Biological safety cabinet belongs to the medical device. Medical device, refers to the use of the human body alone or in combination with instruments, equipment, apparatus, materials or other items, including the required software; its use on the surface of the human body and in vivo is not obtained by means of pharmacology, immunology or metabolism, but there may be these means of participation and play a certain role in assisting; its use is intended to achieve the following intended purpose: (a) the prevention, diagnosis, treatment of disease, monitoring, and palliation; (ii) diagnosis, treatment, monitoring, palliation, and compensation for injury or disability; (iii) study, substitution, and regulation of anatomical or physiological processes; and (iv) pregnancy control.
August 6, 2004, the State Food and Drug Administration issued "on the chest drainage regulator and other products classified and defined notice" (State Food and Drug Administration Measures [2004] No. 385) is clearly as Class III medical device management: low-power ultrasound oncology therapeutic instrument, biological safety cabinets. So the biological safety cabinet is a medical device.