IEC 60601-2-18 Medical Electrical Equipment - Special Requirements for Essential Safety and Essential Performance of Endoscopic Equipment

Medical Device Tests

IEC 60601-2-18 Medical Electrical Equipment - Special Requirements for Essential Safety and Essential Performance of Endoscopic Equipment

IEC 60601-2-18 specifies certain essential safety and essential performance requirements for endoscopic equipment. The minimum safety requirements set forth in this particular standard are considered to provide a practical degree of safety in operating endoscopic equipment.

IEC 60601-2-18 Medical Electrical Equipment - Special Requirements for Essential Safety and Essential Performance of Endoscopic Equipment

IEC 60601-2-18 replaces and supplements IEC 60601-1. This third edition supersedes and supersedes the second edition and Amendment 1996 published in 1. This edition constitutes a technical revision and has been harmonized with IEC 60601-1.

The main changes from the previous edition include:

  • Aligning the requirements with IEC 60601-1:2005;
  • Inclusion of key performance requirements;
  • Standard coverage of powered endoscopes and powered endotherapy devices used through second and subsequent punctures;
  • Reference to IEC 60601-2-2 instead of defining different tests for dielectric strength testing of HF powered endotherapy devices.

EUROLAB assists manufacturers with IEC 60601-2-18 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.

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