BS EN ISO 10993-15-2001 医疗器械的生物评定.金属及合金中降解产物的识别与量化
作者:标准资料网 时间:2024-05-20 18:22:17 浏览:8550
来源:标准资料网
下载地址: 点击此处下载
【英文标准名称】:Biologicalevaluationofmedicaldevices-Identificationandquantificationofdegradationproductsfrommetalsandalloys
【原文标准名称】:医疗器械的生物评定.金属及合金中降解产物的识别与量化
【标准号】:BSENISO10993-15-2001
【标准状态】:作废
【国别】:英国
【发布日期】:2001-07-15
【实施或试行日期】:2001-07-15
【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】:变坏;金属;加速腐蚀试验;化学分析和试验;物理化学法;化学反应;医疗设备;医疗器械;生物分析和试验;合金;降解
【英文主题词】:Alloys;Bioassay;Biologicaltests;Decomposition;Decompositionproducts;Definitions;Degradation;Determination;Evaluations;Identification;Medicaldevices;Medicalproducts;Metals;Quantification;Toxicologicaltesting
【摘要】:ThispartofISO10993providesguidanceongeneralrequirementsforthedesignoftestsforidentifyingandquantifyingdegradationproductsfromfinishedmetallicmedicaldevicesorcorrespondingmaterialsamplesfinishedasreadyforclinicaluse.Itisapplicableonlytothosedegradationproductsgeneratedbychemicalalterationofthefinishedmetallicdeviceinaninvitroaccelerateddegradationtest.Becauseoftheacceleratednatureofthesetests,thetestresultsmaynotreflecttheimplantormaterialbehaviorinthebody.Thedescribedchemicalmethodologiesareameanstogeneratedegradationproductsforfurtherassessments.ThispartofISO10993isnotapplicabletodegradationproductsinducedbyappliedmechanicalstress.NOTEMechanicallyinduceddegradation,suchaswear,maybecoveredintheappropriateproduct-specificstandard.Whereproduct-groupstandardsprovideapplicableproduct-specificmethodologiesfortheidentificationandquantificationofdegradationproducts,thosestandardsshouldbeconsidered.Becauseofthewiderangeofmetallicmaterialsusedinmedicaldevices,nospecificanalyticaltechniquesareidentifiedforquantifyingthedegradationproducts.Theidentificationoftraceelements(<10)containedinthespecificmetaloralloyisnotaddressedinthispartofISO10993,norarespecificrequirementsforacceptablelevelsofdegradationproductsprovidedinthispartofISO10993.ThispartofISO10993doesnotaddressthebiologicalactivityofthedegradationproducts;seeinsteadtheapplicableclausesofISO10993-1andISO10993-17.
【中国标准分类号】:C04
【国际标准分类号】:11_100_20
【页数】:24P;A4
【正文语种】:英语
【原文标准名称】:医疗器械的生物评定.金属及合金中降解产物的识别与量化
【标准号】:BSENISO10993-15-2001
【标准状态】:作废
【国别】:英国
【发布日期】:2001-07-15
【实施或试行日期】:2001-07-15
【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】:变坏;金属;加速腐蚀试验;化学分析和试验;物理化学法;化学反应;医疗设备;医疗器械;生物分析和试验;合金;降解
【英文主题词】:Alloys;Bioassay;Biologicaltests;Decomposition;Decompositionproducts;Definitions;Degradation;Determination;Evaluations;Identification;Medicaldevices;Medicalproducts;Metals;Quantification;Toxicologicaltesting
【摘要】:ThispartofISO10993providesguidanceongeneralrequirementsforthedesignoftestsforidentifyingandquantifyingdegradationproductsfromfinishedmetallicmedicaldevicesorcorrespondingmaterialsamplesfinishedasreadyforclinicaluse.Itisapplicableonlytothosedegradationproductsgeneratedbychemicalalterationofthefinishedmetallicdeviceinaninvitroaccelerateddegradationtest.Becauseoftheacceleratednatureofthesetests,thetestresultsmaynotreflecttheimplantormaterialbehaviorinthebody.Thedescribedchemicalmethodologiesareameanstogeneratedegradationproductsforfurtherassessments.ThispartofISO10993isnotapplicabletodegradationproductsinducedbyappliedmechanicalstress.NOTEMechanicallyinduceddegradation,suchaswear,maybecoveredintheappropriateproduct-specificstandard.Whereproduct-groupstandardsprovideapplicableproduct-specificmethodologiesfortheidentificationandquantificationofdegradationproducts,thosestandardsshouldbeconsidered.Becauseofthewiderangeofmetallicmaterialsusedinmedicaldevices,nospecificanalyticaltechniquesareidentifiedforquantifyingthedegradationproducts.Theidentificationoftraceelements(<10)containedinthespecificmetaloralloyisnotaddressedinthispartofISO10993,norarespecificrequirementsforacceptablelevelsofdegradationproductsprovidedinthispartofISO10993.ThispartofISO10993doesnotaddressthebiologicalactivityofthedegradationproducts;seeinsteadtheapplicableclausesofISO10993-1andISO10993-17.
【中国标准分类号】:C04
【国际标准分类号】:11_100_20
【页数】:24P;A4
【正文语种】:英语
下载地址: 点击此处下载
