35.400Useofsourcesformanualbrachytherapy.

Brachytherapysourcesmustbeusedonlyfortherapeuticmedical,whichmustbeapprovedin
theSealedSourceandDeviceRegistryorforresearchwhenacceptedbytheFDAtoaphysician
whoiscertifiedbyamedicalspecialtyboardthatrequiresthemtoberecognizedbythe
CommissionoranAgreementState.
35.404Surveysaftersourceimplantandremoval&35.406Brachytherapysources
accountability.

Surveyswitharadiationdetectionsurveyinstrumentarerequiredimmediatelyafter
implantingandremovingsourceswithinapatientorresearchsubject.Allsourcesmustbe
removedandaccountedfor.Whetherinstorageorinuse,allsourcesshouldbeaccountedforat
alltimes.Brachytherapysourcesshouldbereturnedtoappropriatesecurestorageassoonas
possibleafterremovalfromapatientorresearchsubject.Licenseesshouldkeeprecordsofthe
sourcesurveysrequiredinCFR35.2404andthesourceaccountabilityinCFR35.2406.
35.410Safetyinstruction.

Licenseesshouldprovideradiationsafetyinstructionsinitiallyandannuallytopersonnel
involvedinbrachytherapyprocedureswherethepatientorsubjectcannotbereleased.Instruction
shouldincludesizeandappearanceofbrachytherapysources,safehandlingandshielding,
patientcontrol,visitorcontrol(ie,routinevisitationofhospitalizedindividuals),andnotifying
theRadiationSafetyOfficerandanauthorizeduserifthepatienthasamedicalemergencyor
dies.Recordsshouldbemaintainedforindividualsreceivingthistraining.
35.415Safetyprecautions.

Forpatientsandresearchsubjectsreceivingbrachytherapywhocannotbereleased,the
licenseesshouldmakesurethatthepatientsarenotheldinaroomwithindividualsnotreceiving
brachytherapy.AlsoaRadioactiveMaterialssignshouldbepostedvisiblyoutsidethepatient
orsubjectsroomaswellasanotewithhowlongvisitorsmaystayinthepatientorsubjects
room.Licenseesshouldalsohaveemergencyresponseequipmentnearbyincaseasourceis
dislodgedfromthepatientorstuckwithinthepatientafterremovaloftheapplicators.
35.432Calibrationmeasurementsofbrachytherapysources.

Beforeuseofbrachytherapysources,licenseesshoulddeterminethesourceoutputor
activityandsourcepositioningaccuracywithinapplicators.AmericanAssociationofPhysicists
inMedicine(AAPM)accreditedsourcemanufacturerorcalibrationlaboratoryprovided

measurementsareconsideredacceptable.Also,outputsandactivitiesshouldbecorrectedfor
physicaldecay.RecordsshouldbekeptforeachcalibrationinaccordancewithCFR35.2432.
35.433Decayofstrontium90sourcesforophthalmictreatments.

Forstrontium90sources,onlyanauthorizedmedicalphysicistcancalculatetheactivity
usedforophthalmictreatmenttimecalculationsanddecaymustbebasedontheactivity
determinedin35.432.ActivitymeasurementsshouldberecordedinaccordancewithCFR
35.2433.
35.457Therapyrelatedcomputersystems.

Acceptancetestingontreatmentplanningsystemsshouldbeperformedinaccordance
withpublishedprotocolsbynationallyrecognizedbodies.Thetestingproceduresmustinclude
verificationofsourcespecificinputparameters,accuracyofdose,dwelltime,andtreatment
time,isodoseplots,graphicdisplays,andsoftwareusedtodeterminesealedsourcepositions
fromradiographicimages.

