Checklist for submission of application form for Licence

*Incomplete submission may cause delay in processing of the application.

Name of the Hospital/Institution:

City
State

Sr.No. Checkpoints Status

1 Application form is completely filled, duly signed and stamped YES/NO

2 Address for correspondence is correctly mentioned with pin code YES/NO

(courier doesn’t reach without pin code)

3 Name of related medical practitioner, operator and RSO is given in the staff list YES/NO

4 TLD badge numbers of radiation workers are provided in the staff list YES/NO

5 Copy of
a) Valid Type Approval/NOC is enclosed YES/NO
b) For nominated RSO, latest qualification certificates are enclosed YES/NO
c) QA report is enclosed YES/NO

6 Layout report and 2 copies of layout are enclosed YES/NO

7 Undertaking/declaration has been duly signed and stamped YES/NO

Place: Signature:

Date: Name of the Applicant:

 Form ID: AERB/RSD/MDX/LIC

Government of India
Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar,
Mumbai – 400 094

APPLICATION FOR LICENCE FOR COMMISSIONING/ OPERATION OF

MEDICAL DIAGNOSTIC X-RAY EQUIPMENT
[COMPUTED TOMOGRAPHY (CT)/INTERVENTIONAL RADIOLOGY (CATH LAB)]
-------------------------------------------------------------------------------------------------------------------------------
a) This Application would be considered by the competent authority for issuance of relevant consents, under the
Atomic Energy (Radiation Protection) Rules, 2004).
b) The duly filled-in form should be sent to 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
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PART A
GENERAL PARTICULARS

A.1 Name and address of the institution:

Telephone No. Fax No

A.2 Name, Designation of the Head of the institution $

Telephone No. Mobile No.

Fax No. Email

A.3 Name and designation of the applicant:#

Telephone No. Mobile No.

Fax No. Email

A.4 Name and designation of the Radiological Safety Officer (RSO)*,

(either nominated or approved)
Telephone No. Mobile No.
Fax No. Email
RSO Approval reference No.: Valid up to

A.5 Address of installation of the X-ray equipment:

--------------------------------------------------------------------------------------------------
# Applicant is the person in whose name the relevant consent may be issued, under AE (RP) R-2004, and should be a full time employer
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” as prescribed in AE(RP)R-2004.
 PART B
PARTICULARS OF THE PROPOSED FACILITY

B.1: Whether the equipment is: New/ pre-owned

B.2 In case of pre-owned: purchased/received from (name and address):

B.3 Purpose

Medical Diagnosis/ Research/ Veterinary/ others (please specify)

B.4 Details of equipment (Attach extra sheets if required)

Sr. Type of Model Supplier Date of NOC / Type Max Max.

No. equipment Name Name installation Approval No. kVp mA/mAs
(attach copy)

B. 5 Quality Assurance report enclosed: YES/NO

B. 6 Layout report is attached: YES/NO

B.7 Availability of Radiation Measuring & Monitoring Instruments and Radiation Protection Accessories

a) Ceiling mounted Lead Glass ( applicable to cath lab) Yes/No

b) Lead aprons Yes/No
c) Couch hanging lead rubber flaps ( applicable to cath lab) Yes/No
d) Dose Area Product (DAP) meter ( applicable to cath lab) Yes/No
c) Personnel Monitoring Badges (TLD) Yes/No
d) Quality Assurance kit (optional) Yes/No
e) Availability of phantom for CT (daily QA) Yes/No
f) Red light, X-Ray Caution Symbol and Warning Placards: Yes/No

B.8 Workload:
For Computed Tomography:
Type of Average No. of mAs/slice kV No. of slices per
Examination examinations/week examination
(approximate)

For Interventional Radiology

Type of Average No. of Total DAP/patient kV Average (total

Examination examinations/week (mGy cm2) mAs/patient)
 PART C
STAFF DETAILS (Please attach separate list if required)

Sr. Name Academic/ Experience PMS Full time

No Professional (TLD /Part time
. Qualification Number)
Related medical
practitioner
Operators
RSO
designate

PART D

APPROVAL /RENEWAL OF RADIOLOGICAL SAFETY OFFICER PLEASE AFFIX

E.1 This application is for
A RECENT
First time RSO approval
PASSPORT
SIZE
Renewal of RSO approval Ref No.: Valid till:
PHOTOGRAPH
Name of
E.2 Present PMS badge (TLD) Number:

E.3 Latest academic qualification and training courses in radiation safety (Please attach certificate of latest
academic qualification and the certificate of training if acquired)

Qualifications University/ Latest Degree/ Year of

Examining body Diploma passing
Academic
Training courses in
radiation safety

E.4 Experience in radiation work (attach copies of experience certificates and present employment
certificate)

Year(s) of work Name of institution and place Radiation equipment handled TLD badge
No.

