{"id":46545,"date":"2022-08-10T12:30:53","date_gmt":"2022-08-10T07:00:53","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=46545"},"modified":"2025-02-26T11:29:19","modified_gmt":"2025-02-26T05:59:19","slug":"aerb-approval-for-x-ray-machines-document-and-procedure","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/aerb-approval-for-x-ray-machines-document-and-procedure\/","title":{"rendered":"AERB Approval for X-Ray Machines: Document and Procedure"},"content":{"rendered":"\n<p>Atomic Energy Regulatory Board (AERB), X \u2013 Rays machines for medicinal use for diagnosis have proven to be immensely beneficial to society. It has also been proven that the use of X-Ray radiation has health risks associated with it; hence, it has required that proper care is exercised during its operation. The Atomic Energy (Radiation Protection) Rules-2004, under the Atomic Energy Act, 1962, provides the framework for safely handling radiation generating equipment \u2013 in the context of X-Ray equipment. All X-ray users must obtain the License for Operation from the <strong>Atomic Energy Regulatory Board<\/strong><sup><a href=\"https:\/\/aerb.gov.in\/\"><strong>[1]<\/strong><\/a><\/sup> to ensure the radiation safety of patients, occupational workers, and public members; further, we will be discussing the AERB Approval for X-Ray Machines.<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_82_2 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title ez-toc-toggle\" style=\"cursor:pointer\">Page Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 eztoc-toggle-hide-by-default' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/corpbiz.io\/learning\/aerb-approval-for-x-ray-machines-document-and-procedure\/#Functions_of_AERB\" >Functions of AERB<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/corpbiz.io\/learning\/aerb-approval-for-x-ray-machines-document-and-procedure\/#Documents_and_Procedure_Required_for_AERB_Approval_for_X-Ray_Machines\" >Documents and Procedure Required for AERB Approval\nfor X-Ray Machines<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/corpbiz.io\/learning\/aerb-approval-for-x-ray-machines-document-and-procedure\/#Details_required_to_be_submitted_regarding_%E2%80%93_AERB_Approval_for_X-Ray_Machines\" >Details required to be submitted regarding &#8211; AERB\nApproval for X-Ray Machines<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/corpbiz.io\/learning\/aerb-approval-for-x-ray-machines-document-and-procedure\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Functions_of_AERB\"><\/span>Functions of AERB<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The following\nare the functions of AERB, which have been discussed below for a better\nunderstanding, knowledge and working of AERB.<\/p>\n\n\n\n<ul>\n<li>Its function is to develop safety policies in\nradiation and industrial safety areas for facilities.<\/li>\n\n\n\n<li>Develop guides, safety codes and standards for\nsitting, construction, design, commissioning, operation and decommissioning of\ndifferent types of nuclear and radiation facilities.<\/li>\n\n\n\n<li>AERB also grants consent for Siting, construction,\ncommissioning, operation and decommissioning after an appropriate safety\nassessment and review for the establishment of nuclear &amp; radiation\nfacilities. <\/li>\n\n\n\n<li>Ensure compliance with the regulatory\nrequirements prescribed by AERB during all stages of consenting through a\nsystem of review and assessments, regulatory inspection and enforcement.<\/li>\n\n\n\n<li>Review qualification, the training program and\nlicensing policies for personnel of nuclear and radiation facilities and\nprescribe the syllabus for training of personnel in safety aspects at all\nlevels.<\/li>\n\n\n\n<li>Necessary steps can be taken to keep the public\ninformed on a significant issue of radiological safety significance.<\/li>\n\n\n\n<li>Promote R&amp;D efforts in the areas of safety<\/li>\n\n\n\n<li>Reviewing the industrial and nuclear safety\naspects in nuclear facilities under its preview<\/li>\n\n\n\n<li>Reviewing the safety-related nuclear security\naspects<\/li>\n\n\n\n<li>Notify the public about nuclear incidents\noccurring in the nuclear installations In India as it is mandated by the Civil\nLiability for Nuclear Damage Act &#8211; 2010. <\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_and_Procedure_Required_for_AERB_Approval_for_X-Ray_Machines\"><\/span>Documents and Procedure Required for AERB Approval\nfor X-Ray Machines<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The following are\nthe procedure and documents required for the AERB Approval for X-Ray Machines.<\/p>\n\n\n\n<p><strong><em>STEP1.\nThe First step is to make a registration application to the Institute with the\nrequired documents mentioned below-<\/em><\/strong><\/p>\n\n\n\n<ul>\n<li>Employer Identity proof, date of birth\n(PAN\/Passport\/Driving License\/Photo ID issued by Government of India)<\/li>\n\n\n\n<li>Employer ship proof<\/li>\n\n\n\n<li>PAN\/TAN any one scanned copy of issued from the\ngovernment authority<\/li>\n\n\n\n<li>Other documents prove that the\nInstituteInstitute is dealing with the supply or use of consumer products and\nscanning facilities.<\/li>\n<\/ul>\n\n\n\n<p><strong><em>STEP2.\nAfter an application is filed with the InstituteInstitute, an authorization\napplication is to be submitted to the Supplier, along with-<\/em><\/strong><\/p>\n\n\n\n<ul>\n<li>&nbsp;Adding an appropriate radiation survey instrument in the instrument management.