BS EN ISO 14937-2001 医疗保健产品的灭菌.消毒剂的特性及医疗装置消毒的开发、确认、和常规控制的一般要求
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【英文标准名称】:Sterilizationofhealthcareproducts-Generalrequirementsforcharacterizationofasterilizingagentandthedevelopment,validationandroutinecontrolofasterilizationprocessformedicaldevices
【原文标准名称】:医疗保健产品的灭菌.消毒剂的特性及医疗装置消毒的开发、确认、和常规控制的一般要求
【标准号】:BSENISO14937-2001
【标准状态】:作废
【国别】:英国
【发布日期】:2001-03-15
【实施或试行日期】:2001-03-15
【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】:医疗器械;质量控制;无菌设备;灭菌器;过程控制;验证;灭菌;医疗设备
【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】:50P;A4
【正文语种】:英语
【原文标准名称】:医疗保健产品的灭菌.消毒剂的特性及医疗装置消毒的开发、确认、和常规控制的一般要求
【标准号】:BSENISO14937-2001
【标准状态】:作废
【国别】:英国
【发布日期】:2001-03-15
【实施或试行日期】:2001-03-15
【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】:医疗器械;质量控制;无菌设备;灭菌器;过程控制;验证;灭菌;医疗设备
【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】:50P;A4
【正文语种】:英语
下载地址: 点击此处下载