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GUIDE NO. AERB/RF/SG/G-3 (Vol. 3 of 4)
GOVERNMENT OF INDIA
CONSENTING PROCESS
FOR
RADIATION FACILITIES
(VOLUME - 3)
CONSENTING PROCESS
FOR
RADIATION FACILITIES
(VOLUME - 3)
March 2011
Price
i
such as industrial safety and environmental protection are not explicitly considered in
this guide. Industrial safety shall be ensured by compliance with the applicable
provisions of the Factories Act, 1948 and the Atomic Energy (Factories) Rules, 1996.
The guide has been prepared by AERB staff. It has been reviewed by experts and the
Advisory Committee on Preparation of Code and Guides and on Governmental
Organisation for Nuclear and Radiation Facilities (ACCGORN).
AERB wishes to thank all individuals and organisations who have prepared and
reviewed the draft and helped in its finalisation. The list of experts, who have
participated in this task, along with their affiliations, is included for information.
(S. S. Bajaj)
Chairman, AERB
ii
DEFINITIONS
Acceptable Limits
Limits acceptable to the regulatory body for accident condition or potential exposure.
Accelerator
A device in which, charged particles are accelerated. Conventional X-ray tube is not
considered as an accelerator.
Activity
The quantity ‘A’ for an amount of radionuclide in a given energy state at a given time,
defined as:
A = dN/dt
where, ‘dN’ is the expectation value of the number of spontaneous nuclear
transformations from the given energy state in a time interval ‘dt’. The SI unit of
activity is the reciprocal of second, (s-1), termed the Becquerel (Bq).
Afterloading Applicator
A device applied to the patient into which radioactive sources are introduced either
manually or by a remotely operated system.
Applicant
Any person who, applies to the competent authority for consent to undertake any of
the actions for which the consent is required.
Approval
A type of consent issued by the regulatory body to a proposal.
Atomic Energy Regulatory Board (AERB)
A national authority designated by the Government of India having the legal authority
for issuing regulatory consent for various activities related to the nuclear and radiation
facility and to perform safety and regulatory functions, including their enforcement
for the protection of site personnel, the public and the environment against undue
radiation hazards.
Authorisation
A type of regulatory consent issued by the regulatory body for all sources, practices
and uses involving radioactive materials and radiation generating equipment (see also
‘Consent’).
Becquerel
See ‘Activity’
iii
Betatron
An electron accelerator in which electrons are accelerated in an increasing magnetic
field maintaining a stable orbit of electrons.
Commissioning
The process during which structures, systems and components of a nuclear and radiation
facility, on being constructed, are made functional and verified to be in accordance
with design specifications and to have met the performance criteria.
Competent Authority
Any official or authority appointed, approved or recognised by the Government of
India for the purpose of the Rules promulgated under the Atomic Energy Act, 1962.
Computed Tomography
Reconstructive tomography in which image recording and processing are effected by
a computing system.
Consent
It is a written permission issued to the ‘consentee’ by the regulatory body to perform
specified activities related to nuclear and radiation facilities. The types of consents
are ‘licence’, ‘authorisation’, ‘registration’, and ‘approval’ and will apply according
to the category of the facility, the particular activity and radiation source involved.
Consentee
A person to whom consent is granted by the competent authority under the relevant
Rules.
Construction
The process of manufacturing, testing and assembling the components of a nuclear or
radiation facility, the erection of civil works and structures, the installation of
components and equipment and the performance of associated tests.
Contamination
Presence of a radioactive substances in or on a material or in the human body or other
place in excess of quantities specified by the competent authority.
Cyclotron
A device in which charged particles (other than electrons) travel in a succession of
semicircular orbits of increasing radii under the influence of a constant magnetic field
and are accelerated by traversing a number of times in an electric field produced by a
high frequency generator.
Decommissioning
The process by which a nuclear or radiation facility is finally taken out of operation, in
iv
a manner that provides adequate protection to the health and safety of the workers, the
public and the environment.
Decontamination
The removal or reduction of contamination by a physical or chemical means .
Disposal
The emplacement of a waste in a repository without the intention of retrieval or the
approved direct discharge of waste into the environment with subsequent dispersion.
Dose
A measure of the radiation absorbed by a target. The quantities termed absorbed dose,
organ dose, equivalent dose, effective dose, committed equivalent dose or committed
effective dose are used, depending on the context. The modifying terms are used when
they are not necessary for defining the quantity of interest.
Dosimeter
A device, instrument or system, which can be used to measure or evaluate any quantity
that can be related to the determination of either absorbed dose or equivalent dose.
Dosimetry
Measurements and/or calculations performed in connection with the determination of
radiation dose and/or dose distributions in the irradiated volume.
Employer
Any person with recognised responsibility, commitment and duties towards a worker
in his or her employment by virtue of a mutually agreed relationship. (A self-employed
person is regarded as being both a worker and employer).
Enclosed Installation
In case of industrial radiography any installation in which radiography operations are
carried out in an enclosure which has walls providing adequate radiation protection to
persons working outside the enclosure, and which prevents unauthorised entry of
persons into the enclosure during radiography operations. Such installations may include
open top installations also.
Ethical Review Committee
A committee of independent, qualified persons to advise on the conditions of exposure
and the dose constraints to be observed for individuals exposed for biomedical research
when there is no direct benefit to the exposed individual.
Fluoroscopy
The technique of imaging by using a fluorescent screen.
v
Handle
Manufacture, possess, store, use, transfer by sale or otherwise export, import, transport
or dispose of.
Industrial Gamma Radiography Exposure Device (IGRED)
An assembly of components necessary to make radiographic exposures and which
includes the source housing, mechanism for securing the source assembly, exposure
mechanism, that includes source drive associated system, positioning devices and guide
tubes.
Industrial radiography
Non-destructive testing of materials employing ionising radiation.
Ionisation
Formation of ions by the division of molecules or by the addition or removal of electrons
from atoms or molecules.
Irradiation
Exposure to ionising radiation.
Irradiators
A facility that houses a particle accelerator, X-ray machine, or large radioactive sources
for imparting high radiation doses to materials.
Licence
A type of regulatory consent, granted by the regulatory body for all sources, practices
and uses for nuclear facilities involving the nuclear fuel cycle and also certain categories
of radiation facilities. It also means authority given by the regulatory body to a person
to operate the above said facilities.
Limit
The value of a parameter or attribute (which is variable) used in certain specific activities
or circumstances that must not be exceeded.
Luminescence
Phenomenon in which certain substances, when excited, emit light of wavelength
characteristic of the substance.
Microtron
A cyclic accelerator in which electrons are guided by a constant magnetic field in
circular orbits of increasing radii, tangential to each other and accelerated at the
beginning of each orbit, by traversing an electric field produced by a radio frequency
generator.
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Monitoring
The continuous or periodic measurement of parameters for determination , assessment
in respect of structure, system or component in a facility or control of radiation.
Nuclear Medicine
The speciality that utilises radio-pharmaceuticals to investigate disorders of anatomy,
physiology and patho-physiology, for diagnosis and/or treatment of diseases.
Package
The packaging with its radioactive contents as prescribed for transport.
Personnel Monitoring
Determination or estimation of the dose received by a person from external and internal
radiation.
Practice
Any human activity that introduces additional sources of exposure or exposure pathways
or extends exposure to additional people or modifies the network of exposure pathways
from existing sources, so as to increase the exposure or the likelihood of exposure of
people, or the number of people exposed.
Prescibed Limits
Limits established or accepted by the regulatory body.
Protective Barrier or Shielding (Radiation)
A barrier of appropriate thickness used to reduce radiation levels to specified values.
Protective Device
Device used for the purpose of radiological protection.
Quality Assurance
Planned and systematic actions necessary to provide adequate confidence that an item
or a facility will perform satisfactorily in service as per the design specifications.
Radiation
Gamma rays, X-rays or rays consisting of alpha particles, beta particles, neutrons,
protons, and other nuclear, sub-atomic particles, but not sound or radio waves, or
visible, infrared, ultraviolet light.
Radiation Facility
Any installation/equipment or a practice involving use of radiation-generating units
or radioisotopes in the field of research, industry, medicine and agriculture.
vii
Radioactive Waste
Material, whatever its physical form, remaining from practices or interventions and
for which no further use is foreseen. It can be (a) that contains or is contaminated with
radioactive substances and has an activity or activity concentration higher than the
level for clearance from regulatory requirements, and (b) exposure to which is not
excluded from regulatory control .
Radioactive Waste Management Facility
Facility specifically designed to handle, treat, condition, temporarily store or
permanently dispose of radioactive waste.
Radioactivity
The phenomenon whereby atoms undergo spontaneous random disintegration, usually
accompanied by the emission of radiation.
Radiography (Medical)
Technique for obtaining, recording and optionally processing, directly or after transfer,
information contained in an X-ray pattern at an image receptor area.
Radiography Source
A source sealed in one or more capsules, or an X-ray tube, or an electron accelerator
or a neutron source used for industrial radiography.
Radiography Technician/Radiography Technologist/Radiographer
A worker, who performs radiography operations employing radiography sources and
possesses a valid qualification, duly recognised by the competent authority for the
specific purpose.
Radiological Safety Officer (or Radiation Safety Officer)
Any person who is so designated by the employer and who, in the opinion of the
competent authority, is qualified to discharge the functions outlined in the Atomic
Energy(Radiation Protection )Rules, 2004.
Radiotherapy/Radiation Therapy
Medical treatment by ionising radiation.
Registration
A type of regulatory consent issued by the regulatory body for all sources, practices
and uses involving radioactive materials and radiation generating equipment.
Regulatory Body
See ‘Atomic Energy Regulatory Board’
viii
Safety Assessment
Review of the aspects of design and operation of a source, which are relevant to the
protection of persons or the safety of the source, including the analysis of the provisions
for safety and protection established in the design and operation of the source and the
analysis of risks associated with normal conditions and accident situations.
Safety Site-in-charge
A person who has the qualifications and training prescribed for Level 2 radiological
safety officer and who is appointed by the ‘consentee’ as the person supervising
industrial radiography operations at an authorised radiography site with approval of
the competent authority.
Sealed Source
Radioactive source material that is (a) permanently sealed in a capsule or (b) closely
bounded and in a solid form. The capsule or material of a sealed source shall be strong
enough to maintain leak tightness under the conditions of use and wear for which the
source was designed, as also under foreseeable mishaps.
Source
Any thing that causes radiation exposure, either by emitting ionising radiation or
releasing radioactive substances or materials.
Source Changer
A device for transferring radiography sources from or to exposure device, and suitable
for transport and storage of the source.
Source Housing
Shielding provided in any device containing a sealed source, in order to:
(i) define the useful beam; and
(ii) limit the radiation level outside of the useful beam to maximum permissible
leakage levels, as specified by the competent authority.
Synchrotron
Particle accelerator in which charged particles travel in circular orbits of constant
radius guided by an increasing magnetic field and accelerated by traversing a number
of times an electric field produced by a high frequency generator in synchronism
with the orbital motion.
Teletherapy
Treatment with external radiation beam(s) where the distance from source to skin is
greater than 5 cm.
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Tomography
Radiography of one or more sections/layers within an object.
Treatment Planning (Radiotherapy)
Planning of the techniques for radiation therapy, which may include treatment simulation
and dosimetry.
Treatment Simulation
Methods by which the techniques and patient positioning for radiotherapy are simulated
without delivering the therapy dose.
Type Approval
Approval, issued by the competent authority, based on evaluation of the device to
ensure that it conforms to safety standards.
Type A package
A Package designed to withstand normal conditions of transport without loss or dispersal
of its contents or loss of shielding integrity. The radioactive material may be transported
in a Type A package, either in special form radioactive material or other form, with the
provision that the activity shall not exceed the applicable limits prescribed in the relevant
code on ‘Transport of Radioactive Materials’.
Type B(U) package
A package designed to contain an activity in excess of A1, if special form radioactive
material, or in excess of A2 if not special form radioactive material, that is designed to
withstand normal and accidental conditions of transport specified in the relevant code
on ‘Transport of Radioactive Materials’.
Unusual Occurrence
Any occurrence which has the potential to impair or impairs the plant safety, radiological
safety, industrial safety and/or environmental safety.
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SPECIAL DEFINITIONS
(Specific for the Present Guide)
Consumer Product
A manufactured product or item containing radioactive substance, which is exempted
from regulatory control.
Field Radiography
Radiography operations carried out on shop floors, erection sites or other such areas
with provisions for adequate radiological safety for the radiography personnel and
others including members of the public.
Person
Any individual, or a company, or association, or body of individuals, whether
incorporated or not; or central government or a state government.
Worker
Any person who works, whether full-time, part-time or temporarily, for an employer
and who has recognised rights and duties in relation to occupational radiation protection.
(A self-employed person is regarded as having the duties of both an employer and a
worker).
X-ray Equipment
Equipment consisting of combination of an X-ray generator, X-ray tube and associated
equipment.
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CONTENTS
FOREWORD ....................................................................... i
Volume - 1
1. INTRODUCTION ..................................................................... 1
1.1 General ....................................................................... 1
1.2 Objective ...................................................................... 1
1.3 Scope ....................................................................... 2
Volume - 2
APPENDIX-8C-I ACCEPTANCE/PERFORMANCE/
(Refer section 3.6.3) QUALITY ASSURANCE TEST
FORCOMPUTED TOMOGRAPHY
(CT) SCANNER ........................................... 230
APPENDIX-8C-II ACCEPTANCE/PERFORMANCE/
(Refer sections 3.6.3 & QUALITY ASSURANCE TEST
3.13.2.5) FORDIAGNOSTIC X-RAY UNIT/
CATH LAB .................................................... 239
APPENDIX-8C-III ACCEPTANCE/PERFORMANCE/
(Refer section 3.13.2.5) QUALITY ASSURANCE TEST
FOR MAMMOGRAPHY UNIT ................... 247
Volume - 3
Volume - 4
BIBLIOGRAPHY ....................................................................... Bi
Form ID : AERB/RSD/GRAPF/SA
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan,
Anushaktinagar,
Mumbai - 400 094
PART A
GENERAL PARTICULARS
A.1 Name and address of the institution:
Telephone No. (O):
Fax No.
E-mail
A.2 Name and address of the Head of the institution$
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
261
A.3 Name and designation of the applicant#:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.4 Representative of the applicant to be contacted regarding the application:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.5 Address for correspondence with PIN code:
$ The head of the institution is the person who would have the responsibilities of
‘employer’ prescribed in AE(RP)R, 2004.
# Applicant is the person in whose name the authorisation (licence) to handle the
source may be issued, under AE(RP)R, 2004, would have the responsibilities of
‘licensee’ prescribed in AE(RP)R, 2004 and should be a full time employee of
the institution.
PART B
262
B.7.3 Distance of site of installation of GRAPF from:
(a) Ammunition storage and explosive dumps
(b) Storage of inflammable materials
(c) Direction of runway of civilian/military airfield
(d) Residential area and public places
(e) Rivers/dams/lake/water reservoir
B.7.4 Distance of proposed site from capable fault, if any
(Documentary evidence from relevant State/Central Government authority)
B.7.5 Provision of access roads to approach the proposed site and its detail.
B 7.6 Distance and location of the nearest railway station and airport from the site
B.8 Documents to be attached with the application
(i) Site assessment report (as per Appendix-2A )
(ii) Installation layout indicating location of the plot with peripheral
occupancy
(iii) Map of the site region upto 2km radius covering details given in
Items B.7.3 and B.7.6
(iv) Proof from local State Government authorities that the land/plot/
site for installation of the facility is in the name of the applicant and
falls in industrial zone.
(v) Any other supporting documents.
PART C
UNDERTAKING
263
(v) the site/facility shall not be transferred/sold/ rented by me/us to any
other party without the prior permission of the competent authority.
(vi) full facilities will be accorded by me/us to any authorised
representatives of the competent authority to inspect the installation
at any time.
(vii) radiation surveillance of the installation and health surveillance of
all persons engaged in radiation work as required by the competent
authority will be duly carried out at my/our expense.
(viii) all stipulations/recommendations made from time to time by the
competent authority in respect of radiation safety measures will be
duly implemented.
(ix) duly qualified/experienced radiological safety officer(s)/operator(s)
will be appointed before the commencement of operation of the
facility.
(x) the procedures approved by AERB regarding decommissioning/
dismantling and reuse of the site of the decommissioned facility will
be strictly complied with.
(xi) I/we will keep AERB informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/or not authentic, then I/we hereby undertake to comply with the
regulatory action(s) enforced against me/us and our institution, in accordance
with the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution:
Designation:
.
(Seal of the Head of the institution)
264
ANNEXURE-2
(Refer section 3.2.1.3)
Form ID.AERB/RSD/GRAPF/L&CA
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar,
Mumbai - 400 094
PART A
GENERAL PARTICULARS
A.1 Name and address of the institution:
Telephone No. (O):
Fax No.
E-mail
A.2 Name and address of the Head of the institution$
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
265
A.3 Name and designation of the applicant #:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.4 Representative of the applicant to be contacted regarding the application:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.5 Address for correspondence with PIN code:
$ The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
# Applicant is the person in whose name the authorisation (licence) to handle
the source may be issued, under AE(RP)R, 2004, would have the
responsibilities of ‘licensee’ prescribed in AE(RP)R, 2004 and should be a
full time employee of the institution
PART B
266
B.4 Name and address of the local vendor agency, if any:
Telephone No. (O): (R)
Fax No.
Mobile No.
Email
B.5 Layout and civil engineering drawings .attached : Yes/No
B.6 Category of GRAPF :
[Specify class as per AERB/SS- 6 (Rev. 1), 2007]
B.7 Purpose of the facility:
B.8 Scale of operation : Commercial/Research/other (Specify):
B.9 Mode of operation: Batch type/Continuous/other (specify)
B.10 Products(s)/material(s) to be irradiated:
B.11 Product movement system:
(specify no. of product boxes and product carriers)
B.12 Particulars of radiation source
267
(vi) Layout and civil engineering drawings
(vii) Security plan for the facility as per AERB safety guide on ‘Security
of Radioactive Sources in Radiation Facilities’ (AERB/RS-RS/
SG-1) and AERB safety guide on ‘Security of Radioactive Material
during Transport’ (AERB/NRF-TS/SG-10)
(viii) Any other supporting documents.
