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    AERB Guidelines Radiology

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    Tejinder
    The document outlines the guidelines and requirements for obtaining regulatory consents from the Atomic Energy Regulatory Board (AERB) for medical diagnostic x-ray equipment users in India. It discusses the application process and required documents for layout approvals, RSO approval, personnel monitoring service, licensing, registration, and renewal of licenses. Specific requirements are provided for different types of x-ray equipment like CT scans, radiography, mammography, and more. Important points around installation, periodic safety reports, and further guidance are also mentioned.

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    AERB Guidelines Radiology

    Uploaded by

    Tejinder
    9K views4 pages
    The document outlines the guidelines and requirements for obtaining regulatory consents from the Atomic Energy Regulatory Board (AERB) for medical diagnostic x-ray equipment users in India. It discusses the application process and required documents for layout approvals, RSO approval, personnel monitoring service, licensing, registration, and renewal of licenses. Specific requirements are provided for different types of x-ray equipment like CT scans, radiography, mammography, and more. Important points around installation, periodic safety reports, and further guidance are also mentioned.

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    The document outlines the guidelines and requirements for obtaining regulatory consents from the Atomic Energy Regulatory Board (AERB) for medical diagnostic x-ray equipment users in India. It discusses the application process and required documents for layout approvals, RSO approval, personnel monitoring service, licensing, registration, and renewal of licenses. Specific requirements are provided for different types of x-ray equipment like CT scans, radiography, mammography, and more. Important points around installation, periodic safety reports, and further guidance are also mentioned.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    9K views4 pages

    AERB Guidelines Radiology

    Uploaded by

    Tejinder
    The document outlines the guidelines and requirements for obtaining regulatory consents from the Atomic Energy Regulatory Board (AERB) for medical diagnostic x-ray equipment users in India. It discusses the application process and required documents for layout approvals, RSO approval, personnel monitoring service, licensing, registration, and renewal of licenses. Specific requirements are provided for different types of x-ray equipment like CT scans, radiography, mammography, and more. Important points around installation, periodic safety reports, and further guidance are also mentioned.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 4

    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

    3 4

    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
    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- 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)

    7)

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