BS EN 13795-1-2002+A1-2009 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.第1部分:制造商,处理装置和产品的一般要求
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【英文标准名称】:Surgicaldrapes,gownsandcleanairsuits,usedasmedicaldevices,forpatients,clinicalstaffandequipment—Part1:Generalrequirementsformanufacturers,processorsandproducts
【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.第1部分:制造商,处理装置和产品的一般要求
【标准号】:BSEN13795-1-2002+A1-2009
【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】:辅助设备;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;作标记;医疗器械;医疗设备;医疗人员;医疗产品;医学科学;医疗技术学;手术服;病人;准备;处理;生产;产品;公共卫生;规范(验收);外科学;外科设备;术语学;测试;治疗;工作服
【英文主题词】:Aids;Clinics;Covercloths;Dataofthemanufacturer;Definitions;Enterprises;Hygiene;Information;Instructionsforuse;Marking;Medicaldevices;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
【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.第1部分:制造商,处理装置和产品的一般要求
【标准号】:BSEN13795-1-2002+A1-2009
【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】:辅助设备;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;作标记;医疗器械;医疗设备;医疗人员;医疗产品;医学科学;医疗技术学;手术服;病人;准备;处理;生产;产品;公共卫生;规范(验收);外科学;外科设备;术语学;测试;治疗;工作服
【英文主题词】:Aids;Clinics;Covercloths;Dataofthemanufacturer;Definitions;Enterprises;Hygiene;Information;Instructionsforuse;Marking;Medicaldevices;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
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