Laparoscopic Robot Safety Compliance, Evaluation Development Tool and Application

In recent years development of new and more efficient laparoscopic devices that serve to improve the experience for both patients and surgeons. Most studies performed are with laboratory tests and few promising ones have gone to clinical studies for use and evaluation on humans. It is utmost important especially in the biomedical engineering field that the device should be evaluated using the best possible safety protocol which is tailored to machines working directly or in contact with humans. In the present situation, only few standards discuss the issue of using robots in human clinical trials. This paper goes to a review of the existing materials to evaluate a robot that works within this type of utilization for a specific preparation for the device to be considered as ready for use in a clinical investigation. This process commonly uses standards that give a general recommendation for how a device should work to be deemed safe. In practice, these standards recommendations are organized into a checklist for the evaluation of the safety level of a; laparoscopic robot.