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Statutory Requirement- Mandatory AERB approval for Radiodiagnostic Centres

(Published- The Tribune, July 29, 2011)
Government of India

ATOMIC ENERGY REGULATORY BOARD

Notice

STATUTORY REQUIREMENTS FOR INSTALLATION AND SAFE OPERATION OF MEDICAL X-RAY EQUIPMENT OF DIAGNOSTIC PURPOSE BY HOSPITALS, CLINICS AND OTHER

MEDICAL INSTITUTIONS IN INDIA

 

Owners of Diagnostic facilities using medical X-Ray equipment such as radiograph. Fluoroscopy units, CT Scanners, Interventional Radiology X-ray Units, Mammography units , Dental X-ray units and Bone Scanners in India should comply with the following regulatory requirements:

·        Obtain Approval for the site and layout of X-ray installation from AERB.

·        Obtain License for CT and interventional Radiology X-ray Unit installations for operation from AERB.

·        Obtain Registration for operation of other medical X-ray units such as Radiograph/Fluoroscopy units, Mammography units, Dental X-ray units and bone Scanners form AERB.

·        Install only AERB Type Approved medical X-ray equipment.

·        Ensure that Quality Assurance Performance Tests of the medical X-ray equipment are carried out by x-ray equipment manufacturer /supplier once in two years.

·        Employ personnel possessing the qualifications as prescribed in Appendix III of AERB/SC/Med-2(Rev.1), 2001.

·        Provide personnel monitoring badges for staff members associated with the operation of X-ray units.

·        Comply with AERB Safety Code No. AERB/SC/Med-2(Rev.1), 2001, Atomic Energy (Radiation Protection) Rules, 2004 and other directives issued in the regard form time to time by AERB.

Medical X-ray installations shall be subject to periodic inspection by personnel authorized under Section 17 of the Atomic Energy Act, 1962, by Chairman, AERB who is the competent Authority for enforcing provisions of radiation safety in the use of iorizing radiation. Non-compliance with the regulatory requirements may result in closure of the X-ray installations.

Legal provisions for regulating medical X-ray equipment are following :

·        Atomic Energy Act, 1962

·        Atomic Energy (Radiation Protection) Rules, 2004

·        Radiation Surveillance Procedures for Medical Applications of Radiation, 1989

·        AERB Safety Code for Medical Diagnostic X-ray Equipment and Installations No. AERB/SC/Med-2(Rev.1), 2001

These Documents and the relevant application forms for medical X-ray equipment may be downloaded from AERB Website http://www.aerb.gov.in

 

Head, Radiological Safety Division

 

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