PART C
UNDERTAKING
I/We hereby certify that
(i) all the statements made above are correct to the best of my/our knowledge
and belief.
(ii) no activity shall be carried out for purposes other than those specified in this
form.
(iii) the siting activities shall be taken up only after receipt of approval from
AERB.
(iv) all provisions of the Atomic Energy (Radiation Protection) Rules, 2004 shall
be strictly complied with.
(v) the site/facility shall not be transferred/sold/rented by me/us to any other
party without the prior permission of the competent authority.
(vi) full facilities will be accorded by me/us to any authorised representatives of
the competent authority to inspect this installation at any time.
(vii) radiation surveillance of the installation and health surveillance of all persons
engaged in radiation work as required by the competent authority will be
duly carried out at my/our expense.
(viii) all stipulations/recommendations made from time to time by the competent
authority in respect of radiation safety measures will be duly implemented.
(ix) duly qualified/experienced radiological safety officer(s)/operator(s) will be
appointed before the commencement of operation of the facility.
(x) the procedures approved by AERB regarding decommissioning/dismantling
and reuse of the site of the decommissioned facility will be strictly complied
with.
(xi) I/we will keep AERB informed about any changes in the information furnished
above.
268
In case, it is found, at any stage, that the information provided by me/us is false and/or
not authentic, then I/we hereby undertake to comply with the regulatory action(s)
enforced against me/us and our institution, in accordance with the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the Institution:
Designation:
269
ANNEXURE-3
(Refer section 3.2.1.5)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar,
Mumbai-400094
(a) This application would be considered by the competent authority for issuance
of relevant consents, under the Atomic Energy (Radiation Protection) Rules,
2004 [AE(RP)R].
(b) The duly filled-in form should be sent to Director/Head, Radiological Safety
Division (RSD), AERB, Niyamak Bhavan, Anushaktinagar, Mumbai-400094
with the necessary documents
(c) Incomplete applications and those without all relevant documents are liable
to be rejected
(d) All the forms pertaining to this facility can be downloaded from the website
(www.aerb.gov.in)
(e) Attach extra sheets wherever required
PART A
GENERAL PARTICULARS
A.1 Name and address of the institution:
Telephone No. (O):
Fax No.
E-mail
A.2 Name and address of the Head of the institution $
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
270
A.3 Name and designation of the applicant #:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.4 Name and designation of the Facility In-charge:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.5 Name and designation of the radiological safety officer (RSO)*:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
RSO Approval reference No.:
Approval valid up to
A.6 Representative of the applicant to be contacted regarding the application:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.7 Address for correspondence with PIN code:
$ The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
# Applicant is the person in whose name the authorisation (licence) to handle
the source may be issued, under AE(RP)R, 2004, would have the
responsibilities of ‘licensee’ prescribed in AE(RP)R, 2004 and should be a
full time employee of the institution.
* RSO is the person who is so designated by employer and approved by
competent authority and have the responsibilities of ‘Radiological Safety
Officer’ prescribed in AE(RP)R, 2004.
PART B
271
S.No. Designation of Name **Academic Type of When and Duration
personnel qualification training/ where of
Experience trained training
1 Operator(s)
2 Radiological
safety officer
(RSO)
272
Required documents Availability
(Yes/No)
Final safety analysis report (FSAR)
AERB safety code on ‘Operation and Maintenance of Land-based
Stationary Gamma Irradiators’, (AERB/SC/IRRAD)
PSAR as approved by AERB
Standard operating procedures (SOP)
Servicing/maintenance manual
Pre-commissioning acceptance test report
Radiation protection manual
Radiation protection survey report (along with drawings and layout
indicating stray radiation levels at different locations of the facility)
Quality assurance manual for operation
Security Plan for the facility as per ‘AERB safety guide on ‘Security
of Radioactive Sources in Radiation Facilities’ (AERB/RF-RS/
SG-1) and AERB Safety Guide on ‘Security during Transport of
Radioactive Material’ (AERB/NRF-TS/SG-10).
UNDERTAKING
I/we hereby certify that
(i) all the statements made above are correct to the best of my knowledge and
belief.
(ii) no operation will be carried out for purposes other than those specified in
this form.
273
(iii) the commissioning/operation activities shall not be commenced without
Licence from AERB.
(iv) all provisions of the Atomic Energy (Radiation Protection) Rules, 2004 shall
be strictly complied with.
(v) the facility shall not be transferred/sold/ rented by me/us to any other party
without the prior permission of the competent authority.
(vi) no radiation source of this facility will be transported without the prior
permission of the competent authority.
(vii) full facilities will be accorded by me/us to any authorised representatives of
the competent authority to inspect this installation at any time.
(viii) radiation surveillance of the installation and health surveillance of all persons
engaged in radiation work as required by the competent authority will be
duly carried out at my/our expense.
(ix) all recommendations made from time to time by the competent authority in
respect of radiation safety measures will be duly implemented.
(x) duly qualified/experienced radiological safety officer(s)/operator(s)/quality
control officers will be appointed before the commencement of operation of
the facility.
(xi) the requirements regarding decommissioning, disposal of decayed sources
and reuse of the site of the decommissioned facility will be strictly complied
with.
(xii) In case of any unforeseen situations such as bankruptcy, damage to the facility
and other such situations, the sources will be returned to its supplier at my/
our own cost without jeopardising safety and security requirements.
(xiii) AERB will be informed about any changes in the information furnished above.
In case, it is found, at any stage, that the information provided by me/us is false and/ or
not authentic, then I/we hereby undertake to comply with the regulatory action(s)
enforced against me/us and our institution, in accordance with the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the Institution:
Designation:
274
ANNEXURE-4
(Refer section 3.2.1.5)
AERB/CA-FORM-III
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar,
Mumbai-400094.
275
(a) Identification number of the facility:
(b) Location and its address
(c) Source details
Name of radionuclide : .............. Activity ................ PBq
X-ray
Electron accelerator
276
10. Please indicate as appropriate:
(a) Irradiation facility is yet to be built.
(b) The irradiation facility is already built and equipped.
(c) Existing irradiation facility is to be modified as per the details
enclosed.
11. I/we hereby certify that
(i) all the statements made above are correct to the best of my knowledge
and belief.
(ii) no operation will be carried out for purposes other than those
specified in this form
(iii) all provisions of the Atomic Energy (Control of irradiation of food)
Rules, 1996 shall be strictly complied with.
(iv) the irradiation facility shall not be transferred/sold/rented by me/us
to any other party without the prior permission of the competent
authority.
(v) no radiation for the irradiation unit will be transported without the
prior permission of the competent authority.
(vi) full facilities will be accorded by me/us to any authorised
representatives of the competent authority or the licensing authority
to inspect the installations at any time.
(vii) radiation surveillance of the installation and health surveillance of
all persons engaged in radiation work as required by the competent
authority will be duly carried out at my/our expense.
(viii) all recommendations that may be made from time to time by the
competent authority in respect of radiation safety measures will be
duly implemented.
(ix) duly qualified/experienced radiological safety officer(s)/operator(s)/
quality officer(s) will be appointed before the commencement of
operation of the facility.
(x) the requirements regarding decommissioning, disposal of decayed
sources and reuse of the site of the decommissioned facility will be
strictly complied with.
277
ANNEXURE-5
(Refer sections 3.2.2.2 and 3.2.2.3)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar,
Mumbai-400 094.
PART A
GENERAL PARTICULARS
278
Mobile No.
E-mail
A.3 Name and designation of the applicant#:
Telephone No. (O): (R)
Fax No.
E-mail
A.4 Address for correspondence with PIN code:
A.5 Name of the Facility In-charge:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
$ The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
# Applicant is the person in whose name the authorisation (licence) to handle
the source may be issued, under AE(RP)R, 2004, would have the
responsibilities of ‘licensee’ prescribed in AE(RP)R, 2004 and should be a
full time employee of the institution.
PART B
PARTICULARS OF THE FACILITY
B.1 Proposed location of the radiation facility
B.2 Site specific information:
B.2.1 Seismic zone as per IS-1893 (current version) (Documentary evidence from
relevant state/central govt. authority)
B.2.2 Maximum level of ground water and maximum flood level for past hundred
years as per the central /state govt. records along with documentary evidence.
B.2.3 Distance of site of installation of facility from
(a) Ammunition storage and explosive dumps
(b) Storage of inflammable materials
(c) Direction of runway of civilian/military airfield
(d) Residential and public place
(e) Rivers/dams/lake/water reservoir
279
B.2.4 Distance of proposed site from capable fault, if any
(Documentary evidence from relevant state /central govt. authority)
B.2.5 Distance and location of the nearest railway station and airport from the site
B.3 Brief description of the Facility:
(a) Type of accelerator to be installed:
(b) Particles to be accelerated:
(c) Purpose of the facility:
(d) Purpose of operation (commercial/research):
(e) Beam specifications : (current, energy, power)
(f) Products(s)/material(s) to be irradiated:
B.4 Layout and civil engineering drawings attached: Yes/No
B.5 Product movement system (Specify no. of product boxes and product carriers):
B.6 Documents to be available with the facility:
280
(ii) no activity shall be carried out for purposes other than those specified
in this form.
(iii) siting and construction activities shall be taken up only after receipt
of approval from AERB.
(iv) all provisions of the Atomic Energy (Radiation Protection) Rules,
2004 shall be strictly complied with.
(v) the facility shall not be transferred/sold/ rented by me/us to any other
party without the prior permission of the competent authority.
(vi) full facilities will be accorded by me/us to any authorised
representatives of the competent authority to inspect this installation
at any time.
(vii) radiation surveillance of the installation and health surveillance of
all persons engaged in radiation work as required by the competent
authority will be duly carried out at my/our expense.
(viii) all recommendations made from time to time by the competent
authority in respect of radiation safety measures will be duly
implemented.
(ix) duly qualified/experienced radiological safety officer(s)/operator(s)
will be appointed before the commencement of operation of the
facility.
(x) the procedures approved by AERB regarding decommissioning/
dismantling and reuse of the site of the decommissioned facility will
be strictly complied with.
(xi) I/we will keep AERB informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/ or not authentic, then I/ we hereby undertake to comply with the
regulatory action(s) enforced against me/us and our institution, in accordance
with the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution:
Designation:
(Seal of the Head of the institution)
281
ANNEXURE-6
( Refer sections 3.2.2.5 & 3.2.2.6)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar,
Mumbai-400 094.
PART A
GENERAL PARTICULARS
A.1 Name and address of the institution:
Telephone No. (O):
Fax No.
E-mail
A.2 Name and address of the Head of the institution$:
Telephone No. (O): (R)
282
Fax No.
Mobile No.
E-mail
A.3 Name and designation of the applicant#:
Telephone No. (O): (R)
Fax No.
E-mail
A.4 Address for correspondence with PIN code:
A.5 Name of the Facility In-charge :
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.6 Name and designation of the Radiological Safety Officer (s) (RSO)* :
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
RSO approval reference No.
Approval valid up to
$ The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
# Applicant is the person in whose name the authorisation (licence) to handle
the source may be issued, under AE(RP)R, 2004, would have the
responsibilities of ‘licensee’ prescribed in AE(RP)R, 2004 and should be a
full time employee of the institution.
* RSO is the person who is so designated by employer and approved by
competent authority and have the responsibilities of ‘Radiological Safety
Officer’ prescribed in in AE(RP)R, 2004.
PART B
283
S. Designation Name **Academic Type of When and Duration PMS
No. of personnel qualification training/ where of No.
experience trained training
1 Operator(s)
2 Radiological
safety officer
(RSO)
284
Required documents Availability
(Yes/No)
PSAR as approved by AERB
Final safety analysis report (FSAR)
Standard operating procedures (SOP)
Servicing/maintenance manual
Pre-commissioning acceptance test report with results
Shielding design and of installation survey (along with
drawings and layout)
Radiation protection survey report (along with drawings and
layout indicating stray radiation levels at different locations
of the facility)
Diagrams for electrical circuits and other interlocks
Radiation protection manual
Quality assurance manual for operation
PART C
UNDERTAKING
285
(iv) all provisions of the Atomic Energy (Radiation Protection) Rules,
2004 shall be strictly complied with.
(v) the facility shall not be transferred/sold/ rented by me/us to any other
party without the prior permission of the competent authority.
(vi) full facilities will be accorded by me/us to any authorised
representatives of the competent authority to inspect this installation
at any time.
(vii) radiation surveillance of the installation and health surveillance of
all persons engaged in radiation work as required by the competent
authority will be duly carried out at my/our expense.
(viii) all recommendations made from time to time by the competent
authority in respect of radiation safety measures will be duly
implemented.
(ix) duly qualified/experienced persons will be appointed before the
commencement of operation of the facility.
(x) the procedures approved by AERB regarding decommissioning,
disposal of decayed sources and reuse of the site of the
decommissioned facility will be strictly complied with.
(xi) I/we will keep AERB informed about any changes in the information
furnished above
In case, it is found, at any stage, that the information provided by me/us is
false and/ or not authentic, then I/we hereby undertake to comply with the
regulatory action(s) enforced against me/us and our institution, in accordance
with the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution:
Designation:
286
ANNEXURE-7
(Refer section 3.3.2)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan,
Anushaktinagar
Mumbai-400 094.
PART A
GENERAL PARTICULARS
287
A.3 Name and designation of the applicant#:
Telephone No. (O): (R)
Fax No.
Mobile No.
Email
A.4 Address for correspondence with PIN code:
A5 Name of the Facility In-charge:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
$
The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
#
Applicant is the person in whose name the authorisation (licence) to handle
the source may be issued, under AE(RP)R, 2004, would have the
responsibilities of ‘licensee’ prescribed in AE(RP)R, 2004 and should be a
full time employee of the institution.
PART B
288
(iii) Map of the site region upto 2km radius covering details of major
facilities and site characteristics (viz, seismicity, population centres,
meteorology, hydrology, geo-hydrology, railway lines, roads etc) in
scale 1:100
(iv) Documentary evidence from local state government authorities that
the land/plot for installation of facility is in the name of the Institution.
(v) Security Plan for the facility as per AERB safety guide on ‘Security
of Radioactive Sources in Radiation Facilities’(AERB/RF-RS/
SG-1)
(vi) Any other supporting documents.
PART C
UNDERTAKING
289
(x) the procedures approved by AERB regarding decommissioning/
dismantling and reuse of the site of the decommissioned facility will
be strictly complied with.
(xi) I/we will keep AERB informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/or not authentic, then I/we hereby undertake to comply with the
regulatory action(s) enforced against me/us and our institution, in accordance
with the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution:
Designation:
290
ANNEXURE-8
(Refer section 3.3.3)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan,
Anushaktinagar
Mumbai – 400 094
PART A
GENERAL PARTICULARS
A.1 Name and address of the institution:
Telephone No. (O):
Fax No.
Mobile No.
E-mail
A.2 Name and address of the Head of the institution$:
Telephone No. (O) (R)
Fax No.
Mobile No.
E-mail
291
A.3 Name and designation of the applicant#:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.4 Address for correspondence with PIN code:
A5 Name of the Facility In-charge :
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
$
The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
#
Applicant is the person in whose name the authorisation (licence) to handle
the source may be issued, under AE(RP)R, 2004, would have the
responsibilities of ‘licensee’ prescribed in AE(RP)R, 2004 and should be a
full time employee of the institution.
PART B
292
B.4 Documents to be attached with the Application
(a) Design manuals of facility
(b) Civil engineering drawings.
(c) Detailed layout of the facility indicating location of the machine,
shielding and its materials (sizes and thickness), mezzanines,
labyrinth, entry-exit points, radiation zoning scheme etc.
(d) Preliminary safety analysis report (as per Appendix-4B, 4D)
(e) Radiation hazard control plans
(i) Organisational set-up including manpower and equipment
(ii) Details of safety interlocks and access control systems and
radiation zoning
(iii) Pre-operational survey report of the background radiation and
radioactivity
(iv) Shielding design drawings with details
(v) Radioactive material handling and waste management details,
if applicable
(f) Construction Schedule
(g) Quality assurance (QA) manual for Construction (as per
Appendix-4F)
(h) Security plan for the facility as per AERB safety guide on ‘Security
of Radioactive Sources in Radiation Facilities’ (AERB/RF-RS/
SG-1).
(i) Details of ventilation system for removal of noxious gases including
radioactive gases and ozone generated. It should also include stack
height.
(j) Liquid effluent quantification and discharge mode should be
specified.
(k) Supporting documents, if any.
PART C
UNDERTAKING
I/we hereby certify that
(i) all the statements made above are correct to the best of my knowledge
and belief .
(ii) no activity shall be carried out for purposes other than those specified
in this form.
293
(iii) construction activities shall be taken up only after receipt of approval
from AERB.
(iv) all provisions of the Atomic Energy (Radiation Protection) Rules,
2004 shall be strictly complied with.
(v) the facility shall not be transferred/sold/rented by me/us to any other
party without the prior permission of the competent authority.
(vi) full facilities will be accorded by me/us to any authorised
representatives of the competent authority to inspect this installation
at any time.
(vii) radiation surveillance of the installation and health surveillance of
all persons engaged in radiation work as required by the competent
authority will be duly carried out at my/our expense.
(viii) all recommendations made from time to time by the competent
authority in respect of radiation safety measures will be duly
implemented.
(ix) duly qualified/experienced radiological safety officer(s)/operator(s)
will be appointed before the commencement of operation of the
facility.
(x) the procedures approved by AERB regarding decommissioning/
dismantling and reuse of the site of the decommissioned facility will
be strictly complied with.
