GUIDELINES FOR OBTAINING REGULATORY CONSENTS FROM AERB FOR OF MEDICAL DIAGNOSTIC X-RAY EQUIPMENT USERS 1) Layout Approvals

(CT/Cathlab /X-ray/Mammo/OPG/BMD etc.): • Completely filled, duly signed and stamped application form ( As per Tables A and B; as applicable) • 2 duly signed and stamped copies of layout to the scale 1:50 indicating positions of gantry, couch, protective barriers, control room, doors(with lead lining), wall thickness, internal dimensions of the room etc. (sample layouts enclosed) • 1 duly signed and stamped copy of floor layout to the scale 1:100 indicating location of X-Ray/ CT-scan/IR installation and occupancy in the surrounding areas. • Copy of valid NOC/Type Approval certificate • DD for Rs. 3300/- (for Government hospitals Rs. 1650.00/- only) in favour of “Pay and Accounts Officer, AERB” on SBI service branch, Mumbai as layout approval charges. 2) RSO Approval: • • • Completely filled, duly signed and stamped application form (AERB/RSD/RSO/APP) Copy of certificates of educational qualifications Minimum eligibility criteria ‐ Qualifications of radiologist/technician as per AERB Safety Code (AERB/SC/MED-2) ‐ Availability of Personnel monitoring number.

3) Personnel Monitoring Service providers
Sr. No. 1 Name of Accredited Laboratory M/s. Avanttec Lab. Private Limited,31,Kamraj Street, Srinivasa Nagar, Padi, Chennai, Tamil Nadu, Pin-600050 M/s. Renentech Lab. Private Limited,C-106, Synthofine Industrial Estate, Off Aarey Road, Goregaon(E),Mumbai,Pin-490063, M/s. Ultratech Lab. Private limited,Cloth Market, G.E. Road, kumhari, Bhilai, Durg, Chhattisgarh, Pin- 490042 Defence Laboratory, Jodhpur States Covered Andhra Pradesh, Tamil Nadu, karnataka, Kerala, Puducherry (Southern Region) Maharashtra, Gujarat, Rajasthan, Goa (Western Region) All other states in the Central, Northern and North Eastern parts of the country All Defence institutions of the country Telephone 044-26345288,04426630553/54/56 022-40037476

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788-3295166, 09981212431

area requirement 25 m2 Requirements for Layout Approval Requirements for Licence Application form: ‐ ‐ ‐ ‐ AERB/RSD/MDX-CT-CATH/SLA & PROC Application form : AERB/RSD/MDX-CT-CATH/LCO AERB Type approved unit 23cm thick brick walls 2mmLead lined doors lead glass viewing window of 2 mm Pb equivalent ‐ Separate control room 2 ‐ Copy of layout approval ‐ Copy of valid NOC/ Type Approval certificate ‐ Copy of RSO approval ‐ Availability of PMS ‐ Copy of QA report ‐ Copy of Radiation Protection Manual     AERB/RSD/MDX-CT-CATH/LCO Interventional Radiology (Cath. Completely filled.4) Licence ( For CT and Interventional Radiology installations ) • • Completely filled.Lab) Any single dimension should not be less than 4m 25 m ‐ ‐ ‐ ‐ ‐ ‐ Application form: AERB/RSD/MDX-CT-CATH/SLA & PROC Application form : AERB Type approved unit 23cm thick brick walls 2mmLead lined doors lead glass viewing window of 2 mm Pb equivalent ‐ Separate control room ‐ Copy of layout approval ‐ Copy of valid NOC/ Type Approval certificate ‐ Copy of RSO approval ‐ Availability of PMS ‐ Copy of QA report ‐ Copy of Radiation Protection Manual . (by hospital authority and counter signed by supplier of the equipment) TABLE -A  Type of X-ray unit Computed Tomography Minimum dimension requirement Any single dimension should not be less than 4m Min. duly signed and stamped application form (AERB/RSD/MDX-CT-CATH/LCO) with authenticated staff list including names of radiologists. technicians and RSO with PMS numbers. duly signed and stamped QA report.

