【英文标准名称】:Chemicaldisinfectantsandantiseptics-Quantitativesuspensiontestfortheevaluationoffungicidalactivityofchemicaldisinfectantsforinstrumentsusedinthemedicalarea-Testmethodandrequirements(phase2,step1)
【原文标准名称】:化学消毒剂与防腐剂.医疗器械用化学消毒剂杀真菌能力评价用定量悬浮液试验.试验方法和要求(第2阶段第1步)
【标准号】:BSEN13624-2003
【标准状态】:现行
【国别】:英国
【发布日期】:2003-12-15
【实施或试行日期】:2003-12-15
【发布单位】:英国标准学会(BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:人用药物;医学科学;评定;卫生学;效率;医疗器械;定义;测定;试验;消毒剂;消毒;悬浮液;灭菌剂;效率试验;防腐剂;药液;规范(验收);悬浮试验;定量分析;消毒剂试验;效应
【英文主题词】:Antiseptics;Chemicals;Definition;Definitions;Determination;Disinfectanttests;Disinfectants;Disinfections;Effects;Efficiency;Efficiencytesting;Evaluations;Fungicides;Humanmedicine;Hygiene;Medicalinstruments;Medicalsciences;Quantitativeanalysis;Specification(approval);Suspensiontests;Suspensions(chemical);Testing
【摘要】:ThisEuropeanStandardspecifiesatestmethodandtheminimumrequirementsforfungicidaloryeasticidalactivityofchemicaldisinfectantproductsthatformahomogeneous,physicallystablepreparationwhendilutedwithhardwateror-inthecaseofready-to-useproducts-withwater.Productscanonlybetestedataconcentrationof80%orlessassomedilutionisalwaysproducedbyaddingthetestorganismsandinterferingsubstance.ThisEuropeanStandardappliestoproductsthatareusedinthemedicalareafordisinfectinginstrumentsbyimmersion-eveniftheyarenotcoveredbytheEEC/93/42DirectiveonMedicalDevices.ThisEuropeanStandardappliestoareasandsituationswheredisinfectionismedicallyindicated.Suchindicationsoccurinpatientcare,forexample:—inhospitals,incommunitymedicalfacilitiesandindentalinstitutions;—inclinicsofschools,ofkindergartensandofnursinghomes;andmayoccurintheworkplaceandinthehome.Itmayalsoincludeservicessuchaslaundriesandkitchenssupplyingproductsdirectlyforthepatients.NOTE1Themethoddescribedisintendedtodeterminetheactivityofcommercialformulationsoractivesubstancesundertheconditionsinwhichtheyareused.NOTE2Thismethodcorrespondstoaphase2step1test(seeannexE).
【中国标准分类号】:C05
【国际标准分类号】:11_080_20
【页数】:42P.;A4
【正文语种】:英语