In October 2019, the Association of German Engineers (VDI) published a new guideline on the purity of medical devices (VDI 2083 Blatt 21: 2019-10). In this article we inform customers and interested parties about essential aspects of the new directive.
It is often surprising for our customers if we find hard mineral particles on their components during residual dirt analysis. Customers ask: "How can that be? We were not able to determine anything in our own cleanliness tests. ”The question of contamination from hard minerals is so important because these particles have an abrasive effect and thus massively damage mechanical systems such as gears and motors.
The determination of technical cleanliness according to VDA-19.1 and ISO-16232 has become an integral part of quality control and error analysis - because the cleanliness of components is crucial for the quality and error-free functioning of the product. In addition to particles, film contamination is a problem, as the following example from quality assurance in the production of electrical drive systems shows.
In order to answer the question of the whereabouts of microplastic particles from tire abrasion, new analysis methods are urgently needed to reliably detect and count these particles. We conducted a pilot study to test the possibilities of automatic SEM-EDX analysis in the quantification of tire wear in environmental samples.
Which problems smallest remainder dirt particles can cause, has recently experienced a German car manufacturer: He had to recall numerous vehicles due to malfunction in the engine. Reason were production residues consisting of hard particles, which lead to a capital engine damage - in the worst case to burning cars. Hard residual dirt particles usually come from the fine machining of surfaces by glass blasting, vibratory grinding, honing [...]
Bearing shells have the function to unroll and support rolling elements. In four-stroke engines, for example, the connecting rod, which connects the piston to the crankshaft, rotates in a bearing. This is lubricated with oil, which reduces the friction and thus wear. In the lubricant, however, various residual dirt particles are contained, which can settle in the bearing shell. In the past, the [...]
Distilled water finds many uses in everyday life, for example, as cooling water in the car or steam iron. It is reputed to be purer than tap water, which is why it is also used in cleanliness analysis in the laboratory with distilled water. Residues in the water would contaminate the samples during the analysis and falsify the results. Before we distilled water for [...]