Hemocompatibility Testing – Hemolysis (ASTM F756)
In medical device testing, hemocompatibility is a critical aspect ensuring that devices interact safely with blood. One of the key tests within this realm is the hemolysis test, as specified in ASTM F756. This test evaluates whether a material or substance used in medical devices causes hemolysis—a breakdown of red blood cells—when exposed to human blood.
The significance of hemocompatibility testing cannot be overstated, especially for intravascular devices like catheters, stents, and vascular grafts. Hemolysis can lead to severe complications such as anemia, jaundice, and even life-threatening conditions if left unchecked. ASTM F756 provides a standardized approach to quantify the amount of hemolysis that occurs during exposure.
During the test, a known volume of blood is mixed with the material or substance under consideration for up to 24 hours. After this period, the mixture undergoes analysis using spectrophotometry to measure the release of hemoglobin into the solution. The degree of hemolysis is then calculated based on the concentration of released hemoglobin.
The ASTM F756 method allows laboratories to provide clear and reliable data, which is essential for regulatory compliance and ensuring product safety. Compliance with such standards helps manufacturers protect their reputation while also adhering to international requirements set forth by organizations like the US FDA, EU Directive 93/42/EEC, and others.
Our lab utilizes advanced instrumentation, including spectrophotometers specifically calibrated for hemolysis testing, ensuring precision and accuracy in results. We follow strict protocols that adhere to ASTM F756 guidelines, providing clients with confidence in the data provided. Our expertise ensures that every test not only meets but exceeds industry expectations.
The importance of this testing extends beyond just medical devices; it also plays a crucial role in ensuring patient safety during clinical trials and post-market surveillance. By offering robust hemocompatibility testing services, we contribute to reducing risks associated with the use of medical devices, ultimately enhancing public health.
Benefits
- Ensures regulatory compliance by meeting ASTM F756 standards.
- Provides reliable data that supports product safety and efficacy claims.
- Facilitates successful submission of products to regulatory bodies like the FDA and EU Directive 93/42/EEC.
- Reduces potential risks associated with medical device use, enhancing patient safety.
- Aids in the development and optimization of new medical devices through thorough testing.
Industry Applications
| Application | Description |
|---|---|
| Intravascular Catheters | Catheters that are implanted within the vascular system require rigorous hemocompatibility testing to ensure they do not cause adverse reactions when interacting with blood. |
| Vascular Grafts | Materials used in grafts must be tested for their ability to prevent hemolysis, ensuring long-term functionality and patient safety. |
| Clinical Trials | Before a new medical device can enter clinical trials or the market, it undergoes extensive testing including ASTM F756 compliance to ensure its suitability for human use. |
| Post-Market Surveillance | Once devices are in use, continuous monitoring helps identify any issues that may arise from hemolysis, ensuring ongoing safety and efficacy. |
