With one of the fastest areas of growth for plastics being the Medical Device Industry, there has been an increased demand for biocompatibility testing. One aspect of evaluating whether a device is safe for use is to test the components of the device. According to USP (United States Pharmacopeia), there are six plastics classes ranging from I to VI, with class VI being the strictest. Many plastics manufacturers find that it is beneficial to be USP Class VI certified, especially if the end use is a medical device. It is often an important level of assurance to give customers who are looking for device component materials. Additionally, many products not regulated by the FDA as “medical devices” may still be used in a laboratory setting. The extra assurance given by USP Class VI certification may be important.
There are three in vivo tests involved in the classification of plastics. The Systemic Injection Test and the Intracutaneous Test are designed to determine the systemic and local biological responses to plastics and other polymers by the single-dose injection of specific extracts prepared from a sample. The third test, the Implantation Test, is designed to evaluate the reaction of living tissue to a test material. The testing for the six different class plastics levels is all done using different combinations of these three tests and different extracts.
Pacific BioLabs is able to perform these tests in-house and is more than happy to assist you with your project or answer any questions that you may have. Click on the links for more info on USP Class VI testing or for a full list of our testing services. If you have further questions or would like a quote, please do not hesitate to contact us.