Hemolysis Testing for Medical Devices | EN ISO 10993-4
The Nanolab Laboratories Group is an accredited laboratory that supports the research, development, manufacturing, and approval of medical devices, adhering to numerous national and international standards and regulations. Given their direct or indirect contact with humans, one of the tests performed on medical devices is the hemolysis test, which measures the destructive effect of the medical device on blood cells (erythrocytes).
The hemolysis studies performed within the scope of biocompatibility testing are documented by us as internationally valid, in accordance with standard EN ISO 10993-4 and GLP Standards (Good Laboratory Practice).
What is Hemolysis?
Hemolytic activity was defined above as the measurement of a medical device's destructive effect on blood cells (erythrocytes). All medical devices or materials that come into contact with blood are expected not to destroy or damage red blood cells. From this perspective, hemolysis testing is required for the following product groups:
- Intravascular catheters
- Blood filtration systems
- Stents
- Dialysis devices
- All medical devices that come into direct contact with blood
Overview of Standard EN ISO 10993-4
EN ISO 10993-4 is an international standard for the biological evaluation of medical device surfaces that come into contact with blood. It also encompasses hemolysis testing within the scope of blood compatibility assessments. To clearly define a product's safety profile and scientifically ascertain whether products may potentially harm blood cells, testing in accordance with this standard is of considerable importance.
Reliable Analyses in Accordance with GLP Standards
As a laboratory holding an OECD Statement of Compliance for 'Good Laboratory Practice', we conduct medical device processes in strict adherence to GLP standards.
Our Scope of Services:
- Hemolytic Effect Tests in Accordance with Standard EN ISO 10993-4
- GLP-Certified, Internationally Valid Analysis Reports
- Biological Safety Assessment of Medical Devices
Why Choose Us
Explore our services to effectively demonstrate the biological safety of your medical devices, thereby facilitating seamless market entry into international markets. We perform tests in accordance with EN ISO 10993-4, ensuring compliance with regulatory requirements by certifying that your products are safe for human health.