Determining the conformity of the surgical diode lasers of the «Photonica Plus Сo» to the requirements of safety standards for medical laser devices

The article considers the issue of protecting patients, medical or service personnel, from unwanted, potentially hazardous laser radiation during the operation of surgical diode lasers of the domestic «Fotonica Plus Co». The main technical characteristics of the surgical diode lasers «LIKA-Surgeon» and «LIKA-Surgeon+» of this manufacturer are given. The results of the «LIKA-Surgeon» laser tests, which relate to protecting people from unwanted laser radiation, are provided. Analysis of the obtained results showed that the product ensures user safety in accordance with the requirements of standards for the safety of medical lasers. It is noted that the manufacturer conducts clinical observations of its products after their implementation, which meets the requirements set forth in the new EU Regulation 2017/745 on medical devices.