“Medical devices--Val” 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 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 19973.2-2018 醫療器械的滅菌 微生物學方法 第2部分:用於滅菌過程的定義、確認和維護的無菌試驗(中英文版) Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition,validation and maintenance of a sterilization process |
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GB/T 19974-2018 醫療保健產品滅菌 滅菌因數的特性及醫療器械滅菌過程的開發、確認和常規控制的通用要求(中英文版) Sterilization of health care products—General requirement for characterization of a sterilization agent and the development,validation and routine control of a sterilization process for medical devices |
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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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YY/T 1276-2016 醫療器械幹熱滅菌過程的開發、確認和常規控制要求(中英文版) (Development of medical devices dry heat sterilization process, validation and routine control) |
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YY/T 1441-2016 體外診斷醫療器械性能評估通用要求(中英文版) (Performance evaluation of in vitro diagnostic medical devices General requirements) |
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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 1464-2016 醫療器械滅菌低溫蒸汽甲醛滅菌過程的開發、確認和常規控制要求(中英文版) (Development of medical devices - Low temperature steam sterilization formaldehyde sterilization process, validation and routine control) |
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YY/T 1465.1-2016 醫療器械免疫原性評價方法 第1部分:體外t淋巴細胞轉化試驗(中英文版) (Evaluation of immunological methods of medical devices - Part 1 in vitro T lymphocyte transformation test) |
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YY/T 1465.2-2016 醫療器械免疫原性評價方法第2部分血清免疫球蛋白和補體成分測定elisa法(中英文版) (Evaluation of immunological methods of medical devices - Part 2 serum immunoglobulins and complement components by ELISA) |
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GB 18280.1-2015 醫療保健產品滅菌 輻射 第1部分:醫療器械滅菌過程的開發、確認和常規控制要求(中英文版) Sterilization of health care products—Radiation—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices |
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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 18279.1-2015 醫療保健產品滅菌 環氧乙烷 第1部分:醫療器械滅菌過程的開發、確認和常規控制的要求(中英文版) Sterilization of health care products—Ethylene oxide—Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices |
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