Wound Dressing Biocompatibility Assessment
topic
Wound dressing biocompatibility testing evaluates haemocompatibility by measuring haemolysis of red blood cells in contact with textile extract; tissue irritation is assessed by intracutaneous injection of aqueous and non-polar extracts in rabbit models or reconstructed human epidermis equivalents under ISO 10993-10, with additional wound fluid absorption, gelling behaviour, and pH measurement under simulated exudate conditions.
Role
Mandatory for regulatory approval of wound contact textile devices including hydrocolloid dressings, alginate fibres, and antimicrobial wound covers under EU Medical Device Regulation and FDA 510(k) pathways, ensuring patient safety and tissue compatibility in direct wound contact applications.