Chemical-physical testing of medical products

To assess a medical device not only its biological risks are to be taken into account but also the chemical and physical characteristics of its material.

The range of chemical and physical tests we perform include:

  • Test for identity and purity of medical devices and materials acc. to Ph. Eur. (3.1 and 3.2)
  • Chemical analysis of medical devices acc. to DIN EN ISO 10993-18
  • Chemical analysis acc. to DIN EN ISO 8536-4 (Appendix B)
  • Test for particulate contamination acc. to Ph. Eur. 2.9.19, DIN EN ISO 8536-4 (appendix A.1), DIN EN ISO 15747 (determination of particulate contamination by microscopy) and Ph. Eur. 2.9.20
  • Detection of seal leaks in porous medical packaging acc. to DIN EN ISO 11607-1 and ASTM F1929 and determination of seal width acc. to DIN EN 868-5
  • Testing of medical devices for residual  pollutants (proteins) based on DIN EN ISO 15883-1
  • Establishment of analyses by means of HPLC acc. to customer's request
  • Determination of osmolality acc. to Ph. Eur. 2.2.35
  • Determination of resistance to corrosion of stainless, surgical and dental instruments acc. to DIN EN ISO 13402 and ASTM F1089
  • Real-time storage and accelerated aging of medical products (temperature-controlled) acc. to ASTM F1980
  • Test for coloring (Ph. Eur. 2.2.2) and opalescence of liquids (Ph. Eur. 2.2.1)
  • Release of active ingredients from plasters and wound dressings (based on DIN EN ISO 10993-12 and DIN EN ISO 10993-18)