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| 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 test |
 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 test |
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 test |
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 test |
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 test |
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 test |
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 test |
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 test |
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 test |
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 test |
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 test |
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 test |
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 test |
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 test |
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 test |
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 test |
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 test |
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 test |
English PDF |
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