SonoSite S-Cath - EMC Standards Classification; Airborne Equipment Standards; HIPAA Standard

Chapter 8: Specifications 139
Specifications
EMC standards classification
EN60601‐1‐2:2001,European Norm,Medical
ElectricalEquipment.GeneralRequirementsfor
Safety‐CollateralStandard.Electromagnetic
Compatibility.RequirementsandTests.
CISPR11:2004,InternationalElectrotechnical
Commission,InternationalSpecialCommitteeon
RadioInterference.Industrial,Scientific,and
Medical(ISM)Radio‐FrequencyEquipment
ElectromagneticDisturbance
Characteristics‐LimitsandMethodsof
Measurement.
TheClassificationfortheultrasoundsystem,

stand,accessories,andperipheralswhen
configuredtogetheris:Group1,ClassA.
Airborne equipment
standards
RTCA/DO‐160E:2004,RadioTechnical
CommissionforAeronautics,Environmental
ConditionsandTestProceduresforAirborne
Equipment,Section 21.0EmissionofRadio
FrequencyEnergy,Category B.
HIPAA standard
TheHealthInsuranceandPortabilityand
AccountabilityAct,Pub.L.No.104‐191(1996).
45CFR160,GeneralAdministrative
Requirements.
45CFR164,SecurityandPrivacy.