【英文标准名称】:Surgicaldrapes,gownsandcleanairsuits,usedasmedicaldevices,forpatients,clinicalstaffandequipment-Generalrequirementsformanufacturers,processorsandproducts
【原文标准名称】:用作医疗用品的病人、医护人员和设备用外科窗帘、工作服和空气清新器.生产者、加工者和产品的一般要求
【标准号】:BSEN13795-1-2002
【标准状态】:作废
【国别】:英国
【发布日期】:2002-11-29
【实施或试行日期】:2002-11-29
【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】:医疗技术学;使用说明;准备;医疗产品;制造日期;作标记;卫生学;外科设备;外科学;公共卫生;术语;病人;生产;企业;信息;医学科学;产品;覆盖布;规范(验收);定义;医疗设备;门诊部;医务用品;医疗人员;手术衣
【英文主题词】:Aids;Clinics;Covercloths;Dataofthemanufacturer;Definition;Definitions;Enterprises;Hygiene;Information;Instructionsforuse;Marking;Medicalequipment;Medicalpersonnel;Medicalproducts;Medicalsciences;Medicaltechnology;Operationshirt;Patients;Preparation;Processing;Production;Products;Publichealth;Specification(approval);Surgery;Surgicalequipment;Terminology;Testing;Treatment;Workclothes
【摘要】:Thisstandardspecifiesinformationtobesuppliedtousersandthirdpartyverifiers,inadditiontotheusuallabellingofmedicaldevices(seeEN980andEN1041),concerningmanufacturingandprocessingrequirements.Thisstandardgivesgeneralguidanceonthecharacteristicsofsingle-useandreusablesurgicalgowns,surgicaldrapesandcleanairsuitsusedasmedicaldevicesforpatients,clinicalstaffandequipment.Itisintendedtopreventthetransmissionofinfectiveagentsbetweenpatientsandclinicalstaffduringsurgicalandotherinvasiveprocedures.Surgicalmasks,surgicalgloves,packagingmaterials,footandheadwearandincisiondrapesarenotcoveredbyEN13795.RequirementsformedicalglovesaregivenintheEN455seriesofEuropeanStandardsandpackagingmaterialsarecoveredbytheEN868series.RequirementsforsurgicalmasksandheadcoveringswillbespecifiedinfutureCEN/TC205standards.EN13795doesnotcoverrequirementsforflammabilityofproductsusedinlasersurgery.Suitabletestmethodsforflammabilityandresistancetopenetrationbylaserradiation,togetherwithanappropriateclassificationsystem,aregiveninENISO11810.AdditionalessentialrequirementsthatapplytosurgicalclothinganddrapesarecoveredbyotherEuropeanStandards.
【中国标准分类号】:C47
【国际标准分类号】:11_140
【页数】:18P;A4
【正文语种】:英语