Quality assurance in medical technology for production and laboratory
In medical technology, the demands on quality of products and components are particualarly high, since they are used for the support or analysis of the human body, or even inserted into the body as implants. High-tech components in modern medical engineering have to fulfill special demands with respect to medical tolerance, durability and wear. The properties of the product's surface like roughness, topography, micro geometry or thickness of coatings, is often crucial for the therapeutic and, therefore, the economic success of a product.
With a high resolution, the optical NanoFocus 3D surface measurement systems provide repeatable parameters for surface quantification. The patented technology even allows the non-contact measurement of polished or transparent surfaces, coatings and steep slopes, as well as roughness measurements according to DIN EN ISO. In the laboratory, the NanoFocus metrology is a cost-efficient and easy-to-use alternative to scanning electron microscopy (SEM).
Examples of application
Alternative to SEM
For many applications in medical technology, the µsurf-technology of NanoFocus is an ideal alternative to scanning electron microscopy. It excels by virtue of its high-detail reproduction and measurement speed. Time consuming sample preparation is also no longer necessary.
Products: µsurf custom
A reactive substance in fluid form is applied as a membrane to the biosensor. With µsurf custom, the coverings of each sensor are examined. Transparent fluids are easily measurable with NanoFocus systems. In many cases, not only one but two substances are applied to the sensor. This means that two measurements are necessary, each after a fluid has been applied. On the one side, the volume of the applied substance is measured; on the other side, if the substance applied first is completely surrounded by the second. Furthermore, the form and surface of the dried membrane is measured.
Dental implants are roughened by sand blasting and by a subsequent etching process. Roughening means the titanium implant heals into the jaw faster and more durably. The ongoing measurement of the 3D surface roughness during the production process guarantees the manufacturer adherence with the roughness tolerances defined in clinical studies. In the past, only qualitative assessment using SEM was available.
Products: µsurf custom, µsoft analysis
In the final machining of hip implants, the polishing process determines the quality of the ultra-smooth surfaces. Polishing for too long exposes hard particles from the material that could later lead to infections and rejections. These particles are captured and quantified by measuring with µsurf. Examination of surface roughness down to the nanometer range ensures the implant´s consistant quality.
Products:µsurf custom, µsoft analysis
In an artificial knee joint, different materials come together. The surface quality of the artifical knee-cap made of polyethylene is of special importance. New developments aim at maximum bio-compatabilty. With NanoFocus measurement technology, delivering surface characteristics in the micrometer and nanometer range, even this development can be facilitated and accelerated. Once the product is finished, the surface rougness, directional preferences (so-called isotropies) and wave areas can be safely determined.
When it comes to the surface properties of tubes, excellent anti-adhesive characteristics and good separating quality are essential. In order to achieve this, tubes are laser structured. During this process, the parameters have to be checked frequently. Small tolerances require precise and reliable measurements which are possible with the NanoFocus 3D surface inspection systems. Measurement results are not affected if the tubes are transparent, half-transparent, opaque, or if they possess reflection caused by the material.
Modern vascular implants (stents) are coated with a bioactive layer to prevent regrowth (restinosis). µsurf custom determines both the layer thickness and its homogeneity, as well as the roughness of the surface at the same time. With µsurf custom, the accuracy of measurements is in the nanometer range. Transparent layers can be captured from 1 µm upwards.
Products: µsurf custom, µsprint topographer, Optical 3D measurement system µsurf custom – Confocal surface measurement systemµsoft analysis
In microfluidics, an areal evaluation of the surface is usually required. The 3D profilometer µscan custom is often the chosen solution. In spite of the steep edges and very even surfaces it reliably determines cross-section areas, height, width, and volume of valves and channels. The software enables the analysis of all paramters with just a few clicks.
Benefits at a glance
- Traceable measurements
- No sample preparation
- Latest 3D roughness parameters
- Layer thickness measurement of transparent coatings
- Cost-effective alternative to SEM
Interview with CTO Jürgen Valentin about surface metrology in medical technology. Watch the video