Table of Contents
PrefacetoRevisionTwo
PrefacetoRevisionOne
Foreword
Scope
Section1REFERENCEDPUBLICATIONS
1.1General
1.2ReferencedPublications
Section2DEFINITIONSANDFORMULAE
2.1GeneralDefinitions
Section3RATIONALE
3.1ClinicalPurpose
3.2RegulatoryPurpose
3.2.1PurposeofVoluntaryStandards
3.3RationaleforChoiceofIndication/DisplayParameter
3.3.1RationaleforThermalIndices
3.3.2RationaleforMechanicalIndex
3.4RationaleRegardingDiversificationofEquipmentTypes
Section4INFORMATIONTOBEPROVIDEDTOOPERATORS
4.1On-EquipmentAcousticOutputIndication/Display
4.1.1Resolution
4.1.2ValuesofIndicestobeDisplayed
4.1.3OtherConditionsonDisplayofIndices
4.2InformationRequiredinOperator'sManual
4.2.1MeaningofIndicesandSpecificationofDisplay
Accuracy
4.2.2DiscussionofOperatorControlFeatures
4.2.3PrudentUseStatement
Section5DEFAULTSETTINGS
5.1EquipmentDesignsAllowingforFullSoftwareControlof
AcousticOutput
5.2EquipmentDesignsNotAllowingforFullSoftwareControl
ofAcousticOutput
Section6MEASUREMENTMETHODOLOGYFORMECHANICALANDTHERMAL
INDICES
6.1General
6.2IndexMeasurementsinUnscannedModes
6.2.1MeasurementofCenterFrequencyf[c](j)inUnscanned
Modes
6.2.2MeasurementofAcousticPower(W(j,v[a]))inUnscanned
Modes
6.2.3(ReservedforFutureUse)
6.2.4MeasurementofMechanicalIndexMI(j,v[a])for
UnscannedModes
6.2.5MeasurementofBoneThermalIndexTIB(j,v[a])for
UnscannedModes
6.2.6MeasurementofSoftTissueThermalIndex(TIS(j,v[a]))
forUnscannedModes
6.2.7MeasurementofCranialBoneThermalIndexTIC(j,v[a])
forUnscannedModes
6.3IndexMeasurementsinScannedModes
6.3.1MeasurementofCenterFrequencyf[c](j)forScanned
Modes
6.3.2MeasurementofAcousticPower(W(j,v[a]))inScanned
Modes
6.3.3MeasurementofAcousticPowerperUnitLengthW/X(j,v[a])
inScannedModes
6.3.4MeasurementofMechanicalIndexMI(j,v[a])forScanned
Modes
6.3.5(ReservedforFutureUse)
6.3.6MeasurementofBoneThermalIndexTIB(j,v[a])for
ScannedModes
6.3.7MeasurementofCranialThermalIndexTIC(j,v[a])for
ScannedModes
6.3.8MeasurementofSoftTissueThermalIndexTIS(j,v[a])
forScannedModes
6.4DeterminingDisplayAccuracy
AppendixASUMMARYOFTHERMALINDEXFORMULAE
A1.1Introduction
A2.1ThermalIndexConcept
A3.1MeasurementParameters
A4.1ThermalIndexCategories
A5.1ThermalIndexModels
A5.1.1SoftTissueatSurface[TIS(scanned),TIB(scanned)]
A5.1.2SoftTissue,Unscanned,LargeAperture[TIS(unscanned)]
A5.1.3SoftTissue,Unscanned,SmallAperture[TIS(unscanned)]
A5.1.4BoneatFocus[TIB(unscanned)]
A5.1.5BoneatSurface[TIC]
A6.1CombinationModes
A7.1DisplayoftheThermalIndex
A8.1Measurements
AppendixBMECHANICALINDEXRATIONALE
B1.1Purpose
B2.1DisplayRequirements
B3.1Formula
Bibliography Abstract
Applicable to diagnostic ultrasound equipment that is intended for use on humans, and is capable of exceeding a thermal index of 1.0, or a mechanical index of 1.0.
