无源医疗器械的生物学检测

无源医疗器械的生物学ISO10993测试当中，包含共17条测试标准

生物相容性分类分别为细胞毒性，刺激及皮肤致敏，材料介入导致热源，急性全身毒性，亚急性毒性，亚慢性毒性，慢性毒性，植入效果，血液相容性，基因毒性，致癌性，生殖与发育毒性等......

我们应先判定器械的种类，接触部位，接触时间，判定如何选择测试标准

测试标准如下：

ISO 10993-2:2006, Biological evaluation of medical devices — Part 2: Animal welfare requirements

ISO 10993-3, Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

ISO 10993-4, Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood

ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

ISO 10993-6, Biological evaluation of medical devices — Part 6: Tests for local effects after implantation

ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

ISO 10993-9, Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products

ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization

ISO 10993-11:2017, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity

ISO 10993-12, Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

ISO 10993-13, Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices

ISO 10993-14, Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics

ISO 10993-15, Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys

ISO 10993-16, Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables

ISO 10993-17, Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances

ISO 10993-18, Biological evaluation of medical devices — Part 18: Chemical characterization of materials

ISO/TS 10993-20, Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices

判定方式如下：

根据ISO 10993-1:2018(E)当中的Figure 1 — Summary of the systematic approach to a biological evaluation of medical devices as part of a risk management process

根据器械特点，判定流程走向

再结合Table A.1 — Endpoints to be addressed in a biological risk assessment

生物学进行综合评估，需要结合制造风险（ISO14971:2019）判定生产工艺流程，是否引入新的生物风险源

总结

生物学报告需要总结出两项内容

1，设备做的生物学检测，是否满足需求

2，制造风险是否有新的生物风险，并且得到控