DIN EN ISO 10651-2
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004); German version EN ISO 10651-2:2009
Beatmungsgeräte für die medizinische Anwendung - Besondere Festlegungen für die grundlegende Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Teil 2: Heimbeatmungsgeräte für vom Gerät abhängige Patienten (ISO 10651-2:2004); Deutsche Fassung EN ISO 10651-2:2009
Overview
Part 2 and Part 6 of the DIN EN ISO 10651 series apply for lung ventilators for ventilatory support of patients which are mainly intended for home care use and which are suitable without continuous professional supervision. The requirements for basic performance of the lung ventilators are specified. This includes requirements for the pneumatic driving-power supplies, spontaneous breathing during power failure, alarm conditions, connectors and the gas leakage from gas supply connections. Furthermore, the standard contains requirements for identification, marking and information to be supplied by the manufacturer. With respect to the editions of August 2009, the information on the transient flow given in 10.101 (Pneumatic driving-power supplies) has been corrected from "200 ml/s" for 3 s to "200 l/min" for 3 s. The standards have been prepared by ISO/TC 121/SC 3 "Lung ventilators and related equipment" (secretariat: ANSI, USA) in collaboration with CEN/TC 215 "Respiratory and anaesthetic equipment") (secretariat: BSI, United Kingdom). The responsible German committee is Working Committee NA 053-03-01 AA "Anästhesie und Beatmung" ("Anaesthesia and respiration") at NARK.
