YY/T 0698.6-2009 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菌屏障系统生产用纸 要求和试验方法
Packaging materials for terminally sterilized medical devices-Part 6: Requirements and test methods for paper used in the production of sterile barrier systems for low-temperature sterilization processes or radiation sterilization
BS EN 866-4:2000 用于测试灭菌器和灭菌过程的生物系统 第 4 部分：用于辐照灭菌器的特殊系统
Biological systems for testing sterilizers and sterilization processes - Part 4: Particular systems for use in irradiation sterilizers
YY/T 0698.7-2009 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
YY/T 0698的本部分提供了用符合YY/T 0698.6的纸生产的可密封涂胶纸的要求和试验方法。 该包装材料用作对最终采用环氧乙烷或辐射灭菌的医疗器械包装。 本部分未对ISO 11607-1的通用要求增加要求，只是在ISO 11607-1、相关国家标准的基础上对各要素提供指南。因此，4.2
Packing 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
ISO/TS 13409:2002 医用产品灭菌.辐射灭菌.小或稀少产品系列用灭菌计量25kGy的验证
This Technical Specification describes a method of substantiating the suitability of 25 kGy as a sterilization dose for radiation sterilization
Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
EN 866-5:1999 用于测试灭菌器和灭菌过程的生物系统 第5部分：用于低温蒸汽和甲醛灭菌器的特殊系统
Biological Systems for Testing Sterilizers and Sterilization Processes - Part 5: Particular Systems for Use in Low Temperature Steam and Formaldehyde Sterilizers
BS EN 866-5:2000 用于测试灭菌器和灭菌过程的生物系统 第 5 部分：用于低温蒸汽和甲醛灭菌器的特殊系统
Biological systems for testing sterilizers and sterilization processes - Part 5: Particular systems for use in low temperature steam and formaldehyde sterilizers
ISO/TR 15844:1998 医疗保健产品灭菌 辐射灭菌 单个生产批用灭菌剂量的选择
This Technical Report describes a method of selecting a sterilization dose to be used for radiation sterilization of a single production batch
Sterilization of health care products - Radiation sterilization - Selection of sterilization dose for a single production batch
DIN 58953-6:2016-12 灭菌 菌供应 第6部分：待灭菌医疗器械包装材料的微生物屏障测试
Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
DIN 58953-6:2023-04 灭菌 菌供应 第6部分：待灭菌医疗器械包装材料的微生物屏障测试
Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized / Note: Date of issue 2023-03-17*Intended as replacement for DIN 58953-6 (2016-12).
DIN 58953-6:2023-11 灭菌 菌供应 第 6 部分：待灭菌医疗器械包装材料的微生物屏障测试
Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
EN 866-3:1997 用于测试灭菌器和灭菌过程的生物系统 第3部分：用于湿热灭菌器的特殊系统
Biological Systems for Testing Sterilizers and Sterilization Processes - Part 3: Particular Systems for Use in Moist Heat Sterilizers
EN 866-6:1999 用于测试灭菌器和灭菌过程的生物系统 第6部分：用于干热灭菌器的特殊系统
Biological Systems for Testing Sterilizers and Sterilization Processes - Part 6: Particular Systems for Use in Dry Heat Sterilizers
DIN 58952-2:2012-04 灭菌 菌屏障系统的运输篮 第2部分：金属制成的灭菌篮
Sterilization - Transport baskets for sterile barrier systems - Part 2: Sterilizing baskets made of metal
UNE 111-725-1989 灭菌．用于包装袋和试管制造的灭菌纸
Esta norma tiene por objeto describir las especificaciones que debe reunir el papel para esterilizar una sola vez, destinado a la fabricación de
EN 866-2:1997 用于测试灭菌器和灭菌过程的生物系统 第2部分：用于环氧乙烷灭菌器的特定系统
Biological Systems for Testing Sterilizers and Sterilization Processes - Part 2: Particular Systems for Use in Ethylene Oxide Sterilizers