(xi) AERB will be informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/ or not authentic, then I/we hereby undertake to comply with the
regulatory action(s) enforced against me/us and our institution, in accordance
with the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution:
Designation:
294
ANNEXURE-9
(Refer section 3.3.4)
295
(a) certify that the individual meets all the requirements spelt out in the approved
document and is fully aware of all radiological aspects of this Facility,
(b) undertake to provide all necessary infrastructure and man-power to the RSO
to discharge his duties and functions effectively,
(c) undertake to inform the Atomic Energy Regulatory Board immediately in
case the RSO is relieved of his duties,
and request the Approval of the Competent Authority for designating the above
individual as the designated/alternate RSO for ............ (Name of the Facility) .........,
for a period of 5 years.
296
ANNEXURE-10
(Refer section 3.3.4)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan,
Anushaktinagar,
Mumbai-400 094.
PART A
GENERAL PARTICULARS
A.1 Name and address of the institution:
Telephone No. (O):
Fax No.
Institution No. for personnel monitoring services
E-mail
A.2 Name and address of the Head of the institution$:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
297
A.3 Name and designation of the applicant#:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.4 Address for correspondence with PIN code:
A.5 Name of the Facility In-charge:
Telephone No. (O) (R)
Fax No.
Mobile No.
E-mail
A.6 Name and designation of the Radiological Safety Officer (s) (RSO)* :
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
RSO approval reference No. :
Valid up to :
$
The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
#
Applicant is the person in whose name the authorisation (licence) to handle
the source may be issued, under AE(RP)R, 2004, would have the
responsibilities of ‘licensee’ prescribed in AE(RP)R, 2004 and should be a
full time employee of the institution.
* RSO is the person who is so designated by employer and approved by
competent authority and have the responsibilities of ‘Radiological Safety
Officer’ prescribed in AE(RP)R, 2004.
PART B
298
B.3 Brief description of the Facility:
(a) Type of accelerator
(b) Particles to be accelerated
(c) Beam energy
(d) Beam current
(e) Average beam Power (mW/kW)
(f) Stored beam energy in case of circular accelerators (Joules)
(g) Number of beam lines
B.4 Name, qualification and experience of personnel
299
(xii) Emergency preparedness plan and procedures of the facility (as per
AERB/SM/O-2)
(xiii) Access control system including search and secure procedure
(xiv) Security Plan for the facility as per AERB Safety Guide on ‘Security
of Radioactive Sources in Radiation Facilities’ (AERB/RF-RS/
SG-1)
(xv) Supporting documents (if any)
PART C
UNDERTAKING
I/we hereby certify that
(i) all the statements made above are correct to the best of my knowledge
and belief.
(ii) no activity shall be carried out for purposes other than those specified
in this form.
(iii) the commissioning activities shall not be commenced without Consent
from competent authority.
(iv) all provisions of the Atomic Energy (Radiation Protection) Rules,
2004 shall be strictly complied with.
(v) the facility shall not be transferred/sold/rented by me/us to any other
party without the prior permission of the competent authority.
(vi) no radiation source of this facility will be transported without the
prior permission of the competent authority.
(vii) full facilities will be accorded by me/us to any authorised
representatives of the competent authority to inspect the
installations at any time.
(viii) radiation surveillance of the installation and health surveillance of
all persons engaged in radiation work as required by the competent
authority will be duly carried out at my/our expense.
(ix) all recommendations that may be made from time to time by the
competent authority in respect of radiation safety measures will be
duly implemented.
(x) duly qualified/experienced radiological safety officer(s)/operator(s)/
quality officer(s) will be appointed before the commencement of
operation of the facility.
300
(xi) the requirements regarding decommissioning, disposal of decayed
sources and reuse of the site of the decommissioned facility will be
strictly complied with.
(xii) I/we will keep AERB informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/or not authentic, then I/we hereby undertake to comply with the
regulatory action(s) enforced against me/us and our institution, in accordance
with the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution:
Designation:
.
(Seal of the Head of the institution)
301
ANNEXURE-11
(Refer section 3.3.5)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan,
Anushaktinagar,
Mumbai-400 094.
PART A
GENERAL PARTICULARS
302
Mobile No.
E-mail
A.3 Name and designation of the applicant#:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.4 Address for correspondence with PIN code:
A.5 Name of the Facility In-charge :
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.6 Name and designation of the Radiological Safety Officer (s) (RSO)* :
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
RSO Approval reference No.:
Valid up to :
A.7 Name and Address of the proposed Facility:
$
The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
#
Applicant is the person in whose name the authorisation (licence) to handle
the source may be issued, under AE(RP)R, 2004, would have the
responsibilities of ‘licensee’ prescribed in AE(RP)R, 2004 and should be a
full time employee of the institution.
* RSO is the person who is so designated by employer and approved by
competent authority and have the responsibilities of ‘Radiological Safety
Officer’prescribed in AE(RP)R, 2004..
PART B
303
B.3 Details of commissioning Consent:
304
PART C
UNDERTAKING
I/we hereby certify that
(i) all the statements made above are correct to the best of my knowledge
and belief.
(ii) no activity shall be carried out for purposes other than those specified
in this application.
(iii) the operation of the facility shall not be commenced without Licence
from AERB.
(iv) fulfil all relevant requirements prescribed in the Atomic Energy Act,
1962 and the Rules issued there under, and in the relevant codes.
(v) meet the requirements prescribed in other relevant statutes.
(vi) all provisions of the Atomic Energy (Radiation Protection) Rules,
2004 shall be strictly complied with.
(vii) the facility shall not be transferred/sold/ rented by me/us to any other
party without the prior permission of the competent authority.
(viii) no radiation source of this facility will be transported without the
prior permission of the competent authority.
(ix) full facility will be accorded by me/us to any authorised
representatives of the competent authority to inspect the installation
at any time.
(x) radiation surveillance of the installation and health surveillance of
all persons engaged in radiation work as required by the competent
authority will be duly carried out at my/our expense.
(xi) all recommendations made from time to time by the competent
authority in respect of radiation safety measures will be duly
implemented.
(xii) duly qualified/experienced radiological safety officer(s)/operator(s)/
quality officer(s) will be appointed before the commencement of
operation of the facility.
(xiii) the requirements regarding decommissioning, disposal of decayed
sources and reuse of the site of the decommissioned facility will be
strictly complied with.
(xiv) I/we will keep AERB informed about any changes in the information
furnished above.
305
In case, it is found, at any stage, that the information provided by me/us is
false and/or not authentic, then I/we hereby undertake to comply with the
regulatory action(s) enforced against me/us and our institution, in accordance
with the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution:
Designation:
306
ANNEXURE-12
(Refer section 3.4.1 )
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar
Mumbai-400 094.
PART A
GENREAL PARTICULARS
307
A.3 Name and designation of the applicant#:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.4 Address for correspondence with PIN code:
$
The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
#
Applicant is the person in whose name the authorisation (licence) to handle
the source may be issued, under AERPR 2004, would have the responsibilities
of ‘licensee’ prescribed in AE(RP)R, 2004 and should be a full time employee
of the institution.
PART B
308
B.7 Documents to be attached with the Application
(i) Installation layout indicating location of the plot with peripheral
occupancy
(ii) Map of the site region upto 30m radius covering details given in
B.6.3 and B.6.5
(iii) Proof from local state govt. authorities that the land/plot for
installation of medical cyclotron facility are in the name of the
applicant.
(iv) Any other supporting documents.
PART C
UNDERTAKING
309
(x) the procedures approved by AERB regarding decommissioning/
dismantling and reuse of the site of the decommissioned facility will
be strictly complied with.
(xi) AERB will be informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/ or not authentic, then I/we hereby undertake to comply with the
regulatory action(s) enforced against me/us and our institution, in accordance
with the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution:
Designation:
.
(Seal of the Head of the institution)
310
ANNEXURE-13
(Refer section 3.4.1.3)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar,
Mumbai-400 094.
PART A
GENERAL PARTICULARS
311
A.3 Name and designation of the applicant#:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.4 Address for correspondence with PIN code:
$
The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
#
Applicant is the person in whose name the authorisation (licence) to handle
the source may be issued, under AE(RP)R, 2004, would have the
responsibilities of ‘licensee’ prescribed in AE(RP)R, 2004 and should be a
full time employee of the institution.
PART B
PART C
UNDERTAKING
312
(i) all the statements made above are correct to the best of my knowledge
and belief.
(ii) no activity will be carried out for purposes other than those specified
in this form.
(iii) the construction activities shall not be commenced without the
approval from AERB.
(iv) all provisions of the Atomic Energy (Radiation Protection) Rules,
2004 shall be strictly complied with.
(v) the facility shall not be transferred/sold/ rented by me/us to any other
party without the prior permission of the competent authority.
(vi) full facility will be accorded by me/us to any authorised
representatives of the competent authority to inspect this installation
at any time.
(vii) radiation surveillance of the installation and health surveillance of
all persons engaged in radiation work as required by the competent
authority will be duly carried out at my/our expense.
(viii) all recommendations made from time to time by the competent
authority in respect of radiation safety measures will be duly
implemented.
(ix) duly qualified/experienced radiological safety officer(s)/operator(s)
will be appointed before the commencement of operation of the
facility;
(x) the procedures approved by AERB regarding decommissioning/
dismantling and reuse of the site of the decommissioned facility will
be strictly complied with.
(xi) AERB will be informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/ or not authentic, then I/ we hereby undertake to comply with the
regulatory action(s) enforced against me/us and our institution, in accordance
with the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution:
Designation:
(Seal of the Head of the institution)
313
ANNEXURE-14
(Refer section 3.4.1.4)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar,
Mumbai-400 094.
PART A
GENERAL PARTICULARS
314
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.3 Name and designation of the applicant#:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.4 Name and designation of the radiological safety officer (RSO)*:
Telephone No. (O): (R):
Fax No.
Mobile No.
E-mail
RSO approval reference No.:
Valid up to
A.5 This application is for
$
The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
#
Applicant is the person in whose name the authorisation (licence) to handle
the source may be issued, under AE(RP)R, 2004, would have the
responsibilities of ‘licensee’ prescribed in AE(RP)R, 2004 and should be a
full time employee of the institution.
* RSO is the person who is so designated by employer and approved by
competent authority and have the responsibilities of ‘Radiological Safety
Officer’ prescribed in AE(RP)R, 2004.
315
PART B
B.3 Monitoring and Measuring Instruments (survey instruments, area gamma zone
monitor, stack monitor and dose calibrator)
316
B.5 List sealed/calibration source(s) if any used in the facility with the
radionuclide, activity, date of procurement, purpose with supplier/
manufacturer details
B.6 Name, qualification and experience of personnel
317
(vii) Copy of appointment and acceptance letters for the radiation workers
(viii) Security Plan for the facility as per AERB safety guide on ‘Security
of Radioactive Sources in Radiation Facilities’ (AERB/RS/RF/
SG-1).
PART C
UNDERTAKING
318
(xiii) AERB will be informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/or not authentic, then I/we hereby undertake to comply with the
regulatory action(s) enforced against me/us and our institution, in accordance
with the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution:
Designation:
319
ANNEXURE-15
(Refer section 3.4.2.2)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar,
Mumbai-400 094.
PART A
GENERAL PARTICULARS
320
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.3 Representative of the applicant to be contacted regarding the application:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.4 Address for correspondence of the applicant with PIN code:
#
Applicant is the person in whose name the relevant consent may be issued,
under AE(RP)R, 2004.
$
In case local supplier is the applicant, in whose name licence to handle the
radiation generating equipment may be issued, under AE(RP)R, 2004, would
have the responsibilities of ‘licensee’ prescribed in [Atomic Energy (Radiation
Protection) Rules, 2004] and should be a full time employee of the institution.
PART B
321
(i) Bone densitometer
(j) Others (specify)
B.2 Details of the equipment to be tested:
(a) Maximum operating potential:
(b) Maximum operating current:
B.3 Documents to be attached with the Application:
(a) Two duly signed and stamped copies of the layout plan (scale 1:50)
indicating the following:
(i) Location of the X-ray unit
(ii) Mobile protective barrier
(iii) Control panel/control room
(iv) Chest stand
(v) Windows, doors along with their lead lining, thickness,
dimensions
(vi) Materials of the walls of the enclosure
(vii) Shielding details
(b) Two duly signed and stamped copies of the design and layout of the
factory plan (scale 1:100) indicating the following:
(i) Location of the testing room(s)
(ii) Dark room
(iii) Other manufacturing areas, if any.
(c) Copy of the certificate issued by BIS for manufacturing of the
equipment.
(d) An undertaking from the supplier that they shall not supply the unit
to any other institution till the unit is type approved by AERB.
(e) Proof from local state govt. authorities that the land/plot for
installation of facility is in the name of the applicant.
PART C
UNDERTAKING
322
(ii) no activity will be carried out for purposes other than those specified
in this form.
(iii) I/we will not take up commercial production of the equipment, unless
license for the same is obtained from AERB.
(iv) all provisions of the Atomic Energy (Radiation Protection) Rules,
2004 shall be strictly complied with.
(v) full facility will be accorded by me/us to any authorised
representatives of the competent authority to inspect the test facility
at any time.
(vi) all recommendations that may be made from time to time by the
competent authority in respect of radiation safety will be duly
implemented.
(vii) duly qualified/experienced radiological safety officer(s)/operator(s)
will be appointed before carrying out the testing of the equipment.
(viii) AERB will be kept informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/ or not authentic, then I/ we hereby accept that appropriate regulatory
actions may be initiated against me/us and our institution, in accordance with
the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
323
ANNEXURE-16
(Refer section 3.4.2.3)
Government of India
Atomic Energy Regulatory Board
PART A
GENERAL PARTICULARS
324
Fax No.
Mobile No.
E-mail
A.3 Representative of the applicant to be contacted regarding the application:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.4 Address for correspondence of the applicant with PIN code:
A.5 Name and designation of the Radiological Safety Officer (RSO)* :
Telephone No. (O): (M)
Fax No.
E-mail
RSO Approval reference No.:
Valid up to:
A.6 Name and address of the authorised agents/local suppliers
for marketing the radiation generating equipment:
#
Applicant is the person in whose name licence to handle the radiation
generating equipment may be issued, under AE(RP)R, 2004, would have the
responsibilities of ‘licensee’ prescribed in [Atomic Energy (Radiation
Protection) Rules, 2004] and should be a full time employee of the institution.
* RSO is the person who is so designated by employer and approved by
competent authority and have the responsibilities of ‘Radiological Safety
Officer’ prescribed in Atomic Energy (Radiation Protection) Rules, 2004.
$
In case local supplier is the applicant, in whose name licence to handle the
radiation generating equipment may be issued, under AE(RP)R, 2004, would
have the responsibilities of ‘licensee’ prescribed in Atomic Energy (Radiation
Protection) Rules, 2004 and should be a full time employee of the institution.
PART B
325
B.1.3 Type of unit:
(a) Computed tomography
(b) Interventional radiology
(c) Fixed radiography (conventional/digital)
(d) Radiography (Mobile)
(e) Combined radiography and fluoroscopy (conventional/IIT/digital)
(f) Ortho-pan-tomography (OPG)
(g) Mammography
(h) Dental
(i) Others (specify)
B.2 Number of units to be manufactured per month:
B.3 Radiation measuring and monitoring instruments, protection accessories
B.3.1 Accessories available:
(a) Lead aprons available : Yes/No
(b) Movable lead glass and protective barrier : Yes/No
(c) Lead rubber flaps provided with the couch
of Cath Lab unit : Yes/No
B.3.2 Personnel monitoring badges (TLD) provided : Yes/No
B.4 Availability of quality assurance kit : Yes/No
B.5 Availability of test phantom : Yes/No
B.6 Availability of red light, X-ray caution symbol and
warning placards : Yes/No
B.7 Specify the standards to which the X-ray unit comply : National/ International
B.8 Availability of qalified staff: (such as service engineer/radiological safety
officer)
326
(ii) Quality assurance manual for design and manufacture.
(iii) Radiation protection manual (to be submitted in case of CT/Cath
Lab only) as per Appendix-8E.
PART C
UNDERTAKING
327
(xii) any incident/accident such as fire, theft, damage etc., involving
radiation generating equipment shall be promptly reported to AERB.
(xiii) all other necessary approvals from the concerned state/central govt.
have been obtained by our institution.
(xiv) AERB will be kept informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/or not authentic, then I/we hereby undertake to comply with the
regulatory action(s) enforced against me/us and our institution, in accordance
with the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
328
ANNEXURE-17
(Refer section 3.4.3.2)
Form ID : AERB/RSD/IFRT/SA
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan,
Anushaktinagar,
Mumbai-400 094.
PART A
GENERAL PARTICULARS
329
A.3 Name and designation of the applicant#:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.4 Representative of the applicant to be contacted regarding the application:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.5 Address for correspondence with PIN code:
$
The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
#
Applicant is the person in whose name the authorisation (licence) to handle
the source may be issued, under AE(RP)R, 2004, would have the
responsibilities of ‘licensee’ prescribed in AE(RP)R, 2004 and should be a
full time employee of the institution.
PART B
330
(a) Ammunition storage and explosive dumps
(b) Storage of inflammable materials
(c) Direction of runway of civilian/military airfield
(d) Residential and public places
(e) Rivers/dams/lake/water reservoir
B.7.4 Distance of site from capable fault, if any
(Documentary evidence from relevant state/central govt. authority)
B.7.5 Documentary evidence from accredited agency that the soil and ground
characteristics (e.g. soil profile, stratum, foundation type, analysis of water,
soil and rock) will not cause deterioration in the strength and integrity
of structure of IFRT
B.7.6 Provision of access roads to approach the proposed site and its detail.
B.7.7 Distance and location of the nearest railway station and airport from the site
B.8 Documents to be attached with the Application
(i) Site assessment report (As per Appendix-6A)
(ii) Installation layout indicating location of the plot with peripheral
occupancy
(iii) Map of the site region upto 2 km radius covering details given in
Items B.7.3 and B.7.6
(iv) Proof from local/state govt. authorities that the land/plot for
installation of the facility is in the name of the applicant and falls in
industrial zone.
(v) Other supporting documents.
PART C
UNDERTAKING
331
(iv) all provisions of the Atomic Energy (Radiation Protection) Rules,
2004 shall be strictly complied with.
