We provide independent proof of a product's biological safety.

Based on the ISO 10993 series of standards (mandatory for EU medical products), we assess a product's compatibility for the skin, mucus membrane and immune system.

  • Cytotoxicity 
    (cell damage)
  • Sensitization test
    (potential to cause allergies)
  • Test for irritation / damage to mucus membranes
    (HET CAM test)
  • Biocompatiblility of coatings
  • Further tests on request

The Hohenstein Quality Label

Identify products that have been tested to medical-grade standards for safety.


Use our reputation for credibility


Ben Mead
Managing Director
Hohenstein Institute America