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Medical Diagnostic Radiology Module

e-Licensing of Radiation Applications (eLORA) System G u id e lin e s. Medical Diagnostic Radiology Module. J u ly 14 , 2 0 16. Table of Content Guidelines for Applying for Licence of Diagnostic Radiology X-ray Equipment through eLORA System

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Medical Diagnostic Radiology Module

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  1. e-LicensingofRadiationApplications(eLORA)System Guidelines MedicalDiagnosticRadiology Module July14,2016

  2. TableofContent • GuidelinesforApplyingforLicenceofDiagnosticRadiologyX-rayEquipmentthrougheLORASystem • GeneralGuidelines(Applicableforalltypesofequipmentsviz.existingaswellasnew) 4 • RegisterYourInstitute 4 • PrerequisitesforLicence 6 • DeclareEmployees 6 • ObtainRSOApproval 9 • AddInstrument 11 • PrepareLayout 12 • QualityAssurance 13GuidelinesforObtainingLicenceforExistingX-rayEquipment 13 • DeclareYourX-rayEquipments 13 • RecordLicenceDetail 14 • FillApplicationFormforLicence 15 • Renewaloflicense 20GuidelinesforObtainingLicenceforNewX-rayEquipment 20 • ProcurementofX-rayEquipment 20 • ApplicationforLicence 21 • GuidelinesforobtainingLicenceforPre-owned(Used/refurbished)X-rayEquipment 22GuidelinesforOtherProcesses 22 • ChangeinLayout 22 • SafetyStatusReport 22 • QATestSummary 23 • RadiationSurveyReport 23 • ProcurementofX-rayTube 23 • IntimationofReceipt 23 • IntimationofDecommissioning 23ImportantMessage 23 • NOLICENSEFEE/PROCESSINGFEEBYAERB 23 • DeletionofduplicateorwrongdeclarationofX-rayequipment 24 • Non-compliance 24 • AuthorisedServiceAgencies,AERBTypeApprovedX-rayequipmentandAERB-LicensedX-rayfacilities 24 • Annexures 25 July14,2016 AlwaysvisiteLORAforrecentguidelines

  3. Annexure-1:RegulatoryrequirementsintheuseofX-rayequipment 25Annexure–2:ListofPersonnelMonitoringService(PMS)Providers 27Annexure-3:StandardLayouts 28 StandardLayoutofX-rayInstallation 28 StandardLayoutofCTInstallation 29 StandardLayoutofInterventionalRadiologyInstallation 30 StandardLayoutofMammographyInstallation 31 Annexure-4:ApplicationFormforRemovalofDuplicateorWrongDeclarationofMedicalX-RayEquipmentineLORA 32 Help Email idforDiagnostic RadiologyUsers elora.dr@aerb.gov.in July14,2016 AlwaysvisiteLORAforrecentguidelines

  4. GeneralGuidelines(Applicableforalltypesofequipmentsviz.existingaswellasnew)GeneralGuidelines(Applicableforalltypesofequipmentsviz.existingaswellasnew) Itismandatoryforallusersofmedicaldiagnosticx-rayequipmentstoobtainLicenceforOperationfromAERBasperAtomicEnergy(RadiationProtection)Rules2004. TofacilitateonlinesubmissionofapplicationsforregulatoryconsentsandestablishchannelofcommunicationwithAERBforotherregulatoryrequirements,AERBhaslaunchedDiagnosticRadiologymoduleinitse-governanceapplicatione-LORA(e-LicensingofRadiationApplications)System.Alldiagnosticx-rayequipmentuserInstitutesarerequiredtouseeLORAforobtainingoperatingLicencefromAERB. 1.RegisterYourInstitute Visitourwebsitewww.aerb.gov.in.ClickonthebuttoneLORA,whichisavailableonwebsitehomepage.ItwillredirectyoutothefollowingscreenofeLORAhomepage. ClickonRegisterInstitute(seeabovefigure).ThiswillopenapplicationformforInstituteRegistration. ImportantNote:GuidelinestofillapplicationformforInstituteRegistrationisavailableoneLORAhomepage.Itisadvisedtoreadtheguidelinesandkeepsoftcopyofrequiredattachmentsreadybeforestartfillingofapplicationform. Filltheapplicationformaspertheguidelines.Importantpointsineachtabarementionedbelow: Tab1:InstituteDetails July14,2016 AlwaysvisiteLORAforrecentguidelines

