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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
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
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
This Part of EN 866 specifies requirements for inoculated carriers and biological indicators intended for use in assessing the performance
Biological systems for testing sterilizers and sterilization processes - Particular systems for use in ethylene oxide sterilizers
ISO 11137-2:2006 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate
Sterilization of health care products - Radiation - Establishing the sterilization dose
1.1 GB/T 19973的本部分规定了医疗器械在经过低于所规定的灭菌剂量作用后，对其进行菌试验的一般要求。这些试验适用于对灭菌过程的确认。 1.2 本部分不适用于： a） 已经过灭菌的日常销售产品的菌试验； b） 药典菌试验； c） 生物指示物
Sterilization of medical devices.Microbiological methods.Part 2: Tests of sterility performed in the validation of a sterilization process
Esta norma tiene por objeto describir las especificaciones que debe reunir el papel para esterilizar una sola vez, destinado a la fabricación de
Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
이 표준에서는 저온증기와 포름알데히드를 멸균제로 사용하는 멸균법을 평가하기 위한 시험 미생
Sterilization of health care products－Biological indicators－Part 5：Biological indicators for low-temperature steam and formaldehyde sterilization processes
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
Sterilization of health care products — Biological indicators —Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
GB 18280的本部分规定了用于满足菌特殊要求的最小剂量的设定方法和证实25 kGy或15 kGy作为能达到10-6菌保证水平(SAL)的灭菌剂量的方法。本部分还规定了剂量审核的方法，以便证明灭菌剂量持续有效。 本部分定义了用于剂量建立和剂量审核的产品族
Sterilization of health care products.Radiation.Part 2: Establishing the sterilization dose
Sterilization of health care products — Radiation —Part 2: Establishing the sterilization dose
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
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
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
This Part of EN 866 specifies requirements for inoculated carriers and biological indicators intended for use in assessing the performance
Biological systems for testing sterilizers and sterilization processes - Particular systems for use in ethylene oxide sterilizers
ISO 11137-2:2006 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate
Sterilization of health care products - Radiation - Establishing the sterilization dose
1.1 GB/T 19973的本部分规定了医疗器械在经过低于所规定的灭菌剂量作用后，对其进行菌试验的一般要求。这些试验适用于对灭菌过程的确认。 1.2 本部分不适用于： a） 已经过灭菌的日常销售产品的菌试验； b） 药典菌试验； c） 生物指示物
Sterilization of medical devices.Microbiological methods.Part 2: Tests of sterility performed in the validation of a sterilization process
Esta norma tiene por objeto describir las especificaciones que debe reunir el papel para esterilizar una sola vez, destinado a la fabricación de
Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
이 표준에서는 저온증기와 포름알데히드를 멸균제로 사용하는 멸균법을 평가하기 위한 시험 미생
Sterilization of health care products－Biological indicators－Part 5：Biological indicators for low-temperature steam and formaldehyde sterilization processes
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
Sterilization of health care products — Biological indicators —Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
GB 18280的本部分规定了用于满足菌特殊要求的最小剂量的设定方法和证实25 kGy或15 kGy作为能达到10-6菌保证水平(SAL)的灭菌剂量的方法。本部分还规定了剂量审核的方法，以便证明灭菌剂量持续有效。 本部分定义了用于剂量建立和剂量审核的产品族
Sterilization of health care products.Radiation.Part 2: Establishing the sterilization dose
Sterilization of health care products — Radiation —Part 2: Establishing the sterilization dose
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