MEDical devices
Reliable sterilization through electron and gamma irradiation
Numerous medical devices must be sterilized before they can be placed on the market and used on patients. Sterility is also essential for in-vitro diagnostics. According to DIN EN 556-1, a medical device is considered sterile if the statistical probability of finding a viable microorganism on or in the product is less than 1:1,000,000.
However, even with the greatest hygienic care and controlled production processes in a clean room, it is not possible to manufacture a sterile product. In order to achieve sterility, the products must undergo a downstream sterilization process after production. One possible method for this is sterilization with electron or gamma irradiation. Treatment with electron beams and gamma rays destroys pathogenic germs quickly, safely and in an environmentally friendly manner, and reliably sterilizes products.
We at BGS support you as an external service provider in the sterilization of, e.g.
Are your medical devices multifunctional, made from a wide variety of materials, or do they need to be sterile despite their complex geometric structures? Radiation-resistant materials and the product packaging are crucial for sterilization with radiation.
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More InformationRadiation sterilization is one of the most common technologies for sterilizing medical devices and in-vitro diagnostics. Irradiation with gamma and electron beams damages the DNA of microorganisms: they reliably lose their reproducability and die. Radiation sterilization is the only process for sterilizing products in sealed end-of-line packaging. No significant increase in temperature or use of chemicals is required here. As the radiation dose can be precisely controlled, radiation sterilization also offers a high level of reliability and reproducibility.
Another advantage of radiation sterilization is its ability to penetrate materials. Gamma rays in particular have a high penetration depth and penetrate entire pallets or containers. After the irradiation process, the applied dose will be measured by dosimeters that were placed on product for processing. If everything meets the specifications, it is immediately released by the quality assurance department. The product is ready for immediate use without any waiting time. Sterilization using electron or gamma rays is the best choice for time-sensitive supply chains.
Are you interested in sterilization or bioburden reduction of medical devices? We would be happy to check your request for the irradiation of your products.
Sterilization processes for medical devices are subject to validation. For radiation sterilization, this is regulated by the standard DIN EN ISO 11137. The following applies to medical devices sterilized with beta and gamma rays: the regulator only allows the manufacturer to place the device on the market if the sterilization process has previously undergone a microbiological, dosimetric and application-related validation process.
Find out how to successfully complete the different validation steps.
In vitro diagnostics occupy a special position among medical devices. They are not used directly on patients, but are used to analyze blood, tissue or urine, for example. Such test results must not be falsified by microorganisms contained in the vessels. Sterility is therefore essential. At BGS, for example, we sterilize routinely:
The sterility requirements for medical devices, medical consumables and in vitro diagnostics are subject to a wide range of standards, laws and regulations. BGS works with a quality management system in accordance with ISO 9001 and DIN EN ISO 13485, which also meets the requirements of EN ISO 11137 for the sterilization of medical devices.