Disinfectant resistance ensures quality
During application, storage and transport material surfaces are faced with different influences. Long-term damage to the product can be identified by surface tests that are used to determine the service life. Latent vulnerabilities can be detected and corrected directly in the next development cycle. Therefore, with regard to the approval of medical products, both mechanical and chemical tests, in particular for risk minimization in accordance with DIN EN ISO 14971, are necessary during the development. The focus is on the Examinations for disinfectant resistance. Disinfectants, such as Sterilium, have an aggressive effect on plastics.
Hygiene in the medical technology
Hygiene and the corresponding reprocessing play a significant role, especially in housing development. In the medical environment, requirements for cleaning methods apply, such as wipe disinfection or sterilizability. These must be taken into account when developing surfaces and selecting components. The evaluation of a possible contamination during use can only be carried out by biology specialists. Chassis fitting may also require modification of the manufacturing process. Thus, this aspect must ideally be taken into account in the concept phase. The operating elements play a major role, as biofilms often form there. To enable optimum cleaning, senetics uses closed control elements, such as membrane keypads or capacitive touch elements, which are labeled with sublimation printing. Standards-compliant abrasion tests with saliva and sweat, as well as scratch hardness tests, prove the stability of the selected technology during development. In the case of the intelligent pulse measuring device, this also ensures the device resistance in mobile use.
- Combined tests of the abrasion resistance with saliva and perspiration according to DIN EN ISO 105 X-12
- Testing with the help of immersion according to DIN EN ISO 2812-1
- Assessment of coating damage according to DIN EN ISO 4628-1
- Automated test on the product to simulate testing
Application example: testing of UDI marking
Current legal requirements of the FDA and the new MDR will be a challenge for all medical technology companies. A labeling of all medical devices is required – also from surgical cutlery. The attached UDI / Data Matrix Code on your medical device must be proven for shelf life over the reprocessing cycle, in the stated lifetime of the product. senetics offers you comprehensive regulatory and durability support.
To check the durability of the UDI code, it is recommended that the product is exposed to at least the same load as in daily use. The sequence is repeated in one frequency, based on the real number of repetitions. Alternatively, a shortened test is conceivable, depending on the time required, since the conditions must already be implemented in August for the FDA next year. For example, senetics has already exposed customers’ surgical instruments to a defined cleaning and sterilization cycle, thereby demonstrating the durability of the UDI code.
These tests are implemented in our test laboratories in Ansbach. Our testing laboratories are certified according to DIN EN ISO 17025. In addition, we offer all necessary tests such as testing for biocompatibility (DIN EN ISO 10993) or germ load of medical devices (Bioburden DIN EN ISO 11737). The concept and implementation are exactly adapted to the product and thus enable reliable statements.
Technical examinations to determine the UDI resistance
Direct markings on medical devices not only have to be high in contrast and durability, they must also not affect their surface quality. The contrast is affected by use. This can be tested using selected tests in real-life scenarios. We also provide you with customized scenarios.
- Scratch test with microscopic analysis according to DIN EN ISO 1518-1
- Abrasion test with cleaning fluids
- Automated endurance test
Examinations to determine the UDI resistance
If you want to examine the amount of times, that laser-labeled surgical instruments can be reprocessed without compromising the quality and legibility of the label, the following tests will help you find the answer.
- Representative tests to verify the long-term durability of the marking of surgical instruments
- Machine cleaning and disinfection in accordance with EN ISO 15883
- Steam sterilization method based on ISO 17665