ISO 13683-1997 医疗保健产品灭菌医疗保健机构湿热灭菌的确认和常规控制要求

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【英文标准名称】:Sterilizationofhealthcareproducts-Requirementsforvalidationandroutinecontrolofmoistheatsterilizationinhealthcarefacilities
【原文标准名称】:医疗保健产品灭菌医疗保健机构湿热灭菌的确认和常规控制要求
【标准号】:ISO13683-1997
【标准状态】:作废
【国别】:国际
【发布日期】:1997-05
【实施或试行日期】:
【发布单位】:国际标准化组织(ISO)
【起草单位】:ISO/TC198
【标准类型】:()
【标准水平】:()
【中文主题词】:加热消毒;规范(验收);定义;绝育;证实;医疗卫生事业;杀菌器具;例行试验
【英文主题词】:Definition;Definitions;Healthservices;Heatsterilization;Routinetest;Specification(approval);Sterilization(birthcontrol);Sterilizingapparatus;Validation
【摘要】:1Inclusions1.1ThisInternationalStandardspecifiesrequirementsfortheuseofmoistheatinsterilizationprocessdevelopment,validationofthesterilizationprocess,andcontrolofroutinesterilizationineitherahealthcarefacilityorafacilitycontractedbyahealthcareorganization.1.2ThisInternationalStandardcoversallmoistheatprocessesinhealthcarefacilitiesinwhichthesterilantiseithersteam,steam/airmixturesorpressurizedwater.NOTE—WhilethegeneralrequirementsofthisInternationalStandardcanapplytothesterilizationofpharmaceuticalproducts,othertechnicalorregulatoryrequirementsmayalsoapply.2Exclusions2.1ThisInternationalStandarddoesnotdescribeaqualityassurancesystemforthecontrolofallstagesofproduction.NOTE—AttentionisdrawntotheInternationalStandardsforqualitysystems(ISO13485orISO13488)whichcontrolallstagesofproductionincludingthesterilizationprocess.ItisnotarequirementofthisInternationalStandardtohaveacompletequalitysystemduringproduction,butcertainelementsofsuchasystemarerequiredandthesearenormativelyreferencedatappropriateplacesinthetext.2.2Exceptforgeneralrequirements,thisInternationalStandarddoesnotprovidedetailedrequirementsforallequipmentusedwithinasterilizationsystem(e.g.washingequipment).2.3ThisInternationalStandarddoesnotaddresssterilizationprocessesthatemployachemical/steammixtureasthesterilant.2.4ThisInternationalStandarddoesnotapplytoindustrialmoistheatsterilization,whichisaddressedbyISO11134.
【中国标准分类号】:C05
【国际标准分类号】:11_080_01
【页数】:33P;A4
【正文语种】:英语