Introduction: Atomic Energy Regulatory Board

AERB License | AERB Licence | AERB Registration | AERB Registration Online

Atomic Energy Regulatory Board provides a license that is a compulsory for indigenous producing of medical diagnostic x-ray equipment and people who imports Radiation Machines to minimise the effect of radiation coming out of the machine and provides safety to the human health.

--------------Blog Contact Form-------------

AERB regulates the amount of radiation to be given in a human body. The basic natural radiation to be given in Human body is 3mSv per year.

Machines That Are Covered To Take E-LORA (E-Licensing Of Radiation Applications) License Are As Follows

• X-Ray Machine (Fixed & Mobile)
• X-Ray Machine (Fluoroscopy)
• Portable X-Ray Machines
• Digital Radiography (DR)
• C Arm / O-Arm
• Dental X-Ray Machines
• Dental Orthopantogram (OPG)
• Cone Beam Computed Tomography (CBCT)
• Mammography
• Bone Mineral Density (BMD)
• Computerized Tomography (CT)  Scan
• Cath Lab

Who Is Responsible For Getting AERB Approvals And Licenses?

The main responsibility for the safety of patients, caretakers, and people in medical staff lies in the hands of the people who actually provide the facilities above. Therefore the facilitate owner should have the onus to prove the safety standards and ensure that all AERB registration is done approval licenses are in place and safety measures have been taken by the people in the premises. 

Validity of License

The license is valid upto 5years and renewal after that.

Pre-Requisites for Obtaining Authorisation for Supply of X-ray Equipment:

OEM Authorisation:

• Supplier shall obtain an OEM authorization for all equipment proposed to be supplied.

Radiation Testing Facilitate for Demonstration of Type Approval:

• A testing facilitator should also be there other than in the area of work not related to testing or radiating.
• Limits are prescribed for radiation workers and the public in the area that is being limited. Protective accessories are also provided in the area of testing.
• A warning placard shall be displayed outside the testing facility.
• The radiation Symbol is placed in the area where radiating is going on and one can get contaminated and should take safety measures to avoid it, generally, the trefoil ionizing radiation symbols are used (Fig. 1, 2). These are magenta or black propellers on yellow background. For radiation hazards associated with an X-ray machine the symbol used is given in Fig. 3. For internal components inside a device/machine that contains radiation hazards the symbol recommended by ISO and IAEA is given in Fig. 4. The chart that is supposed to be posted on AERB approved X-ray facilitate is given in Fig. 5.

Staff Requirements

• Qualified staff should be recruited for testing purposes, QA, and servicing of XRAY machines. Qualification and training shall be prescribed by the AERB authority. 

Radiological Safety Officer (RSO)

• In case if the supplier has in house radiating center than a radiological safety officer (RSO) should also be employed with the approval of the regulatory body.

Conditions of Supplier Authorization

• The Supplier shall supply the equipment that is AERB-approved models.
• Lifetime servicing should also be provided in respect of diagnostic x-ray equipment.
• Ensures that the customer that is purchasing shall have the safety protective devices like a protective barrier, protective apron, couch hanging lead equivalent rubber flaps, as applicable.
• Shall submit the installation report to the regulatory body in the prescribed format. 
• Shall check for layout and shielding adequacy at the customer site.
• Shall carry out dismantling/ decommissioning of equipment at customer end and inform AERB for further action as deemed fir by the department. 
• Any other conditions laid by the Authority from time to time. 

E-Approval/ No Objection Certificate (NOC)

• Approval shall be taken by the Authorised suppliers.
• Prior to marketing the x-ray equipment the supplier of imported equipment shall obtain a Type Approval Certificate from the competent authority, on demonstration of the performance of the prototype of x-ray equipment.
• Import of prototype of x-ray equipment, meant for Type Approval, shall be carried out by the recognized supplier only after obtaining NOC for import for Type Approval, from the competent authority.
• Type Approval/NOC will be issued only if the equipment satisfies the safety specifications of this Code and the standards in force.
• Once x-ray equipment is Type approved, routine Import of the type-approved models shall be carried out only after obtaining procurement permission, for each consignment, from the competent authority.
• Type Approval becomes invalid if any change is made in the design of the Type approved model.

Periodic Safety Reports:

• The Licensee shall submit periodic safety status reports in the format given by the Authorised Body.

Renewal Of Authorization:

• Before expiry, the license shall be renewed. 

Termination of Services:

• AERB shall be intimated in case the supplier decides to cease functioning as a supplier.
• Any person who contravenes the above-prescribed rules shall be punished under the Atomic Energy Act, 1962.
• Enforcement actions by AERB include:
• Enforcement letter
• Issue of written directives
• Orders to curtail activities
• Modification, suspension, or revocation of consents or authorizations, or licenses
• Initiation of other penal actions
• Further, a lead inspector is empowered to implement on-the-spot enforcement action in consultation with Chairman AERB.
• In case of disagreement on the decisions of the regulatory body, the licensee may appeal against such decisions to the Atomic Energy Commission (AEC).

