NEMA MS 4-2006 Acoustic Noise Measurement Procedure For Diagnostic Magnetic Resonance Imaging Devices.pdf
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1、 NEMA Standards Publication MS 4-2006 Acoustic Noise Measurement Procedure For Diagnostic Magnetic Resonance Imaging Devices Published by: National Electrical Manufacturers Association 1300 North 17th Street, Suite 1752 Rosslyn, Virginia 22209 www.nema.org Copyright 2006 by the National Electrical M
2、anufacturers 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. Copyright 2006 by the National Ele
3、ctrical Manufacturers Association. NOTICE AND DISCLAIMER The information 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
4、agreement among every person participating in the development of this document. 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 ou
5、t the views of 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 c
6、ompleteness of 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 indire
7、ctly resulting from the publication, use of, application, or reliance on this document. NEMA disclaims and makes no guaranty or warranty, express or implied, as to the accuracy or completeness of any information published herein, and disclaims and makes no warranty that the information in this docum
8、ent will fulfill any of your particular purposes or needs. NEMA does not undertake to guarantee the performance of any individual manufacturer or seller?s products or services by virtue of this standard or guide. In publishing and making this document available, NEMA is not undertaking to render pro
9、fessional or 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 professiona
10、l in determining 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
11、no power, nor 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 safety?related informat
12、ion in this document shall not be attributable to NEMA and is solely the responsibility of the certifier or maker of the statement. MS 4-2006 Page i Copyright 2006 by the National Electrical Manufacturers Association. CONTENTS Page Preambleii Foreword.iii Introduction .iv Rationale.iv Section 1 REFE
13、RENCED STANDARDS AND DEFINITIONS.1 1.1 SCOPE1 1.2 REFERENCED STANDARDS1 1.3 DEFINITIONS .1 Section 2 DATA ACQUISITION PARAMETERS3 2.1 MAXIMUM GRADIENT ACOUSTIC NOISE (MGAN) METHOD3 2.2 MAXIMUM CLINICAL ACOUSTIC NOISE (MCAN) METHOD.3 Section 3 METHODS OF MEASUREMENT.5 3.1 TEST HARDWARE.5 3.2 HARDWARE
14、 SETUP5 3.3 MGAN MEASUREMENT5 Section 4 RESULTS10 4.1 REPORTING RESULTS.10 Annex A ACOUSTIC NOISE EXPOSURE STANDARDS11 A.1 MOTIVATION FOR THE REVISED STANDARD.11 A.2 COMMENTS ON THE MGAN METHOD11 A.2.1 Rationale for fmax and 3 ! fmax.11 A.2.2 Measurement of the noise spectrum .12 A.2.3 Finding the l
15、oudest spot.12 A.3 COMMENTS ON THE MCAN METHOD12 ? MS 4-2006 Page ii Copyright 2006 by the National Electrical Manufacturers Association. Preamble This is one of a series of test standards developed by the medical diagnostic industry for the measurement of parameters governing the safety of Magnetic
16、 Resonance (MR) Imaging systems. These test standards are intended for the use of equipment manufacturers, testing houses, prospective purchasers, and users alike. Manufacturers are permitted to use these standards for the determination of system performance specifications. This standardization of p
17、erformance specifications is of benefit to the prospective equipment purchaser. The parameters supplied with each NEMA measurement serve as a guide to those factors which can influence the measurement. These standards can also serve as reference procedures for acceptance testing and periodic quality
18、 assurance. It must be recognized, however, that not all test standards lend themselves to measurement at the installation site. Some test standards require instrumentation better suited to factory measurements, while others require the facilities of an instrumentation laboratory to assure stable te
19、st conditions necessary for reliable measurements. The NEMA test procedures shall be carried out using the normal clinical operating mode of the system. For example, standard calibration procedures and standard reconstruction processes shall be used. No modifications to alter test results shall be u
20、sed unless otherwise specified in these standards. The NEMA Technical Committee of the MR Section has identified a set of key magnetic resonance safety parameters. This standard describes the measurement of one of these parameters. Equivalence It is intended and expected that manufacturers or others
21、 who claim compliance with these NEMA standard test procedures for the determination of safety parameters shall have carried out the tests in accordance with the procedures specified in the published standards. In those cases where it is impossible or impractical to follow the literal prescription o
22、f a NEMA test procedure, a complete description of any deviation from the published procedure must be included with any measurement claimed to be equivalent to the NEMA standard. The validity or equivalence of the modified procedure will be determined by each reader. Uncertainty of the Measurements
23、The measurement uncertainty of the safety parameter determined using this standard is to be reported, together with the value of the parameter. Justification for the claimed uncertainty limits shall also be provided by a listing and discussion of sources and magnitudes of error. ? MS 4-2006 Page iii
24、 Copyright 2006 by the National Electrical Manufacturers Association. Foreword This standards publication is classified as a NEMA standard unless otherwise noted. It describes the test conditions and parameters that approximate the worst case acoustic noise levels that a particular magnet/gradient s
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