BS EN ISO 11737-1-2006

G49G50G3G38G50G51G60G44G49G42G3G58G44G55G43G50G56G55G3G37G54G44G3G51G40G53G48G44G54G54G44G50G49G3G40G59G38G40G51G55G3G36G54G3G51G40G53G48G44G55G55G40G39G3G37G60G3G38G50G51G60G53G44G42G43G55G3G47G36G58METHODSPART1DETERMINATIONOFAPOPULATIONOFMICROORGANISMSONPRODUCTSTHEEUROPEANSTANDARDENISO173712006HASTHESTATUSOFABRITISHSTANDARDICS07100101108001STERILIZATIONOFMEDICALDEVICESMICROBIOLOGICALBRITISHSTANDARDBSENISO1173712006BSENISO1173712006THISBRITISHSTANDARDWASPUBLISHEDUNDERTHEAUTHORITYOFTHESTANDARDSPOLICYANDSTRATEGYCOMMITTEEON28APRIL2006BSI2006ISBN0580481654CROSSREFERENCESTHEBRITISHSTANDARDSWHICHIMPLEMENTINTERNATIONALOREUROPEANPUBLICATIONSREFERREDTOINTHISDOCUMENTMAYBEFOUNDINTHEBSICATALOGUEUNDERTHESECTIONENTITLED“INTERNATIONALSTANDARDSCORRESPONDENCEINDEX”,ORBYUSINGTHE“SEARCH”FACILITYOFTHEBSIELECTRONICCATALOGUEOROFBRITISHSTANDARDSONLINETHISPUBLICATIONDOESNOTPURPORTTOINCLUDEALLTHENECESSARYPROVISIONSOFACONTRACTUSERSARERESPONSIBLEFORITSCORRECTAPPLICATIONCOMPLIANCEWITHABRITISHSTANDARDDOESNOTOFITSELFCONFERIMMUNITYFROMLEGALOBLIGATIONSSUMMARYOFPAGESTHISDOCUMENTCOMPRISESAFRONTCOVER,ANINSIDEFRONTCOVER,THEENISOTITLEPAGE,THEENISOFOREWORDPAGE,THEISOTITLEPAGE,PAGESIITOVI,PAGES1TO36,ANINSIDEBACKCOVERANDABACKCOVERTHEBSICOPYRIGHTNOTICEDISPLAYEDINTHISDOCUMENTINDICATESWHENTHEDOCUMENTWASLASTISSUEDAMENDMENTSISSUEDSINCEPUBLICATIONAMDNODATECOMMENTSALISTOFORGANIZATIONSREPRESENTEDONTHISCOMMITTEECANBEOBTAINEDONREQUESTTOITSSECRETARYPRESENTTOTHERESPONSIBLEINTERNATIONAL/EUROPEANCOMMITTEEANYENQUIRIESONTHEINTERPRETATION,ORPROPOSALSFORCHANGE,ANDKEEPUKINTERESTSINFORMEDMONITORRELATEDINTERNATIONALANDEUROPEANDEVELOPMENTSANDPROMULGATETHEMINTHEUKNATIONALFOREWORDTHISBRITISHSTANDARDISTHEOFFICIALENGLISHLANGUAGEVERSIONOFENISO1173712006ITISIDENTICALWITHISO1173712006ITSUPERSEDESBSEN117411996,BSEN117421997ANDBSEN117431997WHICHAREWITHDRAWNTHEUKPARTICIPATIONINITSPREPARATIONWASENTRUSTEDTOTECHNICALCOMMITTEECH/198,STERILIZATIONOFMEDICALINSTRUMENTS,WHICHHASTHERESPONSIBILITYTOAIDENQUIRERSTOUNDERSTANDTHETEXTWWWBZFXWCOMEUROPEANSTANDARDNORMEEUROPENNEEUROPISCHENORMENISO117371APRIL2006ICS07100101108001SUPERSEDESEN117411996,EN117421996,EN117431996ENGLISHVERSIONSTERILIZATIONOFMEDICALDEVICESMICROBIOLOGICALMETHODSPART1DETERMINATIONOFAPOPULATIONOFMICROORGANISMSONPRODUCTSISO1173712006STRILISATIONDESDISPOSITIFSMDICAUXMTHODESMICROBIOLOGIQUESPARTIE1DTERMINATIONDUNEPOPULATIONDEMICROORGANISMESSURDESPRODUITSISO1173712006STERILISATIONVONMEDIZINPRODUKTENMIKROBIOLOGISCHEVERFAHRENTEIL1BESTIMMUNGDERPOPULATIONVONMIKROORGANISMENAUFPRODUKTENISO1173712006THISEUROPEANSTANDARDWASAPPROVEDBYCENON23MARCH2006CENMEMBERSAREBOUNDTOCOMPLYWITHTHECEN/CENELECINTERNALREGULATIONSWHICHSTIPULATETHECONDITIONSFORGIVINGTHISEUROPEANSTANDARDTHESTATUSOFANATIONALSTANDARDWITHOUTANYALTERATIONUPTODATELISTSANDBIBLIOGRAPHICALREFERENCESCONCERNINGSUCHNATIONALSTANDARDSMAYBEOBTAINEDONAPPLICATIONTOTHECENTRALSECRETARIATORTOANYCENMEMBERTHISEUROPEANSTANDARDEXISTSINTHREEOFFICIALVERSIONSENGLISH,FRENCH,GERMANAVERSIONINANYOTHERLANGUAGEMADEBYTRANSLATIONUNDERTHERESPONSIBILITYOFACENMEMBERINTOITSOWNLANGUAGEANDNOTIFIEDTOTHECENTRALSECRETARIATHASTHESAMESTATUSASTHEOFFICIALVERSIONSCENMEMBERSARETHENATIONALSTANDARDSBODIESOFAUSTRIA,BELGIUM,CYPRUS,CZECHREPUBLIC,DENMARK,ESTONIA,FINLAND,FRANCE,GERMANY,GREECE,HUNGARY,ICELAND,IRELAND,ITALY,LATVIA,LITHUANIA,LUXEMBOURG,MALTA,NETHERLANDS,NORWAY,POLAND,PORTUGAL,ROMANIA,SLOVAKIA,SLOVENIA,SPAIN,SWEDEN,SWITZERLANDANDUNITEDKINGDOMEUROPEANCOMMITTEEFORSTANDARDIZATIONCOMITEUROPENDENORMALISATIONEUROPISCHESKOMITEEFRNORMUNGMANAGEMENTCENTRERUEDESTASSART,36B1050BRUSSELS2006CENALLRIGHTSOFEXPLOITATIONINANYFORMANDBYANYMEANSRESERVEDWORLDWIDEFORCENNATIONALMEMBERSREFNOENISO1173712006EWWWBZFXWCOMFOREWORDTHISDOCUMENTENISO1173712006HASBEENPREPAREDBYTECHNICALCOMMITTEEISO/TC198“STERILIZATIONOFHEALTHCAREPRODUCTS“INCOLLABORATIONWITHTECHNICALCOMMITTEECEN/TC204“STERILIZATIONOFMEDICALDEVICES“,THESECRETARIATOFWHICHISHELDBYBSITHISEUROPEANSTANDARDSHALLBEGIVENTHESTATUSOFANATIONALSTANDARD,EITHERBYPUBLICATIONOFANIDENTICALTEXTORBYENDORSEMENT,ATTHELATESTBYOCTOBER2006,ANDCONFLICTINGNATIONALSTANDARDSSHALLBEWITHDRAWNATTHELATESTBYOCTOBER2006THISDOCUMENTSUPERSEDESEN117411996,EN117421996ANDEN117431996THISDOCUMENTHASBEENPREPAREDUNDERAMANDATEGIVENTOCENBYTHEEUROPEANCOMMISSIONANDTHEEUROPEANFREETRADEASSOCIATION,ANDSUPPORTSESSENTIALREQUIREMENTSOFEUDIRECTIVESFORRELATIONSHIPWITHEUDIRECTIVES,SEEINFORMATIVEANNEXZA,WHICHISANINTEGRALPARTOFTHISDOCUMENTACCORDINGTOTHECEN/CENELECINTERNALREGULATIONS,THENATIONALSTANDARDSORGANIZATIONSOFTHEFOLLOWINGCOUNTRIESAREBOUNDTOIMPLEMENTTHISEUROPEANSTANDARDAUSTRIA,BELGIUM,CYPRUS,CZECHREPUBLIC,DENMARK,ESTONIA,FINLAND,FRANCE,GERMANY,GREECE,HUNGARY,ICELAND,IRELAND,ITALY,LATVIA,LITHUANIA,LUXEMBOURG,MALTA,NETHERLANDS,NORWAY,POLAND,PORTUGAL,ROMANIA,SLOVAKIA,SLOVENIA,SPAIN,SWEDEN,SWITZERLANDANDUNITEDKINGDOMENDORSEMENTNOTICETHETEXTOFISO1173712006HASBEENAPPROVEDBYCENASENISO1173712006WITHOUTANYMODIFICATIONSENISO1173712006WWWBZFXWCOMREFERENCENUMBERISO1173712006EINTERNATIONALSTANDARDISO117371SECONDEDITION20060401STERILIZATIONOFMEDICALDEVICESMICROBIOLOGICALMETHODSPART1DETERMINATIONOFAPOPULATIONOFMICROORGANISMSONPRODUCTSSTRILISATIONDESDISPOSITIFSMDICAUXMTHODESMICROBIOLOGIQUESPARTIE1DTERMINATIONDUNEPOPULATIONDEMICROORGANISMESSURDESPRODUITSENISO1173712006WWWBZFXWCOMIIWWWBZFXWCOMIIICONTENTSPAGEFOREWORDIVINTRODUCTIONV1SCOPE12NORMATIVEREFERENCES13TERMSANDDEFINITIONS24QUALITYMANAGEMENTSYSTEMELEMENTS441DOCUMENTATION442MANAGEMENTRESPONSIBILITY443PRODUCTREALIZATION444MEASUREMENT,ANALYSISANDIMPROVEMENTCONTROLOFNONCONFORMINGPRODUCT55SELECTIONOFPRODUCT551GENERAL552SAMPLEITEMPORTIONSIP56METHODSOFDETERMINATIONANDMICROBIALCHARACTERIZATIONOFBIOBURDEN661DETERMINATIONOFBIOBURDEN662MICROBIALCHARACTERIZATIONOFBIOBURDEN77VALIDATIONOFMETHODFORDETERMININGBIOBURDEN78ROUTINEDETERMINATIONOFBIOBURDENANDINTERPRETATIONOFDATA79MAINTENANCEOFTHEMETHODOFDETERMINATIONOFBIOBURDEN891CHANGESTOTHEPRODUCTAND/ORMANUFACTURINGPROCESS892CHANGESTOTHEMETHODOFDETERMINATIONOFBIOBURDEN893REVALIDATIONOFTHEMETHODOFDETERMINATIONOFBIOBURDEN8ANNEXAINFORMATIVEGUIDANCEONDETERMINATIONOFAPOPULATIONOFMICROORGANISMSONPRODUCT9ANNEXBINFORMATIVEGUIDANCEONMETHODSOFDETERMINATIONOFBIOBURDEN22ANNEXCINFORMATIVEVALIDATIONOFBIOBURDENMETHODS31BIBLIOGRAPHY34ANNEXZAINFORMATIVERELATIONSHIPBETWEENTHISEUROPEANSTANDARDANDTHEESSENTIALREQUIREMENTSOFEUDIRECTIVES90/385/EECCONCERNINGACTIVEIMPLANTABLEMEDICALDEVICES,93/42/EECCONCERNINGMEDICALDEVICESAND98/79/ECCONCERNINGINVITRODIAGNOSTICMEDICALDEVICES36ENISO1173712006WWWBZFXWCOMIVFOREWORDISOTHEINTERNATIONALORGANIZATIONFORSTANDARDIZATIONISAWORLDWIDEFEDERATIONOFNATIONALSTANDARDSBODIESISOMEMBERBODIESTHEWORKOFPREPARINGINTERNATIONALSTANDARDSISNORMALLYCARRIEDOUTTHROUGHISOTECHNICALCOMMITTEESEACHMEMBERBODYINTERESTEDINASUBJECTFORWHICHATECHNICALCOMMITTEEHASBEENESTABLISHEDHASTHERIGHTTOBEREPRESENTEDONTHATCOMMITTEEINTERNATIONALORGANIZATIONS,GOVERNMENTALANDNONGOVERNMENTAL,INLIAISONWITHISO,ALSOTAKEPARTINTHEWORKISOCOLLABORATESCLOSELYWITHTHEINTERNATIONALELECTROTECHNICALCOMMISSIONIECONALLMATTERSOFELECTROTECHNICALSTANDARDIZATIONINTERNATIONALSTANDARDSAREDRAFTEDINACCORDANCEWITHTHERULESGIVENINTHEISO/IECDIRECTIVES,PART2THEMAINTASKOFTECHNICALCOMMITTEESISTOPREPAREINTERNATIONALSTANDARDSDRAFTINTERNATIONALSTANDARDSADOPTEDBYTHETECHNICALCOMMITTEESARECIRCULATEDTOTHEMEMBERBODIESFORVOTINGPUBLICATIONASANINTERNATIONALSTANDARDREQUIRESAPPROVALBYATLEAST75OFTHEMEMBERBODIESCASTINGAVOTEATTENTIONISDRAWNTOTHEPOSSIBILITYTHATSOMEOFTHEELEMENTSOFTHISDOCUMENTMAYBETHESUBJECTOFPATENTRIGHTSISOSHALLNOTBEHELDRESPONSIBLEFORIDENTIFYINGANYORALLSUCHPATENTRIGHTSISO117371WASPREPAREDBYTECHNICALCOMMITTEEISO/TC198,STERILIZATIONOFHEALTHCAREPRODUCTSTHISSECONDEDITIONCANCELSANDREPLACESTHEFIRSTEDITIONISO1173711995WHICHHASBEENTECHNICALLYREVISEDANDISO1173732004WHOSECONTENTSITNOWINCORPORATESISO11737CONSISTSOFTHEFOLLOWINGPARTS,UNDERTHEGENERALTITLESTERILIZATIONOFMEDICALDEVICESMICROBIOLOGICALMETHODSPART1DETERMINATIONOFAPOPULATIONOFMICROORGANISMSONPRODUCTSPART2TESTSOFSTERILITYPERFORMEDINTHEVALIDATIONOFASTERILIZATIONPROCESSENISO1173712006WWWBZFXWCOMVINTRODUCTIONASTERILEMEDICALDEVICEISONETHATISFREEOFVIABLEMICROORGANISMSINTERNATIONALSTANDARDSTHATSPECIFYREQUIREMENTSFORVALIDATIONANDROUTINECONTROLOFSTERILIZATIONPROCESSES,REQUIRE,WHENITISNECESSARYTOSUPPLYASTERILEMEDICALDEVICE,THATADVENTITIOUSMICROBIOLOGICALCONTAMINATIONOFAMEDICALDEVICEPRIORTOSTERILIZATIONBEMINIMIZEDEVENSO,MEDICALDEVICESPRODUCEDUNDERSTANDARDMANUFACTURINGCONDITIONSINACCORDANCEWITHTHEREQUIREMENTSFORQUALITYMANAGEMENTSYSTEMSSEE,FOREXAMPLE,ISO13485MAY,PRIORTOSTERILIZATION,HAVEMICROORGANISMSONTHEM,ALBEITINLOWNUMBERSSUCHPRODUCTSARENONSTERILETHEPURPOSEOFSTERILIZATIONISTOINACTIVATETHEMICROBIOLOGICALCONTAMINANTSANDTHEREBYTRANSFORMTHENONSTERILEPRODUCTSINTOSTERILEONESTHEKINETICSOFINACTIVATIONOFAPURECULTUREOFMICROORGANISMSBYPHYSICALAND/ORCHEMICALAGENTSUSEDTOSTERILIZEMEDICALDEVICESCANGENERALLYBESTBEDESCRIBEDBYANEXPONENTIALRELATIONSHIPBETWEENTHENUMBERSOFMICROORGANISMSSURVIVINGANDTHEEXTENTOFTREATMENTWITHTHESTERILIZINGAGENTINEVITABLYTHISMEANSTHATTHEREISALWAYSAFINITEPROBABILITYTHATAMICROORGANISMMAYSURVIVEREGARDLESSOFTHEEXTENTOFTREATMENTAPPLIEDFORAGIVENTREATMENT,THEPROBABILITYOFSURVIVALISDETERMINEDBYTHENUMBERANDRESISTANCEOFMICROORGANISMSANDBYTHEENVIRONMENTINWHICHTHEORGANISMSEXISTDURINGTREATMENTITFOLLOWSTHATTHESTERILITYOFANYONEPRODUCTINAPOPULATIONSUBJECTEDTOSTERILIZATIONPROCESSINGCANNOTBEGUARANTEEDANDTHESTERILITYOFAPROCESSEDPOPULATIONISDEFINEDINTERMSOFTHEPROBABILITYOFTHEREBEINGAVIABLEMICROORGANISMPRESENTONAPRODUCTITEMGENERICREQUIREMENTSOFTHEQUALITYMANAGEMENTSYSTEMFORDESIGNANDDEVELOPMENT,PRODUCTION,INSTALLATIONANDSERVICINGAREGIVENINISO9001ANDPARTICULARREQUIREMENTSFORQUALITYMANAGEMENTSYSTEMSFORMEDICALDEVICEPRODUCTIONAREGIVENINISO13485THESTANDARDSFORQUALITYMANAGEMENTSYSTEMSRECOGNIZETHAT,FORCERTAINPROCESSESUSEDINMANUFACTURING,THEEFFECTIVENESSOFTHEPROCESSCANNOTBEFULLYVERIFIEDBYSUBSEQUENTINSPECTIONANDTESTINGOFTHEPRODUCTSTERILIZATIONISANEXAMPLEOFSUCHAPROCESSFORTHISREASON,STERILIZATIONPROCESSESAREVALIDATEDFORUSE,THEPERFORMANCEOFTHESTERILIZATIONPROCESSISMONITOREDROUTINELYANDTHEEQUIPMENTISMAINTAINEDINTERNATIONALSTANDARDSSPECIFYINGPROCEDURESFORTHEVALIDATIONANDROUTINECONTROLOFTHEPROCESSESUSEDFORTHESTERILIZATIONOFMEDICALDEVICESHAVEBEENPREPAREDSEE,FOREXAMPLE,ISO11135,ISO11137SERIESANDISO17665HOWEVER,ITISIMPORTANTTOBEAWARETHATEXPOSURETOAPROPERLYVALIDATEDANDACCURATELYCONTROLLEDSTERILIZATIONPROCESSISNOTTHEONLYFACTORASSOCIATEDWITHTHEPROVISIONOFASSURANCETHATTHEPRODUCTISSTERILEAND,INTHISRESPECT,SUITABLEFORITSINTENDEDUSEFURTHERMORE,FORTHEEFFECTIVEVALIDATIONANDROUTINECONTROLOFASTERILIZATIONPROCESS,ITISIMPORTANTTOBEAWAREOFTHEMICROBIOLOGICALCHALLENGETHATISPRESENTEDINTHEPROCESS,INTERMSOFNUMBER,CHARACTERISTICSANDPROPERTIESOFMICROORGANISMSTHETERMBIOBURDENISUSEDTODESCRIBETHEPOPULATIONOFVIABLEMICROORGANISMSPRESENTONORINPRODUCTAND/ORASTERILEBARRIERSYSTEMAKNOWLEDGEOFBIOBURDENCANBEUSEDINANUMBEROFSITUATIONSASPARTOFVALIDATIONANDREVALIDATIONOFSTERILIZATIONPROCESSESROUTINEMONITORINGFORCONTROLOFMANUFACTURINGPROCESSESMONITORINGOFRAWMATERIALS,COMPONENTSORPACKAGINGASSESSMENTOFTHEEFFICIENCYOFCLEANINGPROCESSESANOVERALLENVIRONMENTALMONITORINGPROGRAMMEBIOBURDENISTHESUMOFTHEMICROBIALCONTRIBUTIONSFROMANUMBEROFSOURCES,INCLUDINGRAWMATERIALS,MANUFACTURINGOFCOMPONENTS,ASSEMBLYPROCESSES,MANUFACTURINGENVIRONMENT,ASSEMBLY/MANUFACTURINGAIDSEG,COMPRESSEDGASES,WATER,LUBRICANTS,CLEANINGPROCESSESANDPACKAGINGOFFINISHEDPRODUCTTOCONTROLBIOBURDEN,ATTENTIONMUSTBEGIVENTOTHEMICROBIOLOGICALSTATUSOFTHESESOURCESENISO1173712006WWWBZFXWCOMVIITISNOTPOSSIBLETOENUMERATETHEBIOBURDENEXACTLYAND,INPRACTICE,ADETERMINATIONOFBIOBURDENISMADEUSINGADEFINEDMETHODDEFINITIONOFASINGLEMETHODFORUSEINTHEDETERMINATIONOFBIOBURDENINALLSITUATIONSISNOTPRACTICABLEBECAUSEOFTHEWIDEVARIETYOFDESIGNSANDMATERIALSOFCONSTRUCTIONOFMEDICALDEVICESNORISITPOSSIBLETODEFINEASINGLETECHNIQUETOBEUSEDINALLSITUATIONSFORTHEREMOVALOFMICROORGANISMSINPREPARATIONFORENUMERATIONFURTHERMORE,THESELECTIONOFCONDITIONSFORENUMERATIONOFMICROORGANISMSWILLBEINFLUENCEDBYTHETYPESOFMICROORGANISMLIKELYTOBEPRESENTONORINMEDICALDEVICESTHISPARTOFISO11737SPECIFIESTHEREQUIREMENTSTOBEMETINTHEDETERMINATIONOFBIOBURDENTHEREQUIREMENTSARETHENORMATIVEPARTSOFTHISPARTOFISO11737WITHWHICHCOMPLIANCEISCLAIMEDTHEGUIDANCEGIVENINTHEINFORMATIVEANNEXESISNOTNORMATIVEANDISNOTPROVIDEDASACHECKLISTFORAUDITORSTHEGUIDANCEPROVIDESEXPLANATIONSANDMETHODSTHATAREREGARDEDASBEINGASUITABLEMEANSFORCOMPLYINGWITHTHEREQUIREMENTSMETHODSOTHERTHANTHOSEGIVENINTHEGUIDANCEMAYBEUSED,IFTHEYAREEFFECTIVEINACHIEVINGCOMPLIANCEWITHTHEREQUIREMENTSOFTHISPARTOFISO11737ENISO1173712006WWWBZFXWCOM1STERILIZATIONOFMEDICALDEVICESMICROBIOLOGICALMETHODSPART1DETERMINATIONOFAPOPULATIONOFMICROORGANISMSONPRODUCTS1SCOPETHISPARTOFISO11737SPECIFIESREQUIREMENTSANDPROVIDESGUIDANCEFORTHEENUMERATIONANDMICROBIALCHARACTERIZATIONOFTHEPOPULATIONOFVIABLEMICROORGANISMSONORINAMEDICALDEVICE,COMPONENT,RAWMATERIALORPACKAGENOTE1THENATUREANDEXTENTOFMICROBIALCHARACTERIZATIONISDEPENDENTONTHEINTENDEDUSEOFTHEBIOBURDENDATATHISPARTOFISO11737DOESNOTSPECIFYREQUIREMENTSFORTHEENUMERATIONORIDENTIFICATIONOFVIRALORPROTOZOANCONTAMINANTSNOTE2FURTHERMORE,THEREQUIREMENTSSPECIFIEDINTHISPARTOFISO11737ARENOTINTENDEDTOADDRESSTHEREMOVALANDDETECTIONOFTHECAUSATIVEAGENTSOFSPONGIFORMENCEPHALOPATHIESSUCHASSCRAPIE,BOVINESPONGIFORMENCEPHALOPATHYANDCREUTZFELDTJAKOBDISEASETHISPARTOFISO11737DOESNOTSPECIFYREQUIREMENTSFORTHEMICROBIOLOGICALMONITORINGOFTHEENVIRONMENTINWHICHMEDICALDEVICESAREMANUFACTURED2NORMATIVEREFERENCESTHEFOLLOWINGREFERENCEDDOCUMENTSAREINDISPENSABLEFORTHEAPPLICATIONOFTHISDOCUMENTFORDATEDREFERENCES,ONLYTHEEDITIONCITEDAPPLIESFORUNDATEDREFERENCES,THELATESTEDITIONOFTHEREFERENCEDDOCUMENTINCLUDINGANYAMENDMENTSAPPLIESISO10012,MEASUREMENTMANAGEMENTSYSTEMSREQUIREMENTSFORMEASUREMENTPROCESSESANDMEASURINGEQUIPMENTISO134852003,MEDICALDEVICESQUALITYMANAGEMENTSYSTEMSREQUIREMENTSFORREGULATORYPURPOSESISO/IEC170252005,GENERALREQUIREMENTSFORTHECOMPETENCEOFTESTINGANDCALIBRATIONLABORATORIESENISO1173712006WWWBZFXWCOM23TERMSANDDEFINITIONSFORTHEPURPOSESOFTHISDOCUMENT,THEFOLLOWINGTERMSANDDEFINITIONSAPPLY31BIOBURDENPOPULATIONOFVIABLEMICROORGANISMSONORINPRODUCTAND/ORSTERILEBARRIERSYSTEMISO/TS111392006,DEFINITION2232CORRECTIONACTIONTOELIMINATEADETECTEDNONCONFORMITYNOTEACORRECTIONCANBEMADEINCONJUNCTIONWITHACORRECTIVEACTION34ISO90002005,DEFINITION36633CORRECTIONFACTORNUMERICALVALUEAPPLIEDTOCOMPENSATEFORINCOMPLETEREMOVALFROMPRODUCTAND/ORCULTUREOFMICROORGANISMS34CORRECTIVEACTIONACTIONTOELIMINATETHECAUSEOFADETECTEDNONCONFORMITYOROTHERUNDESIRABLESITUATIONNOTE1THERECANBEMORETHANONECAUSEFORANONCONFORMITYNOTE2CORRECTIVEACTIONISTAKENTOPREVENTRECURRENCEWHEREASPREVENTIVEACTION39ISTAKENTOPREVENTOCCURRENCENOTE3THEREISADISTINCTIONBETWEENCORRECTION32ANDCORRECTIVEACTIONISO/TS111392006,DEFINITION2835CULTURECONDITIONSCOMBINATIONOFGROWTHMEDIAANDMANNEROFINCUBATIONUSEDTOPROMOTEGERMINATION,GROWTHAND/ORMULTIPLICATIONOFMICROORGANISMSNOTETHEMANNEROFINCUBATIONMAYINCLUDETHETEMPERATURE,TIMEANDANYOTHERCONDITIONSSPECIFIEDFORINCUBATIONISO/TS111392006,DEFINITION21036ESTABLISHDETERMINEBYTHEORETICALEVALUATIONANDCONFIRMBYEXPERIMENTATIONISO/TS111392006,DEFINITION21737MEDICALDEVICEINSTRUMENT,APPARATUS,IMPLEM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