ONORM EN ISO 80601-2-70:2021

Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment (ISO 80601-2-70:2020)

IEC 60601-1:2005+AMD1:2012+AMD2:2020, section 1 applies with the following exceptions: IEC 60601-1:2005+Amendment 1:2012, 1.1 is replaced by: This document applies to the basic safety and essential performance of sleep apnea breathing therapy devices, hereinafter referred to as ME devices intended to alleviate the symptoms of patients suffering from obstructive sleep apnea by providing these patients with therapeutic respiratory pressure in the respiratory tract. Sleep apnea breathing therapy devices are intended for use both in medical care in the home environment by non-expert operators and in healthcare facilities. For sleep apnea breathing therapy devices, no use of physiological closed control systems is assumed unless a physiological patient variable is used to adjust therapy settings. This document does not cover sleep apnea breathing therapy devices for neuge...