Aug 7, 2026 - Cosmetics
Microbiological testing of material-based medical devices – fast and reliable
Due to their composition, the microbiological examination of material-based medical products such as gels, sprays, or rinsing solutions is essential, as these products often provide an ideal breeding ground for the growth of microorganisms.
The legal basis for the examination includes the European Medical Device Regulation (EU) 2017/745 (MDR), which sets strict requirements for biological safety.
Parallel to this, the manufacturer's quality management system must meet the requirements of the harmonized standard DIN EN ISO 13485 for medical products. For the specific implementation of germ count determinations in the laboratory, the specifications of the European Pharmacopoeia (Ph. Eur.) as well as specific standards such as DIN EN ISO 11737, are relevant.
The BAV Institute tests for you as an accredited testing service:
- Testing for sufficient preservation / Ph. Eur. 5.1.3
- Bioburden determinations / DIN EN ISO 11737-1
- Enumeration of viable microorganisms / Ph. Eur. 2.6.12
- Detection of specified microorganisms / Ph. Eur. 2.6.13
- Germ identification using MALDI-TOF
In addition, we provide comprehensive advice on all topics related to hygiene and microbiology of material-based medical products. We look forward to your message!
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