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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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YY/T 1402-2016 醫療器械蒸汽滅菌過程挑戰裝置適用性的測試方法(中英文版) (Medical devices steam sterilization process challenge device applicability of test methods) |
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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 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 1463-2016 醫療器械滅菌確認選擇微生物挑戰和染菌部位的指南(中英文版) (Medical device sterilization and microbial challenge to confirm the selection of site contamination Guide) |
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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 19973.1-2015 醫療器械的滅菌 微生物學方法 第1部分:產品上微生物總數的測定(中英文版) Sterilization of medical devices—Microbiological methods—Part 1: Determination of a population of microorganisms on products |
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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 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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GB 18278.1-2015 醫療保健產品滅菌 濕熱 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—Moist heat—Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
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YY/T 1264-2015 適用於臭氧滅菌的醫療器械的材料評價(中英文版) Evaluation of materials of medical device subject to ozone sterilization |
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YY/T 1266-2015 適用於過氧化氫滅菌的醫療器械的材料評價(中英文版) Evaluation of materials of medical device subject to hydrogen peroxide sterilization |
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YY/T 1265-2015 適用於濕熱滅菌的醫療器械的材料評價(中英文版) Evaluation of materials of medical device subject to moist heat sterilization |
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YY/T 1267-2015 適用於環氧乙烷滅菌的醫療器械的材料評價(中英文版) Evaluation of materials of medical device subject to ethylene oxide sterilization |
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YY/T 1263-2015 適用於幹熱滅菌的醫療器械的材料評價(中英文版) Evaluation of materials of medical device subject to dry heat sterilization |
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GB 16383-2014 醫療衛生用品輻射滅菌消毒品質控制(中英文版) Quality control for radiation sterilization of medical and hygienical products |
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YY 0970-2013 含動物源材料的一次性使用醫療器械的滅菌液體滅菌劑滅菌的確認與常規控制(中英文版) Sterilization of single- use medical devices incorporating materials of animal origin. Validation and routine control of sterilization by liquid sterilants |
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SN/T 3062.4-2011 進口醫療器械滅菌包裝 第4部分:材料和預成型無菌屏障系統要求(中英文版) Packaging materials for terminally sterilized medical devices for import. Part 4: Requirements for materials and sterile barrier systems of importing medical device sterilization packaging |
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YY/T 0802-2010 醫療器械的滅菌 製造商提供的處理可重複滅菌醫療器械的資訊(中英文版) Sterilization of medical devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices |
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