ASTM Hemolysis

ASTM Hemolysis testing assesses the potential of medical device materials to cause red blood cell destruction (hemolysis) when exposed to blood. This in vitro test helps determine hemocompatibility and safety for clinical use. It can be performed using direct contact or extract methods, and results are measured by the hemolytic index, which quantifies red blood cell damage. The findings support product development and regulatory submissions, ensuring compliance with biocompatibility standards.

Why This Testing is Performed

Hemolysis testing is essential for identifying materials that may damage red blood cells during blood contact. Hemolytic reactions can lead to elevated plasma hemoglobin levels, which may cause kidney stress or other systemic effects. This test ensures that blood-contacting devices—such as catheters, stents, and dialysis components—do not trigger adverse hematological responses.

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Steps in Conducting This Test

1. Sample Preparation: Prepare device materials for either direct contact or extraction.
2. Blood Exposure: Incubate human citrated blood with the test article at 37 ± 2°C for at least 3 hours.
3. Controls: Include positive and negative controls to benchmark results.
4. Measurement: Use spectrophotometry to measure hemoglobin release.
5. Calculation: Calculate the hemolytic index by comparing test results to controls.

Standards, Guidance, and Regulations

• ASTM F756: Standard for assessing hemolytic properties of materials.
• ISO 10993-4: Guidance for selecting tests for blood interactions.
• ISO 10993-12: Covers sample preparation and reference materials.
• ISO 13485 & ISO 17025: Define quality and competence requirements for testing labs.
• 21 CFR Part 58: FDA’s Good Laboratory Practice regulations for nonclinical studies.