BS EN 13727-2003 化学消毒剂和防腐剂.医疗器械用化学消毒剂杀菌活性评价的定量悬浮试验.试验方法和要求(第2阶段/第1步)
作者:标准资料网 时间:2024-05-22 04:28:08 浏览:8697
来源:标准资料网
下载地址: 点击此处下载
【英文标准名称】:Chemicaldisinfectantsandantiseptics-Quantitativesuspensiontestfortheevaluationofbactericidalactivityofchemicaldisinfectantsforinstrumentsusedinthemedicalarea-Testmethodandrequirements(Phase2/Step1)
【原文标准名称】:化学消毒剂和防腐剂.医疗器械用化学消毒剂杀菌活性评价的定量悬浮试验.试验方法和要求(第2阶段/第1步)
【标准号】:BSEN13727-2003
【标准状态】:作废
【国别】:英国
【发布日期】:2003-12-22
【实施或试行日期】:2003-12-22
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:卫生学;试验;评定;消毒剂;规范(验收);悬浮液;杀菌剂;人用的药物;最低要求;消毒剂试验;医疗设备;医学科学;定义;效应;效率;消毒
【英文主题词】:Bacteriocides;Definition;Definitions;Disinfectanttests;Disinfectants;Disinfections;Effects;Efficiency;Evaluations;Fungicides;Humanmedicine;Hygiene;Medicalequipment;Medicalinstruments;Medicalsciences;Minimumrequirements;Specification(approval);Suspensions(chemical);Testing
【摘要】:ThisEuropeanStandardspecifiesatestmethodandtheminimumrequirementsforbactericidalactivityofchemicaldisinfectantproductsthatformahomogeneous,physicallystablepreparationwhendilutedwithhardwater-orinthecaseofready-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】:C12
【国际标准分类号】:11_080_20
【页数】:40P;A4
【正文语种】:英语
【原文标准名称】:化学消毒剂和防腐剂.医疗器械用化学消毒剂杀菌活性评价的定量悬浮试验.试验方法和要求(第2阶段/第1步)
【标准号】:BSEN13727-2003
【标准状态】:作废
【国别】:英国
【发布日期】:2003-12-22
【实施或试行日期】:2003-12-22
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:卫生学;试验;评定;消毒剂;规范(验收);悬浮液;杀菌剂;人用的药物;最低要求;消毒剂试验;医疗设备;医学科学;定义;效应;效率;消毒
【英文主题词】:Bacteriocides;Definition;Definitions;Disinfectanttests;Disinfectants;Disinfections;Effects;Efficiency;Evaluations;Fungicides;Humanmedicine;Hygiene;Medicalequipment;Medicalinstruments;Medicalsciences;Minimumrequirements;Specification(approval);Suspensions(chemical);Testing
【摘要】:ThisEuropeanStandardspecifiesatestmethodandtheminimumrequirementsforbactericidalactivityofchemicaldisinfectantproductsthatformahomogeneous,physicallystablepreparationwhendilutedwithhardwater-orinthecaseofready-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】:C12
【国际标准分类号】:11_080_20
【页数】:40P;A4
【正文语种】:英语
下载地址: 点击此处下载