Hemocompatibility & Blood Interaction Studies
Materials intended for blood contact must be carefully evaluated to ensure they do not disrupt normal hematological function or trigger adverse biological responses. Hemocompatibility & Blood Interaction Studies assess how materials interact with blood components, including red blood cells, platelets, plasma proteins, and the coagulation and complement systems.
At Materials Metric, hemocompatibility testing is conducted in accordance with ISO 10993-4 and FDA guidance, providing quantitative assessment of risks such as hemolysis, thrombosis, platelet activation, coagulation abnormalities, and complement activation. These studies are essential for medical devices, implants, tubing, coatings, and extracorporeal systems where blood contact occurs, helping to prevent complications such as clot formation, inflammation, and cellular damage while supporting robust biological risk assessments and regulatory submissions.
Uses
• Evaluate thrombogenicity and coagulation effects
• Determine hemolysis potential
• Assess platelet adhesion and activation
• Screen for complement activation
• Support FDA submissions for vascular and implantable devices
Applications
• Catheters, stents, vascular grafts
• Blood-handling devices
• Hemodialysis equipment
• Implantable sensors and pumps
• Coated or surface-modified biomaterials
Sample Analysis Process
1. Study Planning
- Select endpoints based on device classification
- Identify extraction or direct-contact requirements
2. Sample Handling
- Preparation under sterile/controlled conditions
- Blood exposure setups per ISO 10993-4
3. Testing & Measurement
- Hemolysis assays (direct/indirect)
- Platelet adhesion and activation
- Coagulation tests (PT, aPTT)
- Complement activation markers
4. Reporting
- Quantitative hemocompatibility data
- Photomicrographs or platelet adhesion images
- ISO 10993-4 classification
- Regulatory interpretation
Why Choose Materials Metric
Materials Metric provides scientifically rigorous hemocompatibility testing tailored to the needs of blood-contacting medical devices. Our team understands the complex interplay between biomaterials and hematologic pathways, enabling deeper insight than standard assays provide.
We offer:
- ISO 10993-4 compliant workflows for hemolysis, coagulation, thrombosis, platelet activation, and complement response
- ISO 9001:2015 accredited quality systems ensuring validated methods and reliable data integrity
- Advanced blood-interaction analytics to assess clotting, activation markers, and cell compatibility
- Multidisciplinary interpretation connecting blood-material interactions to chemistry, surface morphology, and processing history
- Regulator-ready reporting aligned with FDA expectations for vascular, implantable, and extracorporeal devices
Materials Metric helps you demonstrate true blood compatibility and accelerate regulatory approval.
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