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 skin irritation
(using RhE models of the skin) - Test for damage of mucuous membranes
(by means of HET CAM test) - Biocompatibility of coatings
- Further tests on request
The Hohenstein Quality Label
Identify products that have been tested to medical-grade standards for safety.
Downloads
- Factsheet - Biocompatibility Testingpdf
- Factsheet - Cytotoxicitypdf
- Factsheet - Chemical Characterization - DIN EN ISO 10993-18pdf
- Factsheet - Sensitization/Allergen Effectpdf
- Factsheet - HET-CAM Test (Exclusion of Chemical Irritation)pdf
- Factsheet - Quality Assurance for Surgical Textiles - DIN EN 13795-1pdf
- Factsheet - Medical Compression pdf
- Factsheet - Medical Face Maskspdf