China National Standards

China Sterilization Industry Standards English PDF List


  •  China "Sterilization" Industry Standards English PDF List:
  • Standard  Code Standard Title Standard Class Order
    YY/T 1268-2015 Product Addition and Process Equivalence for Ethylene Oxide Sterilization {译}
    环氧乙烷灭菌的产品追加和过程等效
    China Pharmaceutics Industry Standards
    Sterilization

    English PDF
    YY/T 1302.2—2015 Physical and microbiological performance requirements for ethylene oxide Sterilization - Part 2: Microbiological requirements {译}
    环氧乙烷灭菌的物理和微生物性能要求 第2部分:微生物要求
    China Pharmaceutics Industry Standards
    Sterilization

    English PDF
    YY/T 1302.1—2015 Physical and microbiological performance requirements for ethylene oxide Sterilization - Part 1: Physical requirements {译}
    环氧乙烷灭菌的物理和微生物性能要求 第1部分:物理要求
    China Pharmaceutics Industry Standards
    Sterilization

    English PDF
    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

    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

    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

    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

    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

    English PDF
    YY/T 1268-2023 Product Addition and Process Equivalence for Ethylene Oxide Sterilization {译}
    环氧乙烷灭菌的产品追加和过程等效
    China Pharmaceutics Industry Standards
    Sterilization

    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

    English PDF
    JB/T 14397-2022 Food machinery Hydrostatic pressure Sterilization equipment {译}
    食品机械 静水压杀菌设备
    China Machinery Industry Standards
    Sterilization

    English PDF
    YY/T 1464-2022 Sterilization of healthcare products - Low temperature steam formaldehyde - Requirements for the development, validation and routine control of medical device sterilization processes {译}
    医疗保健产品灭菌 低温蒸汽甲醛 医疗器械灭菌过程的开发、确认和常规控制要求
    China Pharmaceutics Industry Standards
    Sterilization

    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

    English PDF
    HJ 1190-2021 Water quality - Identification of Sterilization biological indicators (Bacillus subtilis black var.) - Biological detection method{译} {译}
    水质 灭菌生物指示物(枯草芽孢杆菌黑色变种)的鉴定 生物学检测法
    China Environment Industry Standards
    Sterilization

    English PDF
    HG/T 5958-2021 Technical Specification for Sterilization and Disinfection of Industrial Waste (Sewage) Water {译}
    工业废(污)水杀菌消毒处理技术规范
    China Chemistry Industry Standards
    Sterilization

    English PDF
    JB/T20007.3-2021 Oral liquid glass bottle tunnel Sterilization dryer {译}
    口服液玻璃瓶隧道式灭菌干燥机
    China Machinery Industry Standards
    Sterilization

    English PDF
    HJ 276-2021 Technical specification for high temperature steam Sterilization and centralized treatment of medical waste{译} {译}
    医疗废物高温蒸汽消毒集中处理工程技术规范
    China Environment Industry Standards
    Sterilization

    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

    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

    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

    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

    English PDF
    YY/T 1463-2016 (Medical device Sterilization and microbial challenge to confirm the selection of site contamination Guide)
    医疗器械灭菌确认选择微生物挑战和染菌部位的指南
    China Medicine & Medical Device Standards
    Sterilization

    English PDF
    SN/T 4415-2015 (Export food thermal processing equipment Sterilization UHT sterilization machine inspection regulations)
    出口食品热加工设备杀菌检验规程 uht杀菌机
    China Import Export Inspection Standards
    Sterilization

    English PDF
    SN/T 4414.1-2015 (Export food thermal processing equipment for the inspection of heat distribution - Part 1: steam Sterilization pot)
    出口食品热加工设备热分布检验规程 第1部分:蒸汽杀菌锅
    China Import Export Inspection Standards
    Sterilization

    English PDF
    YY/T 1302.2-2015 Physical requirements and microbiological performance of ethylene oxide Sterilization. Part 2: Microbiological aspects
    环氧乙烷灭菌的物理和微生物性能要求 第2部分:微生物要求
    China Medicine & Medical Device Standards
    Sterilization

    English PDF
    YY/T 1302.1-2015 (Physical and microbiological properties of ethylene oxide Sterilization requirements - Part 1: Physical Requirements)
    环氧乙烷灭菌的物理和微生物性能要求 第1部分:物理要求
    China Medicine & Medical Device Standards
    Sterilization

    English PDF
    YY/T 1268-2015 Product adoption and process equivalence for ethylene oxide Sterilization
    环氧乙烷灭菌的产品追加和过程等效
    China Medicine & Medical Device Standards
    Sterilization

    English PDF
    YY/T 1267-2015 Evaluation of materials of medical device subject to ethylene oxide Sterilization
    适用于环氧乙烷灭菌的医疗器械的材料评价
    China Medicine & Medical Device Standards
    Sterilization

    English PDF
    YY/T 1266-2015 Evaluation of materials of medical device subject to hydrogen peroxide Sterilization
    适用于过氧化氢灭菌的医疗器械的材料评价
    China Medicine & Medical Device Standards
    Sterilization

    English PDF
    YY/T 1265-2015 Evaluation of materials of medical device subject to moist heat Sterilization
    适用于湿热灭菌的医疗器械的材料评价
    China Medicine & Medical Device Standards
    Sterilization

    English PDF
    YY/T 1264-2015 Evaluation of materials of medical device subject to ozone Sterilization
    适用于臭氧灭菌的医疗器械的材料评价
    China Medicine & Medical Device Standards
    Sterilization

    English PDF
    YY/T 1263-2015 Evaluation of materials of medical device subject to dry heat Sterilization
    适用于干热灭菌的医疗器械的材料评价
    China Medicine & Medical Device Standards
    Sterilization

    English PDF
    YY/T 0884-2013 Evaluation of materials of health care product subject to radiation Sterilization
    适用于辐射灭菌的医疗保健产品的材料评价
    China Medicine & Medical Device Standards
    Sterilization

    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

    English PDF
    YY/T 0822-2011 Ethylene oxide liquefied gas for Sterilization
    灭菌用环氧乙烷液化气体
    China Medicine & Medical Device Standards
    Sterilization

    English PDF
    YY/T 0567.5-2011 Aseptic processing of health care products. Part 5: Sterilization in place
    医疗保健产品的无菌加工 第5部分:在线灭菌
    China Medicine & Medical Device Standards
    Sterilization

    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

    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

    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

    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

    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

    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

    English PDF
    SN/T 2100-2008 Rapid Determination of the commercial Sterilization in canned food
    罐头食出商业无菌快速检测方法
    China Import Export Inspection Standards
    Sterilization

    English PDF
    SN/T 2L00-2008 (Commercial Sterilization of canned food for rapid detection method)
    罐头食品商业无菌快速检测方法
    China Import Export Inspection Standards
    Sterilization

    English PDF

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