When working on a brand new biomaterials which has never been used or made in medical device you will need to do all standard ISO (International Standard Organization) evaluating test which basically depend on what body contacts will be involved and contact duration as well.
In general, the tests that will be needed to find out the initial biocompatibility of the material will basically be the cytotoxicity, sensitization and irritation. this will be the basic test needed for most biomaterials. They differ in test depending on the kind of body contact and how long is going to stay in the body or on the surface of the body. For example the orthopedic, since this relates to Bone and is an implant device, at the initial stage the biocompatibility test that would be needed will be cytotoxicity, sensitization, irritation, systemic toxicity and since bone implant is a permanent implant it will also include: sub-chronic (sub-acute) toxicity and genotoxicity implantation. But if it is a neural biomaterial that has to do with circulation of blood it will test for hemocompatibility.
In a nutshell, every new biomaterial biocompatibility will vary depending on body contacts and contact duration as long as it follows the ISO standard 10993-1 which categorizes devices based on nature and duration of contact and what testing will be applicable.
Standard ISO 10993 testing which will help us determine the fitness of a device for human use, and to see whether use of the device can have any potentially harmful physiological effects.In orthopedics, biomaterials are generally chosen for their strength or for mimicking the structure and properties of bone. These desired interface can be tested using standard ISO testing.
As previously said, when it comes to implants or orthopedics, it is critical to adhere to the ISO 10993 table. When it comes to brain biomaterials or medicines used to help in other parts of the body, an ADME test should also be considered. This will help us to determine whether the medicines' absorption, distribution, metabolism, and excretion are appropriate. It's critical to ensure that medicines reach their intended location safely and that they react as predicted.