"Liquid Nitrogen-based Cryoprotectant Chiller
A powerful but compact chiller with a small footprint is desirable for use in the operating room for cooling cryoprotectant perfusion circuits. Suspended Animation has developed such a chiller about the size of a compact, desktop laser printer. It is currently in use at SA for cooling a cryoprotection training circuit used with pig cadavers.
The next generation of this chiller may be used for patient cryoprotection in SA's operating room and for field-level cryoprotection in the future." (Emphasis added.)
Is any type of approval needed for these activities? If so, does SA have such approval?