Haemocompatibility
#MEDISTRI
#MEDISTRI
Medistri continues to be at the forefront of regulatory requirements and quality proficiency.Haemocompatibility, also known as hemocompatibility, is a crucial aspect of biocompatibility testing for medical devices that come into contact with blood. It evaluates the interactions between the medical device and blood components to ensure that the device does not adversely affect blood or cause harmful reactions when used as intended.
Haemocompatibility is a critical aspect of biocompatibility testing for medical devices because it specifically addresses the compatibility of a device with blood. Medical devices that contact blood must not trigger adverse reactions, such as:
Blood Clotting: Devices must not cause unnecessary thrombosis, which can lead to dangerous clots obstructing blood vessels.
Immune Response: They should not activate the body’s immune system in a way that could result in inflammation or other harmful reactions.
Blood Cells: They must not damage blood cells, which could impair oxygen delivery or cause other issues.
Coagulation: They should not interfere with the blood’s natural coagulation process unless intended as part of the therapeutic effect.
Ensuring haemocompatibility is vital for the safety and efficacy of medical devices, as any negative interaction with blood can lead to serious complications for patients.This is why rigorous testing is conducted following standards like ISO 10993-4 to ensure that devices meet these important criteria before they are approved for clinical use.
Haemocompatibility is a range of tests that assess different aspects of blood-device interaction, such as Haemolysis, Thrombosis, Coagulation, Platelet Activation, Complement Activation and Hematology. Each of these tests contributes to a comprehensive understanding of the device’s haemocompatibility, ensuring it is safe for use in contact with blood.
ISO 10993-4:2017 is part of a series of standards that aim to ensure the safety of medical devices by providing a framework for manufacturers to evaluate and demonstrate their products’ biocompatibility. This particular part of the standard is crucial for devices that will come into contact with blood, ensuring they do not cause adverse effects when used in clinical settings.
🎯 To learn more about Medistri’s Haemocompatibility, visit on our website here or directly contact our team at contact@medistri.swiss.
- The Medistri Team
#Medistri
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