DIN EN 13795-1-2009 作为医务用品的病人,医疗人员和医用设备用手术盖单,长外衣和无污染套装.第1部分:厂商,加工者和产品的一般要求(A1:2009),DINEN13795-1:2009-的英文版本
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【英文标准名称】:Surgicaldrapes,gownsandcleanairsuits,usedasmedicaldevices,forpatients,clinicalstaffandequipment-Part1:Generalrequirementsformanufacturers,processorsandproducts(includesAmendmentA1:2009);EnglishversionofDINEN13795-1:2009-10
【原文标准名称】:作为医务用品的病人,医疗人员和医用设备用手术盖单,长外衣和无污染套装.第1部分:厂商,加工者和产品的一般要求(A1:2009),DINEN13795-1:2009-的英文版本
【标准号】:DINEN13795-1-2009
【标准状态】:作废
【国别】:德国
【发布日期】:2009-10
【实施或试行日期】:2009-10-01
【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】:
【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;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】:
【国际标准分类号】:11_140
【页数】:17P.;A4
【正文语种】:英语
【原文标准名称】:作为医务用品的病人,医疗人员和医用设备用手术盖单,长外衣和无污染套装.第1部分:厂商,加工者和产品的一般要求(A1:2009),DINEN13795-1:2009-的英文版本
【标准号】:DINEN13795-1-2009
【标准状态】:作废
【国别】:德国
【发布日期】:2009-10
【实施或试行日期】:2009-10-01
【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】:
【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;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】:
【国际标准分类号】:11_140
【页数】:17P.;A4
【正文语种】:英语
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