Norm

NEN-EN-ISO 80601-2-55:2012 en

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

161,21

Over deze norm

Status Definitief
Aantal pagina's 52
Commissie Anesthesie- en beademingssystemen
Gepubliceerd op 01-01-2012
Taal Engels
This International Standard 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 International Standard specifies requirements for - anaesthetic gas monitoring, - carbon dioxide monitoring, and - oxygen monitoring. 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 standard are not covered by specific requirements in this particular standard, except in 7.2.13 and 8.4.1 of the general standard (IEC 60601-1).

Details

ICS-code 11.040.10
Nederlandse titel Medische elektrische toestellen - Deel 2-55: Bijzondere eisen voor basisveiligheid en essentiƫle prestaties van ademhalingsgassenmonitoren
Engelse titel Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
Vervangt
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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