医疗器械生物学评价
第1部分：评价与试验
GB/T 16886 .1 —2001 idtISO 10993-1：1997
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Biological evaluationof medical devices
ISO 10993consists 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??
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—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??
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—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: Toxicokineticstudy 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 leachablesubstances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 methods for immunotoxicologytesting of medical devicesFuture parts will deal with other relevant aspects of biologicaltesting.有关其他方面的生物试验将有其他部分的标准。??
主要内容
1 范围2 定义3 医疗器械生物学评价基本原则4 医疗器械分类5 试验6 生物学评价试验选择7 试验方法保证
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