JIS-Z2801-2000-Antimicrobial-products-test-for-ant

JISJAPANESEINDUSTRIALSTANDARDTranslatedandPublishedbyJapaneseStandardsAssociationJISZ2801Antimicrobialproducts-TestforantimicrobialactivityandefficacyICS07.100.10;11.100Descriptors:bacteriocide-activitydetermination,microbiological-resistancetests,biologicalhazards,culturetechniquesReferencenumber:JISZ2801:2000(E):20008SJAPANESEINDUSTRIALSTANDARDAntimicrobialproducts—TestforantimicrobialactivityandefficacyIntroductionThisJapaneseIndustrialStandardhasbeenpreparedforstandardizingthemethodforevaluatingantimicrobialefficacyinantimicrobialproductsshowninthereportoftheMeetingonLife-RelatedProcessedProductswithNewFunctions(AntimicrobialProducts):December1998(so-calledGuidelinesforAntimicrobialProducts).Thisstandardspecifiestheantimicrobialefficacy,apartoftheperfor-manceconsideredtobeimportantforantimicrobialproducts,andthetestingmethods.Otherinformationconsideredtobeimportantforantimicrobialproductsincludingsafety,durationofantimicrobialefficacy,andmarkingontheproductshallbereferredtointheGuidelinesforAntimicrobialProducts.1ScopeThisStandardspecifiesthetestingmethodstoevaluateantimicrobialactivityandantimicrobialefficacyonbacteriaonthesurfaceofantimicrobialproducts(includingintermediateproducts).Remarks:Thesecondaryeffectsofantimicrobialefficacy,suchasbeinganti-fungalanddeodorizingefficacy,shallnotbeincludedinthisStan-dard.2NormativereferencesThefollowingstandardscontainprovisionswhich,throughreferenceinthisStandard,constituteprovisionsofthisStandard.Themostrecenteditionsofthestandardsindicatedbelow(includingamendments)shallbeapplied.JISK0950SterilizedplasticpetridishesJISK0970Pistonoperatedmicro-volumetricapparatusJISK3800ClassIIbiologicalsafetycabinetsJISK8101Ethanol(99.5)JISK8150SodiumchlorideJISK8180HydrochloricacidJISK8263AgarJISK8576SodiumhydroxideJISK9007PotassiumdihydrogenphosphateJISK9017DipotassiumhydrogenphosphateJISL1902TestingmethodforantibacterialoftextilesJISR3505Volumetricglassware3DefinitionsThedefinitionsofthemaintermsusedinthisStandardareasfollows:a)antimicrobialTheconditioninhibitingthegrowthofbacteriaonthesurfaceofproducts.JISZ2801:2000Z2801:2000b)antimicrobialfinishAfinishingtreatmentforantimicrobialefficacy.c)antimicrobialproductsProductstreatedwithantimicrobialfinish.d)valueofantimicrobialactivityThisvalueshowsthedifferenceintheloga-rithmicvalueofviablecellcountsbetweenantimicrobialproductsanduntreatedproductsafterinoculationandincubationofbacteria.Informativereference:ThevalueofbacteriostaticactivityinJISL1902ex-pressesthatoftheantimicrobialactivityinthisStan-dard.e)antimicrobialefficacyTheefficacyofantimicrobialproductsjudgedfromthevalueofantimicrobialactivity.4AntimicrobialefficacyThevalueofantimicrobialactivityobtainedbythetestingmethodsofthisStandardshallnotbelessthan2.0fortheantimicrobialefficacyofantimicrobialproducts.Valuesofover2.0maybeapplicablesubjecttotheagreementbetweenpartiesconcernedwithdelivery.5Testingmethod5.1TestingmethodfortextileproductsThetestingmethodfortextileproductsshallbeinaccordancewith8ofJISL1902.5.2Testingmethodforplasticproducts,etc.Thistestingmethodisapplicabletoproductsotherthantextileproducts,suchasplasticproducts,metalproducts,andceramicproducts.Testingmethod5.1maybeused,however,forproductsjudgedtobesuitableforusingthetestingmethodfortextileproductsfromtheusageandformoftheproduct.5.2.1BacteriatobeusedforthetestsThespeciesofbacteriatobeusedforthetestsshallbeasfollows,andeachbacteriashallbeusedforthetest:a)Staphylococcusaureusb)EscherichiacoliAnexampleofthebacterialstraintobeusedforthetestsisshowninTable1.IfthebacterialstrainiscontributedbyotherculturecollectionshowninTable1,thenitshallbeobtainedfrommemberagenciesoftheWorldFederationofCultureCollection(WPCC)ortheJapanSocietyofCultureCollection(JSCC)andthesamestrainasthatshowninTable1.Table1BacterialstraintobeusedforthetestsBacteriaStrainnumberInstitutionofculturecollectionStaphylococcusaureusATCC6538PFDA209PIFO12732AmericanTypeCultureCollectionFoodandDrugAdministrationInstituteforFermentationEscherichiacoliATCC8739IFO3972AmericanTypeCultureCollectionInstituteforFermentation5.2.2Chemicals,materialsandapparatusThechemicals,materialsandapparatustobeusedinthisStandardshallbegivenasfollows,unlessotherwisedesignated.Ethanol(C2H5OH)ClassIasspecifiedinJISK8102orsuperior.BeefextractFormicrobialtests.PeptoneFormicrobialtests.Sodiumchloride(NaCl)GuaranteedreagentspecifiedinJISK8150.Conformstothereferenceofthe13threvisedJapanesePhar-macopoeia.GuaranteedorsuperiorreagentspecifiedinJISK8263.Formicrobialtests.Formicrobialtests.Formicrobialtests.Formicrobialtests.Formicrobialtests.Formicrobialtests.NonionicsurfactantPolyoxyethylenesorbitanmonooleate[Polysorbate80(Tween80)].Potassiumdihydrogenphosphate(KH2PC4)GuaranteedreagentspecifiedinJISK9007.Dipotassiumhydrogenphosphate(K2HPC4)GuaranteedreagentspecifiedinJISK9017.Sodiumhydroxide(NaOH)GuaranteedreagentspecifiedinJISK8576.Hydrochloricacid(HC1)GuaranteedreagentspecifiedinJISE8180.Cottonstopper,etc.OMEcotton,otherwisesilicone,metal,ormortonstopper.Withaloopofabout4mmatthepoi