【英文标准名称】:Sterilizationofmedicaldevices-Lowtemperaturesteamandformaldehyde-Requirementsfordevelopment,validationandroutinecontrolofasterilizationprocessformedicaldevices;EnglishversionofDINEN15424:2007-08
【原文标准名称】:医疗设备灭菌.低温蒸汽和甲醛.医疗设备灭菌过程的制定、确认和常规控制的要求
【标准号】:DINEN15424-2007
【标准状态】:作废
【国别】:德国
【发布日期】:2007-08
【实施或试行日期】:
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:使用;定义;制定;甲醛;卫生学;低温;医疗设备;医疗产品;医学科学;包装件;质量管理;规范(验收);灭菌(卫生学);确认;蒸气
【英文主题词】:Applications;Definition;Definitions;Developments;Formaldehyde;Hygiene;Lowtemperatures;Medicalequipment;Medicalproducts;Medicalsciences;Packages;Qualitymanagement;Specification(approval);Sterilization(hygiene);Validation;Vapours
【摘要】:1.1Inclusions1.1.1ThisEuropeanStandardspecifiesrequirementsforthedevelopment,validationandroutinecontrolofaLowTemperatureSteamandFormaldehyde(LTSF)sterilizationprocessformedicaldevices.NOTEAlthoughthescopeofthisstandardislimitedtomedicaldevices,itspecifiesrequirementsandprovidesguidancethatmaybeapplicabletootherproductsandequipment.1.1.2ThisEuropeanStandardisintendedtobeappliedbyprocessdevelopers,manufacturersofsterilizationequipment,manufacturersofmedicaldevicestobesterilizedandtheorganizationswithresponsibilityforsterilizingmedicaldevices.(SeeENISO14937:2000,TableE.1)1.1.3ThisEuropeanStandardcoverssterilizationprocesseswhichuseamixtureofIowtemperaturesteamandformaldehydeassterilant,andwhichareworkingbelowambientpressureonly.1.2Exclusions1.2.1Sterilizationprocessesvalidatedandcontrolledinaccordancewiththerequirementsofthisstandardshouldnotbeassumedtobeeffectiveininactivatingthecausativeagentsofspongiformencephalopathiessuchasscrapie,bovinespongiformencephalopathyandCreutzfeld-Jakobdisease.Specificrecommendationshavebeenproducedinparticularcountriesfortheprocessingofmaterialspotentiallycontaminatedwiththeseagents.1.2.2Thisstandarddoesnotspecifyrequirementsfordesignatingamedicaldeviceas"STERILE".SuchrequirementsaregiveninEN556-1.1.2.3Thisstandarddoesnotspecifyaqualitymanagementsystemforthecontrolofallstagesofproductionofmedicaldevices.NOTEItisnotarequirementofthisstandardtohaveacompletequalitymanagementsystemduringmanufactureorreprocessing,butthoseelementsofsuchasystemthatarerequiredarenormativelyreferencedatappropriateplacesinthetext.Attentionisdrawntothestandardsforqualitymanagementsystems(seeENISO13485)thatcontrolallstagesofproductionorreprocessingofmedicaldevicesincludingthesterilizationprocess.FurtherguidanceisgiveninE.2ofENISO14937:2000.1.2.4ThisstandarddoesnotspecifyrequirementsforoccupationalsafetyassociatedwiththedesignandoperationofLTSFsterilizationfacilities.NOTE1SafetyrequirementsforsterilizersarespecifiedinEN61010-2-040.NOTE2Attentionisalsodrawntotheexistenceinsomecountriesofregulationsstipulatingsafetyrequirements.1.2.5ThisEuropeanStandarddoesnotcoveranalyticalmethodsfordetermininglevelsorresiduesofformaldehydeand/oritsreactionproducts.NOTE1AttentionisdrawntoEN14180.NOTE2Attentionisdrawntothepossibleexistenceinsomecountriesofstatutoryregulationspecifyinglimitsforthelevelofformaldehyderesiduesonmedicaldevicesandproducts.1.2.6ThisEuropeanStandarddoesnotcoverpreparatorymeasuresthatmaybenecessarybeforesterilizationsuchascleaning,disinfectionandpacking.NOTEForre-sterilizablemedicaldevices,themanufacturer(s)ofthesedevicesshouldsupplyinformationonthepreparatorymeasures(seeENISO17664).
【中国标准分类号】:C47
【国际标准分类号】:11_080_30
【页数】:48P.;A4
【正文语种】:英语