ANSI/AAMI/ISO 14937-2000 医疗保健产品灭菌.医用设备用消毒剂的特性及消毒方法的开发、确认和常规控制的一般要求

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【英文标准名称】:SterilizationofHealthCareProducts-GeneralRequirementsforCharacteristicsofaSterilizingAgentandtheDevelopment,ValidationandRoutineControlofaSterilizationProcess
【原文标准名称】:医疗保健产品灭菌.医用设备用消毒剂的特性及消毒方法的开发、确认和常规控制的一般要求
【标准号】:ANSI/AAMI/ISO14937-2000
【标准状态】:现行
【国别】:美国
【发布日期】:2000-06-07
【实施或试行日期】:
【发布单位】:美国国家标准学会(US-ANSI)
【起草单位】:AAMI
【标准类型】:()
【标准水平】:()
【中文主题词】:医疗产品;灭菌;规范(验收)
【英文主题词】:Characterisations;Definition;Definitions;Developments;Gamma-radiation;Healthprotection;Hygiene;Inspection;Ionizingradiation;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Methods;Qualifications;Qualityassurancesystems;Radiation;Specification;Specification(approval);Sterilization(birthcontrol);Sterilizationbyirradiation;Sterilization(hygiene);Sterilizers;Sterilizingapparatus;Surveillance(approval);Use;Validation
【摘要】:Specifiesgeneralrequirementsforthecharacterizationofasterilizingagent,andforthedevelopment,validationandroutinecontrolofasterilizationprocessformedicaldevices.Althoughthescopeofthisstandardislimitedtomedicaldevices,theprinciplesdescribedmaybeappliedtootherhealthcareproducts.Thisstandardisintendedtobeappliedbyprocessdevelopers,manufacturersofsterilizationequipment,manufacturersofproductstobesterilizedandtheorganizationwithresponsibilityforsterilizingtheproduct.Thisstandarddoesnotsupersedeormodifythepublishedstandardsforparticularsterilizationprocesses.
【中国标准分类号】:C30
【国际标准分类号】:11_080_01
【页数】:41P.;A4
【正文语种】:英语