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【英文标准名称】:Sterilizationofhealthcareproducts-Generalrequirementsforcharacterizationofasterilizingagentandthedevelopment,validationandroutinecontrolofasterilizationprocessformedicaldevices
【原文标准名称】:医疗保健产品灭菌消毒剂的特性及医疗装置消毒的开发、确认和程序控制的一般要求
【标准号】:ISO14937-2000
【标准状态】:作废
【国别】:国际
【发布日期】:2000-12
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC198
【标准类型】:()
【标准水平】:()
【中文主题词】:方法;应用;规范;卫生学;合格;监督(认可);检验;辐射灭菌;灭菌器;医学科学;医疗设备;医疗技术学;绝育;证实;医疗产品;杀菌器具;特性记述;显影;电离辐射;定义;定义;灭菌;辐射;保健;规范(验收);γ辐射;质量保证体系
【英文主题词】:Characterisations;Definitions;Developments;Gamma-radiation;Healthprotection;Hygiene;Inspection;Ionizingradiation;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Methods;Qualifications;Qualityassurancesystems;Radiation;Specification;Specification(approval);Sterilization(birthcontrol);Sterilizationbyirradiation;Sterilization(hygiene);Sterilizers;Sterilizingapparatus;Surveillance(approval);Use;Validation
【摘要】:1ThisInternationalStandardspecifiesgeneralrequirementsforthecharacterizationofasterilizingagent,andforthedevelopment,validationandroutinecontrolofasterilizationprocessformedicaldevices.2ThisInternationalStandardappliestosterilizationprocessesinwhichmicroorganismsareinactivatedbyphysicaland/orchemicalmeans.3ThisInternationalStandarddoesnotapplytoprocessesthatrelysolelyonphysicalremovalofmicroorganisms(forexample,filtration).4ThisInternationalStandarddoesnotdescribedetailedtestproceduresforassessingmicrobialinactivation.5ThisInternationalStandardisintendedtobeappliedbyprocessdevelopers,manufacturersofsterilizationequipment,manufacturersofmedicaldevicestobesterilizedandtheorganizationwithresponsibilityforsterilizingthemedicaldevice.6ThisInternationalStandarddoesnotsupersedeormodifypublishedInternationalStandardsforparticularsterilizationprocesses.NOTE1AlthoughthescopeofthisInternationalStandardislimitedtomedicaldevices,theprinciplesdescribedmayalsobeappliedtootherhealthcareproducts.NOTE2SterilizationprocessesvalidatedandcontrolledinaccordancewiththerequirementsofthisInternationalStandardshouldnotbeassumedtobeeffectiveininactivatingthecausativeagentsofspongiformencephalopathiessuchasscrapie,bovinespongiformencephalopathyandCreutzfeld-Jakobdisease.Specificrecommendationshavebeenproducedinparticularcountriesfortheprocessingofmaterialspotentiallycontaminatedwiththeseagents.
【中国标准分类号】:C47
【国际标准分类号】:11_080_01
【页数】:35P;A4
【正文语种】:英语