E LORA Diagnostic Radiology Guidelines
E LORA Diagnostic Radiology Guidelines
E LORA Diagnostic Radiology Guidelines
Guidelines
Medical Diagnostic
Radiology
Module
General Guidelines (Applicable for all types of equipments viz. existing as well as new) ...........................4
1. Register Your Institute ......................................................................................................................4
2. Prerequisites for Licence ..................................................................................................................6
A. Declare Employees .......................................................................................................................6
B. Obtain RSO Approval ....................................................................................................................9
C. Add Instrument...........................................................................................................................11
D. Prepare Layout ...........................................................................................................................12
E. Quality Assurance .......................................................................................................................13
Guidelines for Obtaining Licence for Existing X-ray Equipment .................................................................13
3. Declare Your X-ray Equipments ......................................................................................................13
4. Record Licence Detail .....................................................................................................................14
5. Fill Application Form for Licence ....................................................................................................15
6. Renewal of license ..........................................................................................................................20
Guidelines for Obtaining Licence for New X-ray Equipment ......................................................................20
7. Procurement of X-ray Equipment...................................................................................................20
8. Application for Licence ...................................................................................................................21
9. Guidelines for obtaining Licence for Pre-owned (Used/refurbished) X-ray Equipment ................22
Guidelines for Other Processes ..................................................................................................................22
9. Change in Layout: ...........................................................................................................................22
10. Safety Status Report ...................................................................................................................22
11. QA Test Summary .......................................................................................................................23
12. Radiation Survey Report .............................................................................................................23
13. Procurement of X-ray Tube ........................................................................................................23
14. Intimation of Receipt ..................................................................................................................23
15. Intimation of Decommissioning .................................................................................................23
Important Message ....................................................................................................................................23
16. NO LICENSE FEE /PROCESSING FEE BY AERB ..............................................................................23
17. Deletion of duplicate or wrong declaration of X-ray equipment ...............................................24
18. Non-compliance..........................................................................................................................24
19. Authorised Service Agencies, AERB Type Approved X-ray equipment and AERB-Licensed X-ray
facilities ...................................................................................................................................................24
20. Annexures: ..................................................................................................................................25
It is mandatory for all users of medical diagnostic x-ray equipments to obtain Licence for Operation
from AERB as per Atomic Energy (Radiation Protection) Rules 2004.
To facilitate online submission of applications for regulatory consents and establish channel of
communication with AERB for other regulatory requirements, AERB has launched Diagnostic Radiology
module in its e-governance application e-LORA (e-Licensing of Radiation Applications) System. All
diagnostic x-ray equipment user Institutes are required to use eLORA for obtaining operating Licence
from AERB.
Click on Register Institute(see above figure). This will open application form for Institute Registration.
Important Note: Guidelines to fill application form for Institute Registration is available on eLORA home
page. It is advised to read the guidelines and keep soft copy of required attachments ready before start
filling of application form.
Fill the application form as per the guidelines. Important points in each tab are mentioned below:
Tab 1: Institute Details
Name: Fill the complete name of employer as appearing in his/her document for Proof of Identity/Date
of Birth (DOB)to be attached.
Date of Birth: Fill the DOB as appearing in the proof of identity/DOB to be attached
Document/card for proof of identity and date of birth (of employer): Select one from the drop down.
(Soft copy of this is a mandatory attachment).
Document/Card No.(of Proof of Identity/DOB): Must match with the proof of identity/DOB attached
E-mail (O): Will be used to send USERNAME and PASSWORD of your eLORA account and for all future
communications. (Make sure to provide correct email address).
