Aerb Guidelines Radiology 1w5w50

GUIDELINES FOR OBTAINING REGULATORY CONSENTS FROM AERB FOR OF MEDICAL DIAGNOSTIC X-RAY EQUIPMENT S 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 s 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

2

3 4

Telephone 044-26345288,04426630553/54/56

M/s. Renentech Lab. Private Limited,C-106, Synthofine Industrial Estate, Off Aarey Road, Goregaon(E),Mumbai,Pin-490063,

States Covered Andhra Pradesh, Tamil Nadu, karnataka, Kerala, Puducherry (Southern Region) Maharashtra, Gujarat, Rajasthan, Goa (Western Region)

M/s. Ultratech Lab. Private limited,Cloth Market, G.E. Road, kumhari, Bhilai, Durg, Chhattisgarh, Pin- 490042 Defence Laboratory, Jodhpur

All other states in the Central, Northern and North Eastern parts of the country All Defence institutions of the country

788-3295166, 09981212431

022-40037476

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:

Application form :

‐ ‐ ‐ ‐

‐ 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/SLA & PROC

AERB Type approved unit 23cm thick brick walls 2mmLead lined doors lead glass viewing window of 2 mm Pb equivalent ‐ Separate control room

AERB/RSD/MDX-CT-CATH/LCO

 

Interventional Radiology (Cath- Lab)

Any single dimension should not be less than 4m

2

25 m

‐ ‐ ‐ ‐ ‐ ‐

Application form: AERB/RSD/MDX-CT-CATH/SLA & PROC

AERB Type approved unit 23cm thick brick walls 2mmLead lined doors lead glass viewing window of 2 mm Pb equivalent ‐ Separate control room

 

Application form :

AERB/RSD/MDX-CT-CATH/LCO

‐ 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

Min. area requirement

Radiography/ Fluoroscopy

Any single dimension should not be less than 4m

18 m2

Any single dimension should not be less than 3.5m

15 m2

Any single dimension

12 m2

Bone densitometry

Dental/OPG

Requirements for Layout Approval

Application form:

Requirements for Registration

Application form :

AERB/RSD/MDX/SLA&PROC

AERB/RSD/MDX/REG

‐ 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

‐ Copy of layout approval ‐ Copy of valid NOC/ Type Approval certificate ‐ Copy of RSO approval ‐ Availability of PMS ‐ Copy of QA report

Application form:

Application form :

AERB/RSD/MDX/SLA&PROC

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

‐ Copy of layout approval ‐ Copy of valid NOC/ Type Approval certificate ‐ Copy of RSO approval ‐ Availability of PMS ‐ Copy of QA report

Application form:

Application form :

AERB/RSD/MDX/SLA&PROC

AERB/RSD/MDX/REG

‐ AERB Type approved unit

‐ Copy of layout approval

‐ 23cm thick brick walls ‐ 1.7 mm Lead lined doors ‐ Mobile protective barrier with lead glass viewing window of 1.7 mm Pb equivalent

should not be less than 3 m

Mammography

C-arm/Mobile

Any single dimension should not be less than 3 m

Not Applicable

10 m2

Application form:

AERB/RSD/MDX/SLA&PROC

‐ 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

Not applicable

Not Applicable

‐ 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 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.

7)

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 ed from www.aerb.gov.in e) Further guidance can be obtained from AERB Safety Code (AERB/SC/MED-2)