Steps for Obtaining a License Through E-LORA

• Step 1: Register your institute with e-LORA
• Step 2: Declaration of x-ray equipment details with e-LORA
• Step 3: If declared x-ray equipment already has valid AERB Licence/Registration: Record Licence details

If declared x-ray equipment does not have valid AERB Licence/Registration: Obtain AERB Licence for operation

Checklist for submission of application form for Licence

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

• Name of the Hospital/Institution: 
• City 
• State
• Checkpoints

• Place:                             Signature: 

Date: Name of the Applicant:

How to register an institute under AERB

• Log in to e-LORA.
• Click ‘Register Institute’ ⇒ fill out the application form 
• In the tab ‘Institute Details’, the following will be required.
  • Proof of registration with the Central govt.: A numbered certificate from the Registrar/Adjutant Hospital stating the Government Of India authority under which the unit was established (as mentioned in the unit policy page). This number will have to be mentioned during registration.
  • Unit PAN/TAN number: TAN number is available in the unit accounts section.
• Select ‘Diagnostic Radiology’ as the type of facilitate from the drop-down list and ‘Medical diagnostic X-ray facilitate’ as the role of the institute from the sublist that appears.

End point: On submission of the completed application form, the employer will receive the login details required for the further registration process.

NB: The hospitals already registered for radiotherapy and/or nuclear medicine facilities only need to add diagnostic radiology in their existing profile and can bypass steps 1–4 above.

Registration of RP

Simply following the steps as illustrated below will enable a smooth registration process for RPs:
eLORA home page ⇒ ‘Register RP’ ⇒ ‘Personal details’. At this stage, carefully select practice as Diagnostic Radiology and professional role as Radiation Safety Professional.
Complete the educational details of each RP and upload the necessary attachments.

NB: A newly posted individual with RSO certification in a previous unit will have to be registered afresh as RP from the present unit for him to be nominated as RSO of the unit.
End point: Upon acceptance of the application, a RP id will be issued

Application for license

• Login to your eLORA account using the employer’s allotted username and password.
• Declare equipment: Click on the tab ‘Declare existing X-ray equipment’. Each piece of equipment will have to be individually declared. During this process, maximum KvP and maximum mAs are to be entered as per the equipment manual.

NB: The manufacturer and model name should be selected from the pre-existing list provided, and if not in the list, it should be carefully typed. Once submitted, it cannot be changed as there is currently no provision for deleting wrong entries.
Endpoint: After submission of details for each piece of equipment note down the unique equipment id.

Add RW – ELORA account home page ⇒ Add employee.

• Provide required information of all RWs, and in case of shortage of RW, roles of both practitioner and operator can be assigned to any medical officer using Ctrl key (ref para 5 of preliminary preparation).

Add RP – eLORA account home page ⇒ Add employee RP ⇒ Select Registration ID and find out name of RP.

• NB: Add as many RPs as feasible for ease in change of RSO in case of transfer of existing RSO.

Nominate RSO – From amongst the RP, an RSO has to be nominated as follows:

• Menu ⇒ regulatory forms ⇒ common forms nominate RSO
• Select the name of the employee in RP.
• At this stage, it is crucial to ‘Freeze’ the completed form and note the generated application number.
• Download and print a portable document format (PDF) of the saved application form ‘My Applications’ on the eLORA account home page. Upload the scanned first page in PDF format, duly stamped and signed by CO hospital and nominated RSO. Application status will now change to signed PDF uploaded.
• Complete submission of the application form (application Status will change to Submitted).
• On acceptance of the nomination, notification will be received in the eLORA account.

Add instrument – Instrument Management’ ⇒ Add Instrument.

• Select the type of instrument as a Safety tool.
• Select the requisite type of safety tool and add details.

Fill application form – click on license for operation of existing equipment and fill the form.

• Employee details and safety tool details will be available as per paras 3–6 above.
• General Details: Select ‘Licence for Operation’ for first-time application and ‘Renewal of Licence for Operation’ for renewal of existing Licence. Select the equipment and select yes for approved RSO.
• Layout details: Upload scanned copies of AERB-approved layout plans for CT and IR equipment. If the layout is not approved, fill in the requisite details vide para 8 (e, f) of preliminary preparation.
• QA test report: Fill in the requisite details from test report.

NB:

Half value thickness (HVT) is Aluminium (Al) thickness added in mm that is closest to 50% transmission. This can be calculated from the graph/table labeled ‘Total filtration’ provided in the report. A value of 2.5 mm or lower will not be accepted by the system.

The accuracy of operating potential can be determined from a table in the report labeled ‘Accelerating voltage’ or ‘Measurement of operating potential’.

Maximum radiation leakage level from the X-ray housing tube should be mentioned in milligray (mGy) in 1 h and not in milliroentgen (mR). The conversion factor of 1 mGy = 100 mR can be used if the report mentions the value only in mR.

Ensure completing steps 3–6 before step 7 to avoid system errors.

• Repeat the above steps separately for all those equipment without a license.

NB: If equipment has an existing valid license, declare the equipment as in para 2 and record the license as follows:

• Click ‘Record Licence for the operation of X-ray equipment’.
• Selected the equipment id from the provided list.
• Enter the reference number, issuance date, and expiry date as appearing on the AERB license and upload a copy of the same.
  1. After submission, the status of all the applications can be checked from ‘My applications’ tab after logging in
  2. It usually takes 1–2 weeks time for an online license to be issued if all the documents are correct.