I agree with others about ISO10993.
I would also like to add a few points. Before a new biomaterial product is going into clinical practice, a few special considerations should be examined:

1. Product characterization: component-cellular, noncellular, combination …
2. Product safety: toxicity (acute/chronic damage to cells, tissues..); physiological effects (effects on vital signs: blood pressure, heart rate); tumorigenicity (propensity to form tumors as a result of implant); infectious disease; adverse immune response;
3. Efficacy
4. Preservation (the ability to preserve cells and tissues).
5. Regulations