Norm

NEN-EN-ISO 80601-2-55:2018 en

Medische elektrische toestellen - Deel 2-55: Bijzondere eisen voor basisveiligheid en essentiële prestaties van ademhalingsgassenmonitoren

161,21 195,06 Incl BTW

Over deze norm

Status Definitief
Aantal pagina's 59
Commissie Anesthesie- en beademingssystemen
Gepubliceerd op 01-03-2018
Taal Engels
NEN-EN-ISO 80601-2-55 specifies particular requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of 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. 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+Amd 1:2012, 7.2.13 and 8.4.1.

Details

ICS-code 11.040.10
Nederlandse titel Medische elektrische toestellen - Deel 2-55: Bijzondere eisen voor basisveiligheid en essentiële prestaties van ademhalingsgassenmonitoren
Engelse titel Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
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