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Exploration in the Evaluation Method in the Safety of Minimally Invasive Surgery (MIS)

  • Yuan Xing,
  • Shuxin Wang,
  • Ke Liang,
  • Shunkang Niu,
  • Jinhua Li

摘要

For MIS robots, safety is the premise to ensure the predetermined performance and achieve all functions, and the implementation of any operation should meet the corresponding safety conditions. As a class III medical device, da Vinci surgical robot system must be evaluated scientifically by FDA to verify its effectiveness, reliability and safety before it can be certified.