China Biological Evaluation Medical GB Standards List

China "Biological Evaluation Medical" GB Standards List:

Standard Code	Standard Title	Standard Class	Order
GB/T 16886.23-2023	Biological evaluation of medical devices Part 23: Stimulation test {译} 医疗器械生物学评价第23部分：刺激试验	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.12-2023	Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials {译} 医疗器械生物学评价第12部分：样品制备与参照材料	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.6-2022	Biological evaluation of medical devices Part 6: local response test after implantation {译} 医疗器械生物学评价第6部分：植入后局部反应试验	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.4-2022	Biological evaluation of medical devices - Part 4: selection of interaction test with blood {译} 医疗器械生物学评价第4部分：与血液相互作用试验选择	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.1-2022	Biological evaluation of medical devices Part 1: evaluation and testing in the process of risk management {译} 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	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.19-2022	Biological evaluation of medical devices - Part 19: Physicochemical, morphological and surface characterization of materials {译} 医疗器械生物学评价第19部分：材料物理化学、形态学和表面特性表征	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.18-2022	Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials in the risk management process {译} 医疗器械生物学评价第18部分：风险管理过程中医疗器械材料的化学表征	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.15-2022	Biological Evaluation of Medical Devices-Part 15: Qualitative and Quantitative Degradation Products of Metals and Alloys {译} 医疗器械生物学评价第15部分：金属与合金降解产物的定性与定量	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.9-2022	Biological evaluation of medical devices - Part 9: Qualitative and quantitative framework for potential degradation products {译} 医疗器械生物学评价第9部分：潜在降解产物的定性和定量框架	China National Standards Biological Evaluation Medical	English PDF
GB/Z 16886.22-2022	Biological Evaluation of Medical Devices Part 22: Guidelines for Nanomaterials {译} 医疗器械生物学评价第22部分：纳米材料指南	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.16-2021	Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables 医疗器械生物学评价第16部分：降解产物与可沥滤物毒代动力学研究设计	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.11-2021	Biological evaluation of medical devices—Part 11:Tests for systemic toxicity 医疗器械生物学评价第11部分：全身毒性试验	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.3-2019	Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity 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	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.10-2017	Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization 医疗器械生物学评价第10部分：刺激与皮肤致敏试验	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.12-2017	Biological evaluation of medical devices—Part 12:Sample preparation and reference materials 医疗器械生物学评价第12部分：样品制备与参照材料	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.5-2017	Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity 医疗器械生物学评价第5部分：体外细胞毒性试验	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.13-2017	Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices 医疗器械生物学评价第13部分：聚合物医疗器械降解产物的定性与定量	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.9-2017	Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products 医疗器械生物学评价第9部分：潜在降解产物的定性和定量框架	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.6-2015	Biological evaluation of medical devices—Part 6: Tests for local effects after implantation 医疗器械生物学评价第6部分：植入后局部反应试验	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.7-2015	Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals 医疗器械生物学评价第7部分：环氧乙烷灭菌残留量	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.20-2015	Biological evaluation of medical devices—Part 20: Principles and methods for immunotoxicology testing of medical devices 医疗器械生物学评价第20部分：医疗器械免疫毒理学试验原则和方法	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.16-2013	Biological evaluation of medical devices―Part 16: Toxicokinetic study design for degradation products and leachables 医疗器械生物学评价第16部分：降解产物与可沥滤物毒代动力学研究设计	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.2-2011	Biological evaluation of medical devices - Part 2: Animal welfare requirements 医疗器械生物学评价第2部分：动物福利要求	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.19-2011	Biological evaluation of medical devices - Part 19: Physico-chemical,morphological and topographical characterization of materials 医疗器械生物学评价第19部分：材料物理化学、形态学和表面特性表征	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.18-2011	Biological evaluation of medical devices - Part 18: Chemical characterization of materials 医疗器械生物学评价第18部分：材料化学表征	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.11-2011	Biological evaluation of medical devices - Part 11: Tests for systemic toxicity 医疗器械生物学评价第11部分：全身毒性试验	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.1-2011	Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process 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	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.3-2008	Biological evaluation of medical devices - Part 3: Tests for genotoxicity,carcinogenicity and reproductive toxicity 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	China National Standards Biological Evaluation Medical	English PDF
GB/T 16175-2008	Biological evaluation test methods for medical organic silicon materials 医用有机硅材料生物学评价试验方法	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.17-2005	Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances 医疗器械生物学评价第17部分：可沥滤物允许限量的建立	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.12-2005	Biological evaluation of medical devices-Part 12:Sample preparation and reference materials 医疗器械生物学评价第12部分:样品制备与参照样品	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.10-2005	Biological evaluation of medical devices-Part 10:Tests for irritation and delayed-type hypersensitivity 医疗器械生物学评价第10部分:刺激与迟发型超敏反应试验	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.5-2003	Biological evaluation ofmedical devices--Part 5: Test for in vitro cytotoxicity 医疗器械生物学评价第5部分: 体外细胞毒性试验	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.4-2003	Biological evaluation of medical devices--Part 4:Selection of tests for interactions with blood 医疗器械生物学评价第4部分: 与血液相互作用试验选择	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.15-2003	Biological evaluation of medical devices--Part 15:Identification and quantification of degradation products from metals and alloys 医疗器械生物学评价第15部分:金属与合金降解产物的定性与定量	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.14-2003	Biological evaluation of medical devices--Part 14:Identification and quantification of degradation products from ceramics 医疗器械生物学评价第14部分:陶瓷降解产物的定性与定量	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.9-2001	Biological evaluation of medical devices--Part 9:Framework for identification and quantification of potential degradation product 医疗器械生物学评价第9部分:潜在降解产物的定性和定量框架	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.7-2001	Biological evaluation of medical devices--Part 7:Ethylene oxide sterilization residuals 医疗器械生物学评价第7部分:环氧乙烷灭菌残留量	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.13-2001	Biological evaluation of medical devices--Part 13:Identification and quantification of degradation products from polymeric medical devices 医疗器械生物学评价第13部分:聚合物医疗器械的降解产物的定性与定量	China National Standards Biological Evaluation Medical	English PDF
GB/T 16886.6-1997	Biological evaluation of medical devices--Part 6:Tests for local effects after implantation 医疗器械生物学评价第6部分:植入后局部反应试验	China National Standards Biological Evaluation Medical	English PDF

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