【英文标准名称】:Biologicalevaluationofmedicaldevices-Establishmentofallowablelimitsforleachablesubstances
【原文标准名称】:医疗器械的生物评定.可浸出物质容许限值的确定
【标准号】:BSENISO10993-17-2002
【标准状态】:作废
【国别】:英国
【发布日期】:2003-04-30
【实施或试行日期】:2003-04-30
【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】:医疗产品;方法;合金;识别;生物测定;极限(数学);测定;降解;合格鉴定;降解能力;定义;生物分析和试验;危险分析;毒理测定;残留物;分解产物;试验;医疗设备;评定;医疗装置;变坏;设置;分解;金属;危害健康;允许;生物试验;可溶的
【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】:ISO10993-17:2002specifiesthedeterminationofallowablelimitsforsubstancesleachablefrommedicaldevices.Itisintendedforuseinderivingstandardsandestimatingappropriatelimitswherestandardsdonotexist.Itdescribesasystematicprocessthroughwhichidentifiedrisksarisingfromtoxicologicallyhazardoussubstancespresentinmedicaldevicescanbequantified.ISO10993-17:2002isnotapplicabletodevicesthathavenopatientcontact(e.g.invitrodiagnosticdevices).Exposuretoaparticularchemicalsubstancemayarisefromsourcesotherthanthedevice,suchasfood,waterorair.ISO10993-17:2002doesnotaddressthepotentialforexposurefromsuchsources.
【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