BS EN 13060-2004+A2-2010 小型蒸汽灭菌器
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【英文标准名称】:Smallsteamsterilizers
【原文标准名称】:小型蒸汽灭菌器
【标准号】:BSEN13060-2004+A2-2010
【标准状态】:现行
【国别】:英国
【发布日期】:2005-08-03
【实施或试行日期】:2005-08-03
【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】:附件;内庭;收费;时计;闭塞物;压缩空气;冷凝物;控制;周期;定义;设计;尺寸规格;门;电气的;电磁学;设备安全性;进给量;给水;手册;卫生学;杂质;指示;安装位置;仪器;钻模;泄漏率;泄漏量;极限(数学);作标记;材料;医疗器械;医疗设备;医疗产品;医学科学;微型消毒器;操作;渗透;性能要求;压力;压力仪;压力读数;过程;合格试验;评定;注册;安全性;安全工程;安全性要求;标志;规范(验收);蒸汽灭菌;蒸汽灭菌器;灭菌;灭菌器;供应;温度;试验程序;试验;蒸气;污物(卫生器具);水
【英文主题词】:Accessories;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(300mm×300mm×600mm)andwithachambervolumenotexceeding60litres.ThisEuropeanStandarddoesnotapplytosmallsteamsterilizersthatareusedtosterilizeliquidsorpharmaceuticalproducts.ThisEuropeanStandarddoesnotspecifysafetyrequirementsrelatedtorisksassociatedwiththezoneinwhichthesterilizerisused(e.g.flammablegases).ThisEuropeanStandarddoesnotspecifyrequirementsforthevalidationandroutinecontrolofsterilizationbymoistheat.NOTERequirementsforthevalidationandroutinecontrolofsterilizationbymoistheataregiveninEN554,whichmayalsobeappliedforsmallsteamsterilizers.
【中国标准分类号】:C47
【国际标准分类号】:11_080_10
【页数】:72P.;A4
【正文语种】:英语
【原文标准名称】:小型蒸汽灭菌器
【标准号】:BSEN13060-2004+A2-2010
【标准状态】:现行
【国别】:英国
【发布日期】:2005-08-03
【实施或试行日期】:2005-08-03
【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】:附件;内庭;收费;时计;闭塞物;压缩空气;冷凝物;控制;周期;定义;设计;尺寸规格;门;电气的;电磁学;设备安全性;进给量;给水;手册;卫生学;杂质;指示;安装位置;仪器;钻模;泄漏率;泄漏量;极限(数学);作标记;材料;医疗器械;医疗设备;医疗产品;医学科学;微型消毒器;操作;渗透;性能要求;压力;压力仪;压力读数;过程;合格试验;评定;注册;安全性;安全工程;安全性要求;标志;规范(验收);蒸汽灭菌;蒸汽灭菌器;灭菌;灭菌器;供应;温度;试验程序;试验;蒸气;污物(卫生器具);水
【英文主题词】:Accessories;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(300mm×300mm×600mm)andwithachambervolumenotexceeding60litres.ThisEuropeanStandarddoesnotapplytosmallsteamsterilizersthatareusedtosterilizeliquidsorpharmaceuticalproducts.ThisEuropeanStandarddoesnotspecifysafetyrequirementsrelatedtorisksassociatedwiththezoneinwhichthesterilizerisused(e.g.flammablegases).ThisEuropeanStandarddoesnotspecifyrequirementsforthevalidationandroutinecontrolofsterilizationbymoistheat.NOTERequirementsforthevalidationandroutinecontrolofsterilizationbymoistheataregiveninEN554,whichmayalsobeappliedforsmallsteamsterilizers.
【中国标准分类号】:C47
【国际标准分类号】:11_080_10
【页数】:72P.;A4
【正文语种】:英语
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