Biocompatibility Testing (for Medical Devices)
Biological Reactivity Tests (USP 87 & 88)
Evaluating the potential biological responses to medical devices, including acute systemic toxicity, intracutaneous reactivity, and implantation tests.
Pharmacopoeial Testing
Conducting tests according to established pharmacopoeial standards, such as pyrogen tests (for fever-inducing substances) and abnormal toxicity tests.
In Vitro Cytotoxicity (ISO 10993:5)
Assessing the potential of medical device materials to cause cell damage, typically via extract elution tests.
Hemocompatibility Studies (ISO 10993:4)
Evaluating the interaction of medical devices with blood, including in vivo thrombosis, in vitro hemolysis, and assessments of coagulation, platelet function, and complement activation.
Skin Sensitization (ISO 10993:10)
Identifying materials that may cause allergic contact dermatitis.
Irritation Studies (ISO 10993:10)
Testing for irritation effects on various mucosal surfaces (ocular, penile, vaginal, rectal, oral) and skin.
