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【英文标准名称】:Biologicalevaluationofmedicaldevices-Part17:Establishmentofallowablelimitsforleachablesubstances
【原文标准名称】:医疗器械的生物评定.第17部分:可浸出物质容许限值的确定
【标准号】:ISO10993-17-2002
【标准状态】:现行
【国别】:国际
【发布日期】:2002-12
【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】:识别;可容许的;极限(数学);医疗产品;方法;评定;定义;合金;医疗器械;测定;降解能力;分解;资格鉴定;设置;生物试验;金属;分解产物;残留物;毒理测定
【英文主题词】:Allowable;Alloys;Bioassay;Biologicalanalysisandtesting;Biologicaltests;Decomposition;Decompositionproducts;Definitions;Degradability;Degradation;Deterioration;Determination;Establishment;Evaluations;Healthhazards;Identification;Limits(mathematics);Medicaldevices;Medicalequipment;Medicalproducts;Metals;Methods;Quantification;Residues;Riskanalysis;Soluble;Testing;Toxicologicaltesting
【摘要】:ThispartofISO10993specifiesamethodforthedeterminationofallowablelimitsforsubstancesteachablefrommedicaldevices.Itisintendedforuseinderivingstandardsandestimatingappropriatelimitswherestandardsdonotexist.Itdescribesasystematicprocessthroughwhichidentifiedrisksarisingfromtoxicologicallyhazardoussubstancespresentinmedicaldevicescanbequantified.ThispartofISO10993isnotapplicabletodevicesthathavenopatientcontact(e.g.invitrodiagnosticdevices).Exposuretoaparticularchemicalsubstancemayarisefromsourcesotherthanthedevice,suchasfood,,waterorair.ThispartofISO10993doesnotaddressthepotentialforexposurefromsuchsources.
【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】:英语