  5. InTypeofFacilitysection,forthefieldPracticeselectDiagnosticRadiologyandforthefieldRoleofInstituteclickonMedicalDiagnosticX-rayFacilityInTypeofFacilitysection,forthefieldPracticeselectDiagnosticRadiologyandforthefieldRoleofInstituteclickonMedicalDiagnosticX-rayFacility • Tab2:EmployerDetails • Name:Fillthecompletenameofemployerasappearinginhis/herdocumentforProofofIdentity/DateofBirth(DOB)tobeattached. • DateofBirth:FilltheDOBasappearingintheproofofidentity/DOBtobeattached • Document/cardforproofofidentityanddateofbirth(ofemployer):Selectonefromthedropdown.(Softcopyofthisisamandatoryattachment). • Document/CardNo.(ofProofofIdentity/DOB):Mustmatchwiththeproofofidentity/DOBattached • mail(O):WillbeusedtosendUSERNAMEandPASSWORDofyoureLORAaccountandforallfuturecommunications.(Makesuretoprovidecorrectemailaddress). • Tab3:Attachments • Uploadoffollowingattachmentsaremandatory: • ProofofIdentityandDateofBirth(ofemployer):Acceptabledocumentsareasfollows: • Passport • PANcardissuedbyIncomeTaxDepartment • DrivingLicenceissuedbyRTO • Photoidentitydocument/cardhavingserialnumberanddateofbirthissuedbyCentral/StateGovernmentorPSU • ProofofEmployership:Example:(i)AppointmentLetterofEmployer,(ii)BoardResolution,(iii)AnyGovt./PUCdocumentsubstantiatingproprietorship(iv)Partnershipdeed(notorised)or(iv)Proprietor’sselfdeclarationoninstituteletterheadaffixedwithinstituteseal • Uploadscancopyofanyoneofthedocument(intherelevantposition)fortheproofofexistenceofinstitute: • PANofInstitute • TANofInstitute • RegistrationwithState/Central/LocalGovernmentAuthority • EntertheCaptchandsubmittheapplicationform. ImportantNote:Fieldsmarkedwith*intheapplicationformaremandatory.Applicationformwillnotbesubmittedifanymandatoryfieldleftblank. July14,2016 AlwaysvisiteLORAforrecentguidelines

  6. Youwillgetacknowledgementmessageuponsuccessfulsubmissionofapplicationform.Thecopyofsubmittedapplication(.pdffile)canbedownloadedforwhichlinkwillbeprovided(pl.note,thislinkwillbeactiveforashotperiod).Youwillalsoreceiveanacknowledgemailwiththecopyofyourapplicationform(.pdffile)inyouremail(emailaddressasprovidedintheapplicationform).Youwillgetacknowledgementmessageuponsuccessfulsubmissionofapplicationform.Thecopyofsubmittedapplication(.pdffile)canbedownloadedforwhichlinkwillbeprovided(pl.note,thislinkwillbeactiveforashotperiod).Youwillalsoreceiveanacknowledgemailwiththecopyofyourapplicationform(.pdffile)inyouremail(emailaddressasprovidedintheapplicationform). • PrerequisitesforLicence • PriortoapplyforLicence;followfollowingsteps: • DeclareEmployees • ForX-rayequipment/installationsuchasCTscan,InterventionalRadiology,C-Arm/O-ArmandequipmentwithFluoroscopymodeshallhaveadequateno.ofOperatorandMedicalPractitionerforobtainingOperationalLicence. • ForobtainingLicenseforallotherX-rayequipmentavailabilityofadequateno.ofOperatorismandatory • Operator&medicalPractitionershallbedeclaredineLORAthrough“addemployee”menu. • ForCTandInterventionalRadiology(IR)equipments,inadditiontoOperatorandMedicalPractitioner,RSO(RadiologicalSafetyOfficer)ismandatoryforobtainingOperationalLicence. • OtherthanCT&IRequipment,ifRSOisnotavailable,“Registrant”maydesignatehimselfasRSO. • TheminimumqualificationrequirementforemployeesinDiagnosticRadiologyisasgivenbelow: Afteracceptanceofyourapplicationform,youwillgetUSERNAMEandPASSWORDofyoureLORAaccountinyouremail.VisittoeLORAhomepagetologintothesystem. Foraddingemployeestoyourinstitution,pleasefollowthepathas: MenuUsermanagementAddEmployeeSelectrequiredTypeofEmployeefromdropdown July14,2016 AlwaysvisiteLORAforrecentguidelines

  7. IndropdownforTypeofEmployee,threeoptionsavailableasfollows: • RadiationWorker(thisistoaddemployeewithroleOperatorandMedicalPractitioner) • NonRadiationWorker(thisistoaddLicenseewhomaynotbearadiationworker) • RadiationProfessional(thisistoaddRadiationProfessionalwhoistobenominatedasRSO) • YouarerequiredtoaddOperatorandMedicalpractitionerinthetypeRadiationWorker. • IntheformforaddingRadiationWorker, • Providerequiredpersonalinformationofemployeeviz.Title,Name,GenderandDateofBirth • Providerequiredserviceinformationofemployeeviz.DateofJoining(ofserviceinyourinstitute),PMSNo.(i.e.completeTLDNo.),Department,Designation,Profile (select ‘Medicaldiagnostic x-ray facility’) , Role (select any one or both using Ctrl key – as applicable) andEducation Qualification (select value from drop down) July14,2016 AlwaysvisiteLORAforrecentguidelines

