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    Import - 1st Time-X-Ray device-NOC-TA

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    bhavin178
    AERB Guidelines for Import of Industrial X Ray machines

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    Import - 1st Time-X-Ray device-NOC-TA

    Uploaded by

    bhavin178
    4 views4 pages
    AERB Guidelines for Import of Industrial X Ray machines

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    Import -1st time-X-ray device-NOC-TA

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    AERB Guidelines for Import of Industrial X Ray machines

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    4 views4 pages

    Import - 1st Time-X-Ray device-NOC-TA

    Uploaded by

    bhavin178
    AERB Guidelines for Import of Industrial X Ray machines

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
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    GUIDELINES FOR X-RAY BASED INDUSTRIAL RADIOGRAPHY DEVICES

    IMPORTED FOR THE FIRST TIME

    For any equipment involving ionizing radiation, which is manufactured outside India, the
    procedure for its use in India is as follows

    A ‘No Objection Certificate (NOC)’ is required for import of each model of device. The NOC
    (for the first time import) can be obtained from AERB by the Indian agent/vendor or Indian
    subsidiary of the parent foreign company. This NOC is issued to facilitate import of the device
    for Type Testing in the presence of representative(s) of AERB. For obtaining type approval, the
    following steps are to be followed:

    i. After the import of the device, the Indian supplier of the device should perform
    radiation safety related tests by using own radiation survey meter and Submit the
    detailed test report to: elora.ir@aerb.gov.in
    ii. Once the submitted test report is found to be satisfactory, inspection process will
    be initiated by AERB
    iii. ‘A regulatory inspection report’ will be generated through e-LORA by the AERB
    inspector(s) based on the observations during Type Approval Inspection
    iv. Once performance of the device is found to be satisfactory, the supplier can
    submit the application for “NOC to Type Approval’
    v. Once Type Approval Certificate (currently valid for 3 years) is issued. The
    supplier can supply any number of equipment to AERB authorised end users.

    Prerequisites for authorization by AERB to be a supplier

    a. Availability of trained man power i.e. Radiography Testing Level-2 (RT-2) qualified
    person
    b. Copy of authorization letter issued by original equipment manufacturer (OEM) indicating
    that the Indian institution is authorized for import, sale and after sales services
    c. Copy of letter issued by (OEM) indicating that the employee(s) of the Indian institution
    is/are trained for servicing (model specific) of devices to be supplied in India
    d. Appropriate Radiation measuring and monitoring instruments.

    At present processing of the applications are done through the online portal of AERB i.e. e-
    LORA (https://elora.aerb.gov.in/ELORA/)

    Steps for a supplier to obtain NOC through e-LORA:

    1. Register your institute (as Supplier-Industrial Radiography Devices) with AERB. The
    guide lines for registration of an institute is available in the following Link:
    https://elora.aerb.gov.in/ELORA/populateLoginAction.htm:

    Once the application for registration of institute is approved, you will receive user id and
    pass word.

    2. Supplier Authorization should be obtained through e-LORA.

    For getting supplier authorization following are the pre- requisites

    (i) Declaration of instruments like survey meter(s), direct reading dosimeter


    (s) (pocket dosimeter), in e-LORA. {After logging into your account go to
    institute management tab click to add instrument tab}
    (ii) Addition of employees like certified radiographer and Site-in-Charge
    {After logging into your account go to user management tab click to
    add employee tab}
    (iii) Nomination of certified radiographer and Site-in-Charge by
    submitting the application “Nominate Employee” (Note: only registered
    radiation professionals i.e. certified radiographer and Site-in-Charge can
    be nominated)Note: After approval of radiographer/Site-in-Charge,
    Application for personal monitoring service need to be submitted to the
    accredited laboratories with a copy of approval letter issued by AERB
    {After logging into your account go to user management tab
    Nominate/relinquish tab}

    3. NOC for import can be obtained by providing documents like:

     Copy of Competent Authority Approval certificate for the equipment


    issued by the country of origin
     A copy of test report with respect to radiation safety
     A copy of national/international standards certificate for the whole device
    e.g. CE certification with respect to electrical and mechanical safety
     A letter indicating (paragraph wise) that the device meets Section 2.4 of
    AERB Safety Code on Industrial Radiography (AERB/RF-IR/SC-1
    (Rev.1))

    4. Once NOC (valid for one year) is issued to the supplier, the end user can approach AERB
    for procurement of device. It may be noted that once NOC is issued to the supplier, the
    particular model name will available for selection in the “Procurement of Radiography
    Device” application form for the end users.

    For end user the steps for obtaining permission for procurement of industrial radiography
    device are:
    Register your institute (as Supplier-Industrial Radiography Devices) with AERB. The
    guide lines for registration of an institute is available in the following Link:

    https://elora.aerb.gov.in/ELORA/populateLoginAction.htm:

    Once the application for registration of institute is approved, end user will receive user
    id and pass word.

    a) Declaration of instruments like survey meter(s), direct reading dosimeter (s)


    (pocket dosimeter), {After logging into your account go to institute management
    tab> click to add instrument tab}
    b) Addition of employees like certified radiographer and Site-in-Charge {After logging
    into your account go to institute management tab> click to add employee tab}
    c) Nomination of certified radiographer and Site-in-Charge by submitting the
    application “Nominate Employee” (Note: only registered radiation professionals i.e.
    certified radiographer and Site-in-Charge can be nominated)Note: After approval of
    radiographer/Site-in-Charge, Application for personal monitoring service need to be
    submitted to the accredited laboratories with a copy of approval letter issued by
    AERB{After logging into your account go to institute management tab> click to user
    management tab. Nominate/relinquish tab}
    d) Recording of site {After logging into your account go to regulatory forms tab> click
    industrial radiography> recording of site/contract awarding party}
    e) Recording of contract awarding party {After logging into your account go to
    regulatory forms tab> click industrial radiography> recording of site/contract
    awarding party}
    f) Source storage room approval/Enclosure Approval in the name of the facility For
    source storage room approval {After logging into your account go to regulatory forms
    tab> click industrial radiography> approval for source storage facility}
    For enclosure approval {After logging into your account go to regulatory forms
    tab> click industrial radiography> approval for enclosure}
    After approval of enclosure, an application “Permission to use enclosure” to be
    submitted.
    Note: While submitting the application for “Permission to use enclosure, a
    report on radiation leakage levels is asked. In the case of non availability of x-ray
    equipment, the facility can give a declaration that the detailed report will be
    submitted once the device is procured and installed.
    g) Procurement of device{After logging into your account go to regulatory forms tab>
    click industrial radiography> procurement of device}
    h) Submission of Equipment receipt intimation (leakage radiation levels for the device
    to be submitted) {After logging into your account go to regulatory forms tab> click
    industrial radiography> equipment receipt intimation}
    i) Application for Licence{After logging into your account go to regulatory forms
    tab> click industrial radiography> license to operate radiography facility}
    j) Application for operation of device{After logging into your account go to regulatory
    forms tab> click industrial radiography> permission to operate radiography device}

    Before the regular use of the device Type Approval from AERB should be obtained by

    the Indian supplier.

    5. Once the equipment/device imported by the end user, supplier should submit the
    application for conversion of NOC to Type Approval application and the type approval
    issued by competent authority as per the procedure explained at the top of the page.

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