NF EN ISO 80601-2-55/A1, S95-186-2-55/A1 (12/2023)

ISO 80601-2-55:2018 specifies particular requirements for the basic safety and essential performance of respiratory gas monitors (mgr), hereinafter referred to as em devices, intended for use in continuous service on a patient. ISO 80601-2-55:2018 specifies requirements relating to: - monitoring of anesthetic gases; - carbon dioxide monitoring; and - oxygen monitoring. NOTE 1 An mgr can be either a stand-alone em device or an em device integrated with another device, for example an anesthesia workstation or a ventilator. MGRs intended for use with flammable anesthetic agents are outside the scope of this document. If an article or paragraph is specifically intended to apply only to em devices or em systems, the title and content of that article or paragraph indicate this. If not, the article or paragraph applies to em devices and em systems, as applicable. Hazards inherent in the intended physiological function of em devices or em systems within the scope of this document are not covered by specific requirements in this document, with the exception of paragraphs 7.2.13 and 8.4 .1 of IEC 60601-1:2005+Amd 1:2012. NOTE 2 Additional information can be found in IEC 60601-1:2005+Amd 1:2012, 4.2.
(Automatic translation from French)