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1、PDISO/TR4752:2025BiotechnologyInventoryofmethodsfordetectionofmicrobiologicalcontaminationinmammaliancellculturebsi.NationalforewordThisPublishedDocumentistheUKimplementationofISO/TR4752:2025.TheUKparticipationinitspreparationwasentrustedtoTechnicalCommitteeBTIllBiotechnologies.Alistoforganizationsr
2、epresentedonthiscommitteecanbeobtainedonrequesttoitscommitteemanager.ContractualandlegalconsiderationsThispublicationhasbeenpreparedingoodfaith,howevernorepresentation,warranty,assuranceorundertaking(expressorimplied)isorwillbemade,andnoresponsibilityorliabilityisorwillbeacceptedbyBSIinrelationtothe
3、adequacy,accuracy,completenessorreasonablenessofthispublication.Allandanysuchresponsibilityandliabilityisexpresslydisclaimedtothefullextentpermittedbythelaw.Thispublicationisprovidedasis,andistobeusedattherecipientsownrisk.Therecipientisadvisedtoconsiderseekingprofessionalguidancewithrespecttoitsuse
4、ofthispublication.Thispublicationisnotintendedtoconstituteacontract.Usersareresponsibleforitscorrectapplication.ThispublicationisnottoberegardedasaBritishStandard.TheBritishStandardsInstitution2025PublishedbyBSIStandardsLimited2025ISBN9780539309225ICS07.080CompliancewithaPublishedDocumentcannotconfe
5、rimmunityfromlegalobligations.ThisPublishedDocumentwaspublishedundertheauthorityoftheStandardsPolicyandStrategyCommitteeon30June2025.Amendments/corrigendaissuedsincepublicationDateTextaffectedPDISO/TR4752:2025TechnicalReportISO/TR4752Firstedition2025-06BiotechnologyInventoryofmethodsfordetectionofmi
6、crobiologicalcontaminationinmammaliancellcultureBiotechnologieInventairedesmethodespourIadetectiondelacontaminationmicrobiologiquedanslacultureCeIIulairedemammiferesReferencenumberISO/TR4752:2025(en)COPYRIGHTPROTECTEDDOCUMENTISO2025Allrightsreserved.Unlessotherwisespecified,orrequiredinthecontextofi
7、tsimplementation,nopartofthispublicationmaybereproducedorutilizedotherwiseinanyformorbyanymeans,electronicormechanical,includingphotocopying,orpostingontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbeloworISO,smemberbodyinthecountryofthereques
8、ter.ISOcopyrightofficeCP401Ch.deBlandonnet8CH-1214Vernier,GenevaPhone:+41227490111Email:copyrightiso.orgWebsite:www.iso.orgPublishedinSwitzerlandContentsPageForewordivIntroductionv1 Scope12 Normativereferences13 Termsanddefinitions14 Generalconcepts34.1 Introduction34.2 Detectionprocess35 Contaminat
9、iontestinformation46 Criticalcontrolpointsindetection56.1 Samples56.2 ReagentsandEquipment56.3 Operation66.4 Personnel66.5 Environment6Annex A (informative)Availableandexemplarytestingmethodsforbacteriaandfungi7Annex B (informative)AvailableandexemplarytestingmethodsforViruses12Annex C (informative)
10、Availableandexemplarytestingmethodsformycoplasma15Bibliography18ForewordISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterest
11、edinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnical
12、standardization.TheproceduresusedtodevelopthisdocumentandthoseintendedforitsfurthermaintenancearedescribedintheISO/IECDirectives,Part1.Inparticular,thedifferentapprovalcriterianeededforthedifferenttypesofISOdocumentshouldbenoted.ThisdocumentwasdraftedinaccordancewiththeeditorialrulesoftheISO/IECDire
13、ctives,Part2(seeWWW.iso.org/directives).ISOdrawsattentiontothepossibilitythattheimplementationofthisdocumentmayinvolvetheuseof（八）patent(三).ISOtakesnopositionconcerningtheevidence,validityorapplicabilityofanyclaimedpatentrightsinrespectthereof.Asofthedateofpublicationofthisdocument,ISOhadnotreceivedn
14、oticeof（八）patent(三)whichmayberequiredtoimplementthisdocument.HoweverlImplementersarecautionedthatthismaynotrepresentthelatestinformation,whichmaybeobtainedfromthepatentdatabaseavailableatWWW.iso.org/patents.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.Anytradenameusedinthisdocu
15、mentisinformationgivenfortheconvenienceofusersanddoesnotconstituteanendorsement.Foranexplanationofthevoluntarynatureofstandards,themeaningofISOspecifictermsandexpressionsrelatedtoconformityassessment,aswellasinformationaboutISOsadherencetotheWorldTradeOrganization(WTO)principlesintheTechnicalBarrier
16、stoTrade(TBT工seeWWW.iso.org/iso/foreword.htmLThedocumentwaspreparedbyTechnicalCommitteeISO/TC276,Biotechnology,SubcommitteeSCLAnalyticalmethods.Anyfeedbackorquestionsonthisdocumentshouldbedirectedtotheusersnationalstandardsbody.AcompletelistingofthesebodiescanbefoundatWWW.iso.org/members.html.IntroductionCellcultureplay
