NEMA UD 2-2004 ACOUSTIC OUTPUT MEASUREMENT STANDARD FOR DIAGNOSTIC ULTRASOUND EQUIPMENT (Revision 3)《超声诊断设备声音输出测量标准(修订版3)》.pdf

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1、NEMA Standards PublicationNational Electrical Manufacturers AssociationNEMA UD 2-2004 (R2009)Acoustic Output Measurement Standard For Diagnostic Ultrasound Equipment, Revision 3NEMA Standards Publication UD 2-2004 (R2009) Acoustic Output Measurement Standard For Diagnostic Ultrasound Equipment, Revi

2、sion 3 Published by: National Electrical Manufacturers Association 1300 North 17th Street, Suite 1752 Rosslyn, Virginia 22209-3801 www.nema.org American Institute of Ultrasound in Medicine 14750 Sweitzer Lane, Suite 100 Laurel, Maryland 20707-5906 www.aium.org Copyright 2004 by the National Electric

3、al Manufacturers Association. All rights including translation into other languages, reserved under the Universal Copyright Convention, the Berne Convention for the Protection of Literary and Artistic Works, and the International and Pan American Copyright Conventions. NOTICE AND DISCLAIMER The info

4、rmation in this publication was considered technically sound by the consensus of persons engaged in the development and approval of the document at the time it was developed. Consensus does not necessarily mean that there is unanimous agreement among every person participating in the development of

5、this document. The National Electrical Manufacturers Association (NEMA) standards and guideline publications, of which the document contained herein is one, are developed through a voluntary consensus standards development process. This process brings together volunteers and/or seeks out the views o

6、f persons who have an interest in the topic covered by this publication. While NEMA administers the process and establishes rules to promote fairness in the development of consensus, it does not write the document and it does not independently test, evaluate, or verify the accuracy or completeness o

7、f any information or the soundness of any judgments contained in its standards and guideline publications. NEMA disclaims liability for any personal injury, property, or other damages of any nature whatsoever, whether special, indirect, consequential, or compensatory, directly or indirectly resultin

8、g from the publication, use of, application, or reliance on this document. NEMA disclaims and makes no guaranty or warranty, expressed or implied, as to the accuracy or completeness of any information published herein, and disclaims and makes no warranty that the information in this document will fu

9、lfill any of your particular purposes or needs. NEMA does not undertake to guarantee the performance of any individual manufacturer or sellers products or services by virtue of this standard or guide. In publishing and making this document available, NEMA is not undertaking to render professional or

10、 other services for or on behalf of any person or entity, nor is NEMA undertaking to perform any duty owed by any person or entity to someone else. Anyone using this document should rely on his or her own independent judgment or, as appropriate, seek the advice of a competent professional in determi

11、ning the exercise of reasonable care in any given circumstances. Information and other standards on the topic covered by this publication may be available from other sources, which the user may wish to consult for additional views or information not covered by this publication. NEMA has no power, no

12、r does it undertake to police or enforce compliance with the contents of this document. NEMA does not certify, test, or inspect products, designs, or installations for safety or health purposes. Any certification or other statement of compliance with any health or safetyrelated information in this d

13、ocument shall not be attributable to NEMA and is solely the responsibility of the certifier or maker of the statement. UD 2-2004 (R2009) Page i Copyright 2004 by the National Electrical Manufacturers Association. CONTENTS Foreword to Revision Three.iv Foreword to May 1998 Edition.v Foreword to Revis

14、ion Onevi Foreword to 1992 Version. vii Purpose. viii Scope .ix Road Mapx Section 1 DEFINITIONS1 Section 2 REFERENCED DOCUMENTS .12 Section 3 MEASUREMENT DEVICE CHARACTERISTICS .17 3.1 Introduction .17 3.2 Scope 17 3.3 Hydrophone Characteristics .17 3.3.1 Hydrophone Sensitivity 18 Table 3-1, Typical

15、 Hydrophone Specification Data at 1 MHz (IEC 1991b)20 3.3.2 Hydrophone System Frequency Response .21 3.3.3 Effective Hydrophone Diameter22 3.3.4 Dynamic Range and Linearity.22 3.3.5 Field Measurement Caution22 3.4 Hydrophone Selection and Minimum Requirements .23 3.5 Hydrophone Measurement System 23

16、 3.5.1 Hydrophone Amplifier .23 Table 3-2, Typical Hydrophone Specifications 24 Table 3-3, Minimum Hydrophone or Hydrophone-Amplifier Combination Specifications24 Table 3-4, Minimum Hydrophone Amplifier Specifications25 Figure 3-1, Diagram of Hydrophone and Amplifier 26 3.5.2 Water Tank.27 3.5.3 Pos

17、itioning System .27 3.5.4 Oscilloscope/Waveform Recorder27 3.5.5 Commercially Available Measurement Systems 28 3.6 Force Balance Characteristics.27 3.6.1 Constructing a Force Balance from Components 28 Figure 3-2, Radiation Force Balance System with Absorbing Target29 Figure 3-3, Radiation Force Bal

