Hemocompatibility tests. UNE-EN ISO 10993-4: 2009. Bilogical Evaluation of Medical Devices, Part 4: Selection of tests for blood interactions.

 

Tests accredited by ENAC.

Tests with the Certificate of Good Laboratory Practices (BPLs).

 

There are several tests that determine the haemocompatibility of a product, investigating its ability to induce thrombosis, coagulation, platelet activation, activation of the complement system, and blood disorders (hemolysis tests).

The UNE-EN ISO 10993-4 standard establishes recommendations for the indicated tests that must be carried out according to the nature and destination of the product to be evaluated, citing as examples in two tables: 1) products that will be in contact with circulating blood, and communicating with the outside, and 2) products, or components of products, in contact with circulating blood.

In the first group, the following products are included as examples: catheters placed for less than 24 hours; blood monitors; equipments for blood storage and blood administration; products for blood collection; catheters placed for more than 24 hours as intravascular endoscopes, intravascular ultrasound; laser systems; retrograde coronary artery catheters; cellular conservators; products for absorption of specific substances from the blood; equipment for donation and therapeutic apheresis and blood cell separation systems; extracorporeal membrane oxygenator systems; hemodialysis/hemofiltration equipment; percutaneous circulatory support products; leukocyte retention filters.

The second group includes, as examples: annuloplasty rings, mechanical heart valves; intraaortic balloon pumps; total artificial hearts; products for ventricular assistance; embolization products; endovascular grafts; defibrillators and implantable cardioverters; pacemaker drivers; grafts and prosthetic patches, including arteriovenous shunts; Vascular endoprotesis -stens-; tissue heart valves; tissue grafts and vascular patches, including arteriovenous shunts; vena cava filters.

According to the type of product, the UNE-EN ISO 10993-4 standard establishes recommendations regarding the recommended test among thrombosis, coagulation, platelets, hemolysis, and complement system. If your product is among those related, indicate it and we will inform you of the recommendation, regarding the tests to be performed.           

Possible tests to perform based on the requirements of the ISO standard for products in continuous contact with blood and methods followed in our laboratory:

Hemolysis:

  • Hemolysis test. UNE-EN ISO 10993-4: Biological evaluation of medical devices - Part 4: Selection of assays for interactions with blood, and ASTM method F 756-93.

Activation of the complement system:

  • Activation of the complement system. UNE-EN ISO 10993: 4: Biological Evaluation of Medical Devices, Part 4-Selection of tests for blood interactions; and ASTM F1984-99 (Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials).

Thrombogenicity:

  • Platelet and Leukocyte Count Test (Platelet Leucocyte Count) - ASTM Standard F2888-13: 2013.
  • Partial thromboplastin time: ASTM F2382-04: 2010. Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT). ASTM, 2010.

Pyrogenicity:

  • Material-induced pyrogenicity. ISO 10993-11: 2006-Biological Evaluation of Medical Devices, Part 11. Tests for Systemic Toxicity; European Pharmacopoeia, 2.6.8. Pyrogens).

Endotoxins:

  • Quantitative detection of endotoxins (European Pharmacopoeia 2.6.14: Method E - Chromogenic end-point method): LAL (Limulus Amebocyte Lysate) - Chromogenic test QCL-1000.