Designation:F1456–01StandardSpecificationforMinimumPerformanceandSafetyRequirementsforCapnometers1ThisstandardisissuedunderthefixeddesignationF1456;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(e)indicatesaneditorialchangesincethelastrevisionorreapproval.INTRODUCTIONThemeasurementofcarbondioxideinagaseousmixturehasbecomeacommonpracticeinmanyareasofclinicalmedicine,suchasanesthesia,pediatrics,respiratorycare,andintensivecare.Thisspecificationestablishesminimumsafetyandperformancerequirementsforcapnometersbasedonparametersthatareachievablewithinthelimitsofexistingtechnology.AppendixX1containsarationaleforthemostimportantrequirements.Itisincludedtoprovideadditionalinsightforthereasoningthatledtotherequirementsandrecommendationsthathavebeenincorporatedintothisspecification.ThisspecificationusesIEC601-1:1988includingAmendment1and2(hereaftercalledtheGeneralStandard)formanyofthegeneralrequirementsforsafety.AdditionalrequirementsspecifictocapnometersbeginatClause60.SECTIONONE—GENERALTheclausesandsubclausesofthissectionoftheGeneralStandardapplyexceptasfollows:1.Scope1.1ThisclauseoftheGeneralStandardappliesexceptasfollows:1.1.1Thisspecificationappliestocapnometersforusewithadults,children,andneonates.1.1.2Itdoesnotapplytoqualitativedevicesordevicessolelyintendedforuseascutaneousmonitors.1.1.3Itdoesnotapplytodevicesintendedforuseinlaboratoryresearchapplicationsornonhumanapplications.1.1.4Thisspecificationdoesnotapplytocapnometersintendedforusewithflammableanestheticmixtures.1.1.5Thisspecificationdoesnotapplytodevicesthatareintendedforuseinsingle-breath,spot-check,ornoncontinuousmonitoringapplications.2.ReferencedDocuments2.1Thefollowingstandardscontainprovisions,whichthroughreferenceinthisspecificationconstituteprovisionsofthisspecification.Atthetimeofpublicationofthisspecifica-tion,theeditionsindicatedwerecurrent.Allstandard...