(v) the facility shall not be transferred/sold/rented by me/us to any other
party without the prior permission of the competent authority.
(vi) full facility will be accorded by me/us to any authorised
representatives of the competent authority to inspect this installation
at any time.
(vii) radiation surveillance of the installation and health surveillance of
all persons engaged in radiation work as required by the competent
authority will be duly carried out at my/our expense.
(viii) all stipulations and recommendations made from time to time by the
competent authority in respect of radiation safety measures will be
duly implemented.
(ix) duly qualified/experienced radiological safety officer(s)/operator(s)
will be appointed before the commencement of operation of the
facility.
(x) the procedures approved by AERB regarding decommissioning/
dismantling and reuse of the site of the decommissioned facility will
be strictly complied with.
(xi) AERB will be kept informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/or not authentic, then I/we hereby undertake to comply with the
regulatory action(s) enforced against me/us and our institution, in accordance
with the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution:
Designation:
332
ANNEXURE-18
(Refer section 3.4.3.3)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar,
Mumbai-400 094.
PART A
GENERAL PARTICULARS
333
A.3 Name and designation of the applicant#:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.4 Representative of the applicant to be contacted regarding the application:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.5 Address for correspondence with PIN code:
$
The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
#
Applicant is the person in whose name the authorisation (licence) to handle
the source may be issued, under AE(RP)R, 2004, would have the
responsibilities of ‘licensee’ prescribed in AE(RP)R, 2004 and should be a
full time employee of the institution.
PART B
334
Fax No.
Mobile No.
E-mail
B.1.4 Name and address of the local vendor agency, if any;
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
B.2 Layout and civil engineering drawings attached : Yes/ No :
B.3 Class and Category of IFRT [specify class as per AERB Safety Standard No.
AERB/RF-IRRAD/SS- 6( Rev-1)]
B.4 Objective/purpose of the facility:
B.5 Radiation Source proposed to be handled:
335
PART C
UNDERTAKING
336
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution:
Designation:
337
ANNEXURE-19
(Refer section 3.4.3.4)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar,
Mumbai-400 094.
PART A
GENERAL PARTICULARS
338
A.3 Name and designation of the applicant#:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.4 Name and designation of the Facility In-charge:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.5 Name and designation of the Radiological Safety Officer (RSO)*:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
RSO approval reference No.:
Approval valid up to
A.6 Representative of the applicant to be contacted regarding the application:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.7 Address for correspondence with PIN code:
$
The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
#
Applicant is the person in whose name the authorisation (licence) to handle
the source may be issued, under AE(RP)R, 2004, would have the
responsibilities of ‘licensee’ prescribed in AE(RP)R, 2004 and should be a
full time employee of the institution.
* RSO is the person who is so designated by employer and approved by
competent authority and have the responsibilities of ‘Radiological Safety
Officer’ prescribed in AE(RP)R, 2004.
339
PART B
340
B.6 Documents to be available with the facility:
PART C
UNDERTAKING
341
(iv) all provisions of the Atomic Energy (Radiation Protection) Rules,
2004 shall be strictly complied with.
(v) the facility shall not be transferred/sold/ rented by me/us to any other
party without the prior permission of the competent authority.
(vi) no radiation source of this facility will be transported without the
prior permission of the competent authority.
(vii) full facility will be accorded by me/us to any authorised
representatives of the competent authority to inspect this installation
at any time.
(viii) radiation surveillance of the installation and health surveillance of
all persons engaged in radiation work as required by the competent
authority will be duly carried out at my/our expense.
(ix) all recommendations made from time to time by the competent
authority in respect of radiation safety measures will be duly
implemented.
(x) duly qualified/experienced radiological safety officer(s)/operator(s)
will be appointed before the commencement of operation of the
facility.
(xi) the requirements regarding decommissioning, disposal of decayed
sources and reuse of the site of the decommissioned facility will be
strictly complied with.
(xii) in case of any unforeseen situations such as bankruptcy, damage to
the facility and other such situations, the sources will be returned to
its supplier at my/our cost without jeopardising safety and security
requirements.
(xiii) AERB will be kept informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/or not authentic, then I/we hereby undertake to comply with the
regulatory action(s) enforced against me/us and our institution, in accordance
with the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution
Designation:
(Seal of the institution)
342
ANNEXURE-20
(Refer section 3.5.1.2 (Teletherapy)
Refer section 3.5.2.2 (MLA)
Refer section 3.8.2 (Brachytherapy)
Refer section 3.12.4.2 (Simulator)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar,
Mumbai-400 094.
PART A
GENERAL PARTICULARS
343
A.2 Name and address of the Head of the institution$:
Telephone No. (O): (R):
Fax No.
Mobile No.
E-mail
A.3 Name and designation of the applicant#:
Telephone No. (O): (R):
Fax No.
Mobile No.
E-mail
A.4 Address for correspondence with PIN code:
A.5 Technical Expert (medical physicist) of the applicant, who was involved in
the planning of the proposed facility(ies), to be contacted regarding the
application
Name and address for correspondence:
Telephone No. (O); (R):
Fax No.
Mobile No.
E-mail
#
Applicant is the person in whose name the consent may be issued, under
AE(RP)R, 2004, and would have the responsibilities of ‘licensee’ prescribed
in AE(RP)R, 2004 and should be a full time employee of the institution.
$
The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
PART B
344
(c) original approved layout plans and
(d) copy of approved layout plan of existing installation
are to be attached along with the new set of layout
plans sent for Approval.
B.2 Address of proposed location of the facility:
B.3 Institution No. allotted by AERB (for existing facility):
B.4 Brief description of the facility covering the following aspects:
(a) Type of facility
(b) Purpose of the facility
(c) Technical Details (fill as applicable)
B.5 Layout plan submitted for approval of (tick the applicable box)
A. TELECOBALT
(i) Number of telecobalt unit(s):
(ii) Radiation source to isocentre distance: ____________cm
(iii) Maximum field size at isocentre : _____cm x_____cm
(iv) Typical radiation leakage* through the head: _____%
(v) Whether unit will have beam stopper:
(vi) If yes, typical radiation leakage* through the beam stopper ___ %
* (Leakage radiation as per manufacturer)
C. SIMULATOR
345
D. ACCELERATOR
346
(v) In case of radiotherapy facility based on new technology which is
yet to be commissioned in India, guidelines for room layout design
and shielding calculations as per manufacturer’s manual.
CHECK LIST
(Drawings should indicate the following items)
347
III. In the Cross-sectional (elevation) Room layout drawings
(a) Isocentre incase of Teletherapy or Source
and Bed position incase of Brachytherapy
is clearly indicated Yes No
(b) Distances of all the walls, ceiling and
floors from isocentre/source are clearly
indicated Yes No
(c) Occupancies all around the Radiotherapy
room clearly indicated Yes No
(d) Wall materials and its density to be used
for construction are clearly indicated Yes No
(e) Dimensions of all the walls are clearly
indicated Yes No
(f) Conduit (incase of teletherapy/remote
afterloading Brachytherapy unit) is
clearly indicated Yes No
(g) Baffle (incase of window air-conditioner)
is clearly indicated Yes No
PART C
UNDERTAKING
348
(vii) radiation surveillance of the installation and health surveillance of
all persons engaged in radiation work as required by the competent
authority will be duly carried out at my/our expense.
(viii) all recommendations made from time to time by the competent
authority in respect of radiation safety and physical security measures
will be duly implemented.
(ix) duly qualified and trained manpower (viz. radiation oncologist,
medical physicist, and radiation therapy technologist) including
radiological safety officer shall be appointed before the
commencement of operation of the facility.
(x) the procedures approved by AERB regarding decommissioning/
dismantling and reuse of the site of the decommissioned facility will
be strictly complied with.
(xi) AERB will be kept informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/ or not authentic, then I/we hereby accept that appropriate regulatory
actions may be initiated against me/us and our institution, in accordance with
the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution:
Designation:
349
ANNEXURE-21
(Refer section 3.5.1.4, (teletherapy)
Refer section 3.5.2.4 (medical linear accelerator)
Refer section 3.8.4 (brachytherapy)
Refer section 3.12.1.3) (simulator)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar,
Mumbai-400 094.
PART A
GENERAL PARTICULARS
350
A.2 Name, designation and address of the Head of the institution$
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.3 Name and designation of the applicant#:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.4 Name and designation of the Radiological Safety Officer (RSO)* :
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
Approval reference No. :
Approval valid up to :
A.5 Institution No. allotted by AERB (for existing facility):
#
Applicant is the person in whose name the authorisation (licence) to handle
the source may be issued, under RPR- 2004, would have the responsibilities
of ‘licensee’ prescribed in AE(RP)R, 2004 and should be a full time employee
of the institution.
$
The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
* RSO is the person who is so designated by employer and approved by
competent authority and have the responsibilities of ‘Radiological Safety
Officer’ prescribed in AE(RP)R, 2004.
PART B
351
(ii) Gamma knife source(s) - attach filled in FORM- AERB/
RT/GKS
(iii) Medical linear accelerator - attach filled in FORM- AERB/
RT/MLA
(iv) Remote afterloading brachy-
therapy source - attach filled in FORM-AERB/
RT/RAL
(v) Manual aterloading brachy-
therapy source(s) - attach filled in FORM- AERB/
RT/MAL
(vi) CT-simulator/simulator - attach filled in FORM- AERB/
RT/SIM
(vii) Check source - attach filled in FORM- AERB/
RT/CHK
(viii) Unit containing depleted
uranium (DU) - attach filled in FORM-AERB/
(without source) RT/DU
B.2 Details of existing Radiation Therapy Facilities in the institution (if applicable)
(a) Number of Telecobalt units
(b) Number of medical linear accelerators
(c) No. of beds for manual afterloading brachytherapy (MAL)
application:
(d) Number of remote after loading (RAL) brachytherapy units:
(e) Any unused radioactive sources/non-functional teletherapy/
brachytherapy/radiation generating equipment available in the
Radiation Therapy Department :
Yes No
If yes, give details of:
(i) such radioactive sources/ non-functional Teletherapy/brachytherapy/
radiation generating equipment below.
(ii) action taken for disposal of above disused radioactive sources and
decommissioning of non-functional Teletherapy/brachytherapy/
radiation generating equipment.
B.3 Details of staff in Radiation Therapy Department [Consent for procurement
shall not be given in case of adequate staff (working full-time) are not available
i.e. radiation oncologist(s), medical physicist(s) and radiotherapy
technologist(s)]
352
Name Date Date of Desig- Basic and Duration Personnel Full-time/
of joining nation of professional and monitoring Part-
birth the personnel qualifica- name of service time**
present tion institution No.
institution* where
worked
* If staff is yet to join, enclose the copy of appointment letter and their
consent of joining without which the permission shall not be issued.
** If any of the above staff works at other radiotherapy institution, please
inform separately.
B.4 Documents to be attached with the Application
(i) Copy of the appointment and acceptance letters if radiotherapy staff
is yet to join.
(ii) Security Plan for the facility as per AERB safety guide on ‘Security
of Radioactive Sources in Radiation Facilities’, (AERB/RF-RS/
SG-1).
(iii) Documentary evidence from local and state/central govt. authorities
that the facility is in the name of the applicant. If the location does
not belong to applicant, give documentary proof for lease/loan etc.
from the owner of land.
(iv) Radiation protection manual as per Appendix 7E (for teletherapy
and brachytherapy units only)
(v) Any other documents.
PART C
UNDERTAKING
353
(v) the unit /radioactive source shall not be transported/ transferred/sold/
rented by me/us to any other party without the prior permission of
the competent authority.
(vi) full facility will be accorded by me/us to any authorised
representatives of the competent authority to inspect our facility at
any time.
(vii) radiation surveillance of the installation and health surveillance of
all persons engaged in radiation work as required by the competent
authority will be duly carried out at my/our expense.
(viii) all stipulations/recommendations made from time to time by the
competent authority in respect of radiation safety and physical
security measures will be duly implemented.
(ix) installation, commissioning, servicing and maintenance of the
equipment shall be carried out by authorised service personnel.
(x) the requirements regarding decommissioning, disposal of
contaminated/decayed sources and reuse of the unit will be strictly
complied with.
(xi) any incident/accident such as fire, theft, damage etc., involving
ionising radiation source shall be promptly reported (within 24 hours)
to AERB.
(xii) In case of any unforeseen situations such as bankruptcy, damage to
the facility/source and other such situations, the sources will be
returned to its supplier at my/our cost without jeopardising safety
and security requirements.
(xiii) all other necessary approvals from the concerned state/central govt.
have been obtained by our institution.
(xiv) AERB will be kept informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/ or not authentic, then I/we hereby undertake to comply with the
regulatory action(s) enforced against me/us and our institution, in accordance
with the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution:
Designation:
(Seal of the institution)
354
PART B.1(i)
Form-AERB/RT/TCS
355
(ii) In case of new unit, whether filled-in
form AERB/RT/DU is attached : Yes No
7. In case of a new unit
(a) Whether **NOC/Type Approval for the unit has been obtained by
the supplier from AERB: Yes No
(b) Whether the unit is already installed: Yes No
(c) Whether the source will be transported to institution:
in a flask in the source head
8. In case of the existing unit
(a) The date of last source loading:
(b) The RMM value of the source at the time of loading:
(c) The present output at the normal treatment distance
(in cGy/minutes):
(d) Whether, performance test report of the unit is
carried out Yes No
9. Name of the medical physicist, who shall be responsible for supervision of
source transfer operation :
Whether the medical physicist was ever involved in source transfer
operation: Yes No
If yes, permission for source transfer operation should be obtained from AERB
by submitting the filled in prescribed proforma AERB/RSD/RT/SSA given
after Part B.1 (ii), 15 days prior to the actual date of source transfer operation.
If no, assistance for supervision of source transfer operation should be taken
from a medical physicist from any other radiotherapy centre having experience
in source transfer supervision. Permission should be obtained from AERB
by submitting the filled in prescribed proforma AERB/RSD/RT/SSA given
after Part B.1 (ii), 15 days prior to the actual date of source transfer operation
along with a letter of consent from the medical physicist endorsed by his/her
employer.
10. Availability of Associated Equipment for the Telecobalt Installation**
(a) Instruments for absolute dose measurement devices (secondary
standard dosimeters)
** If any of the above equipment is not available, attach the copy of confirmation letter from the
supplier about supply of the above equipment, without which permission shall not be issued.
356
(i) Calibrated and working appropriate
Thimble chamber calibrated for
Co-60 energy Available Not available
If available,
Make and model : S.No.: Date of last calibration:
(ii) Calibrated and working Electrometer:
Available Not available
If available,
Make and model : S. No.: Date of last calibration:
(b) Calibrated and working survey meter:
Available Not available
If available,
Make and model : S.No.: Date of last calibration:
Type of detector : Available ranges:
(c) Calibrated and working Gamma Zone Monitor:
in the telecobalt room Available Not available
If available,
Make and model : S. No.:
(d) Working thermometer (factory calibrated):
Available Not available
If available,
Make and model : Type: Mercury Digital Any other
(e) Working barometer Available Not available
(inter compared with any standard lab):
If available,
Make and model : Type: Mercury Aneroid
Digital Any other
(f) Water phantom for absolute dosimetry:
Available Not available
357
(ii) Copy of the AERB site and layout plan approval letter in case of
new/modified installation.
(iii) Filled in Application Form- AERB/RT/DU, in case, DU is used in
new unit.
(iv) Copy of the NOC/Type Approval for the unit/equipment, as
applicable.
(v) An undertaking by the local supplier, from whom the applicant
proposes to procure, that in the case of NOC, the local supplier would
not supply the unit/equipment to any other user, till the unit/equipment
is type approved by AERB.
PART B.1(ii)
Form-AERB/RT/GKS
PROCUREMENT OF SOURCE FOR GAMMA KNIFE UNIT
(This form is a part of Form ID : AERB/RSD/RT/RGE-RS/PROC form,
hence must be submitted along with the Main Application Form)
3. Specify name and postal address of the original supplier of the sources:
4. Whether a copy of the undertaking furnished by the original supplier of the
imported source to take back the disused/decayed source is attached (in the
absence of such undertaking, authorisation shall not be issued)
Yes No
5. Sources shall be used in the installation, which is:
New Modified Existing
358
In case of new/modified installation
(i) whether the installation is approved : Yes No
(if yes, attach a copy of the approval letter)
(ii) whether construction completed
as per approved plan : Yes No
6. Sources shall be used in: New Unit Existing Unit
(a) Make and model of the unit:
(b) S. No. of the existing unit:
(c) Whether unit contains depleted uranium(DU): Yes No
(i) If yes, specify:
A. the parts of the unit containing DU:
B. quantity of DU in each part (in kg):
(ii) In case of new unit, whether filled in
form AERB/RT/DU is attached: Yes No
7. In case of new unit
(a) whether the unit is type approved by AERB: Yes No
(If Yes, attach a copy of Type Approval letter issued by AERB to the
supplier and if No (i) attach copy of NOC letter issued by AERB to
the supplier and (ii) an undertaking from the supplier that they shall
not supply the unit to any other institution till the unit is type approved
by AERB)
(b) whether the unit is already installed: Yes No
8. In case of existing unit
(a) The date of last source loading:
(b) Number of sources available:
(c) The total activity of the present sources:
(d) Whether, performance test report of the
unit is attached : Yes No
9. Name of the Medical Physicist, who shall be responsible for supervision of
source transfer operation:
Whether the Medical Physicist was ever involved
in source transfer operation: Yes No
359
If yes, permission for source transfer operation should be obtained from AERB
by submitting the filled in prescribed proforma AERB/RSD/RT/SSA given
after Part B.1 (ii), 15 days prior to the actual date of source transfer operation.
If no, assistance for supervision of source transfer operation should be taken
from a Medical Physicist from any other Radiotherapy Centre having
experience in source transfer supervision. Permission should be obtained
from AERB by submitting the filled in prescribed proforma AERB/RSD/RT/
SSA given after Part B.1 (ii), 15 days prior to the actual date of source transfer
operation along with a letter of consent from the Medical Physicist endorsed
by his/her employer.
