iso医疗器械生物学评价.pdf

医疗器械生物学评价 第1部分：评价与试验 GB/T 16886 .1 —2001 idt ISO 10993-1 ：1997 李芳 Tel:分机413 msn: xiaofuren3@ Biological evaluation of medical devices ISO 10993 consists of the following parts, under the general title Biological evaluation of medical devices: ISO 10993 的总题目是医疗器械生物学评价，由下列部分组成: —Part 1: Evaluation and testing 第1部分：评价与试验 —Part 2: Animal welfare requirements 第2部分：动物保护要求 —Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity 第3部分；遗传毒性、致癌性和生殖毒性试验 —Part 4: Selection of tests for interactions with blood 第4部分：与血液相互作用试验选择 —Part 5: Tests for cytotoxicity: in vitro methods 第5部分：细胞毒性试验：体外法 —Part 6: Tests for local effects after implantation 第6部分：植入后局部反应试验 —Part 7: Ethylene oxide sterilization residuals 第7部分：环氧乙烷灭菌残留量 —Part 9: Framework for the identification and quantification of potential degradation products 第9部分：潜在降解产物定性与定量框架 —Part 10: Tests for irritation and sensitization 第10部分：刺激与致敏试验 —Part 11: Tests for systemic toxicity 第11部分：全身毒性试验 —Part 12 : Sample preparation and reference materials 第12部分：样品制备与参照样品 —Part 13: Identification and quantification of degradation products from polymers 第13部分：聚合物医疗器械的降解产物的定性与定量 —Part 14: Identification and quantification of degradation products from ceramics 第14部分：陶瓷降解产物定性与定量 —Part 15: Identification and quantification of degradation products from metals and alloys 第15部分：金属与合金降解产物定性与定量 —Part 16: Toxicokinetic study design for degradation products and leachables 第16部分：降解产物与可沥滤物毒性动力学研究设计 — Part 17: Establishment of allowable limits for leachable substances 第17部分：可沥滤物允许限量的建立 — Part 18: Chemical characterization of materials — Part 19: Physico-chemical, morphological and topographical characterization of materials — Part 20: Principles and methodsfor immunotoxicology testing of medical