35.490Trainingforuseofmanualbrachytherapysources.
Anauthorizeduserofamanualbrachytherapysourceforthemedicalusesauthorized
underCFR35.400shallbeaphysicianwhomeetsoneofthefollowingcriteria(exceptas
providedinCFR35.57):
1. CertifiedbyamedicalspecialtyboardrecognizedbytheCommissionoranAgreement
Stateandobtainedwrittenattestationsignedbyapreceptorauthorizeduserwhomeets
therequirementsinCFR35.57,35.490,orequivalentAgreementStaterequirementsto
testifythatthepersonhascompletedallrequirements.
2. Hascompletedastructurededucationalprograminbasicradionuclidehandling
techniquesincluding200hoursclassroomandlaboratorytrainingand500hourswork
experience.Threeyearsofclinicalexperienceinradiationoncologysupervisedunderan
authorizeduserwhomeetstherequirementsinCFR35.57,35.490,orequivalent
AgreementStaterequirementshastobecompleted.Inaddition,writtenattestation
describedaboveisalsoneeded.

35.491Trainingforophthalmicuseofstrontium90.
Anauthorizeduserofstrontium90forophthalmicradiotherapyshallbeaphysicianwho
meetsoneofthefollowingcriteria(exceptasprovidedinCFR35.57):
1. MeetsrequirementsofCFR35.490orequivalentAgreementStaterequirements.

2. Hascompleted24hoursclassroomandlaboratorytrainingandclinicaltrainingin
ophthalmicradiotherapysupervisedunderanauthorizeduseratamedicalfacilitythat
includestheuseofstrontium90fortheophthalmictreatmentoffiveindividuals.In
addition,writtenattestationsignedbyapreceptorauthorizeduserwhomeetsthe
requirementsinCFR35.57,35.490,35.491,orequivalentAgreementStaterequirements
totestifythatthepersonhascompletedallrequirementsisneeded.

35.600Useofasealedsourceinaremoteafterloaderunit,teletherapyunit,orgamma
stereotacticradiosurgeryunit.
Alicenseeshouldonlyuseapprovedsealedsourceandregistereddevicefortherapeutic
treatment.Forresearchpurpose,thedevicehastobecompliedwiththeFDAsIDErequirements.

35.604Surveysofpatientsandhumanresearchsubjectstreatedwitharemoteafterloader
unit.
Alicenseeshouldsurveythepatient,thetreatmentroom,andtheafterloaderwitha
portableradiationsurveymeterbeforereleasingthepatientorthehumanresearchsubject.The
surveymeterreadingtogetherwiththepatient/researchsubjectinformationshouldberecorded.

35.605Installation,maintenance,adjustment,andrepair.
Onlyalicensedperson(bythecommissionoranagreementstate),usuallyaservice
engineerfromthevendor,can1)workonpartsthatinvolvesource(s)shielding,source(s)
driving,orothercomponentsthatmaycompromisetheradiationsafetyonaremoteafterloader,
teletherapyunit,orgammastereotacticradiosurgeryunit2)install,replace,relocate,orremove
ahighdoseratesourcesealedinacontainerortreatmentunits.
Forlowdoseratetreatmentunits,thesourcecanbeinstalled,replaced,relocated,or
removedbyeitheralicenseeoranauthorizedmedicalphysicist.Alicenseeshouldkeepthe
recordforanyworkdonetotheremoteafterloader,teletherapyunitsandgammastereotactic
radiosurgeryunits.

35.610Safetyproceduresandinstructionsforremoteafterloaderunits,teletherapyunits,
andgammastereotacticradiosurgeryunits&35.615Safetyprecautionsforremote
afterloaderunits,teletherapyunits,andgammastereotacticradiosurgeryunits.

