【英文标准名称】:Biologicalevaluationofmedicaldevices-Part14:Identificationandquantificationofdegradationproductsfromceramics(ISO10993-14:2001);GermanversionENISO10993-14:2001
【原文标准名称】:医疗器械的生物评价.第14部分:陶瓷降解产品的识别与量化(ISO10993-14:2001);德文版本ENISO10993-14:2001
【标准号】:DINENISO10993-14-2002
【标准状态】:作废
【国别】:德国
【发布日期】:2002-05
【实施或试行日期】:
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:医疗设备;分解产物;生物试验;分解;陶瓷;变坏;试验;量化;识别;生物测定;医疗产品;评定;定义
【英文主题词】:Bioassay;Biologicaltests;Ceramics;Decomposition;Decompositionproducts;Definitions;Degradability;Deterioration;Evaluations;Identification;Medicaldevices;Medicalequipment;Medicalproducts;Quantification;Testing
【摘要】:ThispartofISO10993specifiestwomethodsofobtainingsolutionsofdegradationproductsfromceramics(includingglasses)forthepurposesofquantification.Italsogivesguidanceontheanalysisofthesesolutionsinordertoidentifythedegradationproducts.BecauseofthegeneralizednatureofthispartofISO10993,productspecificstandards,whenavailable,thataddressdegradationproductformationundermorerelevantconditionsofuse,shouldbeconsideredfirst.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:20P;A4
【正文语种】:德语