Full Description

This International Standard 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.

This International Standard does not apply to material of human origin.

This International Standard does not describe a quality assurance system for the control of all stages of manufacture.

This International Standard does not describe tests to establish the effects of any chosen sterilization method upon the fitness for use of the medical device.

This International Standard does not describe methods for the validation of the inactivation of viruses.

This International Standard does not cover the level of residual sterilant within medical devices.