EJ/T 1243-2017 医疗器械辐射灭菌 确认辐射灭菌剂量的生物负载数据分析方法
BS EN ISO 11137-2:2007 卫生保健品灭菌.辐射.确定灭菌剂量
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
T/CASME 325-2023 湿热型灭菌器性能检测方法
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
YY/T 1733-2020 医疗器械辐射灭菌 辐照装置剂量分布测试指南
KS P ISO 11137:2008 保健品灭菌验证和常规控制要求辐射灭菌
Sterilization of health care products－Requirements for validation and routine control－Radiation sterilization
KS P ISO 11137:2003 保健品灭菌验证和常规控制要求辐射灭菌
Sterilization of health care products－Requirements for validation and routine control－Radiation sterilization
YY/T 1607-2018 医疗器械辐射灭菌 剂量设定的方法
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
KS P ISO 11137-2:2008 保健·医疗灭菌.辐射.第2部分:灭菌剂量的选定
이 표준은 멸균성에 대한 특정 요구사항을 달성하기 위해 필요한 최소선량을 결정하는 방법과2
Sterilization of health care products-Radiation-Part 2:Establishing the sterilization dose
KS P ISO 11137-2:2020 保健产品的灭菌 - 辐射 - 第2部分:建立灭菌剂量
Sterilization of health care products — Radiation —Part 2: Establishing the sterilization dose
KS P ISO 11137-2:2014 保健·医疗灭菌 辐射 第2部分：灭菌剂量的选定
Sterilization of health care products-Radiation-Part 2:Establishing the sterilization dose
NF S98-103:1994 医疗器械的灭菌.辐射灭菌的确认和常规控制方法.要求(EN 552)
Sterilization of medical devices. Validation and routine control of sterilization by irradiation.
GB 18280.2-2015 医疗保健产品灭菌 辐射 第2部分:建立灭菌剂量
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
BS EN ISO 11137-2:2012 保健产品的灭菌.辐射.确定杀菌剂量
Sterilization of health care Products. Radiation. Establishing the sterilization dose
CNS 14709-2002 保健产品之灭菌－辐射灭菌确效与例行管制规定
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
YY/T 1608-2018 医疗器械辐射灭菌 验证剂量实验和灭菌剂量审核的抽样方法
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
SN/T 0677-1997 出口山羊板皮辐射灭菌规程
Regulation for the radiation sterilization of goat skin for export
GOST R 50325-2011 医疗产品.辐射灭菌.剂量技术
Medical products. Radiation sterilization. Dosimetric techniques
TCVN 7393-2-2009 医疗保健产品灭菌.辐射.第2部分:灭菌剂量的确定
Sterilization of health care products.Radiation.Part 2: Establishing the sterilization dose
GB 18280-2000 医疗保健产品灭菌 确认和常规控制要求 辐射灭菌
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
ISO 13004:2022 保健产品的灭菌.辐射.选定灭菌剂量的验证:方法VDmaxSD
Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
ISO 11137:1995 医疗保健产品灭菌 确认和常规控制要求 辐射灭菌
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
ANSI/AAMI ST 67-2003 保健产品的灭菌.验证和常规控制的要求.辐射灭菌
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"
BS EN ISO 11137-2:2015 保健产品的灭菌.辐射.杀菌剂量的确定
Sterilization of health care products. Radiation. Establishing the sterilization dose
BS EN ISO 11137-2:2013 保健产品的灭菌.辐射.杀菌剂量的确定
Sterilization of health care products. Radiation. Establishing the sterilization dose
BS EN ISO 11137-1:2015+A2:2019 保健产品的灭菌.辐射.杀菌剂量的确定
Sterilization of health care products. Radiation. Establishing the sterilization dose
ISO/TR 13409:1996 健康护理制品的灭菌.辐射灭菌.少量产品用25kGy灭菌剂量的实体化证明
Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
GB/T 31995-2015 医疗保健产品灭菌 辐射 证实选定的灭菌剂量 VDmax方法
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
JB/T 20163-2014 药用干热灭菌器
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
编辑：北检院编辑部
