ForewordIntroductionScope, object and related standards* ScopeObjectCollateral standardsParticular standardsNormative referencesTerms and definitionsGeneral requirementsEssential performance* Additional requirements for essential performance* ME equipment or ME system parts that contact the patient* Additional requirements for pressurized gas inputOverpressure requirementCompatibility requirementGeneral requirements for testing of ME equipment* Additional requirements for the general requirements for testing of ME equipmentRespiratory high-flow therapy equipment test conditions* Gas flowrate specifications* Respiratory high-flow therapy equipment testing errorsClassification of ME equipment and ME systemsME equipment identification, marking and documentsInformation to be supplied by the manufacturerAdditional requirements for accessoriesExternal gas sourceAdditional requirements for marking on the outside of ME equipment or ME equipment partsUnits of measurementGeneralAdditional general requirements* Additional requirements for warnings and safety notices* Additional requirements for start-up procedureAdditional requirements for operating instructionsLay operator operating instructionsHealthcare professional operator operating instructionsCleaning, disinfection and sterilizationAdditional requirements for maintenanceAdditional requirements for accessories, supplementary equipment, used material* Additional general requirementsAdditional requirements for the technical descriptionProtection against electrical hazards from ME equipmentProtection against mechanical hazards of ME equipment and ME systemsAdditional requirements for instability from unwanted lateral movementGrips and other handling devicesAdditional requirements for audible acoustic energyProtection against unwanted and excessive radiation hazardsProtection against excessive temperatures and other hazards* Applied parts not intended to supply heat to a patientRisk of fire in an oxygen rich environment* Cleaning and disinfection of ME equipment or ME systemSterilization of ME equipment or ME systemBiocompatibility of ME equipment and ME systemsInterruption of the power supply/supply mains to ME equipment* Additional requirements for interruption of the power supply/supply mains to ME equipment alarm conditionAlarm conditionsAlternative power supply/supply mainsAccuracy of controls and instruments and protection against hazardous outputs* Accuracy of controls and instrumentsContinuous flow breathing-therapy modeFlowrate accuracyAccuracy of delivered oxygen concentrationUsability of ME equipmentProtection against hazardous outputOxygen monitor* Maximum limited pressure protection deviceFlowrate monitoringObstruction alarm condition* Protection against accidental adjustmentsHazardous situations and fault conditions for ME equipment* Additional specific single fault conditions* Independence of delivery control function and related risk control measures* Failure of one gas supply to respiratory high-flow therapy equipment* Programmable electrical medical systems (PEMS)GeneralConstruction of ME equipment* Mode of operationPre-use checkDelivered oxygen concentrationME systemsAdditional general requirements for ME systems* Accompanying documents of an ME systemElectromagnetic compatibility of ME equipment and ME systemsGas connectionsBreathing system connectors* GeneralOther named portsGeneralPatient-connection portAccessory portMonitoring probe portLow-pressure oxygen inletFlow-direction-sensitive componentsNebulization portHigh-pressure oxygen inlet connectorGas intake portRequirements for the breathing system and accessories* GeneralLabellingBreathing sets* Humidification systemBreathing system filter (BSF)Airway devices* Indication of duration of operationFunctional connectionGeneral* Connection to an electronic health record* Connection to a distributed alarm systemConnection for remote controlPower supply cordsRespiratory high-flow therapy equipment securityElectromagnetic disturbances — Requirements and tests* Compliance criteriaRequirements applicable to all ME equipment and ME systems* Additional general requirementsUsabilityPrimary operating functions* TrainingGeneral requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systemsSelection of default alarm preset* Operator alarm system loggingRequirements for medical electrical equipment and medical electrical systems used in the home healthcare environmentAdditional requirements for cleaning, disinfection and sterilizationGeneral requirements for mechanical strengthGuide to marking and labelling requirements for ME equipment and ME systems (informative)Marking on the outside of ME equipment, ME systems or their partsAccompanying documents, generalAccompanying documents, instructions for useAccompanying documents, technical descriptionSymbols on marking (informative)Particular guidance and rationale (informative)General guidanceRationale for particular clauses and subclausesData interface requirements (informative)Background and purposeData definitionReference to the IMDRF essential principles and labelling guidances (informative)Reference to the essential principles (informative)Reference to the general safety and performance requirements (informative)Terminology — Alphabetized index of defined terms (informative)Bibliography