Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices Ingestion-build-50790 The standard for quality management

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Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices Ingestion-build-50790 The standard for quality managementBS 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