10. Availability of associated equipment for the Gamma Knife installation:
(a) Instruments for absolute dose measurement devices (secondary
standard dosimeters)
(i) Calibrated and working appropriate Thimble Chamber:
Available Not available
Calibrated for appropriate beam energy:
Make and model : S. No.: Date of last calibration:
(ii) Calibrated and working Electrometer:
Available Not available
Make and model : S. No.: Date of last calibration:
(b) Calibrated and working survey meter:
Available Not available
Make and model : S.No.: Date of last calibration:
Type of detector : Available ranges:
(c) Working gamma zone monitor in gamma knife room:
Available Not available
Make and model : S. No.:
(d) Working thermometer (factory calibrated):
Available Not available
Make and model : Type:
Alcohol Mercury Digital Any other
(e) Working barometer (intercompared with any standard lab):
Available Not available
360
Make and model : Type:
Mercury Aneroid Digital Any other
(f) Appropriate phantom for absolute dosimetry:
Available Not available
(If any of the above equipment is not available, attach the copy of the firm
purchase order, without which authorisation shall not be issued)
11. Any other information:
12. Documents to be attached with the Application
(i) Copy of the undertaking furnished by the original supplier of the
imported source to take back the disused/decayed source
(ii) Copy of the layout approval letter in case of new/modified installation
(iii) Filled in application form, AERB/RT/DU, in case, DU is used in
new unit.
(iv) Copy of the NOC/type approval for the unit, as applicable.
In case of NOC, an undertaking from the supplier that they shall not
supply the unit to any other institution till the unit is type approved
by AERB.
(v) In case of the existing unit, performance test report of the unit carried
out as per manufacturer’s protocol.
PART B.1(iii)
Form-AERB/RT/MLA
PROCUREMENT OF RADIATION GENERATING EQUIPMENT
(MEDICAL ACCELERATOR)
(This form is a part of Form ID : AERB/RSD/RT/RGE-RS/PROC form,
hence must be submitted along with the Main Application Form)
361
(i) If yes, specify : A, the parts of the unit
containing DU:
(ii) Quantity of DU in each part (in kg):
(g) In case of new unit, whether filled-in form
AERB/RT/DU is attached: Yes No
(h) Other accessories:
(i) MLC: (ii) Micro-MLC:
(iii) X-knife cones: (iv) Portal imaging:
(v) kVCT: (vi) MVCT:
(vii) Gating: (viii) Others (specify):____________
(If any other radiation source such as low energy X-ray (kV) beam
is used along with the accelerator in the same room, filled in FORM-
AERB/RT/SIM also to be submitted)
(i) Special treatment techniques
(i) 3D CRT: (ii) IMRT: (iii) IGRT: (iv) SRS:
(v) SRT: (vi) Any other, specify:
2. Specify name and postal address of the original supplier of the Accelerator:
3. Unit shall be used in the installation,
which is: New Modified Existing
In case of new/modified installation
(i) whether the installation is approved: Yes No
(If yes, attach a copy of the approval letter)
(ii) whether construction completed as per
approved plan : Yes No
4. In case of new unit
(a) Whether the unit is type approved by AERB: Yes No
(If Yes, attach copy of Type Approval letter issued by AERB to the
supplier and if No, (i) attach copy of NOC letter issued by AERB to
the supplier and (ii) an undertaking from the supplier that they shall
not supply the unit to any other institution till the unit is type approved
by AERB)
(b) whether the unit is already installed: Yes No
362
5. Availability of associated equipment for the medical accelerator installation:
(a) Instruments for absolute dose measurement devices (secondary
standard dosimeters)
(i) Calibrated and working appropriate Thimble Chamber:
Available Not available
Calibrated for appropriate beam energy:
Make and model: S. No.: Date of last calibration:
(ii) Calibrated and working Parallel Plate Chamber:
Available Not available
Calibrated for appropriate beam energy:
Make and model: S. No.: Date of last calibration:
(iii) Calibrated and working Electrometer:
Available Not available
Make and model: S .No.: Date of last calibration:
(b) Working radiation field analyser:
Available Not available
Make and model : S. No.:
(c) Calibrated and working sensitive ionisation/scintillation/detector
based survey meter
Available Not available
Make and model : S .No.: Date of last calibration:
Type of detector : Available ranges:
(d) Working thermometer (factory calibrated):
Available Not available
Make and model : Type:
Alcohol Mercury Digital Any other
(e) Working barometer (intercompared with any standard lab):
Available Not available
Make and model : Type:
Mercury Aneroid Digital Any other
363
(f) Water phantom for absolute dosimetry of photon beam(s):
Available Not available
(g) Solid phantom for absolute dosimetry of electron beam(s):
Available Not available
(h) D10/D20 phantom for daily output/energy constancy check:
Available Not available
(If any of the above equipment is not available, attach the copy of the firm
purchase order, without which authorisation shall not be issued: [a(ii) and
(g) are not essential, if only photon beams are available]
6. Any other information:
7. Documents to be attached with the Application
(i) Copy of the layout approval letter in case of new/modified installation
(ii) Filled in application form, AERB/RT/DU, in case, DU is used in
new unit.
(iii) Copy of the NOC/type approval for the unit, as applicable.
(iv) In case of NOC, an undertaking from the supplier that they shall not
supply the unit to any other institution till the unit is type approved
by AERB.
PART B.1(iv)
Form-AERB/RT/RAL
PROCUREMENT OF REMOTE AFTERLOADING (RAL)
BRACHYTHERAPY SOURCE
(This form is a part of Form ID : AERB/RSD/RT/RGE-RS/PROC form,
hence must be submitted along with the Main Application Form)
364
3. Specify name and postal address of the original supplier of the sources:
4. Whether a copy of the undertaking furnished by the original supplier of the
imported source to take back the disused/decayed source is attached (in the
absence of such undertaking, authorisation shall not be issued)
Yes No
5. Sources shall be used in the installation, which is:
New Modified Existing
In case of new/modified installation
(i) whether the installation is approved: Yes No
(if Yes, attach a copy of the approval letter)
(ii) whether construction completed as per approved plan :
Yes No
6. Sources shall be used in: New Unit Existing Unit
(a) Make and model of the unit:
(b) S. No. of the existing unit:
(c) Whether unit contains depleted uranium(DU): Yes No
(i) If Yes, specify:
A. the parts of the unit containing DU:
B. quantity of DU in each part (in kg):
(ii) In case of new unit, whether filled
in form AERB/RT/DU: Yes No
is attached
7. In case of new unit
(a) whether the unit is Type Approved by AERB: Yes No
(If Yes, attach a copy of Type Approval letter issued by AERB to the
supplier and if No (i) attach copy of NOC letter issued by AERB to
the supplier and (ii) an undertaking from the supplier that they shall
not supply the unit to any other institution till the unit is type approved
by AERB)
(b) whether the unit is already installed: Yes No
8. In case of existing unit
(a) the date(s) of last source loading during last one year:
365
(b) whether, performance test report of the
unit is attached : Yes No
9. Availability of associated equipment for the remote after loading
brachytherapy installation:
(a) Instruments for absolute dose measurement devices (secondary
standard dosimeters)
(i) Calibrated and working large volume/well type ion
chamber: for the energy of brachytherapy source to be used
(e.g. Ir-192)
Available Not available
Make and model : S .No.: Date of last calibration:
(ii) Calibrated and working appropriate Thimble Chamber:
calibrated for energy of Brachytherapy Source to be used
(e.g. Ir-192)
Available Not available
Make ane model : S .No.: Date of last calibration:
(iii) Calibrated and working Electrometer:
Available Not available
Make and model S .No.: Date of last calibration:
(b) Special jig for output measurement:
Available Not available
Make and model :
(c) Calibrated and working Survey Meter:
Available Not available
Make and model : S .No.: Date of last calibration:
Type of detector : Available ranges:
(d) Working gamma zone monitor in the Brachytherapy room:
Available Not available
Make and model : S .No.:
(e) Working thermometer (factory calibrated):
Available Not available
Make and model :
366
(f) Working barometer (intercompared with any standard lab):
Available Not available
Make and model : Type:
Mercury Aneroid Digital Any other
(g) Emergency storage container: Available Not available
[If any of the above equipment is not available, attach the copy of the firm
purchase order, without which authorisation shall not be issued: either {a(i)}
or {a(ii) and (b)} must be available]
10. Any other information:
11. Documents to be attached with the Application:
(i) Copy of the undertaking furnished by the original supplier of the
imported source to take back the disused/decayed source.
(ii) Copy of the AERB site and layout plan approval letter in case of
new/modified installation.
(iii) Filled in Application form- AERB/RT/DU, in case, DU is used in
new unit.
(iv) Copy of the NOC/Type Approval for the unit/equipment, as
applicable.
(v) In case of the existing unit/equipment, performance test report of
the unit/equipment (with the existing source)
PART B.1(v)
Form-AERB/RT/MAL
PROCUREMENT OF MANUAL AFTERLOADING (MAL)
BRACHYTHERAPY SOURCE(S)
(This form is a part of Form ID : AERB/RSD/RT/RGE-RS/PROC form,
hence must be submitted along with the Main Application Form)
367
3. Specify name and postal address of the original supplier of the sources:
4. Whether a copy of the undertaking furnished by the original supplier of the
imported source to take back the disused/decayed source is attached (in the
absence of such undertaking, authorisation shall not be issued)
Yes No
5. Sources shall be used in the installation, which is:
New Modified Existing
In case of new/modified installation
(i) whether the installation is approved: Yes No
(if yes, attach a copy of the approval letter)
(ii) whether construction completed as
per approved plan : Yes No
6. Availability of associated equipment for the manul afterloading Brachytherapy
installation:
(a) Working isotope calibrator calibrated for the energy of brachytherapy
source (e.g. Ir-192)
Make and model : S. No.: Date of last calibration:
(b) Calibrated and working survey meter:
Available Not available
Make and model : S. No.: Date of last calibration:
Type of detector : Available ranges:
(c) Calibrated and working contamination monitor:
Available Not available
Make and model : S. No.: Date of last calibration:
(d) Working gamma zone monitor for Brachytherapy installation:
Available Not available
Make and model : S. No.:
(e) Permanent storage container for the Brachytherapy sources:
Available Not available
(f) Transport container for the Brachytherapy sources:
Available Not available
368
(g) Long forceps for handling the Brachytherapy sources:
Available Not available
(h) Lead bed shields for loading the sources to the patient:
Available Not available
(i) In case there is a requirement for brachytherapy source preparation,
whether
(i) L-bench with viewing system: Available Not available
(ii) Source cutter : Available Not available
(iii) Source loader : Available Not available
(If any of the above equipment is not available, attach the copy of the firm
purchase order, without which authorisation shall not be issued)
7. Any other information:
8. Documents to be attached with the Application:
(i) Copy of the undertaking furnished by the original supplier of the
imported source to take back the disused/decayed source
(ii) Copy of the AERB site and layout plan aproval letter in case of new/
modified installation.
PART B.1(vi)
Form-AERB/RT/CHK
PROCUREMENT OF CHECK SOURCE
(This form is a part of Form ID : AERB/RSD/RT/RGE-RS/PROC form,
hence must be submitted along with the Main Application Form)
1. Source specifications:
2. Specify name and postal address of the original supplier of the source:
369
3. Whether a copy of the undertaking furnished by
the original supplier of the imported source to
take back the disused/decayed source is attached Yes No
(In the absence of such undertaking, authorisation shall not be issued)
4. Source shall be used for (thimble chamber, parallel plate chamber, survey
meter etc.):
5. Any other information:
6. Documents to be attached with the Application:
Copy of the undertaking furnished by the original supplier of the imported
source to take back the disused/decayed source
PART B.1(vii)
Form-AERB/RT/SIM
PROCUREMENT OF RADIATION GENERATING
EQUIPMENT(SIMULATOR)
(This form is a part of Form ID : AERB/RSD/RT/RGE-RS/PROC form,
hence must be submitted along with the Main Application Form)
370
(If Yes, attach copy of Type Approval letter issued by AERB to the supplier
and if No, (i) attach copy of NOC letter issued by AERB to the supplier and
(ii) an undertaking from the supplier that they shall not supply the unit to any
other institution till the unit is type approved by AERB)
(b) whether the unit is already installed : Yes No
5. Availability of associated equipment for the simulator installation:
Calibrated and working ionisation/scintillation survey meter:
Available Not available
Make and model : S .No.: Date of last calibration:
Type of detector : Available ranges:
(If any of the above equipment is not available, attach the copy of the firm
purchase order, without which authorisation shall not be issued)
6. Any other information:
7. Documents to be attached with the Application:
(i) Copy of the layout approval letter in case of new/modified installation
(ii) Copy of the NOC/type approval for the unit, as applicable.
(iii) In case of NOC, an undertaking from the supplier that they shall not
supply the unit to any other institution till the unit is type approved
by AERB.
PART B.1(viii)
Form-AERB/RT/DU
DETAILS REGARDING THE USE OF DEPLETED URANIUM IN
RADIATION THERAPY UNIT BEING PROCURED
(This form is a part of Form ID : AERB/RSD/RT/RGE-RS/PROC form,
hence must be submitted along with the Main Application Form)
371
3. Any other information:
4. Documents to be attached with the Application:
(i) Copy of the layout approval letter in case of new/modified installation
(ii) Copy of the NOC/type approval for the unit, as applicable.
(iii) In case of NOC, an undertaking from the supplier that they shall not
supply the unit to any other institution till the unit is type approved
by AERB.
AERB/RSD/RT/SSA
372
3.2 If No, details of the medical physicist, who will assist the applicant
(a) Name of the assisting medical physicist :
(b) Institution Address :
(c) Telephone No.(with STD code) :
(d) E-mail :
(e) No. of times source transfer operation
supervised :
(f) Letter of consent of the medical physicist
endorsed by his/her employer is attached : Yes No
373
I hereby certify that the information furnished above is correct to the best of
my knowledge and belief.
Place: Signature of the applicant
Date: Name :
Designation:
Forwarded by
Signature of Head of the institution:
Name:
Designation:
374
ANNEXURE-22
(Refer section 3.5.1.5)
(Refer section 3.5.2.4)
(Refer section 3.8.5)
(Refer section 3.12.4.5)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar,
Mumbai-400 094.
375
PART A
GENERAL PARTICULARS
#
Applicant is the person in whose name the authorisation (licence) to handle
the source may be issued, under AE(RP)R, 2004, would have the
responsibilities of ‘licensee’ prescribed in AE(RP)R, 2004 and should be a
full time employee of the institution.
$
The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
* RSO is the person who is so designated by employe, approved by competent
authority and have the responsibilities of ‘Radiological Safety Officer’
prescribed in AE(RP)R, 2004).
376
PART B
377
B.3.4 For Simulator:
(i) Maximum tube potential (kV):
(ii) Maximum tube current (mA):
(iii) Special imaging feature (if any):
B.4 In case Radiation Therapy Facility already exists in the institution
(a) Number of medical linear accelerators:
(b) Number of telecobalt units :
(c) Number of Gammaknife units:
(d) Number of Remote After loading brachytherapy units :
(e) No. of beds for Manual brachytherapy application:
B.5 Radiation measuring, monitoring instruments and protection accessories:
(Please mention Available/Not available/Not applicable as the case may be):
B.5.1 Dose measuring and associated devices for Teletherapy/Brachytherapy:
(a) Instruments for absolute dose measurement (secondary standard
dosimeters)
(i) Calibrated and working appropriate Thimble Chamber
calibrated for appropriate beam energy
Available Not available Not applicable
Make and model :
S .No.:
Date of last calibration:
Chamber volume(cc):
Calibration beam energy
(ii) Calibrated and working Parallel Plate Chamber calibrated for
appropriate beam energy:
Available Not available Not applicable
Make and model :
S .No.:
Date of last calibration:
Chamber volume(cc):
Calibration beam energy
(iii) Calibrated and working large volume/well type ion chamber
for the energy of Brachytherapy source to be used (e.g. Ir-
192)
378
Available Not available Not applicable
Make and model :
S .No.:
Date of last calibration:
Chamber volume (cc):
Calibration beam energy
(iv) Calibrated and working electrometer:
Available Not available Not applicable
Make and model :
S .No.:
Date of last calibration:
(b) Working thermometer (factory calibrated):
Available Not available Not applicable
Make and model: Type:
Mercury Digital Any Other
(c) Working barometer (intercompared with any standard lab)
Available Not available Not applicable
Make and model : Type:
Mercury Aneroid Digital Any Other
(d) Jig for output measurement of HDR source:
Available Not available Not applicable
Make and model:
(e) Appropriate phantom(s) for dosimetry of teletherapy beam:
Available Not available Not applicable
Make and model : Type:
Water Solid Any Other _______________
(f) D10/D20 phantom for daily output/energy constancy check:
for accelerator: Available Not available Not applicable
(g) Working radiation field analyser for accelerator:
Make and model : S. No.:
B.5.2 Area monitoring devices for Teletherapy/Brachytherapy:
(i) Calibrated and working survey meter:
379
Available Not available Not applicable
Make and model :
S. No.:
Date of last calibration:
Type of detector :
Available ranges:
(ii) Calibrated and working Contamination Monitor:
Available Not available Not applicable
Make and model :
S. No.:
Date of last calibration:
Type of detector :
Available ranges
(iii) Working gamma zone monitor for the installation to be
commissioned:
Available Not available Not applicable
Make and model :
S. No.:
(iv) Pocket dosimeter for instant dose measurement
Available Not available Not applicable
B.5.3 QA/other associated accessories:
(i) Working treatment planning system for teletherapy/brachytherapy:
Available Not available Not applicable
Make & model : S. No.:
(ii) Therapy verification film for field congruence test:
for teletherapy
Available Not available Not applicable
(iii) Isodose charts (in case of telecobalt unit) are supplied:
Available Not available Not applicable
(iv) Mechanical front pointer(s) (in case of teletherapy unit):
Available Not available Not applicable
(v) QA gadgets for special techniques like 3DCRT/IMRT etc.:
Available Not available Not applicable
380
(vi) Emergency source storage container for remote afterloading
brachytherapy
Available Not available Not applicable
(vii) Permanent source storage container for manual brachytherapy
Available Not available Not applicable
(viii) Transport container for the sources for manual brachytherapy
Available Not available Not applicable
(ix) Long forceps for handling the brachytherapy sources:
Available Not available Not applicable
(x) Lead bed shields for manual brachytherapy:
Available Not available Not applicable
(xi) In case there is a requirement for source preparation in manual
brachytherapy
(a) L-bench with viewing system:
Available Not available Not applicable
(b) Source cutter:
Available Not available Not applicable
(c) Source loader:
Available Not available Not applicable
(xii) Closed circuit TV for patient viewing in the installation to be
commissioned:
Available Not available Not applicable
B.6 Staff details.
