【英文标准名称】:Chemicalsusedfortreatmentofwaterintendedforhumanconsumption-Coppersulfate;GermanversionEN12386:1998
【原文标准名称】:饮用水处理用化合物.硫酸铜
【标准号】:DINEN12386-1999
【标准状态】:作废
【国别】:德国
【发布日期】:1999-03
【实施或试行日期】:
【发布单位】:德国标准化学会(DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:水净化;工业用水;饮用水处理;化学性质;硫酸铜;水常规;给水工程;水处理;特性;给水;试验;规范(验收);储存;处理;饮用水;物理性能;作标记;水;运输
【英文主题词】:
【摘要】:
【中国标准分类号】:G77
【国际标准分类号】:71_100_80
【页数】:9P;A4
【正文语种】:德语


【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