Medical devices are bought for human use. The device has to be safe to use for the biological system and human body. In simple terms, this means that the device should be fit and non-toxic. When using the device in a biological setup, it should not pose any severe psychological threats.
This is where biocomp testing of the devices comes into existence. It helps evaluate the standards of the material used in the manufacturing of the device.
- The testing procedure helps certify the medical device so it can be used for testing purpose
- The process of testing involves evaluation and analysis of the device
- The experts will collect data on toxicity levels during the testing stage
Ø Basic testing procedure
In the basic testing procedure, the expert team will carry out the in-vitro screening of the medical device. The stage involves conducting the cytotoxicity testing of the selected medical device or gadget.
The expert team may also decide to conduct the chemical characterization and extractable leachable testing procedure for the device. These are generally conducted before the in-vitro screening procedure is performed.
Ø Mammalian cells testing
The process of cytotoxicity testing is mainly performed by the team on mammalian cells. Different types of tests are carried out which include direct, overlay and elution testing.
The main aim of carrying out these tests is to determine the chemicals and toxins level that is given out by the medical device when in contact with the mammalian cells in the culture medium. If the material is unsafe then it will be highlighted in the testing reports.
Ø Leachables and extractable detection
Extractable and leachable are related to the chemical characterization of the material used in the manufacturing process. The extractable is extracted from the medical device at pre-decided temperature conditions.
The testing is performed for the device and all its components. If toxic materials or chemicals are given out by the device, then it is rated as unsafe for human use or contact. The testing procedures are performed as per the ISO standards.
Ø Extract and direct methods
Extract and direct methods are conducted by the experts as a part of the hemolysis testing procedure. This testing is important as it helps in deciding the adverse effects any medical device may offer on human contact.
Experts carry out the hemolysis biocompatibility for medical devices testing to study the adverse effects it may have on human blood cells as well. As per the standards, the raw materials used in the manufacturing process must be biodegradable as well.
Ø Right testing method selection
In general, the testing method the expert team may select mainly depends on the usage of the medical device. The testing may not be the same for devices that are being used for internal and external use. In both cases, the toxicity levels might not be the same.
It is essential that the testing be carried out on the devices before they are put to human use in the labs and other use. Any type of bio testing procedure will take over a few weeks to complete. The safety of the device is only decided if the reports have been submitted after the testing.
