【英文标准名称】:Sterilizationofhealthcareproducts-Biologicalandchemicalindicators-Testequipment(ISO18472:2006);EnglishversionofDINENISO18472:2006-10
【原文标准名称】:保健产品的消毒.生物和化学指示剂.试验器械(ISO18472:2006)
【标准号】:DINENISO18472-2006
【标准状态】:现行
【国别】:德国
【发布日期】:2006-10
【实施或试行日期】:
【发布单位】:德国标准化学会(DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:生物指示剂;特性;检验设备;化学指示剂;定义;文献工作;特点;医疗卫生事业;热空气灭菌器;指示器;医学科学;性能要求;记录;记录系统;规范(验收);蒸汽灭菌器;灭菌;杀菌器具;试验设备;试验;试验装置
【英文主题词】:
【摘要】:1.1ThisInternationalStandardspecifiestherequirementsfortestequipmenttobeusedtotestchemicalandbiologicalindicatorsforsteam,ethyleneoxide,dryheatandvaporizedhydrogenperoxideprocessesforconformitytotherequirementsgiveninISO11140-1forchemicalindicators,ortherequirementsgivenintheISO11138seriesforbiologicalindicators.ThisInternationalStandardalsoprovidesinformativemethodsusefulincharacterizingtheperformanceofbiologicalandchemicalindicatorsforintendeduseandforroutinequalitycontroltesting,ISO11138-2,ISO11138-3,ISO11138-4,andISO11140-1requiretheuseofresistometersspecifiedinthisInternationalStandard,andtheseresistometersareusedinconjunctionwiththetestmethodsspecifiedintheappropriatepartsofISO11138andISO11140.NOTEResistometersforformaldehydeindicatorsarenotincludedinthisInternationalStandard.Testmethodsusinglaboratoryapparatusforsteam-formaldehydeareincludedinISO11138-5,ISO11140-3andISO11140-4.1.2ThisInternationalStandarddoesnotaddressthemethodsusedtodemonstratecomplianceofbiologicalorchemicalindicatorstoISO11138andISO11140,asthesearecoveredintheappropriatepartsofthesestandards.Indicatorsusedwithcombinationprocesses,suchaswasher-disinfection,arenotcoveredbythisInternationalStandard.NOTETestequipmentandmethodsnecessaryforISO11140-3,ISO11140-4orISO11140-5arespecifiedinthosestandards.1.3ThisInternationalStandarddoesnotaddresssafetyaspectsofthetestequipmentbecausetheseareusuallycoveredbyspecificregional,nationalorlocalregulations.
【中国标准分类号】:C30
【国际标准分类号】:11_080_01
【页数】:34P.;A4
【正文语种】:英语