CEN EN ISO 80601-2-55 PDF

This document 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 OPERATIONforusewithaPATIENT.

Thisdocumentspecifies requirementsfor

— anaestheticgasmonitoring,

— carbondioxidemonitoring,and

— oxygenmonitoring.

NOTE1 AnRGM can beeitherstand‐aloneME EQUIPMENTorintegratedintootherequipment,e.g.ananaesthetic workstationoraventilator.

Thisdocumentisnotapplicabletoan RGMintendedforuse withflammable anaestheticagents.

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 subclauseappliesbothtoME EQUIPMENTandtoME SYSTEMS,asrelevant.

HAZARDS inherentintheintendedphysiologicalfunctionofME EQUIPMENTorME SYSTEMSwithinthescope of this document are not covered by specific requirements in this document except in IEC60601‐1:2005+Amd1:2012+Amd2:2020 7.2.13and8.4.1.

NOTE2 Additional information can be found in IEC60601‐1:2005+Amd1:2012+Amd2:2020,4.2.