【英文标准名称】:Cardiovascularimplants-Cardiacvalveprostheses
【原文标准名称】:心血管植入物.心脏瓣膜假体
【标准号】:ISO5840-2005
【标准状态】:现行
【国别】:国际
【发布日期】:2005-03
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC150
【标准类型】:()
【标准水平】:()
【中文主题词】:心脏瓣膜;化学性质;定义;设计;尺寸;耐久性;耐用试验;评估;精密机械;心脏;外科植入物;在体外;在体内;检验;作标记;材料试验;材料;测量;医疗技术学;包装件;物理性能;性能;修复装置;质量保证;危险;规范(验收);灭菌;测试;用户信息;血管假体;验证
【英文主题词】:Cardiacvalves;Chemicalproperties;Definitions;Design;Dimensions;Durability;Endurancetests;Englishlanguage;Evaluations;Finemechanics;Heart;Implants(surgical);Invitro;Invivo;Inspection;Marking;Materialtests;Materials;Measurement;Medicaldevices;Medicaltechnology;Packages;Physicalproperties;Properties;Prostheticdevices;Qualityassurance;Risk;Specification(approval);Sterilization(hygiene);Surgicalimplants;Testing;Userinformation;Vascularprostheses;Verification
【摘要】:ThisInternationalStandardisapplicabletoalldevicesintendedforimplantationinhumanhearts,asaheartvalvesubstitute.ThisInternationalStandardisapplicabletobothnewlydevelopedandmodifiedheartvalvesubstitutesandtotheaccessorydevices,packagingandlabellingrequiredfortheirimplantationandfordeterminingtheappropriatesizeofheartvalvesubstitutetobeimplanted.ThisInternationalStandardoutlinesanapproachforqualifyingthedesignandmanufactureofaheartvalvesubstitutethroughriskmanagement.Theselectionofappropriatequalificationtestsandmethodsarederivedfromtheriskassessment.Thetestsmayincludethosetoassessthephysical,chemical,biologicalandmechanicalpropertiesofheartvalvesubstitutesandoftheirmaterialsandcomponents.Thetestsmayalsoincludethoseforpre-clinicalinvivoevaluationandclinicalevaluationofthefinishedheartvalvesubstitute.ThisInternationalStandardimposesdesignspecificationsandminimumperformancespecificationsforheartvalvesubstituteswhereadequatescientificand/orclinicalevidenceexistsfortheirjustification.ThisInternationalStandardexcludesheartvalvesubstitutesdesignedforimplantationinartificialheartsorheartassistdevices.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:84P;A4
【正文语种】:英语


【英文标准名称】:Specificationfor11/2percentnickel-chromium-molybdenumsteel(110/130kgf/mm2(70/83tonf/in2):limitingrulingsection70mm(23/4in))
【原文标准名称】:(11/2)%镍-铬-钼钢规范.[110/130Kgf/mm(70/83吨力/平方英寸)];限定等圆截面70mm(23/4in)]
【标准号】:BSS139-1968
【标准状态】:作废
【国别】:英国
【发布日期】:1968-04-17
【实施或试行日期】:1968-04-17
【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】:棒材;低合金钢;航空运输工程;材料的机械性能;钼钢;镍钢;铬钢;化学成分;抗拉强度;钢;坯锭;飞行器部件;名称与符号;硬度;锻件;合金钢;热处理
【英文主题词】:bars(materials);airtransportengineering;steels;nickelsteels;billets;molybdenumsteels;hardness;chemicalcomposition;forgings;designations;low-alloysteels;mechanicalpropertiesofmaterials;tensilestrength;alloysteels;chromiumsteels;heattreatment;aircraftcomponents
【摘要】:BRITISHSTANDARD:AEROSPACESERIESSPECIFICATIONFOR3/2PERCENTNICKEL-CHROMIUM-MOLYBDENUMSTEEL1.INSPECTIONANDTESTINGPROCEDURE2.PROCESSOFMANUFACTURE3.CHEMICALCOMPOSITION4.SURFACEDRESSING5.CONDITION6.FINALHEATTREATMENT7.MECHANICALPROPERTIES
【中国标准分类号】:V11
【国际标准分类号】:49_025_10
【页数】:4P.;A4
【正文语种】:英语