1、BRITISH STANDARDBS EN 61391-1:2006Ultrasonics Pulse-echo scanners Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function responseThe European Standard EN 61391-1:2006 has the status of a British StandardICS 17.140.50g49g50g3g38g50g51g60g44g49g4
2、2g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58Licensed Copy: Wang Bin, na, Thu Apr 12 03:21:02 GMT+00:00 2007, Uncontrolled Copy, (c) BSIBS EN 61391-1:2006This British Standa
3、rd was published under the authority of the Standards Policy and Strategy Committee on 31 January 2007 BSI 2007ISBN 978-0-580-49923-4National forewordThis British Standard was published by BSI. It is the UK implementation of EN 61391-1:2006. It is identical with IEC 61391-1:2006.The UK participation
4、 in its preparation was entrusted to Technical Committee EPL/87, Ultrasonics.A list of organizations represented on EPL/87 can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct applic
5、ation.Compliance with a British Standard cannot confer immunity from legal obligations.Amendments issued since publicationAmd. No. Date CommentsLicensed Copy: Wang Bin, na, Thu Apr 12 03:21:02 GMT+00:00 2007, Uncontrolled Copy, (c) BSIEUROPEAN STANDARD EN 61391-1 NORME EUROPENNE EUROPISCHE NORM Octo
6、ber 2006 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2006 CENELEC - All rights of exploitation in any form and by any means
7、reserved worldwide for CENELEC members. Ref. No. EN 61391-1:2006 E ICS 17.140.50 English version Ultrasonics - Pulse-echo scanners Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response (IEC 61391-1:2006) Ultrasons - Scanners impulsion
8、 et cho Partie 1: Techniques pour ltalonnage des systmes de mesure spatiaux et des mesures de la rponse de la fonction de dispersion ponctuelle du systme (CEI 61391-1:2006) Ultraschall - Impuls-Echo-Scanner Teil 1: Verfahren fr die Kalibrierung von rumlichen Messsystemen und Messung der Charakterist
9、ik der Punktverwaschungsfunktion des Systems (IEC 61391-1:2006) This European Standard was approved by CENELEC on 2006-10-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standa
10、rd without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other
11、 language made by translation under the responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, the Czech Republic, Denmark
12、, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Licensed Copy: Wang Bin, na, Thu Apr 12 03:21:02 GMT+00:00 2
13、007, Uncontrolled Copy, (c) BSIForeword The text of document 87/336/FDIS, future edition 1 of IEC 61391-1, prepared by IEC TC 87, Ultrasonics, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 61391-1 on 2006-10-01. The following dates were fixed: latest date by which
14、the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2007-07-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2009-10-01 Terms in bold in the text are defined in Clause 3. Annex ZA has
15、 been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 61391-1:2006 was approved by CENELEC as a European Standard without any modification. _ 2 EN 61391-1:2006Licensed Copy: Wang Bin, na, Thu Apr 12 03:21:02 GMT+00:00 2007, Uncontrolled Copy, (c) BSICONTENTS INTRODU
16、CTION.4 1 Scope.5 2 Normative references5 3 Terms and definitions .5 4 Symbols .11 5 General conditions11 6 Techniques for calibrating 2D-measurement systems13 6.1 Test methods 13 6.2 Instruments .13 6.3 Test settings14 6.4 Test parameters 15 7 Methods for calibrating 3D-measurement systems.17 7.1 G
17、eneral .17 7.2 Types of 3D-reconstruction methods18 7.3 Test parameters associated with reconstruction problems19 7.4 Test methods for measurement of 3D-reconstruction accuracy.20 8 Measurement of point-spread and line-spread functions (high-contrast spot size) 24 8.1 General .24 8.2 Test methods 25
18、 8.3 Instruments .25 8.4 Test settings25 8.5 Test parameters 28 Annex A (normative) Test objects Calibration of 2D-spatial measurement systems.33 Annex B (normative) Test objects Measurement and calibration of 3D-image reconstruction accuracy 36 Annex C (normative) Test objects Measurement of point-
19、spread function response39 Bibliography44 3 EN 61391-1:2006Annex ZA (normative) Normative references to international publications with their corresponding European publications.46 Licensed Copy: Wang Bin, na, Thu Apr 12 03:21:02 GMT+00:00 2007, Uncontrolled Copy, (c) BSIINTRODUCTION An ultrasonic p
