ISO 80601-2-13 Medical Electrical Equipment - Special Requirements for Basic Safety and Basic Performance of an Anesthetic Workstation

Medical Device Tests

ISO 80601-2-13 Medical Electrical Equipment - Special Requirements for Basic Safety and Basic Performance of an Anesthetic Workstation

ISO 80601-2-13 applies to the basic safety and essential performance of an anesthetic workstation for administering inhalation anesthesia while under the constant supervision of a professional operator. Specifies the specific requirements for a complete anesthetic workstation and workstation components that can be used in conjunction with other related anesthetic workstation components, although they are considered separate devices in their own right.

ISO 80601-2-13 Medical Electrical Equipment - Special Requirements for Basic Safety and Basic Performance of an Anesthetic Workstation

Anesthetic workstation components;

  • Anesthetic gas delivery system;
  • Anesthetic respiratory system;
  • Anesthetic gas cleaning system;
  • Anesthetic steam delivery system;
  • anesthetic ventilator;
  • imaging equipment;
  • Alarm system;
  • Protection device.

ISO 80601-2-13 is also applicable to accessories whose manufacturers are intended to be attached to the anesthetic workstation and where the characteristics of these accessories may affect the core safety and core performance of the anesthesia workstation.

If a substance or sub-substance is specifically intended to be applicable only to anesthetic workstation components, the title and content of that substance or sub-article shall indicate this. If this is not the case, the substance or sub-substance applies to both the anesthetic workstation and its individual components, as applicable.


EUROLAB assists manufacturers with ISO 80601-2-13 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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