【英文标准名称】:Surgicaldrapes,gownsandcleanairsuits,usedasmedicaldevicesforpatients,clinicalstaffandequipment.Generalrequirementsformanufacturers,processorsandproducts,testmethods,performancerequirementsandperformancelevels
【原文标准名称】:用作医疗器械的患者,医护人员和医疗器械用覆盖巾,手术服和清洁空气套装.生产商,处理器和产品的一般要求,试验方法,性能要求和性能等级
【标准号】:BSEN13795-2011
【标准状态】:现行
【国别】:英国
【发布日期】:2011-03-31
【实施或试行日期】:2011-03-31
【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;门诊部;覆盖布;制造日期;定义(术语);企业;卫生学;信息;使用说明书;医疗器械;医疗器材;医疗人员;医疗产品;医学科学;医疗技术学;手术服;病人;全体人员;生产;产品;公共卫生;规范(验收);外科学;外科设备;测试;工作服
【英文主题词】:Accessories;Clinics;Covercloths;Dataofthemanufacturer;Definitions;Enterprises;Hygiene;Information;Instructionsforuse;Medicaldevices;Medicalequipment;Medicalpersonnel;Medicalproducts;Medicalsciences;Medicaltechnology;Operationshirt;Patients;Personnel;Production;Products;Publichealth;Specification(approval);Surgery;Surgicalequipment;Testing;Workclothes
【摘要】:ThisEuropeanStandardspecifiesinformationtobesuppliedtousersandthirdpartyverifiersinadditiontotheusuallabellingofmedicaldevices(seeEN980andEN1041),concerningmanufacturingandprocessingrequirements.ThisEuropeanStandardgivesinformationonthecharacteristicsofsingle-useandreusablesurgicalgowns,surgicaldrapesandcleanairsuitsusedasmedicaldevicesforpatients,clinicalstaffandequipment,intendedtopreventthetransmissionofinfectiveagentsbetweenpatientsandclinicalstaffduringsurgicalandotherinvasiveprocedures.ThisEuropeanStandardspecifiestestmethodsforevaluatingtheidentifiedcharacteristicsofsurgicaldrapes,gownsandcleanairsuitsandsetsperformancerequirementsfortheseproducts.EN13795doesnotcoverrequirementsforflammabilityofproducts.Suitabletestmethodsforflammabilityandresistancetopenetrationbylaserradiation,togetherwithanappropriateclassificationsystem,aregiveninENISO11810-1andENISO11810-2.AdditionalessentialrequirementsthatapplytosurgicalclothinganddrapesarecoveredbyotherEuropeanStandards.
【中国标准分类号】:
【国际标准分类号】:11_140
【页数】:26P.;A4
【正文语种】:英语