E.5 Details of radiation equipment for which the RSO will be responsible (attach additional sheets, with
complete details)

Radiation equipment Type of equipment Model name Make

 UNDERTAKING BY NOMINATED RSO

I hereby undertake to fulfil Duties and Responsibilities of RSO as follows:

a) I have read and understood the AERB guidelines on radiation protection.
b) I shall ensure that the radiographer/s operating the x-ray equipment are trained in radiation
protection aspects and provided with adequate protective accessories while operating the
equipment
c) I shall ensure that suppliers of x-ray equipment will render training to the x-ray technologist/
operator on safe operation of x-ray equipment.
d) I shall ensure that the QA of the equipment is carried out once in two years, or as recommended
by AERB and maintain records thereof.
e) I shall ensure that the TLD badges are distributed to the radiation workers ( whoever operates
the x-ray equipment /works around the x-ray equipment/ associated with the procedure )
f) I shall ensure that proper instructions on using of TLD badges are given to the radiation workers
g) I shall maintain control TLD badge at a location away from the radiation areas
h) I shall ensure that the TLD badges are sent periodically for evaluation of doses and maintain the
dose records thereof.
i) I shall report any excessive exposures ( above quarterly or annual limit) to AERB
j) I shall ensure that proper warning x-ray symbols , are placed on the door to the room housing
the x-ray equipment
k) I shall ensure that female radiation workers get alternative employment, away from radiation
areas, on declaration of pregnancy. ( for eg, Darkroom assistant, receptionist, record keeping
etc)
l) I shall ensure that lead aprons are properly placed on a stand provided for the purpose, when not
in use.
m) I shall ensure lead aprons are checked once in a year for integrity.
n) I shall prepare and maintain periodic safety status reports which will be made available to
representatives of inspecting agency.
o) I shall advise the management about regulatory requirements for installation of any new x-ray
equipment/ decommissioning of old x-ray equipment
p) I shall inform the AERB, in case of relinquishing the responsibilities of Radiological Safety
Officer.

I have also understood the relevant provisions of the Act, Rules and Safety Code as mentioned above
and radiation safety aspects. I am solely responsible for discharging the duties of Radiological Safety
Officer of diagnostic radiology department as per rule 22 of AE (RP) R-2004.

Place Signature of Registrant/ RSO

Date Name of Registrant/ RSO

 PART E

LAYOUT AND SHIELDING DETAILS OF MEDICAL X-RAY INSTALLATION

Identification of location (Room No.):
(Refer AERB guidelines for layout and shielding of x-ray installations)
Wall Identification Distance from exposure area Material used for Thickness of the
(from centre of the couch) shielding shielding material
Wall A
Wall B
Wall C
Wall D
Patient Entrance Door
Control room door
Window, if any, if at the height
less than 2 m from outside
finished floor of CT/IR room
Floor
Ceiling

Check list to be filled by applicant Status

1 All the walls are identified and distances of walls from the isocentre of the equipment are
indicated in the layout drawing
2 Layout drawing indicates gantry/C-arm, couch, control panel/ control room, windows, doors,
make and model of the CT/IR equipment.
3 Layout drawing is signed and stamped by the applicant.
4 Layout drawing is authenticated by supplier.
5 The layout drawing is as per values filled in the above table.
6 Height of the window from outside finished floor of CT/IR room is > 2 m Yes/ No
7 If No, whether shielding is provided on the window up to 2m Yes/ No

Attach drawing authenticated by supplier in A4 size sheet (scale 1:50) indicating details given above.

Verified by: Name of the applicant:

Signature of applicant:
Signature of the supplier
Name
Designation
Company
 PART F

UNDERTAKING BY HEAD OF THE INSTITUTION AND APPLICANT

I/ We hereby certify that

a) Quality Assurance tests will be conducted within six months from the date of application and records will be
maintained at the premises.
b) All the statement made above are correct to the best of my knowledge and belief
c) No activity will be carried out for purposes other than those specified in this form;
d) Site and layout shall be as per the approved plan only.
e) The equipment shall be put into operation only after obtaining Registration certificate from the Competent
Authority.
f) No person below age of 18 years shall be employed as radiation worker (operator and RSO)
g) All provisions of the Atomic Energy (Radiation Protection) Rules, 2004 shall be strictly complied with.
h) All provisions of AERB Safety Code on Medical Diagnostic X-ray Equipment and Installations, AERB/SC/
MED- 2 (Rev–1) or the revised version thereof currently in force shall be complied with
i) The facility shall not be transferred/sold/ rented by me/us to another without the prior permission of the
competent authority;
j) The installation / maintenance of the equipment would be done by authorized and trained persons.
k) Full facilities will be accorded by me/us to any authorised representatives of the competent authority to
inspect this installations at any time;
l) Radiation surveillance and medical surveillance of all persons engaged in radiation work as required by the
competent authority will be duly carried out at my/our expense
m) All recommendations made from time to time by the competent authority in respect of radiation safety will
be duly implemented;
n) Duly qualified and trained manpower (including radiological safety officer, shall be appointed before the
commencement of operation of the facility;
o) Decommissioning/ dismantling and reuse of the site of the decommissioned facility will be done with prior
intimation to AERB.
p) All necessary facilities will be provided to the RSO to discharge his duties and functions effectively.
q) Atomic Energy Regulatory Board will be immediately informed in case the RSO is relieved of his duties and
his original certificate would be returned.
r) 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 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:

DECLARATION BY THE AUTHORISED SUPPLIER

Our company has installed a Computed Tomography / Interventional Radiology equipment model--------------,
which is having a valid NOC/Type Approval certificate from AERB. Its performance/ acceptance test are
demonstrated to the user’s representative on………………..

Place: _____________________ Signature of the service engineer

Date: _____________________ Name

Designation
Company

SEAL OF THE COMPANY