| ISO 14160 Second edition 2011-07-01 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 |
| Recognition Date | 2017-08-21 |
| Recognition List | 047 |
| Recognition Number | 14-361 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Sterility |
| FDA Tech | Elaine Mayhall FDA/OMPT/CDRH/ODE/DAGID/INCB/ 301-796-6301 Elaine.Mayhall@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| Regulation Number | Device Name | Device Class | Product Code |
| §880.6885 | Sterilant, Medical Devices | Class 2 | MED |
| Guidance for Industry and FDA Reviewers: Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants, Issued January 2000. ANSI/AAMI ST58:2013 Chemical sterilization and high-level disinfection in health care facilities. |