  8. Provideaddressandcontactdetailofemployee • Browseanduploadscancopyofjoining/confirmationletterofemployeeandclickonSubmit • RepeattheaboveproceduretoaddyourotherOperatorsandMedicalpractitioners. ImportantNote:YouwillnotbeabletofillapplicationformforLicence(andwillgetfollowingerrormessage)unlessyoudeclareOperatorandMedicalPractitionerofyourInstitute. IncaseyourinstituteisnothavingvalidRSO,youneedtoobtainRSOapprovalfromAERB.ForapersonrequiredtobenominatedasRSO,youneedtoaddhim/herinthetypeRadiationProfessional(RP).WhileaddingRP,systemwillaskRPregistrationIDandDateofbirthofRP.(ObtainthesedetailsfromtheRadiationProfessional) • IntheformforaddingRadiationProfessional, • EnterRegistrationIDandDateofbirthofRP–personaldetailofRPwillcomeautomatically. • IncaseRPisEmployerofInstitute,select‘Yes’for‘WhetherthepersonisalsoEmployeroftheInstitute?’ • ProvideDateofJoining(ofserviceinyourinstitute),PMSNo.(i.e.completeTLDNo.),DepartmentandDesignation,Profile(i.e.‘Medicaldiagnosticx-rayfacility’)andRole(i.e.‘Operator’,MedicalPractitioner’orboth) • ProvideEmail(O) • Browseanduploadscancopyofjoining/confirmationletterofemployeeandclickonSubmit ImportantNote:RadiationProfessionalcansubsequentlybenominatedfortheapprovalofRadiologicalSafetyOfficer(RSO).ProcessofRSOnominationexplainedinSr.No.:B July14,2016 AlwaysvisiteLORAforrecentguidelines

  9. B. ObtainRSOApproval IncaseyoudonothavevalidRSOforyourCTandInterventionalRadiologyfacility,obtainRSOapproval. ForCTandInterventionalRadiologyfacilities,RSOapprovalismandatory.FornominatingyouremployeeforRSOapproval,followthepathas: MenuRegulatoryFormsCommonForms SelectthenameofemployeeinRadiationProfessional FilltheaskedinformationandclickonFreeze.Thiswillfreezeyourapplicationformandshowyourapplicationnumber.Pleasenote,FreezedoesnotmeansubmissionofapplicationformtoAERB. ForsubmissionofRSOnominationapplicationform,followthepathas: MenuMyapplications July14,2016 AlwaysvisiteLORAforrecentguidelines

  10. SelectrequiredApplicationNo.(ApplicationStatusisshownasPendingforSignedPDF).ClickonShowDetailsanddownloadPDFofyourapplicationformfromDownloadLink.Takeaprintoffirstpage,EmployerandNominatedRSOshalldulysignthefirstpage(theirnameswillappearintheform,signabovetherespectivenames)andaffixinstitutesealonit.Scanthispage(in.pdfformat),Browseanduploadthisscancopy.SelectrequiredApplicationNo.(ApplicationStatusisshownasPendingforSignedPDF).ClickonShowDetailsanddownloadPDFofyourapplicationformfromDownloadLink.Takeaprintoffirstpage,EmployerandNominatedRSOshalldulysignthefirstpage(theirnameswillappearintheform,signabovetherespectivenames)andaffixinstitutesealonit.Scanthispage(in.pdfformat),Browseanduploadthisscancopy. Afteruploadingofscanfile,ApplicationStatuswillchangetoSignedPDFUploaded July14,2016 AlwaysvisiteLORAforrecentguidelines Page10of33

  11. SelecttheApplicationNoandclickonSubmittocompletesubmissionofapplicationform(ApplicationStatuswillchangetoSubmitted).SelecttheApplicationNoandclickonSubmittocompletesubmissionofapplicationform(ApplicationStatuswillchangetoSubmitted). ImportantNote:Theabovementionedprocedureofsubmissionofapplicationisapplicableforotherregulatoryformswheresignatureoftwopersonsrequired. YourRSOnominationformwillbereviewedbyAERBandafteracceptance;youwillgetitsnotificationinyoureLORAaccount. C. AddInstrument DiagnosticX-rayfacilitymusthavecertaintypesofinstruments(listisgiveninTable1:ListofInstrumentsRequired)andthesamemustbedeclaredineLORA. Todeclareinstruments,followthepathas: MenuInstrumentManagementAddInstrument • IndropdownforTypeofInstrument,fouroptionsavailableasfollows: • MeasuringTool(notapplicableforyou) • MonitoringTool(notapplicableforyou) • QATool(notapplicableforyou) • SafetyTool • AddfollowingInstrumentsasapplicabletoeachtypeofequipment: • Table1:ListofInstrumentsRequired July14,2016 AlwaysvisiteLORAforrecentguidelines

