China National Standards

China Sterilization medical devices Industry Standards English PDF List


  •  China "Sterilization medical devices" Industry Standards English PDF List:
  • Standard  Code Standard Title Standard Class Order
    YY/T 1267—2015 Evaluation of Materials for Medical Devices Suitable for Ethylene Oxide Sterilization {译}
    适用于环氧乙烷灭菌的医疗器械的材料评价
    China Pharmaceutics Industry Standards
    Sterilization medical devices

    English PDF
    YY/T 1266—2015 Evaluation of Materials for Medical Devices Suitable for Hydrogen Peroxide Sterilization {译}
    适用于过氧化氢灭菌的医疗器械的材料评价
    China Pharmaceutics Industry Standards
    Sterilization medical devices

    English PDF
    YY/T 1265—2015 Evaluation of Materials for Medical Devices Suitable for Moist Heat Sterilization {译}
    适用于湿热灭菌的医疗器械的材料评价
    China Pharmaceutics Industry Standards
    Sterilization medical devices

    English PDF
    YY/T 1264—2015 Material Evaluation of Medical Devices Suitable for Ozone Sterilization {译}
    适用于臭氧灭菌的医疗器械的材料评价
    China Pharmaceutics Industry Standards
    Sterilization medical devices

    English PDF
    YY/T 1263—2015 Evaluation of Materials for Medical Devices Suitable for Dry Heat Sterilization {译}
    适用于干热灭菌的医疗器械的材料评价
    China Pharmaceutics Industry Standards
    Sterilization medical devices

    English PDF
    YY 0970-2023 Sterilization of healthcare products - Liquid chemical sterilants for single-use medical devices of animal origin - Requirements for the characterization, development, validation and routine control of medical device sterilization processes {译}
    医疗保健产品灭菌 一次性使用动物源性医疗器械的液体化学灭菌剂 医疗器械灭菌过程的特征、开发、确认和常规控制的要求
    China Pharmaceutics Industry Standards
    Sterilization medical devices

    English PDF
    YY/T 0698.2-2022 Packaging materials for terminally sterilized medical devices - Part 2: Requirements and test methods for packaging materials for sterilization {译}
    最终灭菌医疗器械包装材料 第2部分:灭菌包裹材料 要求和试验方法
    China Pharmaceutics Industry Standards
    Sterilization medical devices

    English PDF
    YY/T 1733-2020 Radiation Sterilization of Medical Devices—Guidelines for Dose Distribution Testing of Irradiation Devices {译}
    医疗器械辐射灭菌 辐照装置剂量分布测试指南
    China Pharmaceutics Industry Standards
    Sterilization medical devices

    English PDF
    YY/T 1402-2016 (Medical devices steam sterilization process challenge device applicability of test methods)
    医疗器械蒸汽灭菌过程挑战装置适用性的测试方法
    China Medicine & Medical Device Standards
    Sterilization medical devices

    English PDF
    YY/T 1276-2016 (Development of medical devices dry heat sterilization process, validation and routine control)
    医疗器械干热灭菌过程的开发、确认和常规控制要求
    China Medicine & Medical Device Standards
    Sterilization medical devices

    English PDF
    YY/T 1464-2016 (Development of medical devices - Low temperature steam sterilization formaldehyde sterilization process, validation and routine control)
    医疗器械灭菌低温蒸汽甲醛灭菌过程的开发、确认和常规控制要求
    China Medicine & Medical Device Standards
    Sterilization medical devices

    English PDF
    YY 0970-2013 Sterilization of single- use medical devices incorporating materials of animal origin. Validation and routine control of sterilization by liquid sterilants
    含动物源材料的一次性使用医疗器械的灭菌液体灭菌剂灭菌的确认与常规控制
    China Medicine & Medical Device Standards
    Sterilization medical devices

    English PDF
    SN/T 3062.4-2011 Packaging materials for terminally sterilized medical devices for import. Part 4: Requirements for materials and sterile barrier systems of importing medical device sterilization packaging
    进口医疗器械灭菌包装 第4部分:材料和预成型无菌屏障系统要求
    China Import Export Inspection Standards
    Sterilization medical devices

    English PDF
    YY/T 0802-2010 Sterilization of medical devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices
    医疗器械的灭菌 制造商提供的处理可重复灭菌医疗器械的信息
    China Medicine & Medical Device Standards
    Sterilization medical devices

    English PDF
    YY/T 0698.7-2009 Packaging materials for terminal sterilized medical devices. Part 7: Adhesive coated paper for the manufacture of sealable packs for medical use for sterilization by ethylene oxide or irradiation. Requirements and test methods
    最终灭菌医疗器械包装材料 第7部分:环氧乙烷或辐射灭菌屏障系统生产用可密封涂胶纸 要求和试验方法
    China Medicine & Medical Device Standards
    Sterilization medical devices

    English PDF
    YY/T 0698.8-2009 Packaging materials for terminally sterilized medical devices. Part 8: Re-usable sterilization containers for team sterilizers. Requirements and test methods
    最终灭菌医疗器械包装材料 第8部分:蒸汽灭菌器用重复性使用灭菌容器 要求和试验方法
    China Medicine & Medical Device Standards
    Sterilization medical devices

    English PDF
    YY/T 0698.6-2009 Packaging materials for terminal sterilized medical devices. Part 6: Paper for manufacture of sterile barrier systems intended for sterilization by low temperature sterilization processes or irradiation. Requirements and test methods
    最终灭菌医疗器械包装材料 第6部分:用于低温灭菌过程或辐射灭菌的无菌屏障系统生产用纸 要求和试验方法
    China Medicine & Medical Device Standards
    Sterilization medical devices

    English PDF
    YY/T 0698.2-2009 Packaging materials for terminal sterilized medical devices. Part 2: Sterilization wrap. Requirements and test methods
    最终灭菌医疗器械包装材料 第2部分:灭菌包裹材料 要求和试验方法
    China Medicine & Medical Device Standards
    Sterilization medical devices

    English PDF

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