Thesesectionsdisplaythesafetyprecautionsandproceduresforremoteafterloadersunits
teletherapyunitsandgammastereotacticradiosurgeryunits.Theseprecautionsstartwiththe
licenseecontrollingtheaccesstothetreatmentrooms.Alloperatorsoftheunitneedtobe

providedinstructionabouttheunitonanannualbasis,alongwithparticipatinginemergency
drills.Anauthorizedmedicalphysicistandanauthorizeduserorphysicianneedtobephysically
presenttoinitiatetreatment.Namesoftheauthorizedusers,medicalphysicist,andRadiation
SafetyOfficerincludingtheirphonenumbersshouldbepostedintheeventsthattheunitoperate
abnormally.Alldoorsaccessingtheunitshouldbeequippedwithelectricalinterlocksthat
preventtheoperatorfromstartingtreatmentunlessthedoorsareclosed.Usersneedtoassurethat
theradiationlevelshavegonebackdowntoambientlevelswiththeappropriateradiation
monitorsbeforeenteringtheroomafterprocedures
35.630DosimetryEquipment

Licenseesneedtohaveadosimetrysystemcalibratedinoneoftwoways.Oneoptionis
tohaveitcalibratedwithinthelast2yearsbytheNationalInstituteofStandardsandTechnology
(NIST)orbytheAmericanAssociationofPhysicistsinMedicine(AAPM).Theotheroptionis
tohaveitcalibratedusingthesamemethodwithinthelast4years,andthenwithin18to30
monthsitneedstobecomparedwithanothersystemthatwascalibratedwithin24months,and
theshowingthatthecalibrationfactorshadnotchangedbymorethan2%.
35.632Fullcalibrationmeasurementsonteletherapyunits.

Teletherapyunitsrequirethecompletionofafullcalibrationbyauthorizedmedical
physicistsduringthefollowingtimes:priortothefirstuse,annually,whenperiodicchecks
revealanoutputvarianceofgreaterthan5%,afterasourcereplacement,equipmentrelocation,
orheftyunitrepair.
Requireditemstoincludeinacalibrationincludeanoutputverification(+/3%)for
varyingfieldsizesandSSDs,lightfieldcoincidence,beamuniformity,timeraccuracy,andthe
testingofalllocalizationdevices.Periodicoutputcorrectionsarerequiredtoaccountfor
radioactivedecayfrequencyincludesmonthlyforcobalt60,biannuallyforcesium137,andas
neededforevery1%decayofothernonspecifiedradionuclides.Alldatagatheredineach
calibrationmustbekeptonfileandadheretonationalmeasurementguidelines.

35.633Fullcalibrationmeasurementsonremoteafterloaderunits.

Similartoteletherapyunits,remoteafterloadersrequireafullcalibrationduringthe
followingsituations:priortotheunitsfirstuse,afterasourcereplacement,unitrelocation,or
repair.Inaddition,high,medium,andpulseddoserateremoteafterloaderswhosesources
haveahalflifegreaterthan75daysaretobecalibratedquarterlywhilelowdoserate
afterloadersrequireanannualcheck.Eachofthesemustalsofollownationalmeasurement
guidelines.


Afullcalibrationoftheafterloaderunitmustinclude:anoutputverification(+/5%),
sourcepositioningaccuracy(+/1mm),sourceretractionusingbackupbattery,applicatorand
transfertubelengthandfunctionalitycheck,timeraccuracyandsourceuniformityverification.
Sourceoutputshouldbeaccountedandcorrectedforwithevery1%decayallcalibrationrecords
aretobekeptonfileforreference.

35.635Fullcalibrationmeasurementsongammastereotacticradiosurgeryunits.

Gammastereotacticradiosurgeryunitsrequireafullcalibrationduringthefollowing
times:priortothefirstuse,annually,aftersourcereplacementorrepair,andwhenperiodic
outputchecksvaryfromcalibratedvaluesbymorethan5%.
Thecalibrationprocessmustuseapproveddosimetryequipmentandmustfollow
nationalstandardguidelines.Authorizedmedicalphysicistsmustverifytheunitoutput(+/3%),
helmetfactors,isocentercoincidence,beamuniformity,emergencycircuitsandonofferror,and
theintegrityandpositioningaccuracyofthestereotacticheadframes.Asperallother
calibrationprocedures,outputcorrectionsmustbeperformedmonthlyforcobalt60andata
frequencycorrespondingto1%decayofallotherradioactiveunitsources.