18、ance System with Reflecting Target at 45 Angle to Direction of Propagation 30 Section 4 CALIBRATION METHODS 32 4.1 Introduction 32 4.2 Traceability and the Calibration Process . 32 4.3 Outline of Calibration Procedures34 4.4 Calibrating the Force-Balance System 36 4.4.1 Fundamental Force Balance Equ

19、ations .36 Figure 4-1, Diagram of Major Steps in the Recommended Calibration Procedures .37 4.4.2 Reference Source Transducers38 4.4.3 Force Balance Calibration 38 4.4.4 Force Balance Linearity Verification .38 4.4.5 Spot Checks of Force Balance and Reference Source38 UD 2-2004 (R2009) Page ii Copyr

20、ight 2004 by the National Electrical Manufacturers Association. 4.4.6 Calibration and Spot Checks of Working Source .39 4.5 Local Laboratory Checks of Reference Hydrophone.39 4.5.1 Arrival of the Reference Hydrophone .39 4.5.2 Comparison Waveform Records 39 4.5.3 Spot Checks of the Reference Hydroph

21、one .40 4.6 The Comparison Procedure for the Working Hydrophone 40 4.6.1 Introduction.40 4.6.2 Determination of End-of-Cable Loaded Sensitivity of the Working Hydrophone41 4.7 Spot Checks of Working Hydrophone .41 4.8 Planar Scanning Checks of Hydrophone.42 4.9 Hydrophone Calibration Above 20 MHz.42

22、 Section 5 DIAGNOSTIC ULTRASOUND MEASUREMENT PROCEDURES . 43 5.1 Introduction 43 5.2 Outline of Measurement Procedures . 43 Figure 5-1, Relationships Between Procedural Steps (in Ellipses) Recommended for Carrying Out Measurements, Cross Checks, and the Devices Used in Carrying Them Out (Boxes)44 5.

23、3 Equipment and Setup 45 5.3.1 Equipment Required.45 5.3.2 Set-up .46 Figure 5-2, Measurements and Calculation Requirements for System Labeling 48 Figure 5-2a, Example of a Horizontal Scanning Mechanism.49 Figure 5-3b, Example of a Vertical Scanning System .50 5.4 Measurement of Intensities and Pres

24、sure in Non-Autoscan System 51 5.4.1 Reference Location for Intensity and Pressure Measurements51 5.4.2 Select Operating Condition and Set Maximum Drive Voltage 52 5.4.3 Determine the Beam Axis.52 5.4.4 Find the Spatial Maximum Pulse Intensity Integral.53 5.4.5 Verification of Maximum PII(j,vmj,zmjP

25、II) 53 5.4.6 Waveform Recording53 5.4.7 Calculate the Spatial-Peak Pulse-Average Intensity (ISPPA) .53 5.4.8 Calculate the Peak Rarefactional Pressure (pr)53 5.4.9 Associated Parameters 54 5.4.10 Calculate the Spatial-Peak Temporal-Average Intensity (ISPTA)55 Figure 5-4, Spatial Peak Voltage Wavefor

26、m Signal (Vp) as Seen at Maximum ISPPALocation .56 Figure 5-5, A Typical Pulse Intensity Integral (PII) Waveform.56 Figure 5-6, Beam Profile Parameters for Focused and Unfocused Single-Element Transducers .57 Figure 5-7, Beam Geometry at the Focus of One Pulse (i.e. Image Line) for the Sector Scanni

27、ng Rectangular Transducer Assembly.58 Figure 5-8a, Plot of PII (Normalized J/CM2) Along a Diameter Through the Focus of a Circular Source Transducer58 Figure 5-8b, Plots of PII (Normalized J/CM2) Through the Focus of a Rectangular Transducer Assembly59 5.4.11 Measure the Ultrasonic Power59 5.4.12 Fi

28、nd the Spatial Maximum Derated Pulse Intensity Integral.59 5.4.13 Verification of the Spatial Maximum PII.3(j, vmj, zmIPII.3).59 5.4.14 Waveform Recording60 5.4.15 Calculate the Derated Spatial-Peak Pulse-Average Intensity (ISPPA.3)60 5.4.16 Calculate the Derated Peak Rarefactional Pressure (pr.3)60

29、 5.4.17 Calculate the Derated Spatial-Peak Time-Average Intensity (ISPTA.3).60 UD 2-2004 (R2009) Page iii Copyright 2004 by the National Electrical Manufacturers Association. 5.4.18 Measurement Methods for Equipment Which Produces Continuous Waveforms .60 5.5 Measurement for Intensity and Pressure i

30、n Autoscan Mode.61 5.5.1 Introduction to Autoscan Measurements in Combined Modes.62 5.5.2 Measurement of ISPTA.3in Combined Autoscan Modes 63 5.6 Power Measurements64 5.6.1 Force Balance Methods64 Figure 5-9, Illustration of an R.F.B. Measurement of One Sequence of N = 5 Cycles 66 5.6.2 Alternate Po

