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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

4) Licence ( For CT and Interventional Radiology installations ) Completely filled, 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. Completely filled, duly signed and stamped QA report. (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. 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
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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- 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

5) Registration ( For X-Ray/ Mammography/BMD/Dental/OPG/C-arm/Mobile X-Ray installations ) Completely filled, duly signed and stamped application form (AERB/RSD/MDX/REG) with authenticated staff list including names of radiologists, technicians and RSO with PMS numbers. Completely filled, duly signed and stamped QA report. (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. 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 1.7 mmLead lined doors Mobile protective barrier with lead glass viewing window of 1.7 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 3.5m

Application form:

AERB/RSD/MDX/REG

Application form :

AERB Type approved unit 23cm thick brick walls 1.7 mm Lead lined doors Mobile protective barrier with lead glass viewing window of 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

should not be less than 3 m

23cm thick brick walls 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 1.7 mm Lead lined doors Mobile protective barrier with lead glass viewing window of 1.7 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. Important Points to be noted: a) No two equipments should be installed in the same room. b) X-ray installations should be located as far as away as feasible form areas of high occupancy such as Maternity, Paediatric and Sonography rooms and other departments not directly related to radiation and use. c) Periodic Safety Status reports as per format given in AERB website should be submitted annually for CT/Cathlab facilities. d) All forms and related information could be downloaded from www.aerb.gov.in e) Further guidance can be obtained from AERB Safety Code (AERB/SC/MED-2)

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