Tab 3: Attachments
Proof of Identity and Date of Birth (of employer): Acceptable documents are as follows:
o Passport
o PAN card issued by Income Tax Department
o Driving Licence issued by RTO
o Photo identity document/card having serial number and date of birth issued by
Central/State Government or PSU
Proof of Employership: Example: (i) Appointment Letter of Employer, (ii) Board Resolution, (iii)
Any Govt./PUC document substantiating proprietorship (iv) Partnership deed (notorised) or (iv)
Proprietors self declaration on institute letter head affixed with institute seal
Upload scan copy of any one of the document (in the relevant position) for the proof of
existence of institute:
o PAN of Institute
o TAN of Institute
o Registration with State/Central/Local Government Authority
Important Note: Fields marked with * in the application form are mandatory. Application form will not
be submitted if any mandatory field left blank.
A. Declare Employees
For X-ray equipment/installation such as CT scan, Interventional Radiology, C-Arm/O-Arm and
equipment with Fluoroscopy mode shall have adequate no. of Operator and Medical
Practitioner for obtaining Operational Licence.
For obtaining License for all other X-ray equipment availability of adequate no. of Operator is
mandatory
Operator & medical Practitioner shall be declared in eLORA through add employee menu.
For CT and Interventional Radiology (IR) equipments, in addition to Operator and Medical
Practitioner, RSO (Radiological Safety Officer)is mandatory for obtaining Operational Licence.
Other than CT & IR equipment, if RSO is not available, Registrant may designate himself as
RSO.
The minimum qualification requirement for employees in Diagnostic Radiology is as given below:
In case, no person is having valid AERB RSO approval for your Institute
then any Medical Practitioner (as above) OR Qualified X-ray technologist
(with three years experience in the field of CT/Interventional Radiology)
can be nominated for RSO approval after registering as Radiation
Professional (RP) in e-LORA.
For adding employees to your institution, please follow the path as:
MenuUser managementAdd Employee Select required Type of Employee from drop down
Radiation Worker (this is to add employee with role Operator and Medical Practitioner)
Non Radiation Worker(this is to add Licensee who may not be a radiation worker)
Radiation Professional(this is to add Radiation Professional who is to be nominated asRSO)
You are required to add Operator and Medical practitioner in the type Radiation Worker.
Provide required personal information of employee viz. Title, Name, Gender and Date of Birth
Provide required service information of employee viz. Date of Joining (of service in your
institute), PMS No. (i.e. complete TLD No.), Department, Designation, Profile (select Medical
diagnostic x-ray facility) , Role (select any one or both using Ctrl key as applicable) and
Education Qualification (select value from drop down)
Repeat the above procedure to add your other Operators and Medical practitioners.
Important Note: You will not be able to fill application form for Licence (and will get following error
message) unless you declare Operator and Medical Practitioner of your Institute.
In case your institute is not having valid RSO, you need to obtain RSO approval from AERB. For a person
required to be nominated as RSO, you need to add him/her in the type Radiation Professional
(RP).While adding RP, system will ask RP registration ID and Date of birth of RP. (Obtain these details
from the Radiation Professional)
Enter Registration ID and Date of birth of RPpersonal detail of RP will come automatically.
In case RP is Employer of Institute, select Yes for Whether the person is also Employer of the
Institute?
Provide Date of Joining (of service in your institute), PMS No. (i.e. complete TLD No.),
Department and Designation, Profile (i.e.Medical diagnostic x-ray facility) and Role (i.e.
Operator, Medical Practitioner or both)
Provide Email (O)
Browse and upload scan copy of joining /confirmation letter of employee and click on Submit
Important Note: Radiation Professional can subsequently be nominated for the approval of Radiological
Safety Officer (RSO). Process of RSO nomination explained in Sr. No.:B
For CT and Interventional Radiology facilities, RSO approval is mandatory. For nominating your
employee for RSO approval, follow the path as:
Fill the asked information and click on Freeze. This will freeze your application form and show your
application number. Please note, Freeze does not mean submission of application form to AERB.
For submission of RSO nomination application form, follow the path as:
Menu My applications
After uploading of scan file, Application Status will change to Signed PDF Uploaded
Important Note: The above mentioned procedure of submission of application is applicable for other
regulatory forms where signature of two persons required.
Your RSO nomination form will be reviewed by AERB and after acceptance; you will get its notification
in your eLORA account.
