Philips Expression MR400 - Page 370

A‐2Specifications ExpressionMR400InstructionsforUse
•IEC60068‐2‐64,EnvironmentalTesting–Part2:TestMethodsTestFH:VibrationBroad‐bandRandom(Digital
Control)andGuidance
•IEC60601‐1‐2,MedicalElectricalEquipmentPart1‐2:GeneralRequirementsforSafety‐CollateralStandard:
ElectromagneticCompatibility‐RequirementsandTests
•IEC60601‐
1‐6,MedicalElectricalEquipment‐Par t1‐6:GeneralRequirementsforSafety‐CollateralStandard:
Usability
•IEC60601‐1‐8,MedicalElectricalEquipment–Part1‐8:GeneralRequirementsforBasicSafetyandEssential
Performance–CollateralStandard:GeneralRequirements,TestsandGuidanceforAlarmSystemsinMedical
ElectricalEquipmentandMedical
ElectricalSystems
•IEC60601‐2‐27,ParticularRequirementsforSafety‐SpecificationforElectrocardiographicMonitoring
Equipment
•IEC60601‐2‐33,Particularrequirementsforthesafetyofmagneticresonance equipmentformedicaldiagnosis
•IEC60601‐2‐34,MedicalElectricalEquipment–Part2‐34:ParticularRequirementsfortheSafety,Including
EssentialPerformance,ofInvasive
BloodPressureMonitoringEquipment
•IEC60601‐2‐49,MedicalElectricalEquipment‐Part2‐49:ParticularRequirementsfortheSafetyof
MultifunctionPatientMonitoringEquipment
•IEC80601‐2‐30,MedicalElectricalEquipment‐Part2‐30:ParticularRequirementsfortheSafety,Including
EssentialPerformance,ofAutomaticCyclingNon‐InvasiveBloodPressureMonitoringEquipment
•ISO
80601‐2‐61,MedicalElectricalEquipmentParticularRequirementsfortheBasicSafetyandEssential
PerformanceofPulseOximeterEquipmentforMedicalUse
•ISO80601‐2 ‐55,MedicalElectricalEquipmentParticularRequirementsfortheBasicSafetyandEssential
PerformanceofRespiratoryGasMonitorsandPart2‐55
•DangerousGoodsRegulations2008,DangerousGoods
Regulations2008–UNID3090
•UNDOTT1‐T8,UNTransport TestingforSecondaryLithiumCells
•ISTAProcedure1A,FixedDisplacementVibrationandShockTestingforPackagedProductsweighing150lb(68
kg)orless
• Directive2011/65/EU,Restrictionoftheuseofcertainhazardoussubstancesinelectricalandelectronic
equipment(RoHS2)
•ISO10993‐1,BiologicalEvaluationofMedicalDevices‐Part1:EvaluationandTesting
•ISO10993‐5,BiologicalEvaluationofMedicalDevices‐Part5:TestsforCytotoxicity:Invitromethods
•ISO10993‐10,BiologicalEvaluationofMedicalDevices‐Part10:TestsforIrritationandDelayed‐Type
Hypersensitivity
•21CFRPart801,Codeof
FederalRegulations–MedicalDevices:Labeling
•49CFRPart173.185,CodeofFederalRegulations–Transportation–OtherRegulationsRelatingto
Transportation–PipelineandHazardousMaterialsSafetyAdministration,DepartmentofTransportation–
HazardousMaterialsRegulations–Shippers‐GeneralRequirementsforShipmentsandPackagings–Non‐bulk
packagingforhazardousmaterials
otherthanclass1andclass7–Lithiumcellsandbatteries
• 1999/5/EC,R&TTEDirective(RadioandTelecommunicationsTerminalEquipment)
General