1、 IEC 61157 Edition 2.0 2013-01 INTERNATIONAL STANDARD NORME INTERNATIONALE Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment Critres normaliss de dclaration des missions acoustiques des appareils de diagnostic mdical ultrasons IEC61157:2007/A1:2013AME
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16、RNATIONAL STANDARD NORME INTERNATIONALE Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment Critres normaliss de dclaration des missions acoustiques des appareils de diagnostic mdical ultrasons INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTR
17、OTECHNIQUE INTERNATIONALE H ICS 11.040.50, 17.140.50 PRICE CODE CODE PRIX ISBN 978-2-83220-586-0 AMENDMENT 1 AMENDEMENT 1 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale Warning! Make sure that you obtained this publ
18、ication from an authorized distributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr. 2 61157 Amend.1 IEC:2013 FOREWORD This amendment has been prepared by IEC technical committee 87: Ultrasonics. The text of this amendment is based on the following
19、 documents: FDIS Report on voting 87/517/FDIS 87/523/RVD Full information on the voting for the approval of this amendment can be found in the report on voting indicated in the above table. The committee has decided that the contents of this amendment and the base publication will remain unchanged u
20、ntil the stability date indicated on the IEC web site under “http:/webstore.iec.ch” in the data related to the specific publication. At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. _ 2 Normative references Replace the dated references to IEC 6
21、0050-801:1994, ISO 16269-6:2005 and ISO/IEC Guide 98:1994 by the following undated references: IEC 60050-801, International Electrotechnical Vocabulary Chapter 801: Acoustics and electroacoustics ISO 16269-6, Statistical interpretation of data Part 6: Determination of statistical tolerance intervals
22、 ISO/IEC Guide 98-3, Uncertainty of measurement Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) Replace the existing reference to IEC 62127-1 with the following: IEC 62127-1:2007, Ultrasonics Hydrophones Part 1: Measurement and characterization of medical ultrasonic fields u
23、p to 40 MHz Amendment 1:2013 Add the following new reference: IEC 60050-802, International Electrotechnical Vocabulary Chapter 802: Ultrasonics 61157 Amend.1 IEC:2013 3 3 Terms, definitions and symbols Replace in definitions 3.14, 3.20, 3.31 and 3.32 “expressed in watts per metre squared” by “expres
24、sed in watts per square metre” Replace in definitions 3.6 and 3.18 “expressed in metres squared” by “expressed in square metres” 3.2 acoustic pulse waveform Remove the numbering from Note 1 and replace existing Note 2 by the following: SOURCE: IEC 62127-1:2007, definition 3.1 3.4.1 zero-crossing aco
25、ustic-working frequency fawfReplace the existing text of the definition by the following: number, n, of consecutive half-cycles (irrespective of polarity) divided by twice the time between the commencement of the first half-cycle and the end of the n-th half-cycle NOTE 1 None of the n consecutive ha
26、lf-cycles should show evidence of phase change. NOTE 2 The measurement should be performed at terminals in the receiver, that are as close as possible to the receiving transducer (hydrophone) and, in all cases, before rectification. NOTE 3 This frequency is determined according to the procedure spec
27、ified in IEC/TR 60854. NOTE 4 This frequency is intended for continuous-wave systems only. SOURCE: IEC 62127-1:2007/Amendment 1:, definition 3.3.1 3.4.2 arithmetic-mean acoustic-working frequency fawfAdd the following new note and source reference to the existing definition: NOTE 3 If f2is not found
28、 within the range 3f1, f2is to be understood as the lowest frequency above this range at which the spectrum magnitude is -3 dB from the peak magnitude. SOURCE: IEC 62127-1, definition 3.3.2 3.5 bandwidth Add, after the note, the following: SOURCE: IEC 62127-1:2007, definition 3.6 3.6 beam area Repla
29、ce the symbol by: “Ab,6, Ab,20” Replace the existing text of Note 1 by the following: NOTE 1 If the position of the plane is not specified, it is the plane passing through the point corresponding to the maximum value of the pulse-pressure-squared integral in the whole acoustic field. Replace, in Not
30、e 3, the word “levels” by “fractions”. 4 61157 Amend.1 IEC:2013 3.10 beamwidth Add, after Note 3, the following source reference: SOURCE: IEC 62127-1:2007, definition 3.11 3.14 instantaneous intensity Replace the existing text of Note 1 by the following: NOTE 1 Instantaneous intensity is the product
31、 of instantaneous acoustic pressure and particle velocity. It is difficult to measure intensity in the ultrasound frequency range. For the measurement purposes referred to in this International Standard and under conditions of sufficient distance from the external transducer aperture (at least one t
32、ransducer diameter, or an equivalent transducer dimension in the case of a non-circular transducer) the instantaneous intensity can be approximated by the derived instantaneous intensity. 3.43 ultrasonic transducer element group dimensions Replace, in the definition, the term “ultrasonic transducer
