ENGLISH 24 Particularly when developing housings and innovative coatings in the medical sector, care must be taken to ensure that these devices can withstand everyday stress, such as due to constant disinfection. Yet these requirements are not necessarily known in advance for every material or coating during development. This problem is an ongoing issue, especially when prefabricated parts are involved. Even manufacturers are often unable to provide any information on whether their product/device is resistant to the chemical and physical stress of disinfectants. For this reason, the materials used for development usually have a proven track record over many years and have not demonstrated any shortcomings over time. With regard to the approval of medical devices, both mechanical and chemical tests are necessary during development, especially when it comes to minimizing risks in accordance with DIN EN ISO 14971. The main focus here is on resistance to disinfectants. If you are currently planning to launch something innovative onto the market, whether related to medical instruments/devices, housings, or surface coatings, it is quite possible that one of the following questions will sound familiar to you: • How can I make sure that my medical device is resistant to repeated disinfection? • Which disinfectant is suitable for my medical device? • Is the surface still resistant even after repeated disinfection over many years? • Can the surface be reliably disinfected using a certain disinfectant? • Is my device’s UDI label resistant to my selected disinfectant? Microscopic assessment of coating damage after simulated wipe disinfection over the entire service life of a medical device.
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