C. Add Instrument
Diagnostic X-ray facility must have certain types of instruments (list is given in Table 1: List of
Instruments Required) and the same must be declared in eLORA.
Instruments to be added
Type of Equipment
Type of Instrument Instrument Sub Type
Interventional Radiology Safety Tool Protective Apron (minimum 3)
Protective Rubber Flaps
Ceiling suspended protective glass
Computed Tomography Safety Tool Protective Apron
Radiography & Safety Tool Mobile Protective Barrier with lead equivalent
Fluoroscopy Viewing Window
Protective Apron
Protective Rubber Flaps
Radiography(fixed) Safety Tool Mobile Protective Barrier with lead equivalent
Viewing Window
Protective Apron
Important Note: You will not be able to fill application form for Licence (and will get following error
message) unless you declare required Instrument(s).
D. Prepare Layout
Prepare a sketch of layout (1:50 scale) of each x-ray room(not applicable for Radiography (mobile), C-
Arm, O-Arm, Dental (Intra-oral) and Dental (Hand held) X-ray equipment)providing all the details
about wall dimensions, wall thickness, wall/shielding material, distances of all walls/shielding from x-ray
equipment, relative positions of x-ray equipment, couch, control console/control room, protective
barrier, door(s), window(s) , occupancy around the x-ray room etc. For the preparation layout details,
guidelines and model layout plans are available on AERB website
(http://www.aerb.gov.in/AERBPortal/pages/English/X-Ray/X-Ray_jsp.action) as well as enclosed here as
Annexure - 3: Standard Layouts.
You are required to preserve the duly signed and stamped copy of x-ray room with details of shielding
at your institution and same will be verified during AERB inspection.
There is no requirement to prepare a new layout plan in case you already have AERB approved layout
plan. The same can be used as a record for layout.
If your x-ray room is as per model layout or has AERB approved layout, you need not to submit all
details in the application form for License.
Important Note: While submitting Operational Licence application form for CT and Interventional
Radiology equipment, you will be asked to upload scan copy of duly signed and stamped layout plan.
Important Note: While submitting Operational Licence application form for CT and Interventional
Radiology equipment, you will be asked to upload scan copy of duly signed and stamped QA.
Otherwise, the form for recording license detail can be accessed by clicking on menu Record Licence for
Operation of X-ray Equipment (as shown below)
Equipment Id: To be selected from provided List (all your declared equipments will appear
here)
Reference number of licence for operation: as appearing on AERB licence/registration
Issuance date: as appearing on AERB licence/registration
Expiry date: as appearing on AERB licence/registration
Upload copy of Licence for operation: Browse and upload scanned copy of AERB
licence/registration
After successful submission, following message will be displayed. The submitted application form (pdf
file) can be downloaded from the link provided therein.
Your Licence record detail will be verified by AERB. After acceptance of your submitted detail, you will
receive a system generated message in your registered email address with an acknowledgement letter
as an attachment. An acknowledgement letter can also be downloaded from menu My Applications.
Important Note: You wont be able to fill the application form if required prerequisites are not
completed.
In case you have approved RSO (RSO approval received on paper), select Yes and provide required
detail and upload scan copy of RSO approval letter.
In case you do not have approved RSO, then select No and select one of your employee in the field
Name of the person designated as RSO for this equipment(this will not be applicable for CT and
Interventional Radiology equipment).
Important Note: Obtain prior approval of RSO for CT and Interventional Radiology equipment if you do
not have valid RSO.
After selection of equipment, two more tabs will be displayed (viz. Layout Detail and QA Test Report)
4. Layout Detail: If installation layout of your equipment is as per AERB model layout, then select
Yes
If X-ray equipment installation layout is not as per AERB model layout, then select No.
