UNE EN IEC 60601-2-76:2019
Medical Electrical Equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment (Endorsed by Asociación Española de Normalización in July of 2019.)
Equipos electromédicos. Parte 2-76: Requisitos particulares para la seguridad básica y funcionamiento esencial de los equipos de coagulación de gas ionizado. (Ratificada por la Asociación Española de Normalización en julio de 2019.)
| Označení normy: | UNE EN IEC 60601-2-76:2019 |
| Počet stran: | 35 |
| Vydáno: | 2019-07-01 |
| Status: | Norma |
UNE EN IEC 60601-2-76:2019
201.1.1 Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LOW ENERGY IONIZED GAS HAEMOSTASIS EQUIPMENT hereafter referred to as ME EQUIPMENT. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the General Standard. 30 201.1.2 Object Replacement: The object of this particular standard is to establish particular requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of LOW ENERGY IONIZED GAS HAEMOSTASIS EQUIPMENT as defined in 201.3.207.