  12. Providetherequiredinformationwhileaddingequipment. ImportantNote:YouwillnotbeabletofillapplicationformforLicence(andwillgetfollowingerrormessage)unlessyoudeclarerequiredInstrument(s). • PrepareLayout • Prepareasketchoflayout(1:50scale)ofeachx-rayroom(notapplicableforRadiography(mobile),C-Arm,O-Arm,Dental(Intra-oral)andDental(Hand–held)X-rayequipment)providingallthedetailsaboutwalldimensions,wallthickness,wall/shieldingmaterial,distancesofallwalls/shieldingfromx-rayequipment,relativepositionsofx-rayequipment,couch,controlconsole/controlroom,protectivebarrier,door(s),window(s),occupancyaroundthex-rayroometc.Forthepreparationlayoutdetails,guidelinesandmodellayoutplansareavailableonAERBwebsite(http://www.aerb.gov.in/AERBPortal/pages/English/X-Ray/X-Ray_jsp.action)aswellasenclosedhereasAnnexure-3:StandardLayouts. • Youarerequiredtopreservethedulysignedandstampedcopyofx-rayroomwithdetailsofshieldingatyourinstitutionandsamewillbeverifiedduringAERBinspection. • Thereisnorequirementtoprepareanewlayoutplanin case you already have AERB approved layoutplan.Thesamecanbeusedasarecordforlayout. • Ifyourx-rayroomisaspermodellayoutorhasAERBapprovedlayout,youneednottosubmitalldetailsintheapplicationformforLicense. • Incaseyourx-rayroomdoesnotfollowstandardrequirements, • YouwillberequiredtoprovidethedetailsintheprescribedformatintheapplicationformforoperatingLicence,aswellas • YouwillhavetogetradiationsurveydonefromsupplierofequipmentorauthorizedagenciesasperprescribedformatasgiveninapplicationformforoperatingLicence. ImportantNote:WhilesubmittingOperationalLicenceapplicationformforCTandInterventionalRadiologyequipment,youwillbeaskedtouploadscancopyofdulysignedandstampedlayoutplan. July14,2016 AlwaysvisiteLORAforrecentguidelines

  13. E. QualityAssurance Priortoapplyforlicenseforoperationofexistingx-rayequipment;carryoutitsQualityAssurance(QA)testsasperAERBprescribedformat.QualityAssuranceshallbecarriedoutonlybyAERBAuthorisedagencies.TheQualityAssurance(QA)formatsareavailableonAERBwebsite(http://www.aerb.gov.in/AERBPortal/pages/English/X-Ray/XRAYmanfform_jsp.action). ImportantNote:WhilesubmittingOperationalLicenceapplicationformforCTandInterventionalRadiologyequipment,youwillbeaskedtouploadscancopyofdulysignedandstampedQA. GuidelinesforObtainingLicenceforExistingX-rayEquipment 3.DeclareYourX-rayEquipments Afterlogin,youwillseefollowingscreenwithvariousMenuonlefthandside.YouwillhavetodeclareyourallX-rayequipmentsone-by-one.ClickonDeclareExistingX-rayEquipmenttodeclareyourexistingx-rayequipment. ProvidethedetailasaskedintheformandclickonSubmit. Aftersuccessfulsubmission,anacknowledgementmessagewithequipmentidwillbedisplayed. July14,2016 AlwaysvisiteLORAforrecentguidelines

  14. Youwillreceiveasystemgeneratedmailinyourregisteredemailidwithacknowledgementletterasanattachment.AcknowledgementlettercanalsobedownloadedfrommenuMyApplications.Youwillreceiveasystemgeneratedmailinyourregisteredemailidwithacknowledgementletterasanattachment.AcknowledgementlettercanalsobedownloadedfrommenuMyApplications. RepeatthesameproceduretodeclareyourallX-rayequipment. 4.RecordLicenceDetail IncasethedeclaredX-rayequipmentofyourInstituteishavingvalidlicense(issuedbyAERB)foroperation,select‘Yes’inthebelowscreen.Formforrecordinglicensedetailswillbeopened. Otherwise,theformforrecordinglicensedetailcanbeaccessedbyclickingonmenuRecordLicenceforOperationofX-rayEquipment(asshownbelow) Thiswillopenformasshownbelow: July14,2016 AlwaysvisiteLORAforrecentguidelines

  15. Providefollowingrequireddetailsandsubmittheform: • EquipmentId:TobeselectedfromprovidedList(allyourdeclaredequipmentswillappearhere) • Referencenumberoflicenceforoperation:asappearingonAERBlicence/registration • Issuancedate:asappearingonAERBlicence/registration • Expirydate:asappearingonAERBlicence/registration • UploadcopyofLicenceforoperation:BrowseanduploadscannedcopyofAERBlicence/registration • Aftersuccessfulsubmission,followingmessagewillbedisplayed.Thesubmittedapplicationform(pdffile)canbedownloadedfromthelinkprovidedtherein. YourLicencerecorddetailwillbeverifiedbyAERB.Afteracceptanceofyoursubmitteddetail,youwillreceiveasystemgeneratedmessageinyourregisteredemailaddresswithanacknowledgementletterasanattachment.AnacknowledgementlettercanalsobedownloadedfrommenuMyApplications. 5.FillApplicationFormforLicence Theapplicationformforlicenseisavailableinmenu. MenuLicenceforOperationofExistingEquipments ImportantNote:Youwon’tbeabletofilltheapplicationformifrequiredprerequisitesarenotcompleted. July14,2016 AlwaysvisiteLORAforrecentguidelines

  16. Aformwillbeopenedasshownbelow: Forminitiallywillhavethreetabs: EmployeeDetail:ThiswillshowthelistofemployeesaddedasRadiationProfessional.(Employees added as Radiation Worker and Non Radiation Worker will not be show). SafetyToolsDetail:ThiswillshowthelistofInstrumentsadded. GeneralDetail:InthefieldApplicationfor,selectLicenceforOperationforfirsttimeapplication.Infuture,selectRenewalofLicenceforOperationforsubmissionofformforrenewalofexistingLicence.ThenclickonEquipmentId,itwillshowlistofequipmentsdeclaredbyyou.SelectEquipmentforwhichyouwishtosubmitapplicationform. July14,2016 AlwaysvisiteLORAforrecentguidelines

