【英文标准名称】:Sterilization-Steamsterilizers-Largesterilizers
【原文标准名称】:消毒.蒸气消毒.大型消毒设备
【标准号】:BSEN285-2006+A1-2008
【标准状态】:现行
【国别】:英国
【发布日期】:2006-06-30
【实施或试行日期】:2006-06-30
【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】:检验总量;Bowie和Dick试验;闭塞物;兼容性;连接件;定义;设计;尺寸;湿强度试验(纸);效率;指示装置;检验;检验规范;泄漏量;极限(数学);作标记;材料;测量仪器;医疗设备;医疗产品;医学科学;微生物分析;微生物学;性能要求;压力容器;公共卫生;声功率;规范(验收);蒸汽灭菌器;灭菌;消毒物品;灭菌器;试验设备;测试;热电的
【英文主题词】:Amountofinspection;BowieandDicktest;Closures;Compatibility;Connections;Definition;Definitions;Design;Dimensions;Drainabilitytests;Efficiency;Indicatingdevices;Inspection;Inspectionspecification;Leakage;Limits(mathematics);Marking;Materials;Measuringinstruments;Medicalequipment;Medicalproducts;Medicalsciences;Microbiologicalanalysis;Microbiology;Performancerequirements;Pressurevessels;Publichealth;Soundpower;Specification(approval);Steamsterilizers;Sterilization(hygiene);Sterilizedgoods;Sterilizers;Testequipment;Testing;Thermoelectric
【摘要】:1.1ThisEuropeanStandardspecifiesrequirementsandtherelevanttestsforlargesteamsterilizersprimarilyusedinhealthcareforthesterilizationofmedicaldevicesandtheiraccessoriescontainedinoneormoresterilizationmodules.ThetestloadsdescribedinthisEuropeanStandardareselectedtorepresentthemajorityofloads(i.e.wrappedgoodsconsistingofmetal,rubberandporousmaterials)fortheevaluationofgeneralpurposesteamsterilizerformedicaldevices.However,specificloads(e.g.heavymetalobjectsorlongand/ornarrowlumen)willrequiretheuseofothertestloads.Largesteamsterilizerscanalsobeusedduringthecommercialproductionofmedicaldevices.1.2ThisEuropeanStandardisnotapplicabletosteamsterilizersdesignedtoprocessasizeofloadlessthanonesterilizationmoduleorhavingachambervolumelessthan60l.1.3ThisEuropeanStandarddoesnotdescribeaqualityassurancesystemforthecontrolofallstagesofthemanufactureofthesterilizer.NOTEAttentionisdrawntothestandardsforqualitymanagementsystemse.g.ENISO13485.1.4PlanninganddesignofproductsapplyingtothisEuropeanStandardshouldconsidertheenvironmentalimpactfromtheproductduringitslifecycle.EnvironmentalaspectsareaddressedinAnnexA.NOTEAdditionalaspectsofenvironmentalimpactareaddressedinENISO14971.
【中国标准分类号】:C47
【国际标准分类号】:11_080_10
【页数】:86P.;A4
【正文语种】:英语