NEMA UD 3-2004 (R2009)
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
REAL-TIME DISPLAY OF THERMAL AND MECHANICAL ACOUSTIC OUTPUT INDICES ON DIAGNOSTIC ULTRASOUND EQUIPMENT
03-12-2013
06-12-2012
Preface to Revision Two
Preface to Revision One
Foreword
Scope
Section 1 REFERENCED PUBLICATIONS
1.1 General
1.2 Referenced Publications
Section 2 DEFINITIONS AND FORMULAE
2.1 General Definitions
Section 3 RATIONALE
3.1 Clinical Purpose
3.2 Regulatory Purpose
3.2.1 Purpose of Voluntary Standards
3.3 Rationale for Choice of Indication/Display Parameter
3.3.1 Rationale for Thermal Indices
3.3.2 Rationale for Mechanical Index
3.4 Rationale Regarding Diversification of Equipment Types
Section 4 INFORMATION TO BE PROVIDED TO OPERATORS
4.1 On-Equipment Acoustic Output Indication/Display
4.1.1 Resolution
4.1.2 Values of Indices to be Displayed
4.1.3 Other Conditions on Display of Indices
4.2 Information Required in Operator's Manual
4.2.1 Meaning of Indices and Specification of Display
Accuracy
4.2.2 Discussion of Operator Control Features
4.2.3 Prudent Use Statement
Section 5 DEFAULT SETTINGS
5.1 Equipment Designs Allowing for Full Software Control of
Acoustic Output
5.2 Equipment Designs Not Allowing for Full Software Control
of Acoustic Output
Section 6 MEASUREMENT METHODOLOGY FOR MECHANICAL AND THERMAL
INDICES
6.1 General
6.2 Index Measurements in Unscanned Modes
6.2.1 Measurement of Center Frequency f[c](j) in Unscanned
Modes
6.2.2 Measurement of Acoustic Power (W(j, v[a])) in Unscanned
Modes
6.2.3 (Reserved for Future Use)
6.2.4 Measurement of Mechanical Index MI(j, v[a]) for
Unscanned Modes
6.2.5 Measurement of Bone Thermal Index TIB(j, v[a]) for
Unscanned Modes
6.2.6 Measurement of Soft Tissue Thermal Index (TIS(j, v[a]))
for Unscanned Modes
6.2.7 Measurement of Cranial Bone Thermal Index TIC(j, v[a])
for Unscanned Modes
6.3 Index Measurements in Scanned Modes
6.3.1 Measurement of Center Frequency f[c](j) for Scanned
Modes
6.3.2 Measurement of Acoustic Power (W(j, v[a])) in Scanned
Modes
6.3.3 Measurement of Acoustic Power per Unit Length W/X(j, v[a])
in Scanned Modes
6.3.4 Measurement of Mechanical Index MI(j, v[a]) for Scanned
Modes
6.3.5 (Reserved for Future Use)
6.3.6 Measurement of Bone Thermal Index TIB(j, v[a]) for
Scanned Modes
6.3.7 Measurement of Cranial Thermal Index TIC(j, v[a]) for
Scanned Modes
6.3.8 Measurement of Soft Tissue Thermal Index TIS(j, v[a])
for Scanned Modes
6.4 Determining Display Accuracy
Appendix A SUMMARY OF THERMAL INDEX FORMULAE
A1.1 Introduction
A2.1 Thermal Index Concept
A3.1 Measurement Parameters
A4.1 Thermal Index Categories
A5.1 Thermal Index Models
A5.1.1 Soft Tissue at Surface [TIS (scanned), TIB (scanned)]
A5.1.2 Soft Tissue, Unscanned, Large Aperture [TIS (unscanned)]
A5.1.3 Soft Tissue, Unscanned, Small Aperture [TIS (unscanned)]
A5.1.4 Bone at Focus [TIB (unscanned)]
A5.1.5 Bone at Surface [TIC]
A6.1 Combination Modes
A7.1 Display of the Thermal Index
A8.1 Measurements
Appendix B MECHANICAL INDEX RATIONALE
B1.1 Purpose
B2.1 Display Requirements
B3.1 Formula
Bibliography
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.
DocumentType |
Standard
|
PublisherName |
National Electrical Manufacturers Association
|
Status |
Withdrawn
|
EN 62359:2011/A1:2018 | ULTRASONICS - FIELD CHARACTERIZATION - TEST METHODS FOR THE DETERMINATION OF THERMAL AND MECHANICAL INDICES RELATED TO MEDICAL DIAGNOSTIC ULTRASONIC FIELDS |
EN 60601-2-37:2008/A1:2015 | Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
BS EN 60601-2-37 : 2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-37: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC MEDICAL DIAGNOSTIC AND MONITORING EQUIPMENT |
PD IEC/TR 62799:2013 | Models for evaluation of thermal hazard in medical diagnostic ultrasonic fields |
BS EN 62359 : 2011 | ULTRASONICS - FIELD CHARACTERIZATION - TEST METHODS FOR THE DETERMINATION OF THERMAL AND MECHANICAL INDICES RELATED TO MEDICAL DIAGNOSTIC ULTRASONIC FIELDS |
IEC TR 62799:2013 | Models for evaluation of thermal hazard in medical diagnostic ultrasonic fields |
NEMA PS3.3 : 2017A | DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM) - PART 3: INFORMATION OBJECT DEFINITIONS |
IEC TS 62306:2006 | Ultrasonics - Field characterisation - Test objects for determining temperature elevation in diagnostic ultrasound fields |
DD IEC/TS 62306:2006 | Ultrasonics. Field characterisation. Test objects for determining temperature elevation in diagnostic ultrasound fields |
I.S. EN 60601-2-37:2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-37: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC MEDICAL DIAGNOSTIC AND MONITORING EQUIPMENT |
I.S. EN 62359:2011 | ULTRASONICS - FIELD CHARACTERIZATION - TEST METHODS FOR THE DETERMINATION OF THERMAL AND MECHANICAL INDICES RELATED TO MEDICAL DIAGNOSTIC ULTRASONIC FIELDS |
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