Hemolysis (direct & indirect)

1. Biological Effect: Hemocompatibility Tests 
2. Turnaround time: 6 weeks
3. Sample Requirements:

ISO

120 cm² (test item < 0.5 mm thick);
60 cm² (test item ≥ 0.5 mm thick);
4 grams;
20 ml;
at least 6 test items;

ISO 10993-4

The purpose of the study is to determine the potential hemolytic activity of the medical device and its extract on human blood. The test item is tested in parallel in an indirect (extract in CMF-PBS) and a direct way (medical device). After exposition of the blood to the device, the hemolytic effect is assessed by the amount of free hemoglobin in the sample.