35.642Periodicspotchecksforteletherapyunits.
MonthlyTeletherapyspotchecksshouldbeperformedbyanauthorizedlicensee
coveringTimeraccuracy,timerlinearityovertherangeofuse,onofferrors,theaccuracyofall
distancemeasuringdevicesandaccuracyofthelightbeamlocalizer.Theoutputofthe
teletherapyunitshouldbemeasuredwiththedosimetrysystemin35.630(b).Theactualoutput
shouldbeexpressedasapercentageoftheanticipatedoutput.Theauthorizedlicenseeneedsto
havethemedicalphysicistreviewtheresultsofthespotcheckwithin15daysofthe
measurementstaken.ThePhysicistshouldnotifythelicenseeassoonaspossiblewith
confirmingtheresults.
Theauthorizedlicenseeshouldperformspotchecksofeachteletherapyfacilityonce
everymonthandalsowitheverynewsourceinstallation.Spotchecksshouldbeperformedon
theinterlocksateachteletherapyroomentrance,theexposureindicatorlightsonroomentrance
andconsole,theviewingandintercomsystems,andtheelectricalandmechanicalprimarybeam
stops.Inthecaseofamalfunctionofanyofthesechecks,thelicenseeshalllocktheconsoleand
keepitintheoffpositionexceptwhenrepairingorreplacingthemalfunction.
Thelicenseeshallretainarecordofthespotchecksperformedinaccordancewith
35.2642.

35.643Periodicspotchecksforremoteafterloaderunits.
Anauthorizedlicenseetouseremoteafterloaderunitsshallperformspotchecksforeach
remoteafterloaderfacilityandunit.Spotchecksshallbeperformedeverydaybeforethefirstuse
ofhigh,mediumandpulseddoserateremoteafterloaderunits.Spotchecksshallbeperformed
beforeeveryLDRpatienttreatment.Spotchecksshallbeperformedaftereverysource
installation.Thelicenseeshallperformmeasurementsinaccordancewiththeprocedures
establishedbytheauthorizedmedicalphysicist.Theresultsshallbebroughttothephysicist
within15days.
Minimumacceptancetoassureproperoperationconsistsofspotchecksof:
Electricalinterlocksattheroomentrance
Exposureindicatorlightsontheroomentranceandtheconsole
Viewingandintercomsystemsintheroom
Timeraccuracyandaccuratedateandtimeintheunitcomputer
Radiationmonitorsverifyingthesourceposition
Decayedsourceactivityintheunitcomputer
Emergencyresponseequipment
Inthecaseofamalfunctionofanyofthesechecks,thelicenseeshalllocktheconsole
andkeepitintheoffpositionexceptwhenrepairingorreplacingthemalfunction.Thelicensee
shallretainarecordofthespotchecksperformedinaccordancewith35.2643.
35.645Periodicspotchecksforgammastereotacticradiosurgeryunits.
AnauthorizedlicenseeforuseofthegammaSRSunitshallperformspotchecks
monthly,beforethefirstuseeverydayandaftersourceinstallation.Thelicenseeshallperform
themeasurementsestablishedwiththeauthorizedmedicalphysicist.Thephysicistmustreview
thespotcheckswithin15days.
ThespotcheckminimumrequirementstoassureproperoperationofthegammaSRSunit
includepropertreatmenttableretractionmechanismwhentheunitisoff,properoperationofthe
helmetmicroswitcheslocalizingdevicesandemergencytimingcircuits.Thetimeraccuracyand
linearityovertherangeofuseshouldbecheckedalongwiththeelectronicdoorlockstothe
roomandtheviewingandintercomsystems.Theoutputforthegammaunitshouldbemeasured
with35.630(b)andshouldbeexpressedasapercentageoftheanticipatedoutput.Inthecaseof
amalfunctionofanyofthesechecks,thelicenseeshalllocktheconsoleandkeepitintheoff
positionexceptwhenrepairingorreplacingthemalfunction.Thelicenseeshallretainarecordof
thespotchecksperformedinaccordancewith35.2645.

