ISO 80601-2-55 Medical Electrical Equipment - Special Requirements for Basic Safety and Basic Performance of Respiratory Gas Monitors

Medical Device Tests

ISO 80601-2-55 Medical Electrical Equipment - Special Requirements for Basic Safety and Basic Performance of Respiratory Gas Monitors

ISO 80601-2-55 specifies specific requirements for the essential safety and essential performance of a respiratory gas monitor (rgm), hereinafter referred to as me equipment, intended for continuous use with a patient.

ISO 80601-2-55 Medical Electrical Equipment - Special Requirements for Basic Safety and Basic Performance of Respiratory Gas Monitors

ISO 80601-2-55 specifies the following requirements;

  • Anesthetic gas monitoring;
  • carbon dioxide monitoring;
  • Oxygen monitoring.

ISO 80601-2-55 does not apply to an rgm intended for use with flammable anesthetics.

If an article or sub-article is specifically intended to apply only to my equipment or only to my systems, the title and content of that article or sub-article will indicate this. If this is not the case, the item or sub-clause applies to both my equipment and my systems, as relevant.


EUROLAB assists manufacturers with ISO 80601-2-55 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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