BS EN 13060-2004 小型蒸汽灭菌器

作者:标准资料网 时间:2024-05-30 04:42:40  浏览:9306   来源:标准资料网

【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
【标准状态】:作废
【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】:合格试验;安全工程;设计;试验;定义;安全;小型灭菌器;泄漏量;规范(验收);额定值;医学科学;医疗产品;灭菌器;安全要求;卫生学;材料;标志;性能要求;设备安全;医疗设备;灭菌;蒸汽灭菌;蒸汽灭菌器;试验程序;作标记;尺寸
【英文主题词】:Definition;Definitions;Design;Dimensions;Equipmentsafety;Hygiene;Leakage;Marking;Materials;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Miniaturesterilizer;Performancerequirements;Qualificationtests;Ratings;Safety;Safetyengineering;Safetyrequirements;Signs;Specification(approval);Steamsterilization;Steamsterilizers;Sterilization(hygiene);Sterilizers;Testprograms;Testing
【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】:70P.;A4
【正文语种】:英语