7 mm Pb equivalent ‐ Separate control room ( for X-ray equipment > 125kVp 15 m2 AERB/RSD/MDX/SLA&PROC ‐ Copy of layout approval ‐ Copy of valid NOC/ Type Approval certificate ‐ Copy of RSO approval ‐ Availability of PMS ‐ Copy of QA report Bone densitometry Any single dimension should not be less than 3.7 mmLead lined doors ‐ Mobile protective barrier with lead glass viewing window of 1. duly signed and stamped QA report.7 mm Lead lined doors ‐ Mobile protective barrier with lead glass viewing window of 1. duly signed and stamped application form (AERB/RSD/MDX/REG) with authenticated staff list including names of radiologists.5) Registration ( For X-Ray/ Mammography/BMD/Dental/OPG/C-arm/Mobile X-Ray installations ) • • Completely filled.5m Application form: AERB/RSD/MDX/REG Application form : ‐ AERB Type approved unit ‐ 23cm thick brick walls ‐ 1.7 mm Pb equivalent 12 m2 AERB/RSD/MDX/SLA&PROC ‐ Copy of layout approval ‐ Copy of valid NOC/ Type Approval certificate ‐ Copy of RSO approval ‐ Availability of PMS ‐ Copy of QA report AERB/RSD/MDX/REG Dental/OPG Any single dimension Application form: Application form : ‐ AERB Type approved unit ‐ Copy of layout approval . area requirement 18 m2 Requirements for Layout Approval Requirements for Registration Radiography/ Fluoroscopy AERB/RSD/MDX/SLA&PROC Application form: AERB/RSD/MDX/REG Application form : ‐ AERB Type approved unit ‐ 23cm thick brick walls ‐ 1. Completely filled. (by hospital authority and counter signed by supplier of the equipment) TABLE -B   Type of X-ray unit Minimum dimension requirement Any single dimension should not be less than 4m Min. technicians and RSO with PMS numbers.

Important Points to be noted: a) No two equipments should be installed in the same room.in e) Further guidance can be obtained from AERB Safety Code (AERB/SC/MED-2) 7) .should not be less than 3 m ‐ 23cm thick brick walls ‐ 1. Paediatric and Sonography rooms and other departments not directly related to radiation and use. d) All forms and related information could be downloaded from www.aerb.7 mm Lead lined doors ‐ Mobile protective barrier with lead glass viewing window of 1.7 mm Lead lined doors ‐ Mobile protective barrier with lead glass viewing window of 1.7 mm Pb equivalent 10 m2 Mammography Any single dimension should not be less than 3 m Application form: AERB/RSD/MDX/SLA&PROC ‐ Copy of valid NOC/ Type Approval certificate ‐ Copy of RSO approval ‐ Availability of PMS ‐ Copy of QA report duly signed and stamped by head of institution and the supplier Application form : AERB/RSD/MDX/REG ‐ AERB Type approved unit ‐ 23cm thick brick walls ‐ 1.gov.7 mm Pb equivalent C-arm/Mobile Not Applicable Not applicable Not Applicable ‐ Copy of layout approval ‐ Copy of valid NOC/ Type Approval certificate ‐ Copy of RSO approval ‐ Availability of PMS ‐ Copy of QA report duly signed and stamped by head of institution and the supplier Application form : AERB/RSD/MDX/REG ‐ Copy of valid NOC/ Type Approval certificate ‐ Copy of RSO approval ‐ Availability of PMS ‐ Copy of QA report 6) Renewal of Licence/ Registration: The X-ray equipment should obtain the renewal of the Licence/Registration within a month of the expiry of their Licence/Registration. c) Periodic Safety Status reports as per format given in AERB website should be submitted annually for CT/Cathlab facilities. b) X-ray installations should be located as far as away as feasible form areas of high occupancy such as Maternity.

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