31、wer Measurement/Calculation Using a Hydrophone and Planar Scanning in Non-Autoscan Mode .71 Figure 5-10, Suggested 1 cm Wide Aperture Mask 74 Figure 5-11, Suggested Orientation of Probe, Mask Slit, and RFB Target74 Figure 5-12, Suggested Orientation of Probe, Mask Slit, and 1 cm RFB Target.75 APPEND

32、ICES A Statistical Considerations 76 B Nonlinear Effects 98 C Directivity of Hydrophone 102 D Acoustical Output Quantities in Water and in Tissue Models; Derated Values 104 E Water Degassing Procedure . 109 F Rationale for the Measurement of Selected Parameters 110 G Determination of Control Setting

33、s Resulting in Intensity and Pressure Global Maxima . 112 H Hydrophone Calibration by Planar Scanning Technique 114 I Consistency Checks.122 J Measurement of ISPTAfor a Combined Operating Mode 125 K Rationale for Measurements in Water 127 UD 2-2004 (R2009) Page iv Copyright 2004 by the National Elec

34、trical Manufacturers Association. Foreword to Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, Revision 3 This is the initial revision of the 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. The most noteworthy change in this document is the rev

35、ision of Appendix A, Statistical Considerations. Included in this revised appendix are discussions of the one-sided tolerance limit for normal distributions, Type A and Type B uncertainty specifications, and multiple console/transducer combinations for a particular model, all topics that were not ad

36、dressed in the previous version. In addition, minor notational and typographical corrections were made to the standard. Special thanks for this revision go to the Output Standards Subcommittee (OSS), a joint AIUM/NEMA task group formed by the AIUM Technical Standards Committee. In particular, Marvin

37、 Ziskin is thanked for his spearheading the revision of Appendix A. The current co-chairs of the OSS are Paul Carson and Mark Schafer. The previous co-chairs were Gerald Harris and Charles Hottinger. Past and current subcommittee members, in addition to the past and current co-chairs, are John Abbot

38、t, Paul Biggins, Chris Bohl, Barbara Campbell, Anupam Dattamajumdar, David Dea, Richard Eaton, Peter Edmonds, Jim Gessert, Peng Jiang, Peter Lewin, Michael Macdonald, Ernest Madsen, Dennis Mendoza, Kathy Meschisen, Kurt Sandstrom, Paul Smolenski, Terry Sweeney, Jinxing Tan, Tat-Jin Teo, Kai Thomeniu

39、s, Junru Wu, Jim Zagzebski, Qian Zhang, and Marvin Ziskin. Karen Ophir Chair, AIUM Technical Standards Committee UD 2-2004 (R2009) Page v Copyright 2004 by the National Electrical Manufacturers Association. Foreword to the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, May

40、 1998 In 1996, the decision was made to break the measurement and labeling parts of the Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment (AIUM,1993) into two separate documents. The resulting measurements standard, the Acoustic Output Measurement Standard for Dia

41、gnostic Ultrasound Equipment, is now fully harmonized with and identical to its sister NEMA document, the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (UD 2), Revision 2. The new labeling document, the Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment

42、(AIUM 1998), has been substantially changed, with the original labeling requirements being replaced by the labeling specified in the FDAs 510(k) Guideline (FDA 1997) and, optionally, the labeling specified in IEC 1157 (IEC 1992a). As of this writing, the International Electrotechnical Commission, Te

43、chnical Committee 87, is developing additional standards for ultrasonic output measurement, calibration, and labeling. Their efforts have been helpful in the development of this document. Relevant IEC standards should be consulted for further technical information as they become available. User need

44、s have been considered throughout the development of this publication. Proposed or recommended revisions should be submitted to: Chairman, AIUM Technical Standards Committee American Institute of Ultrasound in Medicine 14750 Sweitzer Lane, suite 100 Laurel MD 20707-5906 Revisions have been included

45、which make the standard consistent with the NEMA UD-2 (as noted above) and The AIUM/NEMA Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, (AIUM/NEMA, 1998). A few improvements are reflected here which represent changes in all three

46、of the documents. Members of the AIUM/NEMA Harmonization Task Group performing this revision were: AIUM NEMA Paul L. Carson, Ph.D. Charles Hottinger, Ph.D. John G. Abbott, Ph.D. Douglas Worth Gerald R. Harris, Ph.D. Kurt Sandstrom Peter Lewin, Ph.D., Chairman The amended requirements supersede those

47、 of all previous revisions of the standard. UD 2-2004 (R2009) Page vi Copyright 2004 by the National Electrical Manufacturers Association. Foreword to the Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment, 1993, Revision 1 In July 1993, the Acoustic Output Measure

48、ment and Labeling Standard for Diagnostic Ultrasound Equipment was amended. The primary purposes of the amendments are to (1) introduce harmonized requirements into both the AIUM publication Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment and the National Electr

49、ical Manufacturers Associations (NEMA) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (UD 2), so that they are technically equivalent with regard to measurement procedures; (2) introduce those improved measurement practices developed for the Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (UD 3) (Output Display Standard) into this standard, so that it represents the latest thoughts on measurement practices; and (3) expand the coverage of the standard to the extent that