MED engineering INTERNATIONAL article: Safe sterilization with rays

In order to convert medical devices to a sterile state, these products must undergo a sterilization process downstream of manufacture. Various processes and technologies are available for this purpose. One of the most common is sterilization with electron and gamma radiation, as this process offers a number of advantages.

Author: Lena Prinz

Published: Last updated:

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1 Min. Reading time
Cover picture and open page of the MEDengineering magazine.
Cover picture and open page of the MEDengineering magazine.

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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