The Importance of Medical Grade Ink
Syringes, catheters, and medical tubing are just a few examples of medical devices used in operating rooms, decorated with ink, that may come in contact with the human body.
Therefore, certain standards and regulations have been put into place by government agencies to ensure biocompatibility.
Determining the most suitable ink system for your medical device can be difficult. Most major ink manufacturers offer suitable Class VI medical grade ink. However, in our experience, select ink systems offer better adhesion than others for certain brand name substrates. Adhesion is key!
Medical Grade Ink Tests
Medical devices may require USP Class VI testing to ensure biocompatibility safety. It is the responsibility of the medical device manufacturer to perform biocompatibility testing. Manufacturers should contact the FDA for appropriate testing requirements. Below are a few biocompatibility testing examples.
Acute Systemic Toxicity Test
The acute systemic toxicity test measures the potential adverse effect of the use of medical devices or its materials when injected into the body over a 72 hour period.
The intracutaneous test measures the reaction of the body’s tissues when introducing a medical device or its materials between the layers of the skin over a 72 hour period.
The implantation test measures the response of live tissue when the material is implanted inside a live animal over a 5 day period.