33、element group” by “ultrasonic transducer element group” (bold font for the entire term). Add the following new definitions: 3.44 derived instantaneous intensity quotient of squared instantaneous acoustic pressure and characteristic acoustic impedance of the medium at a particular instant in time at
34、a particular point in an acoustic field ctptI2)()( = (1) where: p(t) is the instantaneous acoustic pressure; is the density of the medium; c is the speed of sound in the medium. NOTE 1 For measurement purposes referred to in this International Standard, the derived instantaneous intensity is an appr
35、oximation of the instantaneous intensity. NOTE 2 Increased uncertainty should be taken into account for measurements very close to the transducer. NOTE 3 Derived instantaneous intensity is expressed in watts per square metre (W/m2). SOURCE: IEC 62127-1:2007/Amendment 1:, definition 3.78 3.45 number
36、of pulses per ultrasonic scan line npps the number of acoustic pulses travelling along a particular ultrasonic scan line NOTE 1 Here ultrasonic scan line refers to the path of acoustic pulses on a particular beam axis in scanning and non-scanning modes. NOTE 2 This number can be used in the calculat
37、ion of any ultrasound temporal average value from hydrophone measurements. NOTE 3 The following shows an example of the number of pulses per ultrasonic scanline and the number of ultrasonic scanlines (shows the end of a frame): 61157 Amend.1 IEC:2013 5 1 2 3 4; 1 2 3 4; 1 2 3 4 npps=1; nsl= 4 1 1 2
38、2 3 3 4 4; 1 1 2 2 3 3 4 4; npps=2; nsl= 4 1 1 1 1 2 2 2 2 3 3 3 3 4 4 4 4; 1 1 1 1 2 2 2 2 3 3 3 3 4 4 4 4; npps= 4; nsl= 4 1 1 2 2 3 3 4 4 1 1 2 2 3 3 4 4; 1 1 2 2 3 3 4 4 1 1 2 2 3 3 4 4; npps= 4; nsl= 4 (within one frame the pulses down each line may not occur contiguously) Within one frame, all
39、 scan lines may not have the same npps value. An example is: 1 2 2 3 3 4; 1 2 2 3 3 4; avg npps=1,5; max npps= 2; nsl= 4 3.46 number of ultrasonic scanlines nsl the quantity of ultrasonic scanlines that are excited during one scan repetition period NOTE This number can be used in the calculation of
40、any ultrasound temporal average value from hydrophone measurements. Table 1 List of symbols Add the following new symbols: nppsnumber of pulses per ultrasonic scan line nslnumber of ultrasonic scan lines per image for spatial distribution p(t) instantaneous acoustic pressure IEC 62127-1 w6-6 dB beam
41、width IEC 62127-1 w20-20 dB beamwidth IEC 62127-1 Ab,6Ab,20beam area corresponding to -6 dB beam area and -20 dB beam area IEC 62127-1 I(t) instantaneous intensity IEC 62127-1 BW bandwidth IEC 62127-1 zpdistance from the transducer output face to the point of maximum pulse-pressure-squared integral
42、IEC 62127-1 4 Requirements 4.2 Requirements for the reporting of acoustic output information 4.2.2 Detailed operating mode data sheets information format Replace existing item h) by the following: h) Pulse repetition rate (prr) for non-scanning modes. For scanning modes list the scan repetition rate
43、 (srr) and the number of ultrasonic scan lines (nsl). In case there is more than 1 pulse per ultrasonic scan line, list the pulse repetition rate (prr) and the number of pulses per ultrasonic scan line (npps). 4.2.5 Dataset for low acoustic output equipment Replace the last sentence of the second pa
44、ragraph by the following: Table A.1 need not be completed. 5 Compliance statement 5.1 General Replace the existing text of items a) and b) of the second paragraph as follows: 6 61157 Amend.1 IEC:2013 a) the arithmetic mean determined from measurements on a group of n nominally identical systems, eac
45、h with the acoustic output settings yielding the maximum output, where n 3 and b) the overall uncertainty of the value determined under a). This overall uncertainty shall be calculated using an appropriate measure (with 95 % confidence, for 95 % of the population) of the statistical variation and th
46、e measurement uncertainty (at a level of confidence of 95 %). Replace the existing third paragraph with the following text: The tolerance interval is to be understood in accordance with ISO 16269-6. More guidance on assessment of uncertainties is given in IEC 62127-1, Annex I. Measurement uncertaint
47、y involves many components (see IEC 62127-1, Annex I). It shall be an assessment of the contributions of all uncertainties (these referring to measurements made on one system). The measurement uncertainty shall be calculated as expanded uncertainty corresponding to a level of confidence of 95 %. The
48、 method of combining the uncertainty contributions specified by the ISO/IEC Guide 98-3, Guide to the expression of uncertainty in measurement, shall be followed. NOTE “Tolerance interval” refers to the production scatter and “uncertainty” refers to the measurement method. 5.2 Maximum probable values
49、 Replace, in lettered item a) in the first paragraph, “as referred to in 4.2” by “as referred to in 4.2, where n 3”: 61157 Amend.1 IEC:2013 7 Annex A Presentation of acoustic output information Table A.1 An example of reporting of the acoustic output of a 3,5 MHz scan-head for a phased-array sector scanner in accordance with this standard Replace existing Table A.1 (including the captions above the ta
