【英文标准名称】:Biologicalevaluationofmedicaldevices-Part17:Establishmentofallowablelimitsforleachablesubstances(ISO10993-17:2002)
【原文标准名称】:医疗器械的生物学评价.第17部分:浸出物允许限量的确定(ISO10993-17-2002)
【标准号】:BSENISO10993-17-2009
【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】:许可;合金;生物测定;生物分析和试验;生物试验;分解;分解产物;定义;降解能力;降解;变坏;测定;设置;评估;健康危害;识别;极限(数学);医疗器械;医疗设备;医疗产品;金属;方法;量化;残留物;危险分析;可溶的;试验;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】:ThispartofISO10993specifiesamethodforthedeterminationofallowablelimitsforsubstancesleachablefrommedicaldevices.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】:36P.;A4
【正文语种】:英语