Blood Compatibility Testing

What is Blood Compatibility?

Blood compatibility refers to the desired response of blood to exogenous substances or materials. It generally indicates the compatibility between materials and various blood components.

Blood Compatibility Testing Standards

- ISO 10993-4

- ASTM F756

- GB/T 16886.4

Hemolysis Test:

Hemolysis refers to the rupture and dissolution of red blood cells. The hemolysis test observes whether the test material causes hemolysis or red blood cell aggregation.

Test Principle:

Negative control and positive control are exposed to fresh diluted rabbit anticoagulant blood. The absorbance at 545 nm wavelength is measured using a Shimadzu UV-visible spectrophotometer.

Test Result Judgment:

If the negative control tube shows no hemolysis or aggregation and the positive control tube shows hemolysis, the test sample is considered compliant if no hemolysis or aggregation occurs within 3 hours. If hemolysis and/or aggregation occurs within 3 hours in the test sample tube, the sample is considered non-compliant.

Blood Compatibility Testing Timelines

- Hemolysis Test (Rabbit Blood/Human Blood) ISO 10993: 1 week, please contact for details

- Hemolysis Test (Rabbit Blood/Human Blood) ASTM F756: 2 weeks, please contact for details

- Coagulation Test (APTT, PT, TT, Fbg): 8 weeks, please contact for details

- Platelet Count: 1-2 weeks, please contact for details

- In Vitro Thrombus Formation: 2-3 weeks, please contact for details

Sample Requirements

- One complete sample: 150 cm² or 5 grams

- Three complete samples: 50 cm² or 2 grams each

For more information or specific details regarding the testing process and requirements, please contact the relevant testing authority.