Details of staff in Radiation Therapy department (Permission for
commissioning shall not be issued in case adequate number of radiotherapy
staff (working full-time) i.e. Radiation Oncologists, Medical Physicists and
Radiotherapy Technologists are not available)
381
B.7 Any unused radioactive sources/ non-functional teletherapy/
brachytherapy/ radiation generating equipment available
in the radiation therapy department: Yes No
If yes, give details of:
(i) such radioactive sources/non-functional teletherapy/brachytherapy/
radiation generating equipment below.
(ii) action taken for disposal of above disused radioactive sources and
decommissioning of non-functional teletherapy/brachytherapy/
radiation generating equipment.
B.8 Documents to be attached with the Application:
(i) Sketch/layout of installation indicating radiation levels (photon/
neutron) at different operating conditions (eg: photon energies and
their dose rates etc) and at various elevations/rooms including control
console, door etc.
(ii) Copies of letter of correspondence for action taken for disposal of
disused radioactive sources and decommissioning of non-functional
Teletherapy/Brachytherapy/Radiation generating equipment, if
available.
(iii) Radiation Protection Manual as per Appendix 7E (for teletherapy
and brachytherapy units only)
(iv) Security plan for the facility as per AERB safety guide on ‘Security
of Radioactive Sources in Radiation Facilities’ (AERB/RF-RS/
SG-1) and safety guide on ‘Security of Radioactive Material during
Transport’ (AERB/NRF-TS/SG-10)
PART C
UNDERTAKING
382
(v) the unit/radioactive source shall not be transported/ transferred/sold/
rented by me/us to any other party without the prior permission of
the competent authority.
(vi) full facility will be accorded by me/us to any authorised
representatives of the competent authority to inspect our facility at
any time.
(vii) radiation surveillance of the installation and health surveillance of
all persons engaged in radiation work as required by the Competent
Authority will be duly carried out at my/our expense.
(viii) all stipulations/recommendations made from time to time by the
Competent Authority in respect of radiation safety and physical
security measures will be duly implemented.
(ix) installation, commissioning, servicing and maintenance of the
equipment shall be carried out by authorised service personnel.
(x) the rules regarding decommissioning, disposal of contaminated/
decayed sources and reuse of the unit will be strictly complied with.
(xi) any incident/accident such as fire, theft, damage etc., involving
ionising radiation source shall be promptly reported (within 24 hrs-
to AERB.
(xii) in case of any unforeseen situations such as bankruptcy, damage to
the facility/source and other such situations, the sources will be
returned to its supplier at my/our cost without jeopardising safety
and security requirements.
(xiii) all other necessary approvals from the concerned State/Central
Government have been obtained by our institution.
(xiv) AERB will be kept informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/or not authentic, then I/we hereby undertake to comply with the
regulatory action(s) enforced against me/us and our institution, in accordance
with the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution:
Designation:
(Seal of the institution)
383
ANNEXURE-23
(Refer section 3.6.2)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar,
Mumbai-400 094.
PART A
GENERAL PARTICULARS
384
A.3 Name and designation of the applicant#:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.4 Representative of the applicant to be contacted regarding the application:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.5 Address for correspondence with PIN code:
#
Applicant is the person in whose name the relevant consent may be issued,
under AE(RP)R, 2004 and should be a full time employee of the institution.
$
The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
PART B
385
(a) Date and year of installation:
(b) Whether the equipment has been licenced: (Yes/No)
(If No, please attach application for layout approval/licence)
B.8 Documents to be attached:
(i) Copy of the NOC/type approval certificate for the unit, as applicable.
(ii) In case of NOC, an undertaking from the supplier that they shall not
supply the unit to any other institution till the unit is type approved
by AERB.
(iii) Two duly signed and stamped copies of the layout plan (scale 1:50)
indicating the location of the gantry/X-ray unit, control panel/ control
room, windows, doors with appropriate lead lining, wall thickness,
dimensions and material of the walls are enclosed.
(iv) Two duly signed and stamped copies of the floor plan (scale 1:100)
indicating the location of the CT/Cath Lab rooms, waiting area etc.
are enclosed.
(v) Proof from local state govt. authorities that the land/plot for
installation of facility is in the name of the applicant.
PART C
UNDERTAKING
386
(vii) radiation surveillance of the installation and health surveillance of
all persons engaged in radiation work as required by the competent
authority will be duly carried out at my/our expense.
(viii) the facility shall be put into operation only after obtaining Licence
from the competent authority.
(ix) all recommendations made from time to time by the competent
authority in respect of radiation safety and physical security measures
will be duly implemented.
(x) duly qualified and trained manpower including radiological safety
officer, shall be appointed before the commencement of operation
of the facility.
(xi) the procedures approved by AERB regarding decommissioning/
dismantling and reuse of the site of the decommissioned facility will
be strictly complied with.
(xii) AERB will be kept informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/or not authentic, then I/we hereby accept that appropriate regulatory
actions may be initiated against me/us and our institution, in accordance with
the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution:
Designation:
(Seal of the Head of the institution)
(To be filled by the manufacturer/supplier)
Our company will supply a ___________________ unit, which is having a valid NOC/
type-approval certificate from AERB. After installation of the said unit, its performance/
acceptance test will be demonstrated to the AERB and/or user’s representative as the
case may be.
387
ANNEXURE-24
(Refer section 3.6.3)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar,
Mumbai-400 094.
PART A
GENERAL PARTICULARS
388
A.2 Name and address of the Head of the institution$:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.3 Name and designation of the applicant#:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.4 Name and designation of the Facility In-charge:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.5 Name and designation of the radiological safety officer (RSO)*:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
RSO Approval reference No.:
Valid up to:
A.6 Representative of the applicant to be contacted regarding the application:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.7 Address for correspondence with PIN code:
#
Applicant is the person in whose name the licence to handle the source may
be issued, under AE(RP)R, 2004, would have the responsibilities of ‘licensee’
prescribed in AE(RP)R, 2004 and should be a full time employee of the
institution.
$
The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
* RSO is the person who is so designated by employer and approved by
competent authority and have the responsibilities of ‘Radiological Safety
Officer’ prescribed in AE(RP)R, 2004.
389
PART B
390
B.5 Staff details
PART C
UNDERTAKING
391
(ix) full facility will be accorded by me/us to any authorised
representatives of the competent authority to inspect the equipment
at any time.
(x) radiation surveillance of the installation and health surveillance of
all persons engaged in radiation work as required by the competent
authority will be duly carried out at my/our expense.
(xi) all recommendations made from time to time by the competent
authority in respect of radiation safety measures will be duly
implemented.
(xii) all the radiation survey meters/safety instruments will be maintained
and regularly sent for calibration.
(xiii) periodic quality assurance tests shall be conducted and records
maintained.
(xiv) AERB will be kept informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/ or not authentic, then I/ we hereby accept that appropriate regulatory
actions may be initiated against me/us and our institution, in accordance with
the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution:
Designation:
(Seal of the Head of the institution)
(To be filled by the manufacturer/supplier)
392
ANNEXURE-25
(Refer section 3.7.2)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar
Mumbai-400094.
PART A
GENERAL PARTICULARS
393
Fax No.
Mobile No.
E-mail
A.3 Name and designation of the applicant#:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.4 Representative of the applicant to be contacted regarding the application:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.5 Details of RSO*/ Site-in-charge only for proposed site
Telephone No. (O): (M)
Fax No.
E-mail
RSO approval reference No.:
Valid up to:
A.6. Address for correspondence with PIN code:
#
Applicant is the person in whose name the relevant consent for procurement
of IGRED/industrial X-ray machine/radiography source, may be issued,
under AE(RP)R, 2004, and should be a full time employee of the institution.
$
The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
* RSO is the person who is so designated by employer and approved by
competent authority and have the responsibilities of ‘Radiological Safety
Officer’ prescribed in Atomic Energy (Radiation Protection) Rules, 2004.
PART B
394
B.3 Details of the IGREDs
Make, Qua- Mobile/ Name and Name and Maximum Out put Radiation Reference
model ntity Portable address of address of rating of the leakage of NOC/
and /Fixed manu- authorised kV, mA machine level of Type
serial facturer supplier at maxi- machine approval
No. mum issued by
rating (in AERB.
RMM)
395
RSM* 1 2 3
Make
Model
RSM S. No.
Date of recent calibration
Functional status
* There shall be atleast one RSM for each IGRED /X-ray machine
B.7.2 Particulars of pocket dosimeter(s) (PD) :
Pocket dosimeters 1 2 3
Make
Model
PD S. No.
Date of recent calibration
Functional status
396
B.9.3 Name of the contact person with designation at radiography site:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
B.9.4 Details of source storage facility at site:
B.9.5 Whether the radiography site is approved by AERB, (if yes provide approval
ref. no.:) (if no, give reasons)
B.9.6 If the IGREDs/industrial X-ray machine is to be used in an enclosure, whether
the enclosure is approved by AERB/BARC, (if yes provide approval ref.
no.:) (if no, give reasons)
B.9.7 Any other relevant information:
B.10 Documents to be attached with the Application:
(a) Registration of radiography agency with state/central govt. as a
company (for first time procurement of radiation source by the
institution)
(b) Declaration of legal status of applicant (corporation/partnership/
others), if applicable.
(c) Partnership deed with signature of notary on a stamp paper, if
applicable.
(d) Undertaking of all the partners in the institution’s letter head as per
enclosed format, if applicable.
(e) The following documents are to be submitted for approval of certified
radiography personnel:
(i) Duly filled in personal data form (Form No. TLD-4)
(ii) Undertaking as per requirements of AERB/SC/IR-1
(iii) Certificate issued by BARC/AERB
(iv) The cumulative radiation dose received
(f) Duly filled in personnel monitoring service form (Form No.:
PMS-2) with the names of the persons required to be monitored
monthly with their personal data (PD) form. [The PMS-2 and PD
forms (TLD-4) are available with the laboratory accredited by BARC,
if applicable].
(g) The documentary proof of availability of radiation safety accessories
(such as area zone monitor, radiation survey meter (RSM), red
flashing light, red lights, pocket dosimeter with charger, lead pot,
397
C.V. tong, lead collimators, radiation warning placards, cordoning
ropes etc.)
(h) Copy of certificate of type approval of IGREDs/X-ray machine.
(i) Copy of certificate of approval of sealed source (including Serial
No), classification and leak test certificates as per applicable national/
international standards
(j) Undertaking from source(s) supplier for acceptance of decayed/
disused source for disposal.
(k) Copy of the photographs of safe and secure storage facility
authenticated by the contract awarding agency and applicant/
licensee.
(l) Copy of work order for radiography work and site feasibility report
for radiography work.
(m) Security Plan for the facility as per AERB safety guide on ‘Security
of Radioactive Sources in Radiation Facilities’ (AERB/RF-RS/
SG-1) and AERB safety guide on ‘Security of Radioactive Material
during Transport’ (AERB/NRF-TS/SG-10), if applicable.
(n) Emergency response plan and preparedness preferably in consultation
with the principle contract awarding agency.
(o) Any other supporting documents.
PART C
UNDERTAKING
398
applicable transport documents. It shall not be transported in the
passenger cabin of any conveyance (e.g. bus/train/aircraft). However,
it may be transported by road in an exclusive vehicle.
(vii) the radiography source(s) shall be used only at the radiography sites
duly approved by AERB.
(viii) radiation survey meter(s) shall be kept in operable condition at the
site all times and shall be regularly used during radiography work.
Direct reading dosimeter (pocket dosimeter) shall be made available
for use by each radiographer and it would be used regularly in addition
to the personnel monitoring badges.
(ix) the radiography source(s) shall not be moved from one authorised
site to another without obtaining prior permission from AERB.
(x) radioactive source storage facility duly approved by AERB shall be
provided at the site for safe storage of source(s).
(xi) at least one qualified RSO/site-in-charge shall be posted at each site
and all radiography operations shall be undertaken by the certified
radiographer under his supervision.
(xii) the safety and security of the radiography exposure device(s) shall
be ensured all the time during use, store, transport and safeguarded
so as to prevent unauthorised access, operation, removal and theft.
(xiii) the installation/maintenance of the device containing radiation source
would be done by authorized and trained persons.
(xiv) the device shall not be transferred/sold/ rented by me/us to any other
user without the prior permission from the competent authority.
(xv) full facility will be accorded by me/us to any authorised
representatives of the competent authority to inspect the device at
any time.
(xvi) radiation surveillance of the installation and health surveillance of
all persons engaged in radiation work as required by the competent
authority will be duly carried out at my/our expense.
(xvii) all stipulations/recommendations made from time to time by the
competent authority in respect of radiation safety measures and
physical security measures will be duly implemented.
(xviii) the decayed/unused radiation sources shall be returned to the original
supplier.
(xix) the procedures approved by AERB regarding decommissioning/
dismantling and reuse of the site of the decommissioned facility will
be strictly complied with.
399
(xx) AERB will be kept informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/ or not authentic, then I/we hereby undertake to comply with the
regulatory action(s) enforced against me/us and our institution, in accordance
with the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution:
Designation:
400
ANNEXURE-26
(Refer section 3.7.3.2)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar,
Mumbai-400094.
PART A
GENERAL PARTICULARS
401
A.3 Name and designation of the applicant#:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.4 Representative of the applicant to be contacted regarding the application:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.5 Address for correspondence with PIN code:
A.6 Address with pin code of proposed site for radiography enclosure:
#
Applicant is the person in whose name the consent may be issued, under
AE(RP)R, 2004, and should be a full time employee of the institution.
$
The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
PART B
B.1 Status of the layout plans: (Put ‘X’ mark in appropriate box)
B.1.1 New plan(s), submitted for the first time
B.1.2 Plan(s) modified and submitted based on AERB review
B.1.3 Plan(s) already approved but needs modification
B.1.4 Modification of the plan(s) of the existing enclosure
B.2 Type of enclosure: Enclosure with ceiling/Enclosure without ceiling (open
top)/Pit type
B.3 The proposed location for construction of radiography enclosure belongs to:
(Radiography agency/contract awarding agency/others)
B.4 Type approval details of IRGED/X-ray machine:
B.5 Details of radiation sources:
B.5.1 Radiation source to be used: Radioactive source (indicate name)/X-ray
402
B.5.1.1 In case of radioactive source:
403
(i) Site layout drawing (to scale 1:500) indicating location of
radiography enclosure room, associated facilities and
occupancies around the enclosure.
(ii) Cross-sectional view of radiography enclosure room drawing
(to scale 1:50) indicating source/target position, distances of
all the walls from source/target, location of operators room,
density of materials, distance and dimensions of all the walls.
(iii) Elevation view of enclosure room drawings (to scale 1:50)
indicating source/target position, ceiling and floors from
source/target, occupancies around the enclosure, density of
material, distance and dimensions of all the walls, location of
conduit, ventilation system and height of the enclosure
(b) Attachments as per status of the layout plans (see item B.1)
(i) In case of modified plans based on AERB review, copy of
suggested layout plans (see item B.1.2)
(ii) In case of plan(s) already approved but needs modification, a
copy of original approved layout plans (see item B.1.3)
(iii) In case of modification of the plan(s) of the existing enclosure,
a copy of approved layout plan of existing installation (see
item B.1.4)
(c) Report on evaluation of shielding adequacy of the enclosure.
(d) Photographs of the source storage room with pit (all view) duly
authenticated by the applicant and contract awarding agency and
ownership details of the place where the storage room is constructed.
(e) Documentary evidence from local and state/central govt. authorities
that the land/plot of installation of the radiography enclosure is in
the name of the applicant. If the location does not belong to applicant,
give documentary proof for lease/loan etc. from the owner of land.
(f) The supportive documents of the density of the materials used for
the construction.
(g) Security Plan for the facility as per AERB safety guide on ‘Security
of Radioactive Sources in Radiation Facilities’ (AERB/RF-RS/
SG-1) and AERB safety guide on ‘Security of Radioactive Material
during Transport’ (AERB/NRF-TS/SG-10), if applicable.
(h) Any other supporting documents.
404
PART C
UNDERTAKING
405
actions may be initiated against me/us and our institution, in accordance with
the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution:
Designation:
406
ANNEXURE-27
(Refer section 3.7.4)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar,
Mumbai-400094.
GENERAL PARTICULARS
407
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.3 Name and designation of the applicant# :
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.4 Representative of the applicant to be contacted regarding the application:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.5 Address for correspondence with PIN code:
A.6 Site details of existing radiography operations
A.6.1 Address
Telephone No.
Fax Nos.
E-mail
A.6.2 Contact person at the radiography site:
Telephone No. : (O): (R)
Fax No. :
Mobile No. :
E-mail :
A.7 Details regarding proposed site of the radiography operations:
A.7.1 Address:
Telephone No.:
Fax No.:
E-mail:
A.7.2 Name and designation of person responsible for routine radiography
operations at proposed site:
Telephone Nos.: (O): (R)
Fax Nos.:
Mobile No.:
E-mail :
408
A.8 Contract awarding party for proposed site
A.8.1 Name and address:
Telephone Nos. :
Fax No.:
E-mail:
A.8.2 Name and designation of person responsible for radiography operations at
site :
Telephone No.: (O): (R)
Mobile:
Fax No.:
E-mail:
A.9 Details of RSO*/Site-in-charge for proposed site
Telephone No. (O): (M):
Fax No.
