DIN EN ISO 80601-2-55
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018 + Amd 1:2023); German version EN ISO 80601-2-55:2018 + A1:2023
Medizinische elektrische Geräte - Teil 2-55: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Überwachungsgeräten für Atemgase (ISO 80601-2-55:2018 + Amd 1:2023); Deutsche Fassung EN ISO 80601-2-55:2018 + A1:2023
Overview
This document specifies particular requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of a RESPIRATORY GAS MONITOR (RGM), hereafter referred to as ME EQUIPMENT, intended for CONTINUOUS OPERATION for use with a PATIENT. This Amendment includes, among other things, the updating of references, the revision of warnings and safety notes, and revision of Table 201.103. This document (EN ISO 80601-2-55:2018/A1:2023) has been prepared by Technical Committee ISO/TC 121 "Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215 "Respiratory and anesthetic equipment", the secretariat of which is held by BSI (United Kingdom). The responsible national standardization committee is Working Committee NA 176-05-03 AA "Anesthesia and artificial respiration" at DIN Standards Committee Health Technologies (NAGesuTech).
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 176-05-03 AA - Anaesthesia and artificial respiration
Responsible european committee
CEN/TC 215/WG 1 - Anaesthetic machines and related equipment