20、ulse-echo scanner produces images of tissue in an ultrasonic scan plane by sweeping a narrow pulsed beam of ultrasound through the section of interest and detecting the echoes generated at tissue boundaries. A variety of ultrasonic transducer types are employed to operate in a transmit/receive mode
21、for the ultrasonic signals. Ultrasonic scanners are widely used in medical practice to produce images of many soft-tissue organs throughout the human body. This standard describes test procedures that should be widely acceptable and valid for a wide range of types of equipment. Manufacturers should
22、use the standard to prepare their specifications; the users should employ the standard to check specifications. The measurements can be carried out without interfering with the normal working conditions of the machine. Typical test objects are described in the annexes. The structures of the test obj
23、ects have not been specified in detail, rather suitable types of overall and internal structures are described. The specific structure of a test object should be reported with the results obtained using it. Similar commercial versions of these test objects are available. The performance parameters s
24、pecified and the corresponding methods of measurement have been chosen to provide a basis for comparison with the manufacturers specification and between similar types of apparatus of different makes, intended for the same kind of diagnostic application. The manufacturers specification should allow
25、comparison with the results obtained from the tests in this standard. Furthermore, it is intended that the sets of results and values obtained from the use of the recommended methods will provide useful criteria for predicting the performance of equipment in appropriate diagnostic applications. This
26、 standard concentrates on measurements of images by digital techniques. Methods suitable for inspection by eye are covered here as well. Discussion of other visual techniques can be found in IEC 61390 11). Where a diagnostic system accommodates more than one option in respect of a particular system
27、component, for example the ultrasonic transducer, it is intended that each option be regarded as a separate system. However, it is considered that the performance of a machine is adequately specified, if measurements are undertaken for the most significant combinations of machine control settings an
28、d accessories. Further evaluation of equipment is obviously possible but this should be considered as a special case rather than a routine requirement. _ 1)Figures in square brackets refer to the Bibliography. 4 EN 61391-1:2006Licensed Copy: Wang Bin, na, Thu Apr 12 03:21:02 GMT+00:00 2007, Uncontro
29、lled Copy, (c) BSIULTRASONICS PULSE-ECHO SCANNERS Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response 1 Scope This International Standard describes methods of calibrating the spatial measurement facilities and point-spread function
30、of ultrasonic imaging equipment in the ultrasonic frequency range 0,5 MHz to 15 MHz. This standard is relevant for ultrasonic scanners based on the pulse-echo principle of the types listed below: mechanical sector scanners; electronic phased-array sector scanners; electronic linear-array scanners; e
31、lectronic curved-array sector scanners; water-bath scanners based on any of the above four scanning mechanisms; 3D-volume reconstruction systems. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition c
32、ited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. IEC 61102:1991, Measurement and characterisation of ultrasonic fields using hydrophones in the frequency range 0,5 MHz to 15 MHz IEC 61685:2001, Ultrasonics Flow measurement system
33、s Flow test object3 Terms and definitions For the purposes of this document, the following terms and definitions apply. See also related standards and technical reports for definitions and explanations. 1-5 3.1 A-scan class of data acquisition geometry in one dimension, in which echo strength inform
34、ation is acquired from points lying along a single beam axis and displayed as amplitude versus time of flight or distance 5 EN 61391-1:2006Licensed Copy: Wang Bin, na, Thu Apr 12 03:21:02 GMT+00:00 2007, Uncontrolled Copy, (c) BSI3.2 acoustic coupling agent (also, coupling agent) a material, usually
35、 a gel or other fluid, that is used to ensure acoustic contact between the transducer and the patients skin, or between the transducer and the surface of a sealed test object 3.3 acoustic working frequency arithmetic mean of the frequencies f1and f2at which the amplitude of the acoustic pressure spe
