【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


Product Code:SAE AMS5750
Title:Alloy Bars, Forgings, and Rings, Corrosion and Heat Reistant, Nickel Base - 15.5Cr - 16Mo - 3.8W - 5.5Fe, Solution Treated (NONCURRENT)
Issuing Committee:Ams F Corrosion Heat Resistant Alloys Committee
Scope:This specification covers a corrosion and heat resistant nickel-base alloy in the form of bars, forgings, flash welded rings, and stock for forging or flash welded rings. Primarily for parts and assemblies, such as turbine rotors, shafts, blades, and bolts, requiring high strength up to 1500 ° F (816° C) and oxidation resistance up to 2000 ° F ° Centigrade).