【英文标准名称】:Medicalelectricalequipment-Part2:Particularrequirementsforthesafetyofelectroencephalographs(IEC60601-2-26:1994);GermanversionEN60601-2-26:1994
【原文标准名称】:医疗电气设备.第2部分第26节:脑电图机安全性特殊要求
【标准号】:DINEN60601-2-26-1995
【标准状态】:作废
【国别】:德国
【发布日期】:1995-09
【实施或试行日期】:1995-09-01
【发布单位】:德国标准化学会(DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:医疗技术学;医用电气设备;规范(验收);试验;安全工程;安全;安全要求;辐射防护;保护装置;电医学;电气器具;医学科学;电气安全;定义;脑电描记器;环境试验;医疗设备;诊断
【英文主题词】:
【摘要】:
【中国标准分类号】:K60;C36
【国际标准分类号】:11_040_50
【页数】:17P;A4
【正文语种】:德语


【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+A2-2009
【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;医疗器械;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;试验;热电的
【英文主题词】:Amountofinspection;BowieandDicktest;Closures;Compatibility;Connections;Definitions;Design;Dimensions;Drainabilitytests;Efficiency;Indicatingdevices;Inspection;Inspectionspecification;Leakage;Limits(mathematics);Marking;Materials;Measuringinstruments;Medicaldevices;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】:90P.;A4
【正文语种】:英语