Sterilization of health care products - liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - requirements for characterization, development, validation and routine control of a sterilization process for medical devices
医疗保健产品的灭菌.利用动物组织及其衍生物的一次性医疗器械用液体化学灭菌剂.医疗器械灭菌过程的特性、开发、验证和常规控制要求
Specifies requirements for the development, validation, process control and monitoring of the sterilization, by the use of liquid chemical sterilants, of single-use medical devices comprising, in whole or in part, materials of animal origin.