DIN Standards Committee Rescue Services and Hospital
DIN EN ISO 80601-2-69
Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014); German version EN ISO 80601-2-69:2014
Medizinische elektrische Geräte - Teil 2-69: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale für Sauerstoff-Konzentratoren (ISO 80601-2-69:2014); Deutsche Fassung EN ISO 80601-2-69:2014
In recent years the use of oxygen concentrators for patients with long term oxygen therapy in home healthcare environment has been established as a method of treatment . The goal of the therapy is to keep the oxygen saturation above 90 % in patients that require supplemental oxygen. This standard covers the particular requirements for basic safety and essential performance of oxygen concentrators in combination with its accessories. Compared with standard DIN EN ISO 8359:2009-08, both the accompanying documents of the manufacturer as well as the technical requirements as and the associated test methods have been completely revised. During this process, DIN EN ISO 8359:1006/A1:2012-10 has been incorporated into the standard including specifications and test methods for the reduction of fire risks. The standard has been prepared by ISO/TC 121/SC 3 "Lung ventilators and related equipment" (secretariat: ANSI, USA), in collaboration with CEN/TC 215 "Anaesthetic and respiratory equipment" (secretariat: BSI, United Kingdom). At DIN, Working Committee NA 053-03-01 AA "Anästhesie und Beatmung" ("Anaesthesia and artificial respiration") at NARK is responsible.