Radiation Sterilization: Safety in three steps

Sterility means that a product is free from microorganisms capable of reproduction. In technical manufacturing processes, this is only possible up to a point. Therefore the Standard EN 556 on medical devices requires that for a product to be described as ‘sterile’, statistically a maximum of only one in one million items may be found to contain a viable microorganism (sterility assurance level: SAL 10-6)

The validation of radiation sterilization takes place in three parts: