ENGLISH 25 UDI label durability with regular disinfection Current legal requirements from the FDA and the new MDR pose a major challenge to all medical technology companies. The labeling of all medical devices is required to ensure traceability. The durability of the UDI / Data Matrix code applied to a medical device must be confirmed throughout its specified service life (and also over all the reprocessing cycles). In order to guarantee the durability of the UDI code, it is also recommended that the device be tested. When testing the durability of the UDI label, the device is exposed to chemical, thermal, and/or physical stress, similar to the stresses of daily use. Depending on the device and the user, this will need to be determined for each customer individually. The sequence is repeated several times at a specific frequency chosen on the basis of the real number of repetition cycles. Depending on the time required, a shortened test may also be suitable. Laboratory tests Companies in the medical technology sector are therefore faced with a major challenge regarding surfaces and their suitability for disinfection due to the current legal requirements of the FDA and the new MDR. In closing, we would like to offer a few recommendations regarding which test and inspection procedures might be considered reasonable: • Testing by immersion according to DIN EN ISO 2812-1 • Assessment of coating damage according to DIN EN ISO 4628-1 Left: Implementation of a wipe disinfection of a plastic surface. Right: Testing of the UDI label durability with everyday mechanical influences on the human-machine interface of a touch panel.
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