According to the DIN EN 556-1 standard, a medical product is claimed sterile if the theoretical probability of finding a viable reproducible germon the product is less than 1:1,000,000. In order to achieve this state, products have to undergo a subsequent sterilization process. Different procedures and technologies are available to this end. Among the most common is sterilization using beta or electron and gamma rays, since this process offers a number of advantages. X-ray sterilization is in the early stages of development. In addition, chemical processes can be used for sterilizing, for example, exposure to ethylene oxide (EO or EtO) or to heat.
What are the similarities and differences between electron and gamma rays? What are the prerequisites for the use of radiation sterilisation and what are the main advantages of the procedure?
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(MED engineering INTERNATIONAL/2021, Author Dipl.-Ing. Annett Heilmann)