UNE EN ISO 80601-2-55:2018
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018) (Endorsed by Asociación Española de Normalización in April of 2018.)
Equipos electromédicos. Parte 2-55: Requisitos particulares para la seguridad básica y el funcionamiento esencial de los monitores de gas respiratorio (ISO 80601-2-55:2018) (Ratificada por la Asociación Española de Normalización en abril de 2018.)
| Označení normy: | UNE EN ISO 80601-2-55:2018 |
| Počet stran: | 76 |
| Vydáno: | 2018-04-01 |
| Status: | Norma |
UNE EN ISO 80601-2-55:2018
IEC 60601-1:2005+AMD1:2012, 1.1 is replaced by: This document specifies particular requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE o f a RESPIRATORY GAS MONITOR (RGM), hereafter referred to as ME EQUIPMENT, intended for CONTINUOUS OPERATION for use with a PATIENT. This document specifies requirements for anaesthetic gas monitoring, carbon dioxide monitoring, and oxygen monitoring. NOTE 1 An RGM can be either stand-alone ME EQUIPMENT or integrated into other equipment, e.g. an anaesthetic workstation or a ventilator. This document is not applicable to an RGM intended for use with flammable anaesthetic agents. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. 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 IEC 60601-1:2005+AMD1:2012, 7.2.13 and 8.4.1. NOTE 2 Additional information can be found in IEC 60601 1:2005+AMD1:2012, 4.2.
