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
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.