1 Scope
This International Standard 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.
This International Standard 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 can be assessed using other methods (see Note 1).
This International Standard is not applicable to material of human origin.
This International Standard does not describe methods for the validation of the inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (see Note 2).
This International Standard does not describe methods for validation of the inactivation or elimination of protozoa and parasites.
The requirements for validation and routine control described in this International Standard 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 (see Note 4).
This International Standard does not specify tests to establish the effects of any chosen sterilization process upon the fitness for use of the medical device (see Note 5).
This International Standard does not cover the level of residual sterilizing agent within medical devices (see Note 6).
This International Standard does not describe a quality management system for the control of all stages of manufacture (see Note 7).
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 TSE such as bovine spongiform encephalopathy (BSE), or scrapie. Satisfactory validation in accordance with this International Standard does not necessarily demonstrate inactivation of infective agents of this type. Risk controls related to sourcing, collection and handling of animal materials are described in ISO 22442-2.
NOTE 3 The validation of the inactivation, elimination, or elimination and inactivation of viruses and TSE agents is described in ISO 22442-3.
NOTE 4 Manufacturing processes for medical devices containing animal tissues frequently include exposure to chemical agents which can significantly reduce the bioburden on the medical device. Following the manufacturing process, a medical device is exposed to a defined sterilization process.
NOTE 5 Such testing is a crucial part of the design and development of a medical device.
NOTE 6 ISO 10993-17specifies a method to establish allowable limits for residues of sterilizing agents.
NOTE 7 Standards for quality management systems (see ISO 13485) can be used in the control of all stages of manufacture including the sterilization process.
