ISO 14160:2011 specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin.
ISO 14160:2011 covers the control of risks arising from contamination with bacteria and fungi by application of a liquid chemical sterilization process. Risks associated with other microorganisms need to be assessed.
ISO 14160:2011 is not applicable to material of human origin.
ISO 14160:2011 does not describe methods for the validation of the inactivation of viruses and transmissible spongiform encephalopath (TSE) agents.
ISO 14160:2011 does not describe methods for validation of the inactivation, elimination, or elimination and inactivation of protozoa and parasites.
The requirements for validation and routine control described in ISO 14160:2011 are only applicable to the defined sterilization process of a medical device, which is performed after the manufacturing process, and do not take account of the lethal effects of other bioburden reduction steps.
ISO 14160:2011 does not specify tests to establish the effects of any chosen sterilization method upon the fitness for use of the medical device.
ISO 14160:2011 does not cover the level of residual sterilizing agent within medical devices.
ISO 14160:2011 does not describe a quality management system for the control of all stages of manufacture.
Document published on: 2011-07-01 Edition: 2 (Monolingual) ICS: 11.080.01 Status: Published Stage: 60.60 (2011-07-01) TC/SC: ISO/TC 198 Number of Pages: 34
Revises: ISO 14160:1998
No corrigenda or amendments available