35.647Additionaltechnicalrequirementsformobileremoteafterloaderunits.
Thelicenseeisresponsibleforcheckingsurveyinstrumentsdailyandbeforeeveryuse
andcheckforallsourcesbeforepatientsleavethetreatmentroom.Theyalsomustcheckthe
afterloaderunitbeforeeachuseforcorrectoperationofelectricinterlocks,sourceexposure
indicatorlightsinallavailableplaces,theaudioandvisualsystems,applicators/tubes,radiation
monitorsintheroom,sourcepositioning,andmonitorsthatindicatesourcehasreturntothe
shieldedposition.Asimulatedcycleoftreatmentmustbeperformedontheafterloader
daily/beforeuse.Ifanyofthesechecksshowmalfunctionofthesystem,thelicenseeneedsto
lockthecontrolconsoleoffandnotusetheunitexceptforrepair.Recordsmustbekeptofthese
checks.(35.647)
35.652Radiationsurveys.
Alicenseemustperformsurveystoensureradiationdoesnotexceedthemaximumlevel
allowableandthataveragelevelsfromthesourceinthesafepositiondonotexceedlevels
declaredbySealedSourceandDeviceRegistry.Surveysmustbeperformedatinstallationofa
newsourceandafteranyrepairs.Recordsmustbekeptofthesesurveys.
35.655Fiveyearinspectionforteletherapyandgammastereotacticradiosurgeryunits.
Teletherapy(anyradiationtherapyunit)andgammaunits(ex:GammaKnife)mustbe
inspectedandservicedwitheverysourcereplacementoreveryfiveyears.Servicingcanonlybe
performedbysomeonelicensedbythecommissionoragreementstateandrecordsshouldbe
keptofeveryservice/inspection.
35.657Therapyrelatedcomputersystems.
Thelicenseeisresponsiblefortestingthetreatmentplanningsystemforbrachytherapyto
ensuretheaccuracyofthespecificsourceinputparameters,theaccuracyofthedose/dwell
time/timecalculationatcertainpoints,theaccuracyoftheisotopelinesanddisplay,theaccuracy
ofsourcepositionsfromimages,andaccuracyofelectronictransfersoftreatmentplanstothe
treatmentunit.
35.690Trainingforuseofremoteafterloaderunits,teletherapyunits,andgamma
stereotacticradiosurgeryunits.
Aphysicianmustbeauthorizedforusebybeingcertifiedbyaspecialtymedicalboard
thatisrecognizedbythecommissionoranagreementstate.Thisboardrequiresallphysicians
mustsuccessfullycompleteaminimumofthreeyearsresidencytraininginradiationtherapyand
topasstheboardexamthatincludesradiationsafety,radionuclidehandling,treatmentplanning,
QA,useofSRS,andexternalbeam/afterloaderknowledge.Theymusthavecompleteda

structurededucationprogramininternaltherapythatincludes200hoursofclassandlabtraining
inradiationphysics,radiationprotection,mathpertainingtoradioactivity,andradiationbiology.
Acertifiedphysicianbytheboardmustsuperviseatleast500hoursofworkinaninstitutionthat
includescalibrationmeasures/spotchecks,treatmentplanning,useofcontrolstopreventmedical
event,emergencyprocedures,checkswithsurveymeters,andselectingproperdoseand
administration.Theymustalsohavecompletedthreeyearsofsupervisedclinicalexperienceina
boardapprovedprogramandhaveobtainedwrittenverificationofsatisfactorycompletionofall
mentionedhoursandthatsaystheyarecompetentlysufficienttoworkindependently.Theyare
alsorequiredtohavereceivedtrainingindeviceoperation,safety,andclinicaluseofequipment
bythevendororanyauthorizeduserofsaidequipment.