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in vitro Hemocompatibility testing

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As part of the medical device testing panel hemocompatibility testing is essential for evaluating the safety of blood-contacting biomaterials before clinical application.
The in vitro blood exposure models are performed in accordance with the guideline ISO 10993-11, 10993-42 and 10993-123 at Eurofins Munich. For hemocompatibility assessment of a medical device, hemolysis as well as in vitro thrombosis can be tested. The later one can be subcategorized into 4 different categories: coagulation, platelet activation, haematology, and complement activation. Furthermore, Eurofins Munich is also offering testing according to ASTM regulations for the American Market (ASTM F28887, ASTM F 23828 or ASTM F 7569), ISO 1135-45 and -56 testing for transfusion equipment (chapter 7.4 – 7.7 and 8.4 – 8.7) and blood bag testing according to ISO 38264.


The following hemocompatibility tests can be performed to evaluate interactions of medical devices with blood:

 

Workflow of Hemocompatibility testing

Important parameters needed for sample preparation and extraction

  • Type of contact: direct or indirect blood contact
  • Parts of the test material to be extracted
  • Temperature and exposure time
  • Surface, weight or filling volume of the test material
  • Number of blood donors used for testing (Europe: at least one donor, USA/Japan: at least two donors; FDA recommends three donors)
  • Use of a predicate sample for a more precise data interpretation

References

  1. ISO 10993-1: “Evaluation and testing within a risk management process”
  2. ISO 10993-4: 2017 “Selection of tests for interactions with blood”
  3. ISO 10993-12: 2012 “Sample preparation and reference materials”
  4. ISO 3826-1: 2003 “Conventional containers”
  5. ISO 1135-4: 2015 “Transfusion sets for single use, gravity feed”
  6. ISO 1135-5: 2015 “Transfusion sets for single use with pressure infusion apparatus”
  7. ASTM F2888: “Standard Practice for Platelet Leukocyte Count—An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials”
  8. ASTM F 2382: “Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)”
  9. ASTM F 756: “Standard Practice for Assessment of Hemolytic Properties of Materials”