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AERB Approval For X-Ray Machines: Document And Procedure

Atomic Energy Regulatory Board (AERB registration), X-Rays machines for medical use and diagnosis have proved to be immensely helpful to the society. The use of X - Ray radiation is associated with health risks, so it's important to take care when using it. Atomic Energy (Radiation Protection) Rules - 2004 under the Atomic Energy Act - 1962 provides the framework to safely handle radiation generating equipment – in the context of X ray equipment. To ensure radiation safety for patients, workers and the public, all X-ray machines must be licensed by the Atomic Energy Regulatory Board [1].


A image of AERB


Functions of AERB Registration

Below are some of the functions of AERB Certificate that have been described to help you better understand, know and work of AERB Registration.

  • The role of the department is to develop policies for radiation safety and industrial safety in facilities.

  • Create guides, safety standards and codes for the siting, construction, design and commissioning of various types of nuclear and radiological facilities.

  • AERB Certificate grants approval for construction, commissioning and operation of nuclear and radiation facilities after a safety assessment.

  • Assure compliance with regulatory requirements prescribed by AERB at all stages of consenting, through a system that includes review and assessment, regulatory inspections and enforcement.

  • Examine the qualification and training programs for nuclear and radiation facility personnel and the licensing policies and prescribe the syllabus to train personnel at all levels in safety issues.

  • It is possible to take the necessary steps to inform the public about a radiological issue that has significant safety implications.

  • Safety R&D should be promoted

  • Under its preview, it examines the safety of nuclear and industrial facilities.

  • Reviewing safety related nuclear security aspects

  • The Civil Liability for Nuclear Damage Act 2010 mandates that the Indian government notify the public of nuclear incidents in nuclear installations.

Documents and Procedures Required for AERB Approval of X-Ray machines

Here are the documents and procedures required to obtain AERB approval for X-Ray Machines.

STEP1.

  • Employer Identity proof, date of birth (PAN/Passport/Driving License/Photo ID issued by Government of India)

  • Employer ship proof

  • PAN/TAN is a scanned version of the document issued by the government authority

  • Other documents prove the Institute deals with the supply and use of consumer goods or scanning facilities.

STEP2.

  • Add an appropriate instrument for radiation surveys to the instrument management.

  • A letter of agreement from OEM authorizes the Indian Supplier to provide the equipment in India.

  • The OEM or the institution that supplied the equipment must provide a training certificate for the maintenance, servicing, and radiation safety of the equipment.

STEP3The application for NOC must be submitted.

  • Certificate of Conformity for the Device including Generator, X-Ray Tube, and Monoblock - English version of CE / FDA Certificate, or equivalent. Preferably issued by notified/certified bodies.

  • The design certification is issued by the competent authority of the country of manufacture regarding radiological safety.

  • Details of the X-ray tube and generator system (maximum operating voltage (kV), maximum current (mA), capacity of generator (watt), size of focal spot, type cooling system, type High Voltage Generator etc.)

  • The operation manual and technical catalogue of the X-ray equipment/tubes as a unit

  • Maintenance and servicing the equipment until its useful life

  • Report on the measurement of radiation leakage 5 cm away from the outer surface of the cabinet, at maximum kV with maximum mA. (max. (max. The measurement area should preferably not exceed 10 cm2.

Details To Submit Regarding - AERB Approval Of X-Ray Equipment

  • Location and availability of emergency stop buttons

  • Display of beam status (ON/OFF).

  • Details about protective drapes, door and other interlocks.

  • If the machine has a password-protection function and essential control functions.

The licensee must submit periodic safety report in the format and frequency specified by regulator. The renewal of the authorisation must be done before the expiration date for competent authority. The AERB Registration will inform the Supplier if he decides to stop functioning as a provider.

Conclusion

The Atomic Energy Regulatory Board must be consulted for approval to use X-ray machines. In addition, AERB's role has been discussed in detail. For a better understanding, the AERB Approval of X-Ray Machines and required documents have been described in detail.

 

 

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