<\/li>\n\n\n\n<li>An agreement letter from OEM authorized the Indian Supplier to supply the equipment in the country.<\/li>\n\n\n\n<li>A training certificate from the OEM of the person from the supplier Institution for maintenance, servicing and radiation safety aspects of the equipment.<\/li>\n<\/ul>\n\n\n\n<p><strong>Also Read:<\/strong> <strong><a href=\"https:\/\/corpbiz.io\/learning\/how-to-get-aerb-approval-for-dental-x-ray-equipment\/\" target=\"_blank\" rel=\"noreferrer noopener\">How to Obtain AERB Approval for Dental X-Ray Equipment?<\/a><\/strong><\/p>\n\n\n\n<p><strong><em>STEP3<\/em>.<\/strong>\n<strong><em>Application\nfor NOC is to be submitted-<\/em><\/strong><\/p>\n\n\n\n<ul>\n<li>Certificate of conformity for the device\nincluding generator, X-Ray tube, and monoblock -English version of CE \/ FDA\nCertificate or equivalent, preferably issued by notified\/certified body.<\/li>\n\n\n\n<li>Design certification from the Competent\nAuthority of the country of origin concerning radiological safety, as\napplicable.<\/li>\n\n\n\n<li>Technical details of X-ray tube &amp;&nbsp; generator system [maximum operating potential\n(kV), maximum operating current (mA), generator capacity (watt), focal spot\nsize, type of cooling system, type of High Voltage generator etc.]<\/li>\n\n\n\n<li>Operation manual &nbsp;&amp; technical catalogue of X-ray\ntube\/equipment as a whole<\/li>\n\n\n\n<li>Undertaking for maintenance and servicing of the\nequipment till its useful life<\/li>\n\n\n\n<li>Test report for measurement of radiation leakage\nat 5 cm from the outer accessible surface of the cabinet at maximum kV and\ncorresponding maximum mA. (max. Permissible levels are one microsSv\/h). The\ncross-sectional area of measurement preferably should not be greater than 10\ncm2 <\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Details_required_to_be_submitted_regarding_%E2%80%93_AERB_Approval_for_X-Ray_Machines\"><\/span>Details required to be submitted regarding &#8211; AERB\nApproval for X-Ray Machines<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul>\n<li>Availability of emergency stop Buttons and their\nlocations<\/li>\n\n\n\n<li>Whether display on the control for beam status\n(ON\/OFF) is available<\/li>\n\n\n\n<li>A detail about the availability of protective\ndrapes, doors and other interlocks.<\/li>\n\n\n\n<li>Whether essential control operation and password\nprotection operation is provided in the machine.<\/li>\n<\/ul>\n\n\n\n<p>Once the\napplicant has been granted the license, the licensee shall submit periodic\nsafety reports in the format &amp; frequency specified by the regulator body.\nThe authorisation renewal must be renewed before expiry for the competent\nauthority. If the Supplier decides to cease functioning as a supplier, the AERB\nshall be intimating it. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>After reading this article, it can be concluded that approval has to be obtained from the Atomic Energy Regulatory Board for the use of X-ray machines; further, in this writing, the function of AERB has also been mentioned and discussed elaborately. The procedure and documents required for the <strong><a href=\"https:\/\/corpbiz.io\/aerb-approval\">AERB Approval<\/a><\/strong> for X-Ray Machines have been explained in detail for a better understanding and knowledge.<\/p>\n\n\n\n<p class=\"text-left\"><b>Read our Article<\/b>:<mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/corpbiz.io\/learning\/regulation-for-all-medical-devices-under-cdsco-directive\/\">Regulation for all Medical Devices under CDSCO Directive<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Atomic Energy Regulatory Board (AERB), X \u2013 Rays machines for medicinal use for diagnosis have proven to be immensely beneficial to society. It has also been proven that the use of X-Ray radiation has health risks associated with it; hence, it has required that proper care is exercised during its operation. The Atomic Energy (Radiation [&hellip;]<\/p>\n","protected":false},"author":44,"featured_media":46546,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2636],"tags":[2589],"acf":{"service_id":"579"},"authorName":"Saiyam Shah","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/07\/MicrosoftTeams-image-76.jpg","authorDescription":"Saiyam Shah has done his LL.M in Business Law from Amity Institute of Advanced Legal Studies \u2013 Amity University. His area of interest is legal research related to Indirect \u2013 Tax and Company law. He has prior experience in Tax litigation, dealing with various Income \u2013 Tax Assessments and has good drafting skills in filing arguments and replying to Income \u2013 Tax Notices.","postViews":10515,"readingTime":3,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46545"}],"collection":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/users\/44"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=46545"}],"version-history":[{"count":14,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46545\/revisions"}],"predecessor-version":[{"id":68891,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46545\/revisions\/68891"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/46546"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=46545"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=46545"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=46545"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}