  17. ProvideSerialNumberofEquipmentifavailable. IncaseyouhaveapprovedRSO(RSOapprovalreceivedonpaper),selectYesandproviderequireddetailanduploadscancopyofRSOapprovalletter. IncaseyoudonothaveapprovedRSO,thenselectNoandselectoneofyouremployeeinthefieldNameofthepersondesignatedasRSOforthisequipment(thiswillnotbeapplicableforCTandInterventionalRadiologyequipment). ImportantNote:ObtainpriorapprovalofRSOforCTandInterventionalRadiologyequipmentifyoudonothavevalidRSO. Afterselectionofequipment,twomoretabswillbedisplayed(viz.LayoutDetailandQATestReport) 4.LayoutDetail:IfinstallationlayoutofyourequipmentisasperAERBmodellayout,thenselect Yes July14,2016 AlwaysvisiteLORAforrecentguidelines

  18. ImportantNote:WhilesubmittingOperationalLicenceapplicationformforCTandInterventionalRadiologyequipment,youwillbeaskedtouploadscancopyofdulysignedandstampedlayoutplan.ImportantNote:WhilesubmittingOperationalLicenceapplicationformforCTandInterventionalRadiologyequipment,youwillbeaskedtouploadscancopyofdulysignedandstampedlayoutplan. IfX-rayequipmentinstallationlayoutisnotasperAERBmodellayout,thenselectNo. • Providethedetailasperyourroomlayoutplan(asexplainedaboveinsectionD:PrepareLayout) • uploadcopyofroomlayoutplan(incaseofCTandInterventionalRadiology) • ForRadiationSurveyReport:Getradiationsurveydonefromsupplierofequipmentorauthorizedagenciesasperprescribedformatandprovidethedetailsintheapplicationform(asapplicable): • Theexposureparameterstobeselectedforwhilecarryingoutsurveyaregiveninthetable: July14,2016 AlwaysvisiteLORAforrecentguidelines

  19. Exposuretimeshouldnotbelessthan1Sec • Providethevaluesofmaximumradiationlevel(inmR/hr)atfollowingplaces: • Nearcontrolconsole(operatorsposition) • Outsidepatiententrancedoor • Behindcheststandwall • Behindwindow(ifany) • Patientwaitingarea • 5.QATestReport:ReferQAtestreportofx-rayequipmentandproviderequiredtestresults.AttachthecopyofQAtestreportintheprescribedformat(applicableforCTandInterventionalRadiologyequipment). Forsubmissionofyourapplicationform,readandselectthetermsandconditionandclickforSubmit.Aftersuccessfulsubmissionyouwillreceivetheacknowledgementinyourinboxandregisteredemail.RepeatthesameprocedureforsubmissionofLicenceapplicationformforyourotherequipments. July14,2016 AlwaysvisiteLORAforrecentguidelines

  20. 6.Renewaloflicense TheapplicationformforrenewaloflicenseisavailableinMenu:RegulatoryForms>MedicalDiagnosticRadiology>LicenceforOperationofX-rayequipment>equipmentdetailstab GuidelinesforObtainingLicenceforNewX-rayEquipment 7.ProcurementofX-rayEquipment Afterfulfillingthegeneralrequirements,followfollowingpathtoopenProcurementformfornewequipment: RegulatoryFormsMedicalDiagnosticRadiologyProcurementofX-rayEquipment July14,2016 AlwaysvisiteLORAforrecentguidelines Page20of33

  21. Filltheinformationaskedintheformanduploadmandatoryattachments.YourapplicationwillbereviewedbyAERB.Afterapproval/rejection,youwillgetnotificationinyoureLORAaccount.YoucanviewyourcompleteapplicationalongwithAERBletterin‘MyApplications’.Filltheinformationaskedintheformanduploadmandatoryattachments.YourapplicationwillbereviewedbyAERB.Afterapproval/rejection,youwillgetnotificationinyoureLORAaccount.YoucanviewyourcompleteapplicationalongwithAERBletterin‘MyApplications’. ImportantNote:Aftersupplyofequipment,yoursupplierhastosubmitinstallationreportonbehalfofyourinstitute.AfteracceptanceofinstallationreportbyAERB,youneedtosubmitapplicationforLicence.(YouwillgetnotificationofinstallationreportacceptanceinyoureLORAaccountaswellasinyouremail). 8.ApplicationforLicence AfterapprovalofinstallationreportofyourX-rayequipmentbyAERB,filltheapplicationformforLicence.Licenceformhastobesubmittedwithin6monthsfromthedateofacceptanceofinstallationreport.IncaseLicenceformisnotsubmittedwithin6month,youhavetosubmitfreshQAreportbeforeapplyingforLicence. EnsurethatrequiredEmployeeandInstrumentdetailsareprovidedinyouraccount.FollowfollowingpathtoaccessLicenceform: RegulatoryFormsMedicalDiagnosticRadiologyLicenceforOperation Selecttheequipmentid,agreetermsandconditionsandpresssubmitbuttonforsubmissionofyourapplicationform. July14,2016 AlwaysvisiteLORAforrecentguidelines

