The purity testing of ME-medical devices here usually involves the following steps:
- Test purification (extraction of the product)
- Filtration of the extracted liquid, if necessary
- Measurement of the particles (analysis)
This procedure was derived or adopted on the basis of the procedure described for automotive components in accordance with VDA 19.1 and ISO 16232 and was also practiced for medical devices before the VDI guideline was published.
In everyday life, new challenges and questions arise again and again for laboratories, which are to be worked through jointly by the parties concerned in this guideline.
The guideline is intended to provide a common basis for a unified approach by laboratories and thus forms a cornerstone for points to be considered in the context of a revision of VDI 2083 Sheet 21, including possible approaches to solutions.
You can find more information about the event here.