Hemolytic Impact Tests for Medical Devices | EN ISO 10993-4
The NanoLab Laboratories Group is an accredited laboratory that supports the research, development, manufacture and approval of medical devices and complies with numerous national and international standards and regulations. Due to their direct or indirect contact with people, one of the tests performed on medical devices is the hemolytic effect test, in which the destructive effect of the medical device on blood cells (erythrocytes) is measured.
The hemolysis tests carried out as part of the biocompatibility tests are carried out by us in accordance with the standard EN ISO 10993-4 and the GLP standards (good Laboratory practice) internationally validly documented.
What is hemolysis?
The hemolytic effect was defined above as a measurement of the destructive effect of a medical device 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, the hemolysis test is required for the following product groups:
- Intravascular Catheters
- Blood filter systems
- Stents
- Dialysis devices
- All medical devices that come into direct contact with blood
Brief information on the standard EN ISO 10993-4
EN ISO 10993-4 is an international standard for the biological evaluation of medical products surfaces that come into contact with blood. It also includes hemolysis tests as part of the blood impact tests. In order to clearly present the safety profile of a product and to scientifically determine whether products can potentially damage blood cells, tests according to this standard are of great value.
Reliable analyzes according to GLP standards
As a laboratory with the OECD declaration of conformity “Good Laboratory Practice”, we carry out medical device processes in accordance with the GLP standards.
Our scope of services:
- Hemolytic Efficacy Tests in accordance with EN ISO 10993-4 standard
- GLP-certified, internationally valid analysis reports
- Biological safety assessment of medical devices
Why we
Discover our services so that you can demonstrate the biological safety of your medical devices and complete the entry into the international market smoothly. We perform tests in accordance with EN ISO 10993-4 and meet the legal requirements by reporting that your products are harmless to human health.