Hemocompatibility
ISO 10993-4 blood-contact evaluation: hemolysis, complement, platelet and leukocyte counts, PTT, and PF-4. Methods are listed individually so the evaluation can specify direct versus indirect contact and whether a predicate is required.
Hemocompatibility: Complement Activation, SC5b-9 (GLP) - Internationally Sourced
Complement activation asks whether your device triggers the immune cascade that a foreign surface in the bloodstream can set off.
Hemocompatibility: Complete Hemolysis - Direct & Indirect (Rabbit Blood) (GLP) - Internationally Sourced
Complete hemolysis runs both arms in parallel: the device surface in direct contact with blood, and an extract alongside it.
Hemocompatibility: Direct Contact In-Vitro Hemocompatibility (GLP) - Internationally Sourced
Direct contact hemocompatibility asks how your device behaves against whole blood.
Hemocompatibility: Hematology Platelet & Leukocyte - PLC (GLP) - Internationally Sourced
Platelet and leukocyte counts ask whether your device consumes blood cells.
Hemocompatibility: Indirect Contact Hemolysis (GLP) - Internationally Sourced
Indirect contact hemolysis asks whether substances that leach out of your device rupture red blood cells.
Hemocompatibility: Partial Thromboplastin Time - PTT (GLP) - Internationally Sourced
Partial thromboplastin time asks whether your device disturbs the clotting cascade in either direction.
- Method
- Extraction
- Deliverable
- Test system
- Testing location
- Acceptance criteria
- Endpoint
- Standards
- Subcontracted