For many medical devices such as implants, dressings, surgical material, and laboratory diagnostic products, sterility is a mandatory requirement for marketing and safe use on patients.
Attributable to the special technology as well as due to the expense for the operation of the corresponding facilities, sterilization processes are generally outsourced to specialized service providers. Overall, a trend towards radiation sterilization has become apparent in Germany in the past years. Sterilization is carried out particularly frequently using gamma rays and increasingly also beta rays. As with all sterilization methods, the steps necessary to validate radiation sterilization are complex and often associated with numerous questions on the part of the manufacturer.
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