  22. GuidelinesforobtainingLicenceforPre-owned(Used/refurbished)X-rayEquipmentGuidelinesforobtainingLicenceforPre-owned(Used/refurbished)X-rayEquipment • Userisrequiredtosubmitapplicationformfor“Procurementofpre-ownedX-rayequipment”througheLORAaccount. • Afterinstallation&commissioningofX-rayequipment,userwillsubmit“IntimationofReceipt”througheLORA. • Supplier/ServiceAgencyshallprovideinstallationreport&QAreporttouser(RequiredforsubmissionforLicensethrougheLORA) • UserisrequiredtoapplyforLicenseforoperationofpre-ownedX-rayequipmentthrougheLORA. • GuidelinesforOtherProcesses • 9.ChangeinLayout: • Incaseofchangeinlayout(duetoLayoutmodificationofinstallation,relocationandrepositionofequipmentfromitsoriginalplace),youneedtofillformforChangeinLayout.Followfollowingpathtoaccessthisform: • RegulatoryFormsMedicalDiagnosticRadiologyChangeinLayout Pl.note,inthisformyouwillhavetoprovidedetailofshieldingaroundX-rayequipmentasaskedinLicenceform.Fillthedetailasrequiredintheformandsubmit. 10.SafetyStatusReport UsethisformtosubmitsafetyannualsafetystatusofyourInstitute.Followfollowingpathtoaccessthisform: RegulatoryFormsMedicalDiagnosticRadiologySafetyStatusReport(PatientExaminationReport /OperationSafetyReport) July14,2016 AlwaysvisiteLORAforrecentguidelines

  23. QATestSummary UsethisformtosubmitQAtestsummaryofperiodicQAorQAdoneafterlayoutchange.Followfollowingpathtoaccessthisform: RegulatoryFormsMedicalDiagnosticRadiologyQATestSummary RadiationSurveyReport Incaseofchangeinlayout,youneedtosubmitradiationsurveyaroundtheinstallation.ThesameformisalsobeusedtosubmitPeriodicRSR(RSR–RadiationSurveyReport).Followfollowingpathtoaccessthisform: RegulatoryFormsMedicalDiagnosticRadiologyRadiationSurveyReport ProcurementofX-rayTube ThisformisusedtoapplyforprocurementofX-raytube(incaseofreplacementofold/damagedx-raytube).Followfollowingpathtoaccessthisform: RegulatoryFormsMedicalDiagnosticRadiologyProcurementofX-rayTube IntimationofReceipt AfterreceiptofnewX-raytube,youneedtointimateitsreceiptthroughIntimationofReceiptform.Followfollowingpathtoaccessthisform: RegulatoryFormsMedicalDiagnosticRadiologyIntimationofReceipt IntimationofDecommissioning InordertointimatedecommissioningofyourX-rayequipment,usethisform.Followfollowingpathtoaccessthisform: RegulatoryFormsMedicalDiagnosticRadiologyIntimationofDecommissioning ImportantMessage NOLICENSEFEE/PROCESSINGFEEBYAERB ItmaypleasebenotedthatatpresentAERBdoesnotchargeanyfeeforissuanceofregulatoryconsentsincludinglicenseorregistration.However,Ithasbeenbroughttothenoticethatsomeofthesuppliers/agencies,whileprovidingservices/assistancetotheusersofDiagnosticX-rayfacilityforgettingtheirX-rayequipmentlicensedorregisteredbyAERB,aredemandingmoneytobepaidtoAERB.IncaseanybodydemandsforpaymenttobemadetoAERBoranyofitsofficials,kindlyprovideallthedetailsto: TheVigilanceOfficer AtomicEnergyRegulatoryBoardNiyamakBhavan,AnushaktinagarMumbai–400094 Telefax:022-25576255 E-mail:lrbishnoi@aerb.gov.in July14,2016 AlwaysvisiteLORAforrecentguidelines

  24. 17.DeletionofduplicateorwrongdeclarationofX-rayequipment FordeletionofduplicateorwrongdeclarationofX-rayequipmentintheeLORA,youarerequiredtosubmitcompletelyfilled&dulysignedapplicationformasgiveninannexure-3whichisalsoavailablein“Help”meduofeLORA 18.Non-compliance Incase,Non-compliance(NC)israisedagainsttheinstitute,Employerneedstotakeimmediateactiontoresolveit.IfmoretimeisrequiredforresolutionofNC,samemaybeintimatedtoAERBwithnecessaryjustification. 19.AuthorisedServiceAgencies,AERBTypeApprovedX-rayequipmentandAERB-LicensedX-rayfacilities ListofAERBAuthorisedServiceAgencieson: http://www.aerb.gov.in/AERBPortal/pages/English/X-Ray/X-Ray.jsp ListofAERBTypeApprovedX-rayequipmentandAERB-LicensedX-rayfacilitiesisavailableon: https://elora.aerb.gov.in/ELORA/prePopulateGraphData.htm =O=O=O=O=O= July14,2016 AlwaysvisiteLORAforrecentguidelines

  25. 20.Annexures: Annexure-1:RegulatoryrequirementsintheuseofX-rayequipment GeneralRequirements The‘Employer’and‘Licensee’oftheorganizationasdefinedinAtomicEnergy(RadiationProtection)Rules,2004,shallfulfilltheresponsibilitiesprescribedintheAERBsafetycodeonradiationsafetyinmanufacture,supplyanduseOfMedicaldiagnosticx-rayequipment[AERB/RF-MED/SC-3(Rev.2)]. ProcurementofX-rayEquipment TheemployershallprocureNOCvalidated/TypeApprovedX-rayequipmentfromauthorizedsuppliersandafterobtainingprocurementpermissionfromtheCompetentAuthority. OperationofX-rayEquipment NodiagnosticX-rayequipmentshallbeoperatedforpatientdiagnosisunlessLicenceforoperationisobtainedfromtheCompetentAuthority. Pre-requisitesforobtainingLicenceforOperationofX-rayEquipment X-rayRoomLayoutandShieldingRequirement TheroomhousingX-rayequipmentshallhaveanappropriateareatofacilitateeasymovementofstaffandproperpatientpositioning.Appropriatestructuralshieldingshallbeprovidedforwalls,doors,ceilingandflooroftheroomhousingtheX-rayequipmentsothatradiationexposuresreceivedbyworkersandthemembersofthepublicarekepttotheminimumandshallnotexceedtherespectivelimitsforannualeffectivedosesasperdirectivesissuedbytheCompetentAuthority.Appropriateoverlapofshieldingmaterialsshallbeprovidedatthejointsordiscontinuities. Thecontrolconsoleofcomputedtomographyequipmentshallbeinstalledinaseparateroomlocatedoutsidebutadjoiningtocomputedtomographyroomandprovidedwithappropriateshielding,directviewingandoralcommunicationfacilitiesbetweentheoperatorandthepatient.Thegantryandcouchshallbeplacedsuchthatitenablestheoperatortohavethecompleteviewofthepatientfromthecontrolroomviewingwindow. InterventionalRadiologyequipmentroomshallhaveanadjoiningcontrolroomwithappropriatefacilitiesforshielding,directviewingandoralcommunication.Incaseofroomhousingradiographyequipment,cheststandshallbelocatedinX-rayroomsuchthatnosignificantstrayradiationreachesatcontrolconsole/entrancedoor/areasoffulltimeoccupancysuchthatthedoselimitstoradiationworkerandmembersofpublicarenotexceeded. MobileX-rayequipment,whenusedasfixedX-rayequipment,shallcomplywithalltherequirementsofthoseoffixedX-rayinstallation.MovementofmobileX-rayequipmentshallberestrictedwithintheinstitutionforwhichitisregistered. Apermanentradiationwarningsymbolandinstructionsforpregnant/likelytobepregnantwomenshallbepastedontheentrancedooroftheX-rayinstallation,illustratingthattheequipmentemitsx-radiation. July14,2016 AlwaysvisiteLORAforrecentguidelines

  26. VehicleMountedX-rayEquipment: X-rayequipmentinstalledinamobilevanorvehicle,shallbeprovidedwithanappropriateshieldingenclosuretoensureadequatebuilt-inprotectionforpersonslikelytobepresentinandaroundthevehicle.Shieldingshallbeprovidedaroundtheequipmentfromallthesidesuptoheightof2mfromexternalgroundsurface.Radiationwarningsymbolshallbedisplayedonallsidesofthevehicle. StaffingRequirements X-rayinstallationsshallhavearadiologist/relatedmedicalpractitioner/X-raytechnologistwithadequateknowledgeofradiationprotection,tooperatetheX-rayequipment.TheemployeesinvolvedintheseactivitiesareconsideredasradiationworkersandshallcomplywiththedutiesandresponsibilitiesasprescribedinAERBsafetycodeonradiationsafetyinmanufacture,supplyanduseOfMedicaldiagnosticx-rayequipment[AERB/RF-MED/SC-3(Rev.2)].TheminimumqualificationandtrainingshallbeasprescribedbytheCompetentAuthority.AllinstallationshavingX-rayequipmentwithfluoroscopyfacility,computedtomographyandallestablishmentsperformingspecialprocedures,shallhavetheservicesofaqualifiedradiologistorrelatedmedicalpractitioner,withadequateknowledgeofradiationprotectionforinterpretationandreporting. RadiologicalSafetyOfficer(RSO) X-raydepartmentshallhaveaRSOapprovedbytheCompetentAuthority.TheRSOmayeitherbetheemployerhimself/herselforanemployeetowhomtheemployershalldelegatetheresponsibilityofensuringcompliancewithappropriateradiationsafety/regulatoryrequirementsapplicabletohisX-rayinstallation.TheminimumqualificationandtrainingshallbeasprescribedbytheCompetentAuthority. RadiationProtectionDevices Appropriateradiationprotectiondevicessuchasbarrier,apron,goggles,andthyroidshieldsshallbeusedduringoperationofX-rayequipment.Thesedevicesshallbeverifiedperiodicallyfortheirshieldingadequacy.TherequirementsforradiationprotectiondevicesareasspecifiedinAppendix-II. PersonnelMonitoringService Personnelmonitoringservicesshallbeprovidedtoalltheradiationworkers. QualityAssurance(QA)Requirements TheendusershallensurethatperiodicQAoftheequipmentiscarriedoutbyAERBauthorizedagencies.PeriodicQualityAssuranceshallbecarriedoutatleastonceintwoyearsandalsoafteranyrepairshavingradiationsafetyimplications. Servicing TheendusershallensurethatservicingoftheX-rayequipmentiscarriedoutbyagenciesauthorizedbytheregulatorybody. PeriodicSafetyReports July14,2016 AlwaysvisiteLORAforrecentguidelines

