标准摘要
[中文适用范围]： 本标准适用于医疗设备灭菌过程中辐射灭菌方法的开发、验证和常规控制。 [外文原描述]： ISO 11137-1 specifies requirements for the sterilization of health care products, particularly those involving radiation processes . It provides comprehensive guidelines on how to achieve sterilization and ensure the reliability and effectiveness of the process. This standard is crucial for manufacturers and health care providers who use radiation to sterilize medical devices.
英文名称Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices