Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilants
This International Standard specifies requirements for the development, validation, process control and monitoring of the sterilization, by the use of liquid chemical sterilants, 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.
This International Standard does not describe a quality assurance system for the control of all stages of manufacture.
NOTE 1 Attention is drawn to the standards for quality systems (see ISO 9001 and ISO 13485 or ISO 9002 and ISO 13488) which can be used in the control of all stages of manufacture including the sterilization process.
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 2 Such testing is a crucial part of the design and development of a medical device.
This International Standard does not describe methods for the validation of the inactivation of viruses.
NOTE 3 In developing a method for processing medical devices containing materials of animal origin, consideration of the effects of liquid chemical sterilization on potential viral contaminants will also be necessary because of the source of materials used in the
manufacture of these particular medical devices. The importance of validation of viral inactivation for processes within the scope of this International Standard is recognized. This aspect is excluded from this International Standard; a separate European Standard is in
preparation (EN 12442-3).
NOTE 4 Liquid chemical sterilants traditionally employed to sterilize animal tissues in medical devices may not be effective in inactivating the causative agents of transmissible spongiform encephalopathies 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 cover the level of residual sterilant within medical devices.
NOTE 5 ISO 14538 is concerned with this issue.