BS EN 15424:2007 PDF

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 . 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: