ISO 17664-2004 医疗器械的消毒.生产商提供的可重复消毒医疗器械的处理信息
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【英文标准名称】:Sterilizationofmedicaldevices-Informationtobeprovidedbythemanufacturerfortheprocessingofresterilizablemedicaldevices
【原文标准名称】:医疗器械的消毒.生产商提供的可重复消毒医疗器械的处理信息
【标准号】:ISO17664-2004
【标准状态】:现行
【国别】:国际
【发布日期】:2004-03
【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】:说明书;消费者与供货者的关系;医疗产品;特性记述;定义;灭菌;医疗设备;保健;规范(验收);产品信息;监督(认可);危险分析;制造日期;卫生学;包装件;消毒;自加工;绝育;消毒物品;操作程序;消毒能力;规范;清洁处理;灭菌器;证实;去污染;重新使用;企业
【英文主题词】:Capabilityofsterilization;Characterisations;Cleaning;Consumer-supplierrelations;Dataofthemanufacturer;Decontaminations;Definitions;Disinfections;Enterprises;Healthprotection;Hygiene;Instructions;Medicaldevices;Medicalequipment;Medicalproducts;Packages;Productinformation;Reprocessing;Reuse;Riskanalysis;Sequenceofoperations;Specification;Specification(approval);Sterilization(birthcontrol);Sterilization(hygiene);Sterilizedgoods;Sterilizers;Surveillance(approval);Treatment;Validation;Verification
【摘要】:Thisstandardspecifiestheinformationtobeprovidedbythemedicaldevicemanufacturerontheprocessingofmedicaldevicesclaimedtobere-sterilizableandmedicaldevicesintendedtobesterilizedbytheprocessor.Thisstandardspecifiesrequirementsfortheinformationtobeprovidedbythemedicaldevicemanufacturer,sothatthemedicaldevicecanbeprocessedsafelyandwillcontinuetomeetitsperformancespecification.Requirementsarespecifiedforprocessingthatconsistsofallorsomeofthefollowingactivities:?preparationatthepointofuse;?preparation,cleaning,disinfection;?drying;?inspection,maintenanceandtesting;?packaging;?sterilization;?storage.Whenprovidinginstructionsfortheseactivities,medicaldevicemanufacturersareexpectedtobeawareofthetrainingandknowledgeofprocedures,andoftheprocessingequipmentavailabletothepersonslikelytoberesponsibleforprocessing.Itislikelythatsomeprocessingprocedureswillbegenericandwellknownandwilluseequipmentandconsumablesconformingtorecognizedstandards.Inthiscase,areferenceintheinstructionsisallthatisrequired.Forthosemedicaldeviceswhereinstructionsforusearenotrequiredtoaccompanythemedicaldevice,othermeansofcommunicatingtheinformationcanbeused,e.g.usermanuals,symbolsorwallchartssuppliedseparately.Thisstandardexcludestextiledevicesusedinpatientdrapingsystemsorsurgicalclothing.
【中国标准分类号】:C47
【国际标准分类号】:11_080_01
【页数】:18P;A4
【正文语种】:英语
【原文标准名称】:医疗器械的消毒.生产商提供的可重复消毒医疗器械的处理信息
【标准号】:ISO17664-2004
【标准状态】:现行
【国别】:国际
【发布日期】:2004-03
【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】:说明书;消费者与供货者的关系;医疗产品;特性记述;定义;灭菌;医疗设备;保健;规范(验收);产品信息;监督(认可);危险分析;制造日期;卫生学;包装件;消毒;自加工;绝育;消毒物品;操作程序;消毒能力;规范;清洁处理;灭菌器;证实;去污染;重新使用;企业
【英文主题词】:Capabilityofsterilization;Characterisations;Cleaning;Consumer-supplierrelations;Dataofthemanufacturer;Decontaminations;Definitions;Disinfections;Enterprises;Healthprotection;Hygiene;Instructions;Medicaldevices;Medicalequipment;Medicalproducts;Packages;Productinformation;Reprocessing;Reuse;Riskanalysis;Sequenceofoperations;Specification;Specification(approval);Sterilization(birthcontrol);Sterilization(hygiene);Sterilizedgoods;Sterilizers;Surveillance(approval);Treatment;Validation;Verification
【摘要】:Thisstandardspecifiestheinformationtobeprovidedbythemedicaldevicemanufacturerontheprocessingofmedicaldevicesclaimedtobere-sterilizableandmedicaldevicesintendedtobesterilizedbytheprocessor.Thisstandardspecifiesrequirementsfortheinformationtobeprovidedbythemedicaldevicemanufacturer,sothatthemedicaldevicecanbeprocessedsafelyandwillcontinuetomeetitsperformancespecification.Requirementsarespecifiedforprocessingthatconsistsofallorsomeofthefollowingactivities:?preparationatthepointofuse;?preparation,cleaning,disinfection;?drying;?inspection,maintenanceandtesting;?packaging;?sterilization;?storage.Whenprovidinginstructionsfortheseactivities,medicaldevicemanufacturersareexpectedtobeawareofthetrainingandknowledgeofprocedures,andoftheprocessingequipmentavailabletothepersonslikelytoberesponsibleforprocessing.Itislikelythatsomeprocessingprocedureswillbegenericandwellknownandwilluseequipmentandconsumablesconformingtorecognizedstandards.Inthiscase,areferenceintheinstructionsisallthatisrequired.Forthosemedicaldeviceswhereinstructionsforusearenotrequiredtoaccompanythemedicaldevice,othermeansofcommunicatingtheinformationcanbeused,e.g.usermanuals,symbolsorwallchartssuppliedseparately.Thisstandardexcludestextiledevicesusedinpatientdrapingsystemsorsurgicalclothing.
【中国标准分类号】:C47
【国际标准分类号】:11_080_01
【页数】:18P;A4
【正文语种】:英语
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