NF L00-015-1997 航空航天.质量管理和保障.一致性声明
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【英文标准名称】:Aerospace.Qualitymanagementandassurance.Statementofconformity.
【原文标准名称】:航空航天.质量管理和保障.一致性声明
【标准号】:NFL00-015-1997
【标准状态】:现行
【国别】:法国
【发布日期】:1997-12-01
【实施或试行日期】:1997-12-20
【发布单位】:法国标准化协会(AFNOR)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:质量保证;认证(认可);供应商;合格证明书;文献;准则;测定;产品;检验;合格试验;定义;规范(验收);质量控制;合格;试验;企业;格式(纸);产品试验;空白格式;认证
【英文主题词】:
【摘要】:
【中国标准分类号】:V04
【国际标准分类号】:03_120_20
【页数】:10P;A4
【正文语种】:其他
【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
Product Code:SAE AMS2646
Title:Contrast Dye Penetrant Inspection (Cancelled Apr 1999, Superseded by ASTM E 1220)
Issuing Committee:Ams K Non Destructive Methods And Processes Committee
Scope:Detection of discontinuities such as cracks, laps, porosity, cold shuts, lack of bond, and similar defects. Because inspection can be performed in normal light, this method can be used when fluorescent penetrant inspection is impracticable.