Provide the detail as per your room layout plan (as explained above in section D: Prepare
Layout)
upload copy of room layout plan(in case of CT and Interventional Radiology)
For Radiation Survey Report: Get radiation survey done from supplier of equipment or authorized
agencies as per prescribed format and provide the details in the application form (as applicable):
The exposure parameters to be selected for while carrying out survey are given in the table:
Provide the values of maximum radiation level (in mR/hr) at following places:
Near control console (operators position)
Outside patient entrance door
Behind chest stand wall
Behind window (if any)
Patient waiting area
5. QA Test Report: Refer QA test report of x-ray equipment and provide required test results.
Attach the copy of QA test report in the prescribed format (applicable for CT and
Interventional Radiology equipment).
For submission of your application form, read and select the terms and condition and click for Submit.
After successful submission you will receive the acknowledgement in your inbox and registered email.
Repeat the same procedure for submission of Licence application form for your other equipments.
Important Note: After supply of equipment, your supplier has to submit installation report on behalf of
your institute. After acceptance of installation report by AERB, you need to submit application for
Licence. (You will get notification of installation report acceptance in your eLORA account as well as in
your email).
Ensure that required Employee and Instrument details are provided in your account. Follow following
path to access Licence form:
Select the equipment id, agree terms and conditions and press submit button for submission of
your application form.
User is required to submit application form for Procurement of pre-owned X-ray equipment
through eLORA account.
After installation & commissioning of X-ray equipment, user will submit Intimation of Receipt
through eLORA.
Supplier/ Service Agency shall provide installation report & QA report to user (Required for
submission for License through eLORA)
User is required to apply for License for operation of pre-owned X-ray equipment through
eLORA.
9. Change in Layout:
In case of change in layout (due to Layout modification of installation, relocation and reposition of
equipment from its original place), you need to fill form for Change in Layout. Follow following path to
access this form:
Pl. note, in this form you will have to provide detail of shielding around X-ray equipment as asked in
Licence form. Fill the detail as required in the form and submit.
Regulatory Forms Medical Diagnostic RadiologySafety Status Report (Patient Examination Report
/Operation Safety Report)
Important Message
18. Non-compliance
In case, Non-compliance (NC) is raised against the institute,Employer needs to take immediate action to
resolve it. If more time is required for resolution of NC, same may be intimated to AERB with necessary
justification.
19. Authorised Service Agencies, AERB Type Approved X-ray equipment and AERB-
Licensed X-ray facilities
List of AERB Authorised Service Agencies on:
http://www.aerb.gov.in/AERBPortal/pages/English/X-Ray/X-Ray.jsp
List of AERB Type Approved X-ray equipment and AERB-Licensed X-ray facilities is available on:
https://elora.aerb.gov.in/ELORA/prePopulateGraphData.htm
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The Employer and Licensee of the organization as defined in Atomic Energy (Radiation
Protection) Rules, 2004, shall fulfill the responsibilities prescribed in the AERB safety code on
radiation safety in manufacture, supply and use Of Medical diagnostic x-ray equipment [AERB/RF-
MED/SC-3 (Rev. 2)].
The employer shall procure NOC validated/ Type Approved X-ray equipment from authorized
suppliers and after obtaining procurement permission from the Competent Authority.
No diagnostic X-ray equipment shall be operated for patient diagnosis unless Licence for operation
is obtained from the Competent Authority.
The room housing X-ray equipment shall have an appropriate area to facilitate easy movement of
staff and proper patient positioning. Appropriate structural shielding shall be provided for walls,
doors, ceiling and floor of the room housing the X-ray equipment so that radiation exposures
received by workers and the members of the public are kept to the minimum and shall not exceed
the respective limits for annual effective doses as per directives issued by the Competent Authority.
Appropriate overlap of shielding materials shall be provided at the joints or discontinuities.
The control console of computed tomography equipment shall be installed in a separate room
located outside but adjoining to computed tomography room and provided with appropriate
shielding, direct viewing and oral communication facilities between the operator and the patient.
The gantry and couch shall be placed such that it enables the operator to have the complete view of
the patient from the control room viewing window.
