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GB/T 16886.23-2023 Biological evaluation of medical devices Part 23: Stimulation test 医疗器械生物学评价 第23部分：刺激试验 - 中英文版 |
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GB/T 16886.12-2023 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 - 中英文版 |
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GB/T 16886.6-2022 Biological evaluation of medical devices Part 6: local response test after implantation 医疗器械生物学评价 第6部分：植入后局部反应试验 - 中英文版 |
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GB/T 16886.4-2022 Biological evaluation of medical devices - Part 4: selection of interaction test 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 - 中英文版 |
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GB/T 16886.1-2022 Biological evaluation of medical devices Part 1: evaluation and testing in the process of risk management 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 - 中英文版 |
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GB/T 16886.19-2022 Biological evaluation of medical devices - Part 19: Physicochemical, morphological and surface 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 - 中英文版 |
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GB/T 16886.18-2022 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials in the risk management process 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 - 中英文版 |
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GB/T 16886.15-2022 Biological evaluation of Medical Devices-Part 15: Qualitative and Quantitative Degradation Products of 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 - 中英文版 |
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GB/T 16886.9-2022 Biological evaluation of medical devices - Part 9: Qualitative and quantitative framework for 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 - 中英文版 |
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GB/Z 16886.22-2022 Biological evaluation of Medical Devices Part 22: Guidelines for Nanomaterials 医疗器械生物学评价 第22部分：纳米材料指南 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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GB/T 39029-2020 Technical specification of efficacy evaluation for removing of heavy metal by biological products 生物产品去除重金属功效评价技术规范 - 中英文版 |
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GB/T 38793-2020 Technical specification of efficacy evaluation for degradation of heterocyclic pesticides by biological products 生物产品降解杂环类农药功效评价技术规范 - 中英文版 |
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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 - 中英文版 |
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GB/T 27420-2018 Conformity assessment—Application guide for evaluation and expression of uncertainty in biological sample measurement 合格评定 生物样本测量不确定度评定与表示应用指南 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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GB/T 33420-2016 Evaluation standard of biological for moist heat sterilization processes 压力蒸汽灭菌生物指示物检验方法 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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