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 AERB certificate

Saiyam Shah
| Updated: 25 Aug, 2022 | Category: AERB Approval

How to Obtain AERB Approval for Dental X-Ray Equipment?

AERB Approval for Dental X-Ray Equipment
Reading Time: 3 minutes

AERB is a statutory body established on 15th November 1983 by The President of India, utilizing the power vested under Section 27 of the Atomic Energy Act, 1962[1]. It has been established to conduct regulatory and Safety functions. The main aim of AERB is to use ionizing radiation and nuclear energy in India to prevent health and environmental risk. The sole purpose of AERB is to reduce the amount of radiation introduced to humans. Consequently, AERB must administer rules & regulations to make sure radiology safety in India. Also, to ensure industrial Safety in the Department of Atomic Energy units, AERB regulates provisions of the Factory Act, 1948. Further in this piece of article, we shall discuss the AERB Approval for Dental X-Ray Equipment.

Is it mandatory to have AERB certificate?

The AERB – Atomic Energy Regulatory Board certificate is mandatory for all manufacturing Indigenous Medical Diagnostic X-Ray products and importing machinery with radiation to minimize the radiation effect for the Safety of humans. Thus without an AERB approval, the manufacturer will not be able to manufacture or import medical comprising radiation in India.

Function of AERB – Atomic Energy Regulatory Board

The following are some fundamental functions of AERB, they are:

  • AERB develop a safety policy in radiation, nuclear and industrial safety areas.
  • They also grant consent for siting, commissioning, construction, design etc. After an appropriate safety review and assessment for establishing nuclear and radiation facilities.
  • AERB also Ensure compliance with regulatory compliance through all stage of consenting through a system of review and assessment.
  • AERB body will also prescribe the nuclear exposure limit
  • It will also take the initiative to keep the public informed about the nuclear incident occurring in the nuclear installation in India.
  • It also promotes the Research & Development effort in the area of Safety.

Procedure for Obtaining AERB Approval for Dental X-Ray Equipment

The following are the Step by Step involved in obtaining the AERB Approval for Dental X-Ray Equipment

  • STEP1. On the official website, apply for institute Registration
  • STEP2. If your equipment is manufactured in India, an application for registration of Indigenous dental X-ray equipment has to be applied
  • STEP3. If your machinary or  equipment is not manufactured in India, an application for X-Ray obtaining will be filed. After that, an application for import Dental X-Ray equipment registration will be filed.
  • STEP4. If your equipment and submitted information comply with the prescribed standards, an AERB certificate/ license will be issued.
  • A detailed procedure has been mentioned for obtaining AERB Approval for Dental X-Ray Equipment.   

Checklist for Dental Radiology Regulatory Requirements

The following is the checklist for Dental Radiology Regulatory Requirements for Dental Practise.

  1. Institution Registration: The Dental clinic must register with any agencies accredited by Bhabha Atomic Research Centre to provide personnel radiation monitoring services. The following is the list of Agencies is:
    • RENENTECH LABORATORIES PVT LTD
    • AVANTTEC LABORATORIES PVT LTD (CHENNAI)
    • ULTRATECH LABORATORIES PVT LTD (CHHATISGARH)
  • The application form can be obtained by conducting any of the above–mentioned agencies & submitted back to the agency as per their submission process.
  • Once the application is submitted, the agency will register and send an email to the Atomic energy Regulatory Board – AREB website along with login credentials to the email id filled in the form.
  1. Personnel Monitoring: Details for gaining TLD dosimeter (badges) for the operators of the dental X-ray equipment should be filled in the Institute registration form itself.
  • It’s not compulsory to have a TLD badge for the operators of the dental X-Ray equipment. However, monitoring radiation exposure on a timely basis is essential to avoid radiation hazards. Each TLD pouch has two components:
    • External cassette.
    • Inner Refill Pouch
  • A new Refill pouch must replace the inner refill pouch on a quarterly basis. The agency will provide the new refill pouch, & the old refill pouch will be sent back to the agency to analyze & provide the TLD reading report.

Please note: The institute will also be getting a control TLD Badge which has to be kept in the radiation-free area of the clinic.

  1. Machine Registration: The X-Ray machine of the clinic has to be registered with the Atomic Energy Regulatory Board as per the instruction mentioned on site.
  1. Periodic Quality Assurance: The quality Test has to be performed on the X-Ray machine, the result has to be uploaded on the AERB portal with login credentials, and the test has to be conducted every five years. Once the results are uploaded, it will take 30-45 days to obtain a license from AERB to operate the X-ray machine.
  1. Decommissioning: It is Compulsory to intimate the AERB in case of withdrawal of the X-Ray units from services in case of clinic closure or relocation.

Validity

The Validity of the operating license is valid for initial five years. However, it has to be renewed upon the expiration of the term. 

Conclusion In this writing, we have elaborated on the AERB Approval for Dental X-Ray Equipment, though; the procedure of Atomic Energy Regulatory Board approval is quite comprehensive because it involves appropriate knowledge of aspects of the AERB certificate regulatory inspection, compliance with official requirements, and more.  

Read our Article:AERB Approval for X-Ray Machines: Document and Procedure

Saiyam Shah

Saiyam Shah has done his LL.M in Business Law from Amity Institute of Advanced Legal Studies – Amity University. His area of interest is legal research related to Indirect – Tax and Company law. He has prior experience in Tax litigation, dealing with various Income – Tax Assessments and has good drafting skills in filing arguments and replying to Income – Tax Notices.

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