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【英文标准名称】:Biologicalevaluationofmedicaldevices-Part18:Chemicalcharacterizationofmaterials
【原文标准名称】:医疗器械的生物学评价.第18部分:材料的化学特性
【标准号】:ISO10993-18-2005
【标准状态】:现行
【国别】:国际
【发布日期】:2005-07
【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/TC194
【标准类型】:()
【标准水平】:()
【中文主题词】:定义;化学性质;使用;特性;规范(验收);评定;试验;方法;测定;金属;合金;危害健康;医疗器械;生物试验;医疗产品;医疗设备;识别;生物测定;陶瓷;化学分析和试验;化学的
【英文主题词】:Alloys;Applications;Bioassay;Biologicaltests;Ceramics;Characteristics;Chemical;Chemicalanalysisandtesting;Chemicalproperties;Definitions;Determination;Evaluations;Healthhazards;Identification;Medicaldevices;Medicalequipment;Medicalproducts;Metals;Methods;Specification(approval);Testing
【摘要】:ThispartofISO10993describesaframeworkfortheidentificationofamaterialandtheidentificationandquantificationofitschemicalconstituents.Thechemicalcharacterizationinformationgeneratedcanbeusedforarangeofimportantapplications,forexample:—Aspartofanassessmentoftheoverallbiologicalsafetyofamedicaldevice(ISO10993-1and14971).—Measurementofthelevelofaleachablesubstanceinamedicaldeviceinordertoallowtheassessmentofcompliancewiththeallowablelimitderivedforthatsubstancefromhealthbasedriskassessment(ISO10993-17).—Judgingequivalenceofaproposedmaterialtoaclinicallyestablishedmaterial.—Judgingequivalenceofafinaldevicetoaprototypedevicetochecktherelevanceofdataonthelattertobeusedtosupporttheassessmentoftheformer.—Screeningofpotentialnewmaterialsforsuitabilityinamedicaldeviceforaproposedclinicalapplication.ThispartofISO10993doesnotaddresstheidentificationorquantificationofdegradationproducts,whichiscoveredinISO10993-9,ISO10993-13,ISO10993-14andISO10993-15.TheISO10993seriesofstandardsisapplicablewhenthematerialordevicecomesintocontactwiththebodydirectlyorindirectly(see4.2.1ofISO10993-1:2003).ThispartofISO10993isintendedforsuppliersofmaterialsandmanufacturersofmedicaldevices,whencarryingoutabiologicalsafetyassessment.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:17P;A4
【正文语种】:英语