“Biological evaluatio” 中國GB標準檢索結果 |
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GB/T 16886.11-2021 醫療器械生物學評價 第11部分:全身毒性試驗(中英文版) Biological evaluation of medical devices—Part 11:Tests for systemic toxicity |
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GB/T 16886.16-2021 醫療器械生物學評價 第16部分:降解產物與可瀝濾物毒代動力學研究設計(中英文版) Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables |
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GB/T 39029-2020 生物產品去除重金屬功效評價技術規範(中英文版) Technical specification of efficacy evaluation for removing of heavy metal by biological products |
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GB/T 38793-2020 生物產品降解雜環類農藥功效評價技術規範(中英文版) Technical specification of efficacy evaluation for degradation of heterocyclic pesticides by biological products |
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GB/T 16886.3-2019 醫療器械生物學評價 第3部分:遺傳毒性、致癌性和生殖毒性試驗(中英文版) Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
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GB/T 27420-2018 合格評定 生物樣本測量不確定度評定與表示應用指南(中英文版) Conformity assessment—Application guide for evaluation and expression of uncertainty in biological sample measurement |
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GB/T 16886.10-2017 醫療器械生物學評價 第10部分:刺激與皮膚致敏試驗(中英文版) Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization |
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GB/T 16886.5-2017 醫療器械生物學評價 第5部分:體外細胞毒性試驗(中英文版) Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity |
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GB/T 16886.12-2017 醫療器械生物學評價 第12部分:樣品製備與參照材料(中英文版) Biological evaluation of medical devices—Part 12:Sample preparation and reference materials |
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GB/T 16886.13-2017 醫療器械生物學評價 第13部分:聚合物醫療器械降解產物的定性與定量(中英文版) Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices |
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GB/T 16886.9-2017 醫療器械生物學評價 第9部分:潛在降解產物的定性和定量框架(中英文版) Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products |
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GB/T 33420-2016 壓力蒸汽滅菌生物指示物檢驗方法(中英文版) Evaluation standard of biological for moist heat sterilization processes |
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YY/T 0127.18-2016 口腔醫療器械生物學評價 第18部分:牙本質屏障細胞毒性試驗(中英文版) (Oral Biological evaluation of medical devices - Part 18: dentin barrier Cytotoxicity test) |
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YY/T 0616.1-2016 一次性使用醫用手套 第1部分:生物學評價要求與試驗(中英文版) (Disposable medical gloves - Part 1: Requirements and test biological evaluation) |
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GB/T 16886.7-2015 醫療器械生物學評價 第7部分:環氧乙烷滅菌殘留量(中英文版) Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals |
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GB/T 16886.20-2015 醫療器械生物學評價 第20部分:醫療器械免疫毒理學試驗原則和方法(中英文版) Biological evaluation of medical devices—Part 20: Principles and methods for immunotoxicology testing of medical devices |
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GB/T 16886.6-2015 醫療器械生物學評價 第6部分:植入後局部反應試驗(中英文版) Biological evaluation of medical devices—Part 6: Tests for local effects after implantation |
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YY/T 1295-2015 醫療器械生物學評價 納米材料:細菌內毒素試驗(中英文版) Biological evaluation of medical devices. Nanomaterial: Endotoxin test |
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YY/T 0993-2015 醫療器械生物學評價 納米材料:體外細胞毒性試驗(mtt試驗和ldh試驗(中英文版) Biological evaluation of medical devices. Nanomaterial: In vitro cytotoxicity tests (MTT assay and LDH assay) |
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YY/T 0127.17-2014 口腔醫療器械生物學評價 第17部分:小鼠淋巴瘤細胞(TK)基因突變試驗(中英文版) Biological evaluation of medical devices used in dentistry. Part 17: Mouse lymphoma cells (TK) gene mutation test |
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