E-mail
RSO Approval reference No. :
Valid up to :
#
The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
$
Applicant is the person in whose name the site approval may be issued,
under AE(RP)R, 2004 and should be a full time employee of the institution.
* RSO is the person who is so designated by employer and approved by
competent authority and have the responsibilities of ‘Radiological Safety
Officer’ prescribed in AE(RP)R, 2004.
PART B
409
B.1.2 Particulars of industrial X-ray equipment:
410
B.5.1 Particulars of source storage room at the proposed site.
B.5.2 Whether the source storage room was inspected
by representative of AERB : Yes/No
(If yes, date of inspection)
B.6 Details of proposed radiography work:
(a) Nature of job :
(b) Maximum job thickness in mm :
(c) No. of exposures per day Panaromic : Collimated:
(d) Average time of each exposure in minutes:
(e) The shift hours when radiography work will be carried out:
(f) Cordoned-off area available (radial) in meter :
B.7 Proposed date of movement of the radiography device to the site:
B.8 Duration of the proposed radiography work :
B.9 Location and address where the radiography exposure device is proposed to
be returned after completion of radiography work:
B.10 Proposed mode of transport of the radiography
device*: Rail/road/air/sea
B.10.1 If transported by road provide vehicle details (such as vehicle type,
registration number, colour etc.) :
B 10.2 If transported by rail provide details (such as train name and number):
(*The IGRED shall be transported as an item of cargo and declared as such
in the applicable transport documents and it shall not be transported in the
passenger cabin of any conveyance e.g. bus/train/aircraft.. However, it may
be transported by road in an exclusive vehicle)
B.11. Any other relevant information:
B.12 Documents to be attached with the Application:
(i) Authenticated layout plan of radiography site including sketch of
the site, type of occupancy around the immediate vicinity of the
radiography site including occupancies around the proposed open
field radiography site.
(ii) Copy of the letter and work order along with site assessment from
and the contract awarding agency/client for radiography work.
(iii) Particulars of the type approved IGRED to be operated and maximum
radiography work load.
411
(iv) Photographs of the source storage room with pit (all views) duly
authenticated by the applicant and contract awarding agency and
ownership details of the place where the storage room is constructed.
(v) Emergency preparedness plans and procedures specific to the
radiography sites preferably in consultation with the principle
contract awarding agency.
(vi) Security plan for the facility as per AERB safety guide on ‘Security
of Radioactive Sources in Radiation Facilities’ (AERB/RF-RS/
SG-1) and AERB safety guide on ‘Security of Radioactive Material
during Transport’ (AERB/NRF-TS/SG-10), if applicable.
(vii) Any other supporting documents.
PART C
UNDERTAKING
412
(ix) the procedures approved by AERB regarding decommissioning/
dismantling and reuse of the site of the decommissioned facility will
be strictly complied with.
(x) the device would display the radioactivity label and also labels
indicating the category of the package. It would be ensured by us
that the particulars regarding the contents of the package displayed
in the labels are correct. Names and addresses of the consignor and
the consignee would be properly displayed on the exterior of the
package.
(xi) radiation survey meter(s) shall be kept in operable condition at the
site all times and shall be regularly used during radiography work.
Direct reading dosimeter (pocket dosimeter) shall be made available
for use by each radiographer and it would be used regularly in addition
to the personnel monitoring badges.
(xii) at least one qualified RSO/Site-in-charge will be posted at each site
and all radiography operations shall be undertaken by the certified
radiographer under his supervision.
(xiii) AERB will be kept informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/ or not authentic, then I/we hereby undertake to comply with the
regulatory action(s) enforced against me/us and our institution, in accordance
with the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution:
Designation:
413
ANNEXURE-28
(Refer section-3.7.5)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar
Mumbai-400094.
PART A
GENERAL PARTICULARS
414
Fax No.
Mobile No.
E-mail
A.3 Name and designation of the applicant#:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.4 Representative of the applicant to be contacted regarding the application:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.5 Address for correspondence with PIN code:
A.6 This application is for
First time
#
Applicant is the person in whose name the Licence for commissioning and
operation of the facility, may be issued, under AE(RP)R, 2004 should be a
full time employee of the institution.
$
The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
PART B
415
B.2. Details of the industrial X-ray equipment(s):
B.3.3 Name of RSO (s) who is entrusted with management of radiation protection
in the department and responsible in case of emergency
Telephone No : (O): (R)
Mobile
E-mail:
B.4 Particulars of the radiation survey meter(s) (RSM) and pocket dosimeter(s)
(PD) :
B.4.1 Particulars of RSM
416
Radiation survey monitor* 1 2 3
Make and type
Model
RSM S. No.
Date of recent calibration
Functional status
B.4.2 Particulars of PD
Pocket dosimeters 1 2 3
Make and type
Model
PD S. No.
Date of recent calibration
Functional status
Name and address of radiography Site(s) AERB site approval ref. No.
417
(iii) Report on the radiation protection survey around radiography
enclosure and open field radiography site
(iv) Radiation protection manual as per Appendix-9E
(v) Emergency response plan and preparedness.
(vi) Security Plan for the facility as per AERB safety guide on ‘Security
of Radioactive Sources in Radiation Facilities’ (AERB/RF-RS/
SG-1) and AERB safety guide on ‘Security of Radioactive Material
during Transport’ (AERB/NRF-TS/SG-10), if applicable, if not,
attach at the time of procurement of radiography source.
(vii) Any other supporting documents.
PART C
UNDERTAKING
418
(xi) the device shall not be transferred/sold/ rented by me/us to any other
user without the prior permission from the competent authority.
(xii) full facility will be accorded by me/us to any authorised
representatives of the competent authority to inspect the device at
any time.
(xiii) radiation surveillance of the installation and health surveillance of
all persons engaged in radiation work as required by the competent
authority will be duly carried out at my/our expense.
(xiv) all stipulations/recommendations made from time to time by the
competent authority in respect of radiation safety measures and
physical security measures will be duly implemented.
(xv) the decayed/unused radiation sources shall be returned to the original
supplier.
(xvi) the procedures approved by AERB regarding decommissioning/
dismantling and reuse of the site of the decommissioned facility will
be strictly complied with.
(xvii) AERB will be kept informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/or not authentic, then I/we hereby undertake to comply with the
regulatory action(s) enforced against me/us and our institution, in accordance
with the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution:
Designation
419
ANNEXURE-29
(Refer section 3.7.8.2)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar,
Mumbai-400094.
PART A
GENERAL PARTICULARS
420
A.3 Name and designation of the applicant#:
Telephone No. (O) (R):
Fax No.
Mobile No.
E-mail
A.4 Address for correspondence with PIN code:
A.5 Name of the Facility In-charge :
Telephone No. (O) (R):
Fax No.
Mobile No.
E-mail
#
Applicant is the person in whose name the authorisation (licence) to handle
the source may be issued, under AE(RP)R, 2004, would have the
responsibilities of ‘licence’ prescribed in AE(RP)R, 2004 and should be a
full time employee of the institution.
$
The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
PART B
421
B.3 Brief description of the facility:
(i) Type of accelerator to be installed:
(ii) Purpose of facility:
(iii) Category of device (mobile/fixed):
(iv) Beam specification (current, energy, power)
B.4 Layout and civil engineering drawings attached: Yes/No
B.5 Documents to be available with the facility:
PART C
UNDERTAKING
422
(iv) all provisions of the Atomic Energy (Radiation Protection) Rules,
2004 shall be strictly complied with.
(v) the facility shall not be transferred/sold/rented by me/us to another
user without the prior permission of the competent authority.
(vi) full facility will be accorded by me/us to any authorised
representatives of the competent authority to inspect this installation
at any time.
(vii) radiation surveillance of the installation and health surveillance of
all persons engaged in radiation work as required by the competent
authority will be duly carried out at my/our expense.
(viii) all recommendations made from time to time by the competent
authority in respect of radiation safety measures will be duly
implemented.
(ix) duly qualified/experienced radiological safety officer(s)/operator(s)
will be appointed before the commencement of operation of the
facility.
(x) the procedures approved by AERB regarding decommissioning/
dismantling and reuse of the site of the decommissioned facility will
be strictly complied with.
(xi) AERB will be informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/or not authentic, then I/we hereby undertake to comply with the
regulatory action(s) enforced against me/us and our institution, in accordance
with the applicable Rules.
Place: Signature:
Date: Name of the applicant
Designation:
Signature:
Name of Head of the institution:
Designation:
423
ANNEXURE-30
(Refer section 3.7.8.3)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar,
Mumbai-400094.
PART A
GENERAL PARTICULARS
424
Fax No.
Mobile No.
E-mail
A.3 Name and designation of the applicant#:
Telephone No. (O) (R):
Fax No.
Mobile No.
E-mail
A.4 Address for correspondence with PIN code:
A.5 Name of the Facility In-charge :
Telephone No. (O) (R):
Fax No.
Mobile No.
E-mail
A.6 Representative of the applicant to be contacted regarding the application:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.7 Name and designation of the Radiological Safety Officer(s) (RSO)* :
Telephone No. (O) (R):
Fax No.
Mobile No.
E-mail
RSO Approval reference No.:
Approval valid up to:
#
Applicant is the person in whose name the authorisation (licence) to handle
the source may be issued, under AE(RP)R, 2004, would have the
responsibilities of ‘licensee’ prescribed in AE(RP)R, 2004 and should be a
full time employee of the institution.
$
The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
* RSO is the person who is so designated by employer and approved by
competent authority and have the responsibilities of ‘Radiological Safety
Officer’ prescribed in AE(RP)R, 2004.
425
PART B
426
B.5 Documents to be available with the facility:
PART C
UNDERTAKING
427
(iv) the facility shall not be transferred/sold/rented by me/us to another
user without the prior permission of the competent authority.
(v) no radiation source of this facility will be transported without the
prior permission of the competent authority.
(vi) full facility will be accorded by me/us to any authorised
representatives of the competent authority to inspect this installation
at any time.
(vii) radiation surveillance of the installation and health surveillance of
all persons engaged in radiation work as required by the competent
authority will be duly carried out at my/our expense.
(viii) all recommendations made from time to time by the competent
authority in respect of radiation safety measures will be duly
implemented.
(ix) duly qualified/experienced radiological safety officer(s)/operator(s)
will be appointed before the commencement of operation of the
facility.
(x) the requirements regarding decommissioning, disposal of decayed
sources and reuse of the site of the decommissioned facility will be
strictly complied with.
(xi) AERB will be kept informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/or not authentic, then I/we hereby undertake to comply with the
regulatory action(s) enforced against me/us and our institution, in accordance
with the applicable Rules.
Place: Signature:
Date: Name of the applicant
Designation:
Signature:
Name of Head of the institution:
Designation:
428
ANNEXURE-31
(Refer section 3.9.2)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar,
Mumbai-400094.
PART A
GENERAL PARTICULARS
429
Fax No.
Mobile No.
E-mail
A.3 Name and designation of the applicant# :
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.4 Representative of the applicant to be contacted regarding the application:
Telephone No. (O); (R)
Fax No.
Mobile No.
E-mail
A.5 Address for correspondence with PIN code:
#
Applicant is the person in whose name the no objection certificate to import/
procure the source may be issued, under AE(RP)R, 2004, and should be a
full time employee of the institution.
$
The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
PART B
430
B.4.5 Sealed source classification no.:
(As per relevant national/international
standards)
B.4.6 Reference of AERB NOC/
Type approval certificate for the GIC
B.5 Name and address of manufacturer
of GIC Telephone No. Fax No.E-mail
B.6 Name and address of the supplier
of GIC Telephone No. Fax No.
Mobile No. E-mail
B.7 Whether a copy of the undertaking
furnished by the supplier of the
source to take back the disused/
decayed source is attached ? Yes/No
B.8 In case of replacement of source,
furnish the following details
B.8.1 Whether permission for disposal
of decayed source has been
obtained from AERB ? Yes/No
B.8.2 If yes, reference number of AERB
approval/permission for disposal
431
B.12.1 Particulars of trained personnel
Name(s)
Designation
Academic qualifications
Training course on radiation safety
aspects of GIC
Year of passing
Experience in handling of GIC
Whether the person who has If yes, furnish the following details :
undergone training on radiation (i) Approval ref. No. :
safety aspects of GIC, has obtained (ii) Date of issuance :
the Radiological Safety Officer (iii) Approval valid till:
(RSO) approval from AERB If No, the institution should nominate the
person who has successfully completed the
training course on ‘Radiation safety aspects of
GIC’ for RSO approval to AERB.
B.12.2 If there is no individual who has undergone the required training to qualify
for RSO, please furnish the following undertaking. (Please delete the following
undertaking, if not applicable)
I hereby undertake to
(a) get one of our personnel trained on radiation safety aspects of GIC
before the procurement of the radiation sources, and
(b) obtain RSO approval from AERB, before commissioning and
operation of GIC.
Signature of Applicant
(Seal of Institution)
B.13 Particulars of persons who will handle GIC:
432
B.14 Whether a radiation survey meter (RSM) is available
in working condition: Yes / No
B.14.1 If ‘Yes’, (Please furnish the following particulars relating to the RSM)
Particulars of RSM 1 2 3
Make and type
Model
RSM S. No.
Date of recent calibration
Functional status
Signature of applicant
(Seal of institution)
B.15 Additional information, if any:
B.16 Documents to be attached with the Application:
(a) Two copies of duly signed and stamped document on layout plan
(scale 1:100) of GIC installation room indicating the following :
(i) Size of the room
(ii) Thickness of the walls and shielding material details
(iii) Location of entrance door, position of windows (if any) along
with height from ground level
(iv) Pit size (as applicable)
(v) Occupancy in the immediate vicinity of the installation room
(vi) Floor loading capacity as prescribed by GIC supplier.
(b) Copy of certificate of approval of sealed source (including Serial
No.), classification and leak test certificates as per applicable
national/international standard
(c) Copy of the AERB Type Approval certificate for the GIC
433
(d) Copy of the document of the institution registration with the local/
state/central Government authorities.
(e) Security plan for the facility as per AERB Safety Guide on ‘Security
of Radioactive Sources in Radiation Facilities’ (AERB/RF-RS/
SG-1) and AERB Safety Guide on ‘Security of Radioactive Material
during Transport’ (AERB/NRF-TS/SG-10).
(f) A copy of the undertaking furnished by the supplier of the source to
take back the disused/decayed source
(g) Nomination of personnel in the standard format of application form
for training in radiation safety aspects of GIC (in case the personnel
trained in radiation safety are not available)
(h) Any other relevant documents.
PART C
UNDERTAKING
434
(x) radiation surveillance of the installation and health surveillance of
all persons engaged in radiation work as required by the competent
authority will be duly carried out at my/our expense.
(xi) all stipulations/recommendations made from time to time by the
competent authority in respect of radiation safety measures and
physical security measures will be duly implemented.
(xii) the decayed/unused radiation sources shall be returned to the original
supplier.
(xiii) the procedures approved by AERB regarding decommissioning/
dismantling and reuse of the site of the decommissioned facility will
be strictly complied with.
(xiv) AERB will be kept informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/ or not authentic, then I/we hereby undertake to comply with the
regulatory action(s) enforced against me/us and our institution, in accordance
with the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution:
Designation:
435
ANNEXURE-32
(Refer section 3.9.3)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar,
Mumbai-400 094.
(a) This application would be considered by the competent authority for issuance
of relevant consents, under the Atomic Energy (Radiation Protection) Rules,
2004) [AE(RP)R, 2004].
(b) This form is intended to enable AERB to assess the suitability of the institution
for procurement and use of radiation sources, which includes radiation
generating equipment (hereinafter referred to as ‘source’)
(c) The duly filled-in form should be sent to Director/Head, Radiological Safety
Division (RSD), AERB, Niyamak Bhavan, Anushaktinagar, Mumbai-400094
with the necessary documents.
(d) Incomplete applications and those without all relevant documents are liable
to be rejected.
(e) All the forms pertaining to this facility can be downloaded from the website
www.aerb.gov.in
(f) Attach extra sheets wherever required.
PART A
GENERAL PARTICULARS
436
Mobile No.
E-mail
A.3 Name and designation of the applicant# :
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.4 Representative of the applicant to be contacted regarding the application:
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.5 Address for correspondence with PIN code:
A.6 Name and designation of the Radiological Safety Officer (s) (RSO)* :
Telephone No. (O): (R):
Fax No.
Mobile No.
E-mail
RSO Approval reference No.:
Valid up to:
#
Applicant is the person in whose name authorisation for use of the device
may be issued, under AE(RP)R, 2004, would have the responsibilities of
‘licensee/consentee’ prescribed in AE(RP)R, 2004 and should be a full
time employee of the institution
$
The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
* RSO is the person who is so designated by employer and approved by
competent authority and have the responsibilities of ‘Radiological Safety
Officer’ prescribed in AE(RP)R, 2004.
PART B
PARTICULARS OF DEVICE
B.1 This application is for:
First time Authorisation
Renewal of Authorisation Ref No.: Date: Valid till:
437
B.2 Purpose of the gamma irradiation
chamber (GIC)
B.3 Type of GIC Gamma chamber/Blood irradiator/
Gamma cell
B.4 Technical details of GIC
B.4.1 Make, model and S. No.
B.4.2 Name of radioisotope
B.4.3 Isotope physical and chemical form
B.4.4 Maximum activity Bq (Ci)
B.4.5 Number of integrated source
units (ISU)/source pencils
incorporated in the GIC
B.4.6 S. No(s). of the each source(s)
B.4.7 Classification of the sealed
source(s); if not submitted earlier:
(As per relevant national/
international standards)
B.4.8 Reference of AERB NOC/Type
Approval certificate for GIC
B.5 Name and address of manufacturer
GIC:
Telephone No.
Fax No.
E-mail
B.6 Name and address of the supplier
of GIC:
Telephone No.
Fax No.
Mobile No.
E-mail
438
B.7 Particulars of the radiation survey meter (RSM) available in working condition
Particulars of RSM 1 2 3
Make
Model
RSM S. No.
