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Saiyam Shah
| Updated: 10 Aug, 2022 | Category: AERB Approval

AERB Approval for X-Ray Machines: Document and Procedure

AERB Approval for X-Ray Machines
Reading Time: 3 minutes

Atomic Energy Regulatory Board (AERB), X – Rays machines for medicinal use for diagnosis have proven to be immensely beneficial to society. It has also been proven that the use of X-Ray radiation has health risks associated with it; hence, it has required that proper care is exercised during its operation. The Atomic Energy (Radiation Protection) Rules-2004, under the Atomic Energy Act, 1962, provides the framework for safely handling radiation generating equipment – in the context of X-Ray equipment. All X-ray users must obtain the License for Operation from the Atomic Energy Regulatory Board[1] to ensure the radiation safety of patients, occupational workers, and public members; further, we will be discussing the AERB Approval for X-Ray Machines.

Functions of AERB

The following are the functions of AERB, which have been discussed below for a better understanding, knowledge and working of AERB.

  • Its function is to develop safety policies in radiation and industrial safety areas for facilities.
  • Develop guides, safety codes and standards for sitting, construction, design, commissioning, operation and decommissioning of different types of nuclear and radiation facilities.
  • AERB also grants consent for Siting, construction, commissioning, operation and decommissioning after an appropriate safety assessment and review for the establishment of nuclear & radiation facilities.
  • Ensure compliance with the regulatory requirements prescribed by AERB during all stages of consenting through a system of review and assessments, regulatory inspection and enforcement.
  • Review qualification, the training program and licensing policies for personnel of nuclear and radiation facilities and prescribe the syllabus for training of personnel in safety aspects at all levels.
  • Necessary steps can be taken to keep the public informed on a significant issue of radiological safety significance.
  • Promote R&D efforts in the areas of safety
  • Reviewing the industrial and nuclear safety aspects in nuclear facilities under its preview
  • Reviewing the safety-related nuclear security aspects
  • Notify the public about nuclear incidents occurring in the nuclear installations In India as it is mandated by the Civil Liability for Nuclear Damage Act – 2010.

Documents and Procedure Required for AERB Approval for X-Ray Machines

The following are the procedure and documents required for the AERB Approval for X-Ray Machines.

STEP1. The First step is to make a registration application to the Institute with the required documents mentioned below-

  • Employer Identity proof, date of birth (PAN/Passport/Driving License/Photo ID issued by Government of India)
  • Employer ship proof
  • PAN/TAN any one scanned copy of issued from the government authority
  • Other documents prove that the InstituteInstitute is dealing with the supply or use of consumer products and scanning facilities.

STEP2. After an application is filed with the InstituteInstitute, an authorization application is to be submitted to the Supplier, along with-

  •  Adding an appropriate radiation survey instrument in the instrument management.
  • An agreement letter from OEM authorized the Indian Supplier to supply the equipment in the country.
  • A training certificate from the OEM of the person from the supplier Institution for maintenance, servicing and radiation safety aspects of the equipment.

STEP3. Application for NOC is to 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 body.
  • Design certification from the Competent Authority of the country of origin concerning radiological safety, as applicable.
  • Technical details of X-ray tube &  generator system [maximum operating potential (kV), maximum operating current (mA), generator capacity (watt), focal spot size, type of cooling system, type of High Voltage generator etc.]
  • Operation manual  & technical catalogue of X-ray tube/equipment as a whole
  • Undertaking for maintenance and servicing of the equipment till its useful life
  • Test report for measurement of radiation leakage at 5 cm from the outer accessible surface of the cabinet at maximum kV and corresponding maximum mA. (max. Permissible levels are one microsSv/h). The cross-sectional area of measurement preferably should not be greater than 10 cm2

Details required to be submitted regarding – AERB Approval for X-Ray Machines

  • Availability of emergency stop Buttons and their locations
  • Whether display on the control for beam status (ON/OFF) is available
  • A detail about the availability of protective drapes, doors and other interlocks.
  • Whether essential control operation and password protection operation is provided in the machine.

Once the applicant has been granted the license, the licensee shall submit periodic safety reports in the format & frequency specified by the regulator body. The authorisation renewal must be renewed before expiry for the competent authority. If the Supplier decides to cease functioning as a supplier, the AERB shall be intimating it.

Conclusion

After reading this article, it can be concluded that approval has to be obtained from the Atomic Energy Regulatory Board for the use of X-ray machines; further, in this writing, the function of AERB has also been mentioned and discussed elaborately. The procedure and documents required for the AERB Approval for X-Ray Machines have been explained in detail for a better understanding and knowledge.

Read our Article:Regulation for all Medical Devices under CDSCO Directive

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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Saiyam Shah
Saiyam Shah | Date: 25 Aug, 2022

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