36、ctrum is 3 dB below the peak amplitude (See 3.4.2 of IEC 61102) 3.4 automatic time-gain compensation ATGC automatic working time gain control based on the observed decrease in echo amplitudes due to the attenuation in ultrasonic pulse amplitude with depth 3.5 axial resolution minimum separation alon
37、g the beam axis of two equally scattering volumes or targets at a specified depth for which two distinct echo signals can be displayed 3.6 backscatter coefficient mean acoustic power scattered in the 180 direction by a specified object with respect to the direction of the incident beam, per unit sol
38、id angle per unit volume, divided by the incident beam intensity. For a volume filled with many scatterers, the scatterers are considered to be randomly distributed. The mean power is obtained from different spatial realisations of the scattering volume NOTE Backscatter coefficient is commonly refer
39、red to as the differential scattering cross-section per unit volume in the 180 direction 3.7 backscatter contrast (normalized) difference between the backscatter coefficients from two defined regions divided by the square root of the product of the two backscatter coefficients 3.8 beam axis the long
40、itudinal axis of the pulse-echo response pattern of a given B-mode scan line, a pulse-echo equivalent to the transmitted beam axis of IEC 61828 2 3.9 B-scan class of data acquisition geometry in which echo information is acquired from points lying in an ultrasonic scan plane containing interrogating
41、 ultrasonic beams. See B-mode below. NOTE B-scan is a colloquial term for B-mode scan or image. (See 3.10) 6 EN 61391-1:2006Licensed Copy: Wang Bin, na, Thu Apr 12 03:21:02 GMT+00:00 2007, Uncontrolled Copy, (c) BSI3.10 Brightness-modulated display B-mode method of presentation of B-scan information
42、 in which a particular section through an imaged object is represented in a conformal way by the scan plane of the display and echo amplitude is represented by local brightness or optical density of the display IEC 60854: definition 3.18, modified 3.11 displayed dynamic range ratio, expressed in dec
43、ibels, of the amplitude of the maximum echo that does not saturate the display to the minimum echo that can be distinguished in the display under the scanner test settings 3.12 elevational resolution minimum separation perpendicular to the ultrasonic scan plane of two equally scattering targets at a
44、 specified depth for which two distinct echo signals can be displayed. Often used here informally for slice thickness for purposes of 3D-scanning 3.13 field-of-view area in the ultrasonic scan plane which is insonated by the ultrasound beam during the acquisition of echo data to produce one image fr
45、ame 3.14 frame rate number of sweeps comprising the full-frame refresh rate that the ultrasonic beam makes per second through the field-of-view 3.15 gain ratio of the output to the input of a system, generally an amplifying system, usually expressed in decibels 3.16 grey scale range of values of ima
46、ge brightness, being either continuous between two extreme values or, if discontinuous, including at least three discrete values IEC 60854: definition 3.14 3.17 lateral resolution minimum separation of two line targets at a specified depth in a test object made of tissue-mimicking material for which
47、 two distinct echo signals can be displayed. The line targets should be perpendicular to the scanned plane; the separation between the targets should be perpendicular to the beam-alignment axis 3.18 line-spread function LSF characteristic response in three dimensions of an imaging system to a high-c
48、ontrast line target 7 EN 61391-1:2006Licensed Copy: Wang Bin, na, Thu Apr 12 03:21:02 GMT+00:00 2007, Uncontrolled Copy, (c) BSI3.19 line target cylindrical reflector whose diameter is so small that the reflector cannot be distinguished by the imaging system from a cylindrical reflector with diamete
49、r an order of magnitude smaller, except by signal amplitude. The backscatter from a standard line target should be a simple function of frequency over the range of frequencies studied 3.20 M-mode time-motion mode method of presentation of M-scan information in which the motion of structures along a fixed beam axis is depicted by presenting their positions on a line which moves across a display to show the variation with time of the echo 3.21 M-scan time-motion scan class of ac