Date of recent calibration
Functional status
PART C
UNDERTAKING
439
(iii) the device shall be put into operation only after obtaining
Authorisation from AERB.
(iv) all provisions of the Atomic Energy (Radiation Protection) Rules,
2004 shall be strictly complied with.
(v) the device shall be stored, installed and safeguarded so as to prevent
unauthorised operation, removal and theft.
(vi) the device containing radiation source would be installed/maintained
by authorized and trained persons.
(vii) the device shall not be transferred/sold/ rented by me/us to another
user without the prior permission from the competent authority.
(viii) full facility will be accorded by me/us to any authorised
representatives of the competent authority to inspect the device at
any time.
(ix) radiation surveillance of the installation and health surveillance of
all persons engaged in radiation work as required by the competent
authority will be duly carried out at my/our expense.
(x) all recommendations made from time to time by the competent
authority in respect of radiation safety measures and physical security
measures will be duly implemented.
(xi) the periodic status report of all devices in the possession of the
institution shall be submitted to AERB.
(xii) all the radiation survey meters/safety instruments will be maintained
in functional condition all the time and will be calibrated periodically.
(xiii) the decayed/unused radiation sources shall be returned to the original
supplier.
(xiv) the procedures approved by AERB regarding decommissioning/
dismantling and reuse of the site of the decommissioned facility will
be strictly complied with.
(xv) any incident/accident such as fire, theft, damage etc., involving
ionising radiation source and/or GIC shall be promptly reported to
AERB.
(xvi) an emergency response manual prescribing specific action plans to
identified persons for specific emergency scenarios shall be prepared
and periodically updated.
(xvii) AERB will be kept informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/or not authentic, then I/we hereby undertake to comply with the
440
regulatory action(s) enforced against me/us and our institution, in accordance
with the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution:
Designation
441
ANNEXURE-33a
(Refer section.3.10.1.2)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan,
Anushaktinagar,
Mumbai-400094.
PART A
GENERAL PARTICULARS
442
A.3 Name and designation of the Applicant#:
Telephone No. (O): (R)
Fax No.
Mobile No.
Email
A.4 Address for correspondence with PIN code:
$
The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
#
Applicant is the person in whose name relevant consents may be issued,
under AE(RP)R, 2004, would have the responsibilities of ‘licensee’ prescribed
in AERPR-2004 and should be a full time employee of the institution
PART B
443
(i) Location of facility drawing indicating the floor, nature
of occupancy around, above and below, if any.
(ii) Layout plan of the facility (with dimensions on B3
size paper, i.e. 353 X 500 mm2) indicating required
facilities such as hot lab, radiopharmacy, source
storage area, injection room, gamma camera/PET-CT
room, control console, radioactive waste storage and
decontamination, general patient waiting area, post
administration waiting area with attached toilet facility,
doctor’s room, staff room, work station etc. location
of doors, windows, workbenches, sink, fume hood (if
applicable) and exhaust in the rooms.
(2) Therapy Facility
(i) Location drawing of isolation ward, indicating the
floor, nature of occupancy around, above and below,
if any.
(ii) Layout plan of isolation ward (with dimensions on
B3 size paper, i.e. 353 X 500 mm2) indicating nursing
station, dose administration area with fumehood
location, linen storage area, and rooms for
hospitalisation of patients with toilet facility giving
patient bed position.
(iii) Delay tank drawing (with dimensions on B3 size paper,
i.e. 353 X 500 mm2), its location (underground/over
ground) and capacity.
(d) Security plan as per AERB safety guide ‘Security of Radioactive
Sources in Radiation Facilities’ (AERB/RF-RS/SG-1).
(e) Any other supporting documents.
PART C
UNDERTAKING
444
(iii) layout and construction activities shall be carried out only on
obtaining approval from the competent authority.
(iv) all provisions of the Atomic Energy (Radiation Protection) Rules,
2004 shall be strictly complied with.
(v) the facility shall not be transferred/sold/ rented by me/us to another
user without the prior permission of the competent authority.
(vi) full facility will be accorded by me/us to any authorised
representatives of the competent authority to inspect this installation
at any time.
(vii) radiation surveillance of the installation and health surveillance of
all persons engaged in radiation work as required by the competent
authority will be duly carried out at my/our expense.
(viii) all recommendations made from time to time by the competent
authority in respect of radiation safety and physical protection
measures will be duly implemented.
(ix) duly qualified/experienced radiological safety officer(s)/operator(s)
will be appointed before the commencement of operation of the
facility.
(x) AERB will be kept informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/ or not authentic, then I/we hereby accept that appropriate regulatory
actions may be initiated against me/us and our institution, in accordance with
the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution:
Designation:
445
ANNEXURE-33b
(Refer section.3.10.1.2)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar,
Mumbai-400094.
PART A
GENERAL PARTICULARS
446
A.3 Name and designation of the applicant#:
Telephone No. (O) (R)
Fax No.
Mobile No.
E-mail
A.4 Layout approval of the facility:
(Give AERB reference no.)
#
Applicant is the person in whose name the relevant consent may be issued,
under AE(RP)R, 2004, would have the responsibilities of ‘licensee’ prescribed
in AE(RP)R, 2004, and should be a full time employee of the institution.
$
The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
PART B
TABLE-A
447
TABLE-B
PART C
UNDERTAKING
448
(iv) the sources shall be used only after obtaining Authorisation for
commissioning and operation of the facility from the cmpetent
authority.
(v) all provisions of the Atomic Energy (Radiation Protection) Rules,
2004 shall be strictly complied with.
(vi) all provisions of the AERB Safety Code on ‘Nuclear Medicine
Facilities’ [(AERB/RF-MED/SC-2 (Rev. 2)] shall be strictly complied
with.
(vii) the sources shall be handled by authorized and trained persons.
(viii) the sources shall not be transferred/sold/ rented by me/us to another
user without the prior permission of the competent authority.
(ix) full facility will be accorded by me/us to any authorised
representatives of the competent authority to inspect the facility at
any time.
(x) radiation surveillance of the installation and health surveillance of
all persons engaged in radiation work as required by AERB will be
duly carried out at my/our expense.
(xi) the periodic status report of radiation safety of the facility shall be
submitted to AERB.
(xii) all the radiation survey meters /safety instruments will be maintained
in functional condition all the time and will be calibrated periodically.
(xiii) all recommendations made from time to time by the competent
authority in respect of radiation safety and physical security measures
will be duly implemented.
(xiv) duly qualified/experienced radiological safety officer(s)/operator(s),
shall be appointed prior to the procurement of the sources.
(xv) the procedures approved by AERB regarding decommissioning/
dismantling and reuse of the site of the decommissioned facility will
be strictly complied with.
(xvi) the decayed/unused radiation sources shall be disposed safely as per
procedures approved by AERB.
(xvii) AERB shall be informed about the absence of any qualified
manpower immediately.
(xviii) any incident/accident such as fire, theft, damage etc., involving
radioactive sources shall be promptly reported to AERB.
(xix) AERB will be kept informed about any changes in the information
furnished above.
449
In case, it is found, at any stage, that the information provided by me/us is
false and/ or not authentic, then I/ we hereby accept that appropriate regulatory
actions may be initiated against me/us and our institution in accordance with
the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of the Head of institution:
450
ANNEXURE-34
(Refer section 3.10.1.4 )
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar,
Mumbai-400094.
PART A
GENERAL PARTICULARS
451
A.3 Name and designation of the Applicant# :
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.4 Name and designation of the Radiological Safety Officer (RSO)*:
Telephone No. (O) (R):
Fax No.
Mobile No.
E-mail
RSO approval reference No. :
Valid up to
A.5 Address for correspondence with PIN code:
$
The head of the institution is the person who would have the responsibilities
of ‘employer’ prescribed in AE(RP)R, 2004.
#
Applicant is the person in whose name the authorisation (licence) to handle
the source may be issued, under AE(RP)R, 2004, would have the
responsibilities of ‘licencee’ prescribed in AE(RP)R, 2004 and should be a
full time employee of the institution.
* RSO is the person who is so designated by employer and approved by
competent authority and have the responsibilities of ‘Radiological Safety
Officer’ prescribed in AE(RP)R, 2004.
PART B
452
B.1.1 In-vivo diagnosis
B.1.3 List of sealed source(s) if any (to be used for calibration/quality assurance)
used in the facility with the radionuclide, activity, date of procurement,
purpose, supplier/manufacturer details
B.2 Equipments details
B.2.1 Imaging equipment
B.3 Isolation wards for therapy patients (undergoing treatment with high doses)
453
B.4 Monitoring and measuring instruments (survey instruments and dose
calibrator)
Name of the Make, model Measurement Working Date of last
instrument and serial No. range status calibration
454
B.8 Procedures for disposal of radioactive waste
PART C
UNDERTAKING
455
(vii) full facility will be accorded by me/us to any authorised
representatives of the competent authority to inspect this installation
at any time.
(viii) radiation surveillance of the installation and health surveillance of
all persons engaged in radiation work as required by the competent
authority will be duly carried out at my/our expense.
(ix) all recommendations made from time to time by the competent
authority in respect of radiation safety and physical security measures
will be duly implemented.
(x) duly qualified/experienced radiological safety officer(s)/operator(s),
will be appointed before the commencement of operation of the
facility.
(xi) the procedures approved by AERB regarding decommissioning/
dismantling and reuse of the site of the decommissioned facility will
be strictly complied with.
(xii) AERB shall be informed about the absence of any qualified
manpower (as given in table B.6) immediately.
(xiii) AERB will be kept informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/ or not authentic, then I/we hereby accept that appropriate regulatory
actions may be initiated against me/us and our institution, in accordance with
the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution:
Designation:
456
ANNEXURE-35
(Refer section 3.11.1)
Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar,
Mumbai-400094.
PART A
GENERAL PARTICULARS
457
A.3 Representative of the applicant to be contacted regarding the application# :
Telephone No. (O): (R)
Fax No.
Mobile No.
E-mail
A.4 Name and designation of the Radiological Safety Officer (RSO)* :
Telephone No. (O) (M):
Fax No.
E-mail
RSO Approval reference No. :
Approval valid up to:
A.5 Address for correspondence with PIN code:
#
Applicant is the person in whose name Authorisation to handle the radiation
generating equipment may be issued, under Atomic Energy (Radiation
Protection) Rules, 2004 [AE(RP)R, 2004], would have the responsibilities
of ‘Licensee’ rescribed in AE(RP)R, 2004 and should be a full time employee
of the institution.
* RSO is the person who is so designated by employer and approved by
competent authority and have the responsibilities of ‘Radiological Safety
Officer’ prescribed in AE(RP)R, 2004.
PART B
458
B.6 Particulars of emergency handling accessories:
(a) Emergency handling tools
(b) Shielding container (Type-A package)
(c) Auxiliary shielding material
B.7 Details of systems available in source handling room:
(Area monitor, red warning light, radiation caution symbol, warning placards
etc.):
B.8 Physical security measures provided for facility:
B.9 Particulars of the radiation monitoring and measuring instruments:
Particulars of monitor 1 2 3
Make and model
Model
S. No.
Date of recent calibration
Functional status
459
(v) Location of windows, doors along with height from ground
(vi) Occupancy around the source storage room and calibration
room
(b) Copy of the Type Approval certificates issued for all models of
IRGDs/NGs.
(c) Copy of the registration certificate issued by state/central authority
as an industrial unit
(d) Security plan for the facility as per AERB safety guide on ‘Security
of Radioactive Sources in Radiation Facilities’ (AERB/RF-RS/
SG-1) and AERB Safety Guide on ‘Security of Radioactive Material
during Transport’ (AERB/NRF-TS/SG-10).
(e) Any other relevant document
PART C
UNDERTAKING
460
(ix) radiation surveillance of the installation and health surveillance of
all persons engaged in radiation work as required by the competent
authority will be duly carried out at my/our expense.
(x) all stipulations/recommendations made from time to time by the
competent authority in respect of radiation safety and physical
security measures will be duly implemented.
(xi) the installation, commissioning, servicing and maintenance of the
equipment shall be carried out by our authorised service personnel.
(xii) any incident/accident such as fire, theft, damage etc., involving
radiation generating equipment shall be promptly reported to AERB.
(xiii) all other necessary approvals from the concerned state/central govt.
have been obtained by our institution.
(xiv) AERB will be kept informed about any changes in the information
furnished above.
In case, it is found, at any stage, that the information provided by me/us is
false and/or not authentic, then I/we hereby undertake to comply with the
regulatory action(s) enforced against me/us and our institution, in accordance
with the applicable Rules.
Place: Signature:
Date: Name of the applicant:
Designation:
Signature:
Name of Head of the institution:
Designation:
461
BIBLIOGRAPHY
Bi
Containing Radioactive Substances’, AERB Safety Standard No. AERB/SS/
4, Mumbai, India (1991).
16. ATOMIC ENERGY REGULATORY BOARD, Safety Standard on
‘Radiological Safety in the Design and Manufacture of X-ray Analysis
Equipment’, AERB Safety Standard No. AERB /SS/5, Mumbai, India (1992).
17. ATOMIC ENERGY REGULATORY BOARD, Safety Standard on ‘Land
Based Stationary Gamma Irradiators’, AERB Safety Standard No. AERB/
RF-IRRAD/SS-6 (Rev. 1), Mumbai, India (2007).
18. INTERNATIONAL COMMISSION ON RADIOLOGICA PROTECTION,
ICRP-103, (2007).
19. INTERNATIOANL ATOMIC ENERGY AGENCY(IAEA), Safety Series No.
115, International Basic Safety Standards for Protection against Ionising
Radiation and for the Safety of Radiation Sources, Vienna (1996).
20. INTERNATIOANL ATOMIC ENERGY AGENCY (IAEA), Standards Series
No. TS-R-1, Regulations for the Safe Transport of Radioactive Material,
Vienna (2009).
21. INTERNATIONAL ELECTROTECHNICAL COMMISSION (IEC),
Medical Electrical Equipment- Part-1: General Requirements for Basic Safety
and Essential Performance; IEC 60601-1 (2005)
22. INTERNATIONAL ELECTROTECHNICAL COMMISSION (IEC),
Medical Electrical Equipment- Part-2-1: Particular Requirements for Safety
of Electron Accelerators in the Range of 1 MeV to 50 MeV IEC-60601-2-
1 (1998)
23. INTERNATIONAL ELECTROCHEMICAL COMMISSION (IEC), Medical
Electrical Equipment- Part-2 : Particular Requirements for the Safety of
Gamma Beam Therapy Equipment: IEC-60601-2-11 (1997).
24. INTERNATIONAL ELECTROTECHNICAL COMMISSION (IEC),
Medical Electrical Equipment- Part-2: Particular Requirements for the Safety
of Automatically-Controlled Brachytherapy Afterloading Equipment; IEC-
60601-2-17 (2005).
25. INTERNATIONAL ELECTROTECHNICAL COMMISSION (IEC),
Medical Electrical Equipment- Part 2-7: Particular Requirements for the
Safety of High-Voltage Generators of Diagnostic X-Ray Generators; IEC-
60601-2-7 (1998).
26. INTERNATIONAL ELECTROTECHNICAL COMMISSION (IEC),
Medical Electrical Equipment- Part-2: Particular Requirements for the Safety
of Associated Equipment of X-Ray Equipment; IEC-601-2-32 (1994).
Bii
27. BUREAU OF INDIAN STANDARDS (BIS), Specifications for Diagnostic
Medical X-ray Equipment, Part-1: General and Safety Requirements, IS-7620
(1986).
28. BUREAU OF INDIAN STANDARDS (BIS), Specifications for Diagnostic
Medical X-ray Equipment, Part-2: Performance Requirements, IS-7620
(1986).
29. BUREAU OF INDIAN STANDARDS (BIS), Specifications for Diagnostic
Medical X-ray Equipment, Part-3: Radiation Safety Requirements, IS-7620
(1991).
30. BUREAU OF INDIAN STANDARDS (BIS), Specifications for Dental X-
ray Equipment, Radiation Safety Requirements, IS-13709 (1993).
31. NATIOANAL BUREAU OF STANDARDS, NBS Handbook-127, American
National Standards N433.1, Safe Design and Use of Self Contained, Dry
Source Storage Gamma Irradiators (Category-I) (1979).
32. NATIOANAL BUREAU OF STANDARDS, NBS Handbook-142, American
National Standards N43.10, Safe Design and Use of Panoramic, Wet Source
Storage Gamma Irradiators (Category-IV) (1984).
33. INTERNATIONAL STANDARD, Sealed Radioactive Sources - General
Requirements and Classification; ISO 2919:1999 (E) (1999).
34. INTERNATIONAL STANDARD, Radiation Protection – Sealed Radioactive
Sources - Leakage Test Methods; ISO 9978:1992 E (1992).
35. INTERNATIONAL STANDARD, Apparatus for Gamma Radiography-
Specification ISO 3999 (2000).
36. INTERNATIONAL STANDARD, Radionuclide Gauges - Gauging Designed
for Permanent Installation, ISO-7205 (1986).
Biii
LIST OF PARTICIPANTS
WORKING GROUP
Li
LIST OF PARTICIPANTS
ACKNOWLEDGEMENTS (2008-2010)
(for contributions in revision of document)
Lii
ADVISORY COMMITTEE ON PREPARATION OF CODES,
GUIDES AND MANUALS ON GOVERNMENTAL
ORGANISATION FOR NUCLEAR AND RADIATION
FACILITIES (ACCGORN)
Liii
ADVISORY COMMITTEE ON PREPARATION OF CODES,
GUIDES AND MANUALS ON GOVERNMENTAL
ORGANISATION FOR NUCLEAR AND RADIATION
FACILITIES (ACCGORN) (Contd.)
Liv
PROVISIONAL LIST OF CODES, GUIDES AND MANUALS
FOR REGULATION OF NUCLEAR AND RADIATION
FACILITIES
Pi
AERB SAFETY GUIDE NO. AERB/RF/SG/G-3 (Vol. 3 of 4)