BS EN 15424 describes the requirements that will enable the demonstration that a low temperature steam and formaldehyde sterilization process has appropriate microbicidal activity. Also that this activity is both reliable and reproducible, such that the relationship for the inactivation of micro-organisms can be extrapolated with reasonable confidence to low levels of probability of there being a viable micro-organism present on a product after sterilization.
Requirements of the quality management system for medical device design/development, production, installation and servicing are given in BS EN ISO 13485. The standard for quality management systems recognizes that, for certain processes used in manufacturing or reprocessing, the effectiveness cannot be fully verified by subsequent inspection and testing of the product. Sterilization is an example of such a process. For this reason, sterilization processes are validated for use, the performance of the sterilization process monitored routinely and the equipment maintained.
Exposure to a properly validated, accurately controlled sterilization process is not the only factor associated with the provision of reliable assurance that the product is sterile and, in this regard, suitable for its intended use. Attention is therefore given to a number of factors including:
- The microbiological status of incoming raw materials and/or components
- The validation and routine control of any cleaning and disinfection procedures used on the product
- The control of the environment in which the product is manufactured, assembled and packaged
- The control of equipment and processes
- The control of personnel and their hygiene
- The manner and materials in which the product is packaged
- The conditions under which the product is transported and stored.