【英文标准名称】:Sterilization-Steamsterilizers-Largesterilizers(includesAmendmentA2:2009);EnglishversionofDINEN285:2009-08
【原文标准名称】:灭菌.蒸汽灭菌器.大型灭菌器(包括修改件A2-2009).英文版本DINEN285-2009-08
【标准号】:DINEN285-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-08
【实施或试行日期】:
【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】:检验总量;布维-狄克试验;闭塞物;兼容性;连接;定义;设计;尺寸;湿强度试验(纸);效率;设备;指示装置;检验;检验规范;安装位置;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;安全性;声功率;规范(验收);蒸汽灭菌器;灭菌(卫生学);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;Equipment;Indicatingdevices;Inspection;Inspectionspecification;Installationlocations;Leakage;Limits(mathematics);Marking;Materials;Measuringinstruments;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Microbiologicalanalysis;Microbiology;Performancerequirements;Pressurevessels;Publichealth;Safety;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.1.2ThisEuropeanStandardisnotapplicabletosteamsterilizersdesignedtoprocessasizeofloadlessthanonesterilizationmoduleorhavingachambervolumelessthan60I.1.3ThisEuropeanStandarddoesnotdescribeaqualityassurancesystemforthecontrolofallstagesofthemanufactureofthesterilizer.NOTEAttentionisdrawntothestandardsforqualitymanagementsystemse.g.ENISO13485.1.4PlanninganddesignofproductsapplyingtothisEuropeanStandardshouldconsidertheenvironmentalimpactfromtheproductduringitslifecycle.EnvironmentalaspectsareaddressedinAnnexA.NOTEAdditionalaspectsofenvironmentalimpactareaddressedinENISO14971.
【中国标准分类号】:C46
【国际标准分类号】:11_080_10
【页数】:88P.;A4
【正文语种】:英语