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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
本文件规定了湿热型灭菌器的术语和定义、性能（计时检查、温度传感器准确性、压力检查、热分布、热穿透、生物指示剂）的检测方法
Testing method for performance of moist heat sterilizer
Sterilization of health care products－Requirements for validation and routine control－Radiation sterilization
Sterilization of health care products－Requirements for validation and routine control－Radiation sterilization
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
이 표준은 멸균성에 대한 특정 요구사항을 달성하기 위해 필요한 최소선량을 결정하는 방법과2
Sterilization of health care products-Radiation-Part 2:Establishing the sterilization dose
Sterilization of health care products — Radiation —Part 2: Establishing the sterilization dose
Sterilization of health care products-Radiation-Part 2:Establishing the sterilization dose
Sterilization of medical devices. Validation and routine control of sterilization by irradiation.
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. Establishing the sterilization dose
本标准适用于保健产品辐射灭菌的确效规定、过程控制与例行监测。适用于使用钴60与铯137核种的加马连续型或批次型加马射线的产生装置，及适用于使用电子束或X射线等之辐射产生装置。补助资料参见附录。设施设计、执照核发、操作训练及辐射安全相关因素并非本标准适用范围。本
Sterilization of health care products-requirements for validation and routine control-radiation sterliization
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
Regulation for the radiation sterilization of goat skin for export
Medical products. Radiation sterilization. Dosimetric techniques
Sterilization of health care products.Radiation.Part 2: Establishing the sterilization dose
本标准规定了医疗保健产品在辐射灭菌中的确认、加工控制和常规监测的各种要求。它适用于应用放射性核素钴-60和铯-137的连续型和批量型的γ辐照装置，以及使用电子束或X射线发生器的辐照装置。 本标准的附录中还提供了补充参考资料。 装置的设计、取得许可证、操作人员培训和与辐射
Sterilization of health care products--Requirement for validation and routine control--Radiation sterilization
Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
Specifies requirements for validation, process control and routine monitoring in the radiation sterilization of health care products. Applies
Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
Establishes requirements and provides guidance for the selection of an appropriate Sterility Assurance Level (SAL) for terminally sterilized medical
Sterilization of Health Care Products - Requirements for products labeled "STERILE"
Sterilization of health care products. Radiation. Establishing the sterilization dose
Sterilization of health care products. Radiation. Establishing the sterilization dose
Sterilization of health care products. Radiation. Establishing the sterilization dose
Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
本标准规定了辖射灭菌使医疗保健产品达到10-6菌保证水平的选定的灭菌剂量的证实和剂量审核方法。 本标准适用于整个产品单元的平均生物负载符合选定剂量所要求的平均生物负载范围的医疗保健产品
Sterilization of health care products.Radiation.Substantiation of a selected sterilization dose method VDmax
本标准规定了药用干热灭菌器的分类和标记、要求、试验方法、检验规则,以及标志、使用说明书、包装、运输和储存。本标准适用于制药领域不宜湿热灭菌或除热原物品的药用干热灭菌器(以下简称灭菌器
Pharmaceutical dry heating sterilizer
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