As the other before me have said, the biomedical device will have to comply with ISO 10993. This means that the medical device in question cannot harm a subject depending on the application. This can be viewed in the toxicity chart from this week’s lecture. You’ll have to narrow down your device into a category related to the body contact involved with the device (surface, external communicating, or implant). After that you’ll have to further narrow down the type of device until you get to the point where you can see what biological effects you have to test for for your particular medical device. Typically, all devices will have to test for cytotoxicity, sensitization, and irritation or intracutaneous reactivity. Other tests may have to be performed for effects such as genotoxicity if the device is more invasive.