware that she
is pregnant, notify the employer, licensee and
Radiological Safety Officer in order that her working
conditions may be modified, if necessary.
