DANSK DSF/PREN ISO 14160 PDF

1.1 This International Standard specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of the sterilization, by the use of liquid chemical sterilizing agents, 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. 1.2 This International Standard does not describe a quality management system for the control of all stages of manufacture. NOTE Attention is drawn to standards for quality management systems (see ISO 13485), which can be used in the control of all stages of manufacture including the sterilization process. 1.3 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. NOTE Such testing is a crucial part of the design and development of a medical device. 1.4 This International Standard addresses the control of risks related to contamination with bacteria and fungi by application of a liquid chemical sterilization process. NOTE 1 The prior application of risk management principles to medical devices utilizing animal tissues, as described in ISO 22442-1, is important. NOTE 2 Liquid chemical sterilizing agents traditionally employed to sterilize animal tissues in medical devices might not be effective in inactivating the causative agents of transmissible spongiform encephalopathies (TSEs) such as bovine spongiform encephalopathy (BSE), or scrapie. Satisfactory validation in accordance with this International Standard should not be assumed to demonstrate inactivation of infective agents of this type. This International Standard does not describe methods for the validation of the inactivation of viruses and TSE agents. Risk controls related to sourcing, collection and handling of animal materials are described in ISO 22442-2. The validation of the inactivation and/or elimination of viruses and TSE-agents is described in ISO 22442-3. This International Standard does not describe methods for validation of the inactivation and/or elimination of protozoa and parasites. 1.5 Manufacturing processes for medical devices containing animal tissues frequently include exposure to chemical agents which can reduce significantly the bioburden on the medical device. Following the manufacturing process, a medical device is exposed to a defined sterilization process; the requirements for validation and routine control described in this International Standard apply only to this defined sterilization process and do not take account of the lethal effects of other bioburden reduction steps. 1.6 This International Standard does not cover the level of residual sterilizing agent within medical devices. NOTE See ISO 10993-17 for a method to establish allowable limits for residues of sterilizing agents.