BS EN ISO 10993-18-2009 医疗器械的生物学评价.第18部分:材料的化学表征(ISO10993-18-2005)
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【英文标准名称】:Biologicalevaluationofmedicaldevices-Part18:Chemicalcharacterizationofmaterials(ISO10993-18:2005)
【原文标准名称】:医疗器械的生物学评价.第18部分:材料的化学表征(ISO10993-18-2005)
【标准号】:BSENISO10993-18-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2009-06-30
【实施或试行日期】:2009-06-30
【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】:合金;应用;生物测定;生物试验;陶瓷;特性;化学的;化学分析和试验;化学性质;定义;测定;评估;健康危害;识别;医疗器械;医疗设备;医疗产品;金属;方法;规范(验收);试验
【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】:28P.;A4
【正文语种】:英语
【原文标准名称】:医疗器械的生物学评价.第18部分:材料的化学表征(ISO10993-18-2005)
【标准号】:BSENISO10993-18-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2009-06-30
【实施或试行日期】:2009-06-30
【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】:合金;应用;生物测定;生物试验;陶瓷;特性;化学的;化学分析和试验;化学性质;定义;测定;评估;健康危害;识别;医疗器械;医疗设备;医疗产品;金属;方法;规范(验收);试验
【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】:28P.;A4
【正文语种】:英语
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