YY/T 0698.6-2009 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菌屏障系统生产用纸 要求和试验方法
Packaging materials for terminally sterilized medical devices-Part 6: Requirements and test methods for paper used in the production of sterile barrier systems for low-temperature sterilization processes or radiation sterilization
BS EN 866-4:2000 用于测试灭菌器和灭菌过程的生物系统 第 4 部分：用于辐照灭菌器的特殊系统
Biological systems for testing sterilizers and sterilization processes - Part 4: Particular systems for use in irradiation sterilizers
YY/T 0698.7-2009 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
YY/T 0698的本部分提供了用符合YY/T 0698.6的纸生产的可密封涂胶纸的要求和试验方法。 该包装材料用作对最终采用环氧乙烷或辐射灭菌的医疗器械包装。 本部分未对ISO 11607-1的通用要求增加要求，只是在ISO 11607-1、相关国家标准的基础上对各要素提供指南。因此，4.2
Packing 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
ISO/TS 13409:2002 医用产品灭菌.辐射灭菌.小或稀少产品系列用灭菌计量25kGy的验证
This Technical Specification describes a method of substantiating the suitability of 25 kGy as a sterilization dose for radiation sterilization
Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
EN 866-5:1999 用于测试灭菌器和灭菌过程的生物系统 第5部分：用于低温蒸汽和甲醛灭菌器的特殊系统
Biological Systems for Testing Sterilizers and Sterilization Processes - Part 5: Particular Systems for Use in Low Temperature Steam and Formaldehyde Sterilizers
BS EN 866-5:2000 用于测试灭菌器和灭菌过程的生物系统 第 5 部分：用于低温蒸汽和甲醛灭菌器的特殊系统
Biological systems for testing sterilizers and sterilization processes - Part 5: Particular systems for use in low temperature steam and formaldehyde sterilizers
ISO/TR 15844:1998 医疗保健产品灭菌 辐射灭菌 单个生产批用灭菌剂量的选择
This Technical Report describes a method of selecting a sterilization dose to be used for radiation sterilization of a single production batch
Sterilization of health care products - Radiation sterilization - Selection of sterilization dose for a single production batch
DIN 58953-6:2023-04 灭菌 菌供应 第6部分：待灭菌医疗器械包装材料的微生物屏障测试
Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized / Note: Date of issue 2023-03-17*Intended as replacement for DIN 58953-6 (2016-12).
DIN 58953-6:2016-12 灭菌 菌供应 第6部分：待灭菌医疗器械包装材料的微生物屏障测试
Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
DIN 58953-6:2023-11 灭菌 菌供应 第 6 部分：待灭菌医疗器械包装材料的微生物屏障测试
Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
EN 866-3:1997 用于测试灭菌器和灭菌过程的生物系统 第3部分：用于湿热灭菌器的特殊系统
Biological Systems for Testing Sterilizers and Sterilization Processes - Part 3: Particular Systems for Use in Moist Heat Sterilizers
EN 866-6:1999 用于测试灭菌器和灭菌过程的生物系统 第6部分：用于干热灭菌器的特殊系统
Biological Systems for Testing Sterilizers and Sterilization Processes - Part 6: Particular Systems for Use in Dry Heat Sterilizers
DIN 58952-2:2012-04 灭菌 菌屏障系统的运输篮 第2部分：金属制成的灭菌篮
Sterilization - Transport baskets for sterile barrier systems - Part 2: Sterilizing baskets made of metal
UNE 111-725-1989 灭菌．用于包装袋和试管制造的灭菌纸
Esta norma tiene por objeto describir las especificaciones que debe reunir el papel para esterilizar una sola vez, destinado a la fabricación de
EN 866-2:1997 用于测试灭菌器和灭菌过程的生物系统 第2部分：用于环氧乙烷灭菌器的特定系统
Biological Systems for Testing Sterilizers and Sterilization Processes - Part 2: Particular Systems for Use in Ethylene Oxide Sterilizers
编辑：北检院编辑部
