Medical Device Hemocompatibility Lab Testing Services Following ISO 10993-4

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Major US and EU Labs Performing ISO 10993 Testing

If your medical device makes direct or indirect contact with circulating blood, ensuring its Hemocompatibility is non-negotiable. Regulatory bodies worldwide, including the US FDA and EU Notified Bodies, require rigorous testing and data as specified in ISO 10993-4: Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood.

NAMSA is the global leader and pioneer in medical device testing, offering comprehensive, state-of-the-art labs in the US and Europe to meet all your ISO 10993-4 testing requirements. Partner with us to generate the trusted, compliant data necessary for accelerated market access.

Your ISO 10993-4 Compliance Roadmap

ISO 10993-4 requires a systematic approach to assessing a device’s potential to cause hemolysis, thrombosis, immune reactions, and other adverse blood interactions. Our experienced team of toxicologists and scientists will help you select and execute the right battery of tests for your specific device’s clinical use and blood contact duration.

Core Hemocompatibility Test Categories:

NAMSA conducts a wide variety of tests for medical devices that come into contact with circulating blood. These tests include:

Endpoint	NAMSA Core Services	Regulatory Relevance
Coagulation	Partial Thromboplastin Time (aPTT)	Measures intrinsic and common pathway coagulation cascade.
Coagulation	Prothrombin Time (PT)	Measures extrinsic and common pathway coagulation cascade.
Coagulation	Thrombin Time (TT)	Measures the final step of the coagulation cascade.
Coagulation	Fibrinogen and Anti-FXa Assays	Evaluates the overall hemostatic process and heparin activity.
Hemolysis	In Vitro Hemolysis (ASTM, ISO)	Measures the rate of red blood cell damage/lysis caused by the device material.
Thrombosis	Platelet Count and Platelet Activation Assays	Assesses device-induced platelet adhesion, aggregation, and consumption.
Complement Activation	C3a, SC5b-9, and Bb Assays	Evaluates the device’s potential to activate the immune system through the complement cascade.
Leukocyte Activation	Leukocyte/Granulocyte Count Assays	Measures changes in white blood cell counts and activation markers.

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Don’t risk delays due to incomplete or poorly justified hemocompatibility data. Leverage NAMSA’s integrated approach to move confidently toward market clearance.

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Comprehensive Safety Strategy for Devices in Contact with Circulating Blood

Hemocompatibility testing is a critical component of the broader biological evaluation strategy outlined in ISO 10993-1. NAMSA integrates your Part 4 data seamlessly with other required biocompatibility testing to ensure a complete and defensible package.

NAMSA Services for Complex Devices:

Biocompatibility Strategy Consulting: Our toxicologists design a definitive Biological Evaluation Plan (BEP) and generate the final Biological Evaluation Report (BER) that incorporates your Hemocompatibility strategy into the overall ISO 10993-1 framework.
Preclinical In Vivo Models: For long-term implants or complex cardiovascular devices (stents, grafts, pumps), we design and execute relevant GLP-compliant animal studies to provide clinically predictive data on in-vivo thrombogenicity and foreign body response.
Chemical Characterization (ISO 10993-18): Often a critical precursor, we perform Extractables & Leachables (E&L) testing to identify chemical components that could leach into the blood and cause adverse systemic or local effects, including blood-related issues.

Why NAMSA is the Premier Choice for ISO 10993-4 Testing

With decades of experience and a singular focus on medical device safety and compliance, NAMSA delivers data that is trusted by global regulators.

Expert Interpretation: Our board-certified toxicologists and hematology specialists don’t just run tests—they interpret the data within the context of your device’s clinical application and global regulatory requirements.
Global Regulatory Acceptance: NAMSA test reports are recognized and accepted by the FDA, EMA, PMDA (Japan), and other major regulatory bodies worldwide, streamlining your global submission process.
Customized Solutions: Whether you have a minimally invasive catheter, an artificial heart valve, or a complex extracorporeal circuit, we customize the test battery to match the specific geometry, materials, and blood contact dynamics of your product.

Frequently Asked Questions (FAQs)

Any medical device that has direct or indirect contact with circulating blood must undergo hemocompatibility assessment. This includes devices used for short-term contact (less than 24 hours), medium-term (24 hours to 30 days), and long-term contact (greater than 30 days). Examples include catheters, guide wires, stents, heart valves, oxygenators, dialysis equipment, extracorporeal circuits, and blood administration sets.

ISO 10993-4 categorizes interactions with blood into five critical endpoints that must be evaluated based on the device’s contact type and duration:

Hemolysis: The breakdown (lysis) of red blood cells and release of hemoglobin.
Thrombosis/Thrombogenicity: The potential to cause blood clot (thrombus) formation.
Coagulation: The effect on the coagulation cascade (e.g., changes to clotting times like PT or aPTT).
Platelets: The potential to cause platelet adhesion, activation, or consumption.
Complement Activation: The device’s potential to trigger the humoral immune response via the complement system.

Material-Induced Hemolysis: This is the classical test that assesses if chemicals or surface characteristics of the device material can damage red blood cells (RBCs). This is typically measured using in vitro extraction or direct contact methods.
Mechanically-Induced Hemolysis: This test is required for devices that redirect flow or create turbulence or shear forces within the circulatory system (e.g., blood pumps, heart valves, hemodialyzers).10 It assesses if the mechanical design of the device physically damages RBCs as blood flows through it. This usually requires a specialized flowing loop model that simulates clinical use conditions.

The need for in vivo (animal) testing to assess thrombogenicity depends on the device’s risk profile and duration of blood contact.

Long-Term Contact Devices (e.g., implanted vascular grafts or heart valves) often require in vivo models to provide clinically predictive data on thrombus formation under physiological conditions.
Short/Medium-Term Contact Devices may be able to justify using only advanced in vitro thrombogenicity and coagulation assays as sufficient evidence, especially if combined with robust chemical characterization (ISO 10993-18). The decision is always risk-based and must be justified in your regulatory submission.

Hemocompatibility is just one component of the broader biological safety strategy defined by ISO 10993-1.

Initial Step: The process starts with a Biological Evaluation Plan (BEP), which identifies all biological risks (cytotoxicity, irritation, hemocompatibility, etc.) based on the device’s materials, manufacturing, and contact type/duration.
Testing and Data: Hemocompatibility testing is executed according to the BEP.
Final Report: The test results are synthesized into a Biological Evaluation Report (BER). This report uses the hemocompatibility data, along with all other testing and chemical characterization data, to conclude whether the device is safe for its intended clinical use.