Like microorganisms, particles on medical devices can trigger immune reactions. To improve the compatibility of your product, you should rinse test specimens to enable a microscopic count of the eluate.
For medical devices, less than 90 particles per product are considered standard.
- Microscopic counting of particles in eluates according to DIN EN ISO 8536, part 4 Annex 1.4.2
- Support for particle reduction approaches
- Clean room monitoring
Further information can be found here.