Interventional Radiology equipment room shall have an adjoining control room with appropriate
facilities for shielding, direct viewing and oral communication. In case of room housing
radiography equipment, chest stand shall be located in X-ray room such that no significant stray
radiation reaches at control console/entrance door/ areas of full time occupancy such that the dose
limits to radiation worker and members of public are not exceeded.
Mobile X-ray equipment, when used as fixed X-ray equipment, shall comply with all the
requirements of those of fixed X-ray installation. Movement of mobile X-ray equipment shall be
restricted within the institution for which it is registered.
A permanent radiation warning symbol and instructions for pregnant/likely to be pregnant women
shall be pasted on the entrance door of the X-ray installation, illustrating that the equipment emits
x-radiation.
X-ray equipment installed in a mobile van or vehicle, shall be provided with an appropriate
shielding enclosure to ensure adequate built-in protection for persons likely to be present in and
around the vehicle. Shielding shall be provided around the equipment from all the sides up to
height of 2m from external ground surface. Radiation warning symbol shall be displayed on all
sides of the vehicle.
Staffing Requirements
X-ray installations shall have a radiologist/related medical practitioner/ X-ray technologist with
adequate knowledge of radiation protection, to operate the X-ray equipment. The employees
involved in these activities are considered as radiation workers and shall comply with the duties
and responsibilities as prescribed in AERB safety code on radiation safety in manufacture, supply
and use Of Medical diagnostic x-ray equipment [AERB/RF-MED/SC-3 (Rev. 2)]. The minimum
qualification and training shall be as prescribed by the Competent Authority. All installations
having X-ray equipment with fluoroscopy facility, computed tomography and all establishments
performing special procedures, shall have the services of a qualified radiologist or related medical
practitioner, with adequate knowledge of radiation protection for interpretation and reporting.
Radiological Safety Officer (RSO)
X-ray department shall have a RSO approved by the Competent Authority. The RSO may either be
the employer himself/herself or an employee to whom the employer shall delegate the
responsibility of ensuring compliance with appropriate radiation safety/regulatory requirements
applicable to his X-ray installation. The minimum qualification and training shall be as prescribed
by the Competent Authority.
Appropriate radiation protection devices such as barrier, apron, goggles, and thyroid shields shall
be used during operation of X-ray equipment. These devices shall be verified periodically for their
shielding adequacy. The requirements for radiation protection devices are as specified in
Appendix-II.
The end user shall ensure that periodic QA of the equipment is carried out by AERB authorized agencies.
Periodic Quality Assurance shall be carried out at least once in two years and also after any repairs
having radiation safety implications.
Servicing
The end user shall ensure that servicing of the X-ray equipment is carried out by agencies
authorized by the regulatory body.
Renewal of Licence
The Licence accorded by the Competent Authority shall be renewed before its expiry.
Decommissioning of the X-ray equipment shall be carried out by authorized agencies with prior
intimation to the Competent Authority.
[Seal of Institute]
[Seal of Institute]
[Seal of Institute]
[Seal of Institute]
GOVERNMENT OF INDIA
ATOMIC ENERGY REGULATORY BOARD
NIYAMAK BHAVAN, ANUSHAKTINAGAR, MUMBAI 400 094
AERB/RSD/DRG-eLORA
(Completely filled & duly signed application form in hard copy needs to be submitted in case the institution has
incorrectly declared/made duplicate entries of medical diagnostic x-ray equipment in e-LORA. Please send the
filled in form to the Head, Radiological Safety Division, Atomic Energy Regulatory Board (AERB), Niyamak
Bhavan-B, Anushaktinagar, Mumbai-400094)
4. City:
5. Pin code:
6. State:
7. Name of the Licensee:
8. Name of the Employer:
UNDERTAKING:
I hereby certify that the particulars provided in this application are true and correct to the
best of myknowledge and belief. I understand that if at any stage it is found that the information
provided by me isfalse or not authentic, appropriate regulatory action may be initiated against me
and my institution.
Date:
Name: Name:
Designation: Designation:
SEAL
Verified by:
Approved by:
Date:
Signature