DIN EN ISO 10993-18-2005 医疗装置的生物评价.第18部分:材料的化学表征
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【英文标准名称】:Biologicalevaluationofmedicaldevices-Part18:Chemicalcharacterizationofmaterials(ISO10993-18:2005);GermanversionENISO10993-18:2005
【原文标准名称】:医疗装置的生物评价.第18部分:材料的化学表征
【标准号】:DINENISO10993-18-2005
【标准状态】:作废
【国别】:德国
【发布日期】:2005-10
【实施或试行日期】:
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:生物测定;识别;医疗装置;陶瓷;医疗设备;化学的;危害健康;特性记述;生物试验;金属;合金;医疗产品;材料;方法;化学分析和试验;使用;测定;定义;规范(验收);化学性质;试验;评定;特性
【英文主题词】:Alloys;Applications;Bioassay;Biologicaltests;Ceramics;Characterisations;Characteristics;Chemical;Chemicalanalysisandtesting;Chemicalproperties;Definitions;Determination;Evaluations;Healthhazards;Identification;Materials;Medicaldevices;Medicalequipment;Medicalproducts;Metals;Methods;Specification(approval);Testing
【摘要】:ThispartofISO10993describesaframeworkfortheidentificationofamaterialandtheidentificationandquantificationofitschemicalconstituents.Thechemicalcharacterizationinformationgeneratedcanbeusedforarangeofimportantapplications,forexample:--Aspartofanassessmentoftheoverallbiologicalsafetyofamedicaldevice(ISO10993-1and14971).Measurementofthelevelofaleachablesubstanceinamedicaldeviceinordertoallowtheassessmentofcompliancewiththeallowablelimitderivedforthatsubstancefromhealthbasedriskassessment(ISO10993-17).--Judgingequivalenceofaproposedmaterialtoaclinicallyestablishedmaterial.--Judgingequivalenceofafinaldevicetoaprototypedevicetochecktherelevanceofdataonthelattertobeusedtosupporttheassessmentoftheformer.--Screeningofpotentialnewmaterialsforsuitabilityinamedicaldeviceforaproposedclinicalapplication.ThispartofISO10993doesnotaddresstheidentificationorquantificationofdegradationproducts,whichisAcoveredinISO10993-9,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】:25P;A4
【正文语种】:德语
【原文标准名称】:医疗装置的生物评价.第18部分:材料的化学表征
【标准号】:DINENISO10993-18-2005
【标准状态】:作废
【国别】:德国
【发布日期】:2005-10
【实施或试行日期】:
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:生物测定;识别;医疗装置;陶瓷;医疗设备;化学的;危害健康;特性记述;生物试验;金属;合金;医疗产品;材料;方法;化学分析和试验;使用;测定;定义;规范(验收);化学性质;试验;评定;特性
【英文主题词】:Alloys;Applications;Bioassay;Biologicaltests;Ceramics;Characterisations;Characteristics;Chemical;Chemicalanalysisandtesting;Chemicalproperties;Definitions;Determination;Evaluations;Healthhazards;Identification;Materials;Medicaldevices;Medicalequipment;Medicalproducts;Metals;Methods;Specification(approval);Testing
【摘要】:ThispartofISO10993describesaframeworkfortheidentificationofamaterialandtheidentificationandquantificationofitschemicalconstituents.Thechemicalcharacterizationinformationgeneratedcanbeusedforarangeofimportantapplications,forexample:--Aspartofanassessmentoftheoverallbiologicalsafetyofamedicaldevice(ISO10993-1and14971).Measurementofthelevelofaleachablesubstanceinamedicaldeviceinordertoallowtheassessmentofcompliancewiththeallowablelimitderivedforthatsubstancefromhealthbasedriskassessment(ISO10993-17).--Judgingequivalenceofaproposedmaterialtoaclinicallyestablishedmaterial.--Judgingequivalenceofafinaldevicetoaprototypedevicetochecktherelevanceofdataonthelattertobeusedtosupporttheassessmentoftheformer.--Screeningofpotentialnewmaterialsforsuitabilityinamedicaldeviceforaproposedclinicalapplication.ThispartofISO10993doesnotaddresstheidentificationorquantificationofdegradationproducts,whichisAcoveredinISO10993-9,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】:25P;A4
【正文语种】:德语
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