DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN IEC 60601-2-76
; VDE 0750-2-76:2024-09
Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment (IEC 60601-2-76:2018 + AMD1:2023); German version EN IEC 60601-2-76:2019 + A1:2023
Medizinische elektrische Geräte - Teil 2-76: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Niedrigenergie-Ionengas-Hämostasegeräten (IEC 60601-2-76:2018 + AMD1:2023); Deutsche Fassung EN IEC 60601-2-76:2019 + A1:2023
Overview
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LOW ENERGY IONIZED GAS HEMOSTATIC EQUIPMENT. The minimum safety requirements specified in these particular requirements are considered to be a reasonable level of safety for the operation of LOW ENERGY IONIZED GAS HEMOSTATIC EQUIPMENT. These particular requirements modify and supplement IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance", hereinafter referred to as the General requirements (see 201.1.4). The requirements are followed by specifications for the corresponding tests. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general requirements. The standard differs from DIN EN IEC 60601-2-76 (VDE 0750-2-76):2020-02 as follows: a) adaptation of terms and definitions in accordance with IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
