BS EN ISO 10993-14-2001 医疗器械的生物评定.陶瓷降解产品的识别与量化试验
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【英文标准名称】:Biologicalevaluationofmedicaldevices-Identificationandquantificationofdegradationproductsfromceramics
【原文标准名称】:医疗器械的生物评定.陶瓷降解产品的识别与量化试验
【标准号】:BSENISO10993-14-2001
【标准状态】:作废
【国别】:英国
【发布日期】:2001-12-14
【实施或试行日期】:2001-12-14
【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】:降解;加速度试验;生物分析和试验;识别方法;玻璃陶瓷;生物学;变坏;陶瓷;化学分析和试验;医疗设备;定量分析;分解反应
【英文主题词】:Bioassay;Biologicaltests;Ceramics;Decomposition;Decompositionproducts;Definitions;Deterioration;Evaluations;Identification;Medicaldevices;Medicalequipment;Medicalproducts;Quantification;Testing
【摘要】:ThispartofIS010993providesguidanceongeneralrequirementsforthedesignoftestsforidentifyingandquantifyingdegradationproductsfromfinishedmetallicmedicaldevicesorcorrespondingmaterialsamplesfinishedasreadyforclinicaluse.Itisapplicableonlytothosedegradationproductsgeneratedbychemicalalterationofthefinishedmetallicdeviceinaninvitroaccelerateddegradationtest.Becauseoftheacceleratednatureofthesetests,thetestresultsmaynotreflecttheimplantormaterialbehaviorinthebody.Thedescribedchemicalmethodologiesareameanstogeneratedegradationproductsforfurtherassessments.ThispartofIS010993isnotapplicabletodegradationproductsinducedbyappliedmechanicalstress.NOTEMechanicallyinduceddegradation,suchaswear,maybecoveredintheappropriateproduct-specificstandard.Whereproduct-groupstandardsprovideapplicableproduct-specificmethodologiesfortheidentificationandquantificationofdegradationproducts,thosestandardsshouldbeconsidered.Becauseofthewiderangeofmetallicmaterialsusedinmedicaldevices,nospecificanalyticaltechniquesareidentifiedforquantifyingthedegradationproducts.Theidentificationoftraceelements(e10-6)containedinthespecificmetaloralloyisnotaddressedinthispartofIS010993,norarespecificrequirementsforacceptablelevelsofdegradationproductsprovidedinthispartofIS010993.ThispartofIS010993doesnotaddressthebiologicalactivityofthedegradationproducts;seeinsteadtheapplicableclausesofIS010993-1andIS010993-17.
【中国标准分类号】:C04
【国际标准分类号】:11_100_20
【页数】:26P;A4
【正文语种】:英语
【原文标准名称】:医疗器械的生物评定.陶瓷降解产品的识别与量化试验
【标准号】:BSENISO10993-14-2001
【标准状态】:作废
【国别】:英国
【发布日期】:2001-12-14
【实施或试行日期】:2001-12-14
【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】:降解;加速度试验;生物分析和试验;识别方法;玻璃陶瓷;生物学;变坏;陶瓷;化学分析和试验;医疗设备;定量分析;分解反应
【英文主题词】:Bioassay;Biologicaltests;Ceramics;Decomposition;Decompositionproducts;Definitions;Deterioration;Evaluations;Identification;Medicaldevices;Medicalequipment;Medicalproducts;Quantification;Testing
【摘要】:ThispartofIS010993providesguidanceongeneralrequirementsforthedesignoftestsforidentifyingandquantifyingdegradationproductsfromfinishedmetallicmedicaldevicesorcorrespondingmaterialsamplesfinishedasreadyforclinicaluse.Itisapplicableonlytothosedegradationproductsgeneratedbychemicalalterationofthefinishedmetallicdeviceinaninvitroaccelerateddegradationtest.Becauseoftheacceleratednatureofthesetests,thetestresultsmaynotreflecttheimplantormaterialbehaviorinthebody.Thedescribedchemicalmethodologiesareameanstogeneratedegradationproductsforfurtherassessments.ThispartofIS010993isnotapplicabletodegradationproductsinducedbyappliedmechanicalstress.NOTEMechanicallyinduceddegradation,suchaswear,maybecoveredintheappropriateproduct-specificstandard.Whereproduct-groupstandardsprovideapplicableproduct-specificmethodologiesfortheidentificationandquantificationofdegradationproducts,thosestandardsshouldbeconsidered.Becauseofthewiderangeofmetallicmaterialsusedinmedicaldevices,nospecificanalyticaltechniquesareidentifiedforquantifyingthedegradationproducts.Theidentificationoftraceelements(e10-6)containedinthespecificmetaloralloyisnotaddressedinthispartofIS010993,norarespecificrequirementsforacceptablelevelsofdegradationproductsprovidedinthispartofIS010993.ThispartofIS010993doesnotaddressthebiologicalactivityofthedegradationproducts;seeinsteadtheapplicableclausesofIS010993-1andIS010993-17.
【中国标准分类号】:C04
【国际标准分类号】:11_100_20
【页数】:26P;A4
【正文语种】:英语
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