PD ISO-TR 4752 2025.docx

PDISO/TR4752:2025BiotechnologyInventoryofmethodsfordetectionofmicrobiologicalcontaminationinmammaliancellculturebsi.NationalforewordThisPublishedDocumentistheUKimplementationofISO/TR4752:2025.TheUKparticipationinitspreparationwasentrustedtoTechnicalCommitteeBTIllBiotechnologies.Alistoforganizationsrepresentedonthiscommitteecanbeobtainedonrequesttoitscommitteemanager.ContractualandlegalconsiderationsThispublicationhasbeenpreparedingoodfaith,howevernorepresentation,warranty,assuranceorundertaking(expressorimplied)isorwillbemade,andnoresponsibilityorliabilityisorwillbeacceptedbyBSIinrelationtotheadequacy,accuracy,completenessorreasonablenessofthispublication.Allandanysuchresponsibilityandliabilityisexpresslydisclaimedtothefullextentpermittedbythelaw.Thispublicationisprovidedasis,andistobeusedattherecipientsownrisk.Therecipientisadvisedtoconsiderseekingprofessionalguidancewithrespecttoitsuseofthispublication.Thispublicationisnotintendedtoconstituteacontract.Usersareresponsibleforitscorrectapplication.ThispublicationisnottoberegardedasaBritishStandard.©TheBritishStandardsInstitution2025PublishedbyBSIStandardsLimited2025ISBN9780539309225ICS07.080CompliancewithaPublishedDocumentcannotconferimmunityfromlegalobligations.ThisPublishedDocumentwaspublishedundertheauthorityoftheStandardsPolicyandStrategyCommitteeon30June2025.Amendments/corrigendaissuedsincepublicationDateTextaffectedPDISO/TR4752:2025TechnicalReportISO/TR4752Firstedition2025-06BiotechnologyInventoryofmethodsfordetectionofmicrobiologicalcontaminationinmammaliancellcultureBiotechnologieInventairedesmethodespourIadetectiondelacontaminationmicrobiologiquedanslacultureCeIIulairedemammiferesReferencenumberISO/TR4752:2025(en)COPYRIGHTPROTECTEDDOCUMENT©ISO2025Allrightsreserved.Unlessotherwisespecified,orrequiredinthecontextofitsimplementation,nopartofthispublicationmaybereproducedorutilizedotherwiseinanyformorbyanymeans,electronicormechanical,includingphotocopying,orpostingontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbeloworISO,smemberbodyinthecountryoftherequester.ISOcopyrightofficeCP401Ch.deBlandonnet8CH-1214Vernier,GenevaPhone:+41227490111Email:copyrightiso.orgWebsite:www.iso.orgPublishedinSwitzerlandContentsPageForewordivIntroductionv1 Scope12 Normativereferences13 Termsanddefinitions14 Generalconcepts34.1 Introduction34.2 Detectionprocess35 Contaminationtestinformation46 Criticalcontrolpointsindetection56.1 Samples56.2 ReagentsandEquipment56.3 Operation66.4 Personnel66.5 Environment6Annex A (informative)Availableandexemplarytestingmethodsforbacteriaandfungi7Annex B (informative)AvailableandexemplarytestingmethodsforViruses12Annex C (informative)Availableandexemplarytestingmethodsformycoplasma15Bibliography18ForewordISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardization.TheproceduresusedtodevelopthisdocumentandthoseintendedforitsfurthermaintenancearedescribedintheISO/IECDirectives,Part1.Inparticular,thedifferentapprovalcriterianeededforthedifferenttypesofISOdocumentshouldbenoted.ThisdocumentwasdraftedinaccordancewiththeeditorialrulesoftheISO/IECDirectives,Part2(seeWWW.iso.org/directives).ISOdrawsattentiontothepossibilitythattheimplementationofthisdocumentmayinvolvetheuseof（八）patent(三).ISOtakesnopositionconcerningtheevidence,validityorapplicabilityofanyclaimedpatentrightsinrespectthereof.Asofthedateofpublicationofthisdocument,ISOhadnotreceivednoticeof（八）patent(三)whichmayberequiredtoimplementthisdocument.HoweverlImplementersarecautionedthatthismaynotrepresentthelatestinformation,whichmaybeobtainedfromthepatentdatabaseavailableatWWW.iso.org/patents.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.Anytradenameusedinthisdocumentisinformationgivenfortheconvenienceofusersanddoesnotconstituteanendorsement.Foranexplanationofthevoluntarynatureofstandards,themeaningofISOspecifictermsandexpressionsrelatedtoconformityassessment,aswellasinformationaboutISO'sadherencetotheWorldTradeOrganization(WTO)principlesintheTechnicalBarrierstoTrade(TBT工seeWWW.iso.org/iso/foreword.htmLThedocumentwaspreparedbyTechnicalCommitteeISO/TC276,Biotechnology,SubcommitteeSCLAnalyticalmethods.Anyfeedbackorquestionsonthisdocumentshouldbedirectedtotheuser'snationalstandardsbody.AcompletelistingofthesebodiescanbefoundatWWW.iso.org/members.html.IntroductionCellcultureplay