ISO 10993-13:2010 医疗器械的生物学评价.第13部分:聚合物医疗器械降解产物的鉴定与定量 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices 点击打开全屏PDF预览
医疗装置的生物学评定.第13部分:聚合物医疗设备产生的降解物的识别和量化, Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymer
ISO1099313WASPREPAREDBYTECHNICALCOMMITTEEISO/TC194,BIOLOGICALEVALUATIONOFMEDICALDEVICESTHISSECONDEDITIONCANCELSANDREPLACESTHEFIRSTEDITIONISO10993131998,WHICHHASBEENTECHNICALLYREVISEDISO10993CONSISTSOFTHEFOLLOWINGPARTS,UNDERTHEGENERALTITLEBIOLOGICALEVALUATIONOFMEDICALDEVICESPART1EVALUATIONANDTESTINGWITHINARISKMANAGEMENTPROCESSPART...
EN ISO 10993-1:2009/AC:2010 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) EN ISO 10993-3:2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (...
Part3:Testsforgenotoxicity,carcinogenicityandreproductivetoxicity医疗器械生物学评价第3部分:遗传毒性、致癌性和生殖毒性试验(中英文版)2024年03月翻译ReferencenumberISO10993-3:2014(E)PAGE:1©ISO2014–AllrightsreservedISO10993-3:2014(E)中英文版目录Foreword前言4...
Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devicesdoi:BS 08/30156451 DC交叉引用:ISO 3696:1987ISO 10993-1ISO 10993-9ISO 10993-12:1996ISO 10993-16ISO 10993-17ISO 13781:1997ISO 10993-6ISO 14971...
Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices ISO 10993-14:2001 陶瓷降解产物定性与定量分析 Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics ...
ISO10993-13,医疗器械的生物评价—第13部分:聚合物医疗器械降解产物的识别和定量 ISO10993-14,Biologicalevaluationofmedicaldevices—Part14:Identificationandquantificationof degradationproductsfromceramics ISO10993-14,医疗器械的生物评价—第14部分:陶瓷降解产物的识别和定量 ISO10993-15,Biologicalevaluationofmedicaldevices...
生物相容性参考标准-iso10993.pdf,2016生醫產業商品化人才培訓系列課程 10993 陳佳君 研究助理教授 國立台北科技大學 化學工程與生物科技系所 105.09.26 醫療器材 (Medical Device) 藥事法第4條:本法所稱之藥物,係指藥品及醫療器材 藥事法第13條: 醫療器材係用於診斷 、
GB/T —×××/ISO 10993-1:2009 代替GB/T -2001 医疗器械生物学评价 第 1 部分:风险管 理过程中的评价与试验 Biological evaluation of medical devices— Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009,IDT) (报批...