Any medical device or accessory launched should always be safe for human use and the environment. The biological system can easily get polluted if the device gives out pollutants. Any device may start disintegrating pollutants on reaching specific temperature and pressure conditions.
Effective biocompatibility testing is the right solution to ensure the device launched is safe for humans and the biological system.
Ø Why is this testing performed on devices?
The main reason to carry out this testing is to help determine the overall health and toxicity of the device. Any medical and biological device has to be safe for human use or application. Even if it has to be used as a dental implant, the material should not be hazardous to your health.
The testing is carried out by the professional team. Once the testing is done, they will be able to determine the safety levels of the device.
Ø How the testing is conducted?
This type of testing is considered highly reliable. The top benefit of undergoing bio-comp testing is that it is always carried out in multiple stages. The expert team will carry out the testing and collect data at different stages.
- The collected data is analyzed by experts using the Vitro screening process
- Once the data is analyzed, confirmatory testing is performed
- The verification report is produced at the end of the testing procedure
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Testing needs extensive planning
The entire testing system has been designed to protect human life. This is why the testing process is conducted only after relevant data has been extracted and analyzed. The data is documented for future and current use.
The data that is extracted is always evaluated to determine the safety and the hazards of using any medical device or accessories. This is one of the most important factors especially if any device will stay in human touch for an extended period. This testing will also help in evaluating the safe time limits till when the human body can safely be exposed to any medical device or equipment.
Ø What is conducted during this testing?
The testing procedure will always be conducted to analyze the material used in the manufacturing of the medical device or any other part. If the device or its part will extract any leachable material on reaching specific temperatures, then potential harm and threats are evaluated.
In general, biocompatibility testing for dental materials will analyze the cytotoxicity and the harsh chemicals that raw material might extract under specific conditions. If the chemicals are harmful to the human body, then it is of concern to the authorities.
Ø Turnaround time
In general, any such testing will offer a turnaround rate ranging from one or two months to over several months or a year. It mainly depends on the type of material that has to be tested. They may also range from implantation testing to skin irritability testing.
The main motive of the testing is to analyze the entire data that has been collected during the procedure. The data is only interpreted by a professional team. The results are produced and analyzed. This is important for the safety of the humans and the device.
