iso10993-1医疗器械生物学评价[1].pdf

医疗器城生物学评价
第1部分:评价与试验
GB/T16886.1-200 idt ISO10993-1:1997
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Biological evaluation of medical devices
ISO 10993 consists of the following parts, under the general title
Biological evaluation of medical devices
ISO10993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
分:浮价与试验
Part 2 Animal welfare requirements
第2部分:动物炉要求
Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
第部分;遗传薄性、致瘺性和生殖毒试验
- Part 4. Selection oftests for interactions with blood
第4部分:与血液互作∥试验选择
Part 5: Tests for cytotoxicity in vitro methods
第5部分:细毒性验:体外法
Part 6: Tests for local effects after implantation
第6部分:入后局部反应试
-Part 7. Ethylene oxide sterilization residual
第7部分:环氧乙烷灭葛残留量
Part 9: Framework for the identification and quantification of potential
degradation products
第ρ部分:涔在降解产物定性与定量を架
- Part 10: Tests for irritation and sensitization
10部分:刻激与数数试验
Part 11: Tests for systemic toxicit
第I1部分:全身毒性试验
Part 12: Sample preparation and reference materials
第12部分:品制各与参照品
-Part 13: Identification and quantification of degradation products from
polymers
第3部分:発合物医器的降解物的定性与定量
-Part 14: Identification and quantification of degradation products from
ceramics
第4部分:瓷降解产物定性与定量
-Part 15: Identification and quantification of degradation products from
metals and allovs
第5部分:金属与合金降解照产物定性与定量
-Part 16: Toxicokineticstudy design for degradation products and
leachables
第6部分:降解产物与バ滤物毒性动力学仍究设
Part 17. Establishment of allowable limits for leachable substances
第17部分:可汤物か许限量的建立
Part 18: Chemical characterization of materials
Part 19: Physico-chemical, morphological and topographical
characterization of materials
Part 20: Principles and methods for immunotoxicology testing of
medical devices
Future parts will deal with other relevant aspects of biological testing
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