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 measures the terminal complement complex SC5b-9 generated when human serum meets your device.
Hemocompatibility: Complete Hemolysis - Direct & Indirect (Rabbit Blood) (GLP) - Internationally Sourced
Complete hemolysis runs both arms of the ISO 10993-4 hemolysis test in parallel: the device in direct contact with rabbit blood, and an extract of the device against the same blood.
Hemocompatibility: Direct Contact In-Vitro Hemocompatibility (GLP) - Internationally Sourced
Direct-contact in vitro hemocompatibility places the device itself, not an extract, against fresh blood under static conditions and assesses the blood-interaction markers specified in the study design against negative and positive reference materials.
Hemocompatibility: Hematology Platelet & Leukocyte - PLC (GLP) - Internationally Sourced
The platelet and leukocyte count (PLC) study exposes human whole blood to your device and measures whether platelets and white cells are consumed or depleted.
Hemocompatibility: Indirect Contact Hemolysis (GLP) - Internationally Sourced
Indirect-contact hemolysis exposes rabbit blood to an extract of the device rather than the device itself and measures the fraction of red cells lysed.
Hemocompatibility: Partial Thromboplastin Time - PTT (GLP) - Internationally Sourced
Partial thromboplastin time (PTT) exposes human plasma to your device and measures whether the intrinsic coagulation pathway is activated or inhibited.
- Turnaround band
- Testing location
- Endpoint
- Standards
- Subcontracted