Haemocompatibility and thrombogencity
FDA guidelines for blood contacting devices
- Cytoxicity in vitro
- Hemolysis
- Complement activation
- Protein adsorbtion
- Whole blood contacting time for thrombogenicity
- Pyrogenicity
- Genotoxicity
- Acute sytemic toxicity
- Intracutaneous injection
- Implantation
- Guinea pig maximization for delayed sensitization
- Subchronic toxicity
- Thrombogenicity by examining:
- Platelets
- Fibrinogen
- Thrombus formation
- Any resulting emboli