  27. Theutilityshallsubmitperiodicsafetyreportsintheformatandfrequencyspecifiedbytheregulatorybody.Theutilityshallsubmitperiodicsafetyreportsintheformatandfrequencyspecifiedbytheregulatorybody. RenewalofLicence TheLicenceaccordedbytheCompetentAuthorityshallberenewedbeforeitsexpiry. DecommissioningofX-rayEquipment DecommissioningoftheX-rayequipmentshallbecarriedoutbyauthorizedagencieswithpriorintimationtotheCompetentAuthority. Annexure–2:ListofPersonnelMonitoringService(PMS)Providers ThefollowingAccreditedLaboratoriesprovideTLDservicesintherespectivestatesasmentionedbelow: July14,2016 AlwaysvisiteLORAforrecentguidelines

  28. Annexure-3:StandardLayouts a)StandardLayoutofX-rayInstallation Legend: ExaminationTable SpotFilmDevice ColumnStand X-rayTubeHead ChestStand ControlUnit MobileProtectiveBarrierwithleadglassviewingwindowof1.7mmleadequivalence [SealofInstitute] July14,2016 AlwaysvisiteLORAforrecentguidelines

  29. b)StandardLayoutofCTInstallation Legend: CTGantry ExaminationTable3,4.ControlUnit 5.Viewingglasswindowof100cmx80cmof2.0mmleadequivalence [SealofInstitute] July14,2016 AlwaysvisiteLORAforrecentguidelines

  30. c)StandardLayoutofInterventional Radiology Installation Legend: C-arm ExaminationTable 5.FixedRadiationShield6,7,8.ControlUnit 9.Viewingglasswindowof120cmx100cmof2.0mmleadequivalence [SealofInstitute] July14,2016 AlwaysvisiteLORAforrecentguidelines Page30of33

  31. d)StandardLayoutofMammography Installation Legand: MammographyEquipment ControlUnitwithprotectivebarrierof1.5mmleadequivalence [SealofInstitute] July14,2016 AlwaysvisiteLORAforrecentguidelines

  32. Annexure-4:ApplicationFormforRemovalofDuplicateorWrongDeclarationofMedicalX-RayEquipmentineLORAAnnexure-4:ApplicationFormforRemovalofDuplicateorWrongDeclarationofMedicalX-RayEquipmentineLORA GOVERNMENTOFINDIAATOMICENERGYREGULATORYBOARD NIYAMAKBHAVAN,ANUSHAKTINAGAR,MUMBAI–400094 AERB/RSD/DRG-eLORA APPLICATIONFORMFORREMOVALOFDUPLICATEORINCORRECTDECLARATIONOFMEDICALX-RAYEQUIPMENTINe-LORA (Completelyfilled&dulysignedapplicationforminhard copy needstobesubmittedincasetheinstitutionhasincorrectlydeclared/madeduplicateentriesofmedicaldiagnosticx-rayequipmentine-LORA.PleasesendthefilledinformtotheHead,RadiologicalSafetyDivision,AtomicEnergyRegulatoryBoard(AERB),NiyamakBhavan-B,Anushaktinagar,Mumbai-400094) PART-A(GeneralInformation) InstituteRegistrationNoissuedbyAERB: NameoftheInstitute: Address: City: Pincode: State: NameoftheLicensee: NameoftheEmployer: PART-B(EquipmentDetails) July14,2016 AlwaysvisiteLORAforrecentguidelines

  33. SpecifyreasonforremovaloftheaboveX-rayequipment(s)ineLORA(withdocumentaryproof):SpecifyreasonforremovaloftheaboveX-rayequipment(s)ineLORA(withdocumentaryproof): .............................................................................................................................................................................................................. .............................................................................................................................................................................................................. .............................................................................................................................................................................................................. .............................................................................................................................................................................................................. .............................................................................................................................................................................................................. ..... UNDERTAKING: Iherebycertifythattheparticularsprovidedinthisapplicationaretrueandcorrecttothebestofmyknowledgeandbelief.Iunderstandthatifatanystageitisfoundthattheinformationprovidedbymeisfalseornotauthentic,appropriateregulatoryactionmaybeinitiatedagainstmeandmyinstitution. Date: SignatureoftheLicensee: SignatureoftheHeadofInstitution(Employer) Name:Name:Designation: Designation: SEAL FOR AERB OFFICE USE Verifiedby:Approvedby:Date: Entryremovedon...................by.......................................................................................................................... Signature July14,2016 AlwaysvisiteLORAforrecentguidelines

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