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灭菌包裹材料-用于低温灭菌过程或辐射灭菌的无菌屏障系统生产用纸检测

发布时间:2024-05-27 17:49:26 - 更新时间:2024年06月29日 15:22

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军工检测 其他检测

YY/T 0698.6-2009 最终医疗器械 第6部分: 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 测试器和 第 4 部分:特殊

Biological systems for testing sterilizers and sterilization processes - Part 4: Particular systems for use in irradiation sterilizers

YY/T 0698.7-2009 最终医疗器械.第7部分:环氧乙烷可密封涂胶.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..小稀少计量25kGy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 测试器和 第5部分:蒸汽和甲醛特殊

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 测试器和 第 5 部分:蒸汽和甲醛特殊

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 单个剂量选择

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 供应 第6部分:待医疗器械测试

Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized

DIN 58953-6:2023-04 供应 第6部分:待医疗器械测试

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 供应 第 6 部分:待医疗器械测试

Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized

EN 866-3:1997 测试器和 第3部分:湿热特殊

Biological Systems for Testing Sterilizers and Sterilization Processes - Part 3: Particular Systems for Use in Moist Heat Sterilizers

EN 866-6:1999 测试器和 第6部分:干热特殊

Biological Systems for Testing Sterilizers and Sterilization Processes - Part 6: Particular Systems for Use in Dry Heat Sterilizers

DIN 58952-2:2012-04 运输篮 第2部分:金属制成

Sterilization - Transport baskets for sterile barrier systems - Part 2: Sterilizing baskets made of metal

UNE 111-725-1989 装袋和试管制造

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 测试器和 第2部分:环氧乙烷特定

Biological Systems for Testing Sterilizers and Sterilization Processes - Part 2: Particular Systems for Use in Ethylene Oxide Sterilizers

YY/T 0698.6-2009 最终医疗器械 第6部分: 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 测试器和 第 4 部分:特殊

Biological systems for testing sterilizers and sterilization processes - Part 4: Particular systems for use in irradiation sterilizers

YY/T 0698.7-2009 最终医疗器械.第7部分:环氧乙烷可密封涂胶.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..小稀少计量25kGy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 测试器和 第5部分:蒸汽和甲醛特殊

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 测试器和 第 5 部分:蒸汽和甲醛特殊

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 单个剂量选择

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 供应 第6部分:待医疗器械测试

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 供应 第6部分:待医疗器械测试

Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized

DIN 58953-6:2023-11 供应 第 6 部分:待医疗器械测试

Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized

EN 866-3:1997 测试器和 第3部分:湿热特殊

Biological Systems for Testing Sterilizers and Sterilization Processes - Part 3: Particular Systems for Use in Moist Heat Sterilizers

EN 866-6:1999 测试器和 第6部分:干热特殊

Biological Systems for Testing Sterilizers and Sterilization Processes - Part 6: Particular Systems for Use in Dry Heat Sterilizers

DIN 58952-2:2012-04 运输篮 第2部分:金属制成

Sterilization - Transport baskets for sterile barrier systems - Part 2: Sterilizing baskets made of metal

UNE 111-725-1989 装袋和试管制造

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 测试器和 第2部分:环氧乙烷特定

Biological Systems for Testing Sterilizers and Sterilization Processes - Part 2: Particular Systems for Use in Ethylene Oxide Sterilizers

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