RO
SR EN ISO 14160:2011
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 (ISO 14160:2011)
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 manufacturin
Status :
Withdrawn
Approval date : 12/23/2011
Withdrawal date : 9/30/2021
Number of pages : 44
ICS : 11.080.01 Sterilization and desinfectation
Technical Committee : 377 - Medical devices
- Replaces SR EN ISO 14160:2003
- Normative reference SR EN ISO 13485:2004/AC:2010
- Normative reference SR EN ISO 10012:2004
- Normative reference SR EN ISO 10993-1:2010
- Normative reference SR EN ISO 10993-17:2009
- Normative reference SR EN ISO 11737-1:2006
- Normative reference SR EN ISO 22442-2:2008
- Normative reference SR EN ISO 13485:2004
- Normative reference SR EN ISO 11737-1:2006/AC:2009
- Normative reference SR EN ISO 10993-1:2010/AC:2010
- Replaced by SR EN ISO 14160:2021