DIN EN 13060-2009 小型蒸汽灭菌器,德文版本EN13060:2004+A1:2009
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【英文标准名称】:Smallsteamsterilizers;GermanversionEN13060:2004+A1:2009
【原文标准名称】:小型蒸汽灭菌器,德文版本EN13060:2004+A1:2009
【标准号】:DINEN13060-2009
【标准状态】:作废
【国别】:德国
【发布日期】:2009-10
【实施或试行日期】:2009-10-01
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:Accessories;Automatic;Chambers;Charge;Chronometers;Closures;Compressedair;Condensates;Control;Cycle;Definitions;Design;Dimensions;Doors;Electrical;Electromagnetism;Equipmentsafety;Feed;Feed-waters;Handbooks;Hygiene;Impurities;Indications;Installationlocations;Instruments;Jigs;Leakrate;Leakage;Limits(mathematics);Marking;Materials;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Miniaturesterilizer;Operation;Penetrations;Performancerequirements;Pressure;Pressureinstruments;Pressurereading;Process;Qualificationtests;Ratings;Registration;Safety;Safetyengineering;Safetyrequirements;Signs;Specification(approval);Steamsterilization;Steamsterilizers;Sterilization(hygiene);Sterilizers;Supply;Temperature;Testprograms;Testing;Vapours;Wastes(sanitaryappliances);Water
【摘要】:ThisEuropeanStandardspecifiestheperformancerequirementsandtestmethodsforsmallsteamsterilizersandsterilizationcycleswhichareusedformedicalpurposesorformaterialsthatarelikelytocomeintocontactwithbloodorbodyfluids.ThisEuropeanStandardappliestoautomaticallycontrolledsmallsteamsterilizersthatgeneratesteamusingelectricalheatersorusesteamthatisgeneratedbyasystemexternaltothesterilizer.ThisEuropeanStandardappliestosmallsteamsterilizersusedprimarilyforthesterilizationofmedicaldevicesandunabletoaccommodateasterilizationmodule(300mmx300mmx600mm)andwithachambervolumenotexceeding60litres.ThisEuropeanStandarddoesnotapplytosmallsteamsterilizersthatareusedtosterilizeliquidsorpharmaceuticalproducts.ThisEuropeanStandarddoesnotspecifysafetyrequirementsrelatedtorisksassociatedwiththezoneinwhichthesterilizerisused(e.g.flammablegases).ThisEuropeanStandarddoesnotspecifyrequirementsforthevalidationandroutinecontrolofsterilizationbymoistheat.NOTERequirementsforthevalidationandroutinecontrolofsterilizationbymoistheataregiveninEN554,whichmayalsobeappliedforsmallsteamsterilizers.
【中国标准分类号】:
【国际标准分类号】:11_080_10
【页数】:70P.;A4
【正文语种】:德语
【原文标准名称】:小型蒸汽灭菌器,德文版本EN13060:2004+A1:2009
【标准号】:DINEN13060-2009
【标准状态】:作废
【国别】:德国
【发布日期】:2009-10
【实施或试行日期】:2009-10-01
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:Accessories;Automatic;Chambers;Charge;Chronometers;Closures;Compressedair;Condensates;Control;Cycle;Definitions;Design;Dimensions;Doors;Electrical;Electromagnetism;Equipmentsafety;Feed;Feed-waters;Handbooks;Hygiene;Impurities;Indications;Installationlocations;Instruments;Jigs;Leakrate;Leakage;Limits(mathematics);Marking;Materials;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Miniaturesterilizer;Operation;Penetrations;Performancerequirements;Pressure;Pressureinstruments;Pressurereading;Process;Qualificationtests;Ratings;Registration;Safety;Safetyengineering;Safetyrequirements;Signs;Specification(approval);Steamsterilization;Steamsterilizers;Sterilization(hygiene);Sterilizers;Supply;Temperature;Testprograms;Testing;Vapours;Wastes(sanitaryappliances);Water
【摘要】:ThisEuropeanStandardspecifiestheperformancerequirementsandtestmethodsforsmallsteamsterilizersandsterilizationcycleswhichareusedformedicalpurposesorformaterialsthatarelikelytocomeintocontactwithbloodorbodyfluids.ThisEuropeanStandardappliestoautomaticallycontrolledsmallsteamsterilizersthatgeneratesteamusingelectricalheatersorusesteamthatisgeneratedbyasystemexternaltothesterilizer.ThisEuropeanStandardappliestosmallsteamsterilizersusedprimarilyforthesterilizationofmedicaldevicesandunabletoaccommodateasterilizationmodule(300mmx300mmx600mm)andwithachambervolumenotexceeding60litres.ThisEuropeanStandarddoesnotapplytosmallsteamsterilizersthatareusedtosterilizeliquidsorpharmaceuticalproducts.ThisEuropeanStandarddoesnotspecifysafetyrequirementsrelatedtorisksassociatedwiththezoneinwhichthesterilizerisused(e.g.flammablegases).ThisEuropeanStandarddoesnotspecifyrequirementsforthevalidationandroutinecontrolofsterilizationbymoistheat.NOTERequirementsforthevalidationandroutinecontrolofsterilizationbymoistheataregiveninEN554,whichmayalsobeappliedforsmallsteamsterilizers.
【中国标准分类号】:
【国际标准分类号】:11_080_10
【页数】:70P.;A4
【正文语种】:德语
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