ISO 11137-1:20 06规定了医疗器械辐射灭菌工艺的开发、验证和常规控制的要求。尽管ISO 11137-1:20 06的范围仅限于医疗器械，但它规定了可能适用于其他产品和设备的要求并提供了指导。 ISO 11137-1:20 06涵盖了采用使用放射性核素60Co或137Cs的辐照器、来自电子发生器的射束或来自X射线发生器的射束的辐射过程。 ISO 11137-1:20 06不: 规定灭活海绵状脑病（如羊瘙痒病、牛海绵状脑病和克雅氏病）病原体的工艺的开发、验证和常规控制要求；将医疗器械指定为无菌的详细规定要求；规定医疗器械生产各阶段控制的质量管理体系；规定与辐照设施的设计和操作有关的职业安全要求；规定使用过或再加工器械的灭菌要求。

ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide ⁶⁰Co or ¹³⁷Cs, a beam from an electron generator or a beam from an X-ray generator. ISO 11137-1:2006 does not:

• specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease;
• detail specified requirements for designating a medical device as sterile;
• specify a quality management system for the control of all stages of production of medical devices;
• specify requirements for occupational safety associated with the design and operation of irradiation facilities;
• specify requirements for the sterilization of used or reprocessed devices.