BS EN ISO 11138-5-2017 Biological indicators for low-temperature steam and formaldehyde sterilization processes

BSENISO1113852017STERILIZATIONOFHEALTHCAREPRODUCTSBIOLOGICALINDICATORSPART5BIOLOGICALINDICATORSFORLOWTEMPERATURESTEAMANDFORMALDEHYDESTERILIZATIONPROCESSESISO1113852017BSISTANDARDSPUBLICATIONWB11885_BSI_STANDARDCOVS_2013_AWINDD115/05/20131506BSENISO1113852017BRITISHSTANDARDNATIONALFOREWORDTHISBRITISHSTANDARDISTHEUKIMPLEMENTATIONOFENISO1113852017ITSUPERSEDESBSENISO1113852006WHICHISWITHDRAWNTHEUKPARTICIPATIONINITSPREPARATIONWASENTRUSTEDTOTECHNICALCOMMITTEECH/198,STERILIZATIONANDASSOCIATEDEQUIPMENTANDPROCESSESALISTOFORGANIZATIONSREPRESENTEDONTHISCOMMITTEECANBEOBTAINEDONREQUESTTOITSSECRETARYTHISPUBLICATIONDOESNOTPURPORTTOINCLUDEALLTHENECESSARYPROVISIONSOFACONTRACTUSERSARERESPONSIBLEFORITSCORRECTAPPLICATIONTHEBRITISHSTANDARDSINSTITUTION2017PUBLISHEDBYBSISTANDARDSLIMITED2017ISBN9780580898358ICS1108001COMPLIANCEWITHABRITISHSTANDARDCANNOTCONFERIMMUNITYFROMLEGALOBLIGATIONSTHISBRITISHSTANDARDWASPUBLISHEDUNDERTHEAUTHORITYOFTHESTANDARDSPOLICYANDSTRATEGYCOMMITTEEON30APRIL2017AMENDMENTS/CORRIGENDAISSUEDSINCEPUBLICATIONDATETEXTAFFECTEDEUROPEANSTANDARDNORMEEUROPENNEEUROPISCHENORMENISO111385MARCH2017ICS1108020SUPERSEDESENISO1113852006ENGLISHVERSIONSTERILIZATIONOFHEALTHCAREPRODUCTSBIOLOGICALINDICATORSPART5BIOLOGICALINDICATORSFORLOWTEMPERATURESTEAMANDFORMALDEHYDESTERILIZATIONPROCESSESISO1113852017STRILISATIONDESPRODUITSDESANTINDICATEURSBIOLOGIQUESPARTIE5INDICATEURSBIOLOGIQUESPOURLASTRILISATIONLAVAPEURD'EAUETAUFORMALDHYDEBASSETEMPRATUREISO1113852017STERILISATIONVONPRODUKTENFRDIEGESUNDHEITSFRSORGEBIOLOGISCHEINDIKATORENTEIL5BIOLOGISCHEINDIKATORENFRSTERILISATIONSVERFAHRENMITNIEDERTEMPERATURDAMPFFORMALDEHYDISO1113852017THISEUROPEANSTANDARDWASAPPROVEDBYCENON19JANUARY2017CENMEMBERSAREBOUNDTOCOMPLYWITHTHECEN/CENELECINTERNALREGULATIONSWHICHSTIPULATETHECONDITIONSFORGIVINGTHISEUROPEANSTANDARDTHESTATUSOFANATIONALSTANDARDWITHOUTANYALTERATIONUPTODATELISTSANDBIBLIOGRAPHICALREFERENCESCONCERNINGSUCHNATIONALSTANDARDSMAYBEOBTAINEDONAPPLICATIONTOTHECENCENELECMANAGEMENTCENTREORTOANYCENMEMBERTHISEUROPEANSTANDARDEXISTSINTHREEOFFICIALVERSIONSENGLISH,FRENCH,GERMANAVERSIONINANYOTHERLANGUAGEMADEBYTRANSLATIONUNDERTHERESPONSIBILITYOFACENMEMBERINTOITSOWNLANGUAGEANDNOTIFIEDTOTHECENCENELECMANAGEMENTCENTREHASTHESAMESTATUSASTHEOFFICIALVERSIONSCENMEMBERSARETHENATIONALSTANDARDSBODIESOFAUSTRIA,BELGIUM,BULGARIA,CROATIA,CYPRUS,CZECHREPUBLIC,DENMARK,ESTONIA,FINLAND,FORMERYUGOSLAVREPUBLICOFMACEDONIA,FRANCE,GERMANY,GREECE,HUNGARY,ICELAND,IRELAND,ITALY,LATVIA,LITHUANIA,LUXEMBOURG,MALTA,NETHERLANDS,NORWAY,POLAND,PORTUGAL,ROMANIA,SERBIA,SLOVAKIA,SLOVENIA,SPAIN,SWEDEN,SWITZERLAND,TURKEYANDUNITEDKINGDOMEUROPEANCOMMITTEEFORSTANDARDIZATIONCOMITEUROPENDENORMALISATIONEUROPISCHESKOMITEEFRNORMUNGCENCENELECMANAGEMENTCENTREAVENUEMARNIX17,B1000BRUSSELS2017CENALLRIGHTSOFEXPLOITATIONINANYFORMANDBYANYMEANSRESERVEDWORLDWIDEFORCENNATIONALMEMBERSREFNOENISO1113852017EDOWNLOADFROMHTTP/BBSINFOEACHCOMDOWNLOADFROMHTTP/BBSINFOEACHCOMBSENISO1113852017ENISO1113852017E3EUROPEANFOREWORDTHISDOCUMENTENISO1113852017HASBEENPREPAREDBYTECHNICALCOMMITTEEISO/TC198“STERILIZATIONOFHEALTHCAREPRODUCTSINCOLLABORATIONWITHTECHNICALCOMMITTEECEN/TC102“STERILIZERSANDASSOCIATEDEQUIPMENTFORPROCESSINGOFMEDICALDEVICES”,THESECRETARIATOFWHICHISHELDBYDINTHISEUROPEANSTANDARDSHALLBEGIVENTHESTATUSOFANATIONALSTANDARD,EITHERBYPUBLICATIONOFANIDENTICALTEXTORBYENDORSEMENT,ATTHELATESTBYSEPTEMBER2017ANDCONFLICTINGNATIONALSTANDARDSSHALLBEWITHDRAWNATTHELATESTBYSEPTEMBER2017ATTENTIONISDRAWNTOTHEPOSSIBILITYTHATSOMEOFTHEELEMENTSOFTHISDOCUMENTMAYBETHESUBJECTOFPATENTRIGHTSCENAND/ORCENELECSHALLNOTBEHELDRESPONSIBLEFORIDENTIFYINGANYORALLSUCHPATENTRIGHTSTHISDOCUMENTSUPERSEDESENISO1113852006THESTANDARDISAFULLTECHNICALREVISIONOFTHEPREVIOUSVERSIONTHEFOLLOWINGAMENDMENTSHAVEBEENMADEINCOMPARISONWITHENISO1113852006REQUIREMENTSONDETERMINATIONOFRESISTANCECHARACTERISTICS96REVISEDENISO11138CONSISTSOFTHEFOLLOWINGPARTS,UNDERTHEGENERALTITLESTERILIZATIONOFHEALTHCAREPRODUCTSBIOLOGICALINDICATORSPART1GENERALREQUIREMENTSPART2BIOLOGICALINDICATORSFORETHYLENEOXIDESTERILIZATIONPROCESSESPART3BIOLOGICALINDICATORSFORMOISTHEATSTERILIZATIONPROCESSESPART4BIOLOGICALINDICATORSFORDRYHEATSTERILIZATIONPROCESSESPART5BIOLOGICALINDICATORSFORLOWTEMPERATURESTEAMANDFORMALDEHYDESTERILIZATIONPROCESSESACCORDINGTOTHECENCENELECINTERNALREGULATIONS,THENATIONALSTANDARDSORGANIZATIONSOFTHEFOLLOWINGCOUNTRIESAREBOUNDTOIMPLEMENTTHISEUROPEANSTANDARDAUSTRIA,BELGIUM,BULGARIA,CROATIA,CYPRUS,CZECHREPUBLIC,DENMARK,ESTONIA,FINLAND,FORMERYUGOSLAVREPUBLICOFMACEDONIA,FRANCE,GERMANY,GREECE,HUNGARY,ICELAND,IRELAND,ITALY,LATVIA,LITHUANIA,LUXEMBOURG,MALTA,NETHERLANDS,NORWAY,POLAND,PORTUGAL,ROMANIA,SERBIA,SLOVAKIA,SLOVENIA,SPAIN,SWEDEN,SWITZERLAND,TURKEYANDTHEUNITEDKINGDOMENDORSEMENTNOTICETHETEXTOFISO1113852017HASBEENAPPROVEDBYCENASENISO1113852017WITHOUTANYMODIFICATIONDOWNLOADFROMHTTP/BBSINFOEACHCOMDOWNLOADFROMHTTP/BBSINFOEACHCOMBSENISO1113852017ISO1113852017EFOREWORDIVINTRODUCTIONV1SCOPE12NORMATIVEREFERENCES13TERMSANDDEFINITIONS14GENERALREQUIREMENTS15TESTORGANISM26SUSPENSION27CARRIERANDPRIMARYPACKAGING28INOC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