GOST IEC 61157-2013 Medical electrical equipment Devices for ultrasonic diagnostics Requirements for the declaration of acoustic output parameters in technical documents《医疗电气设备 超声诊.pdf

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1、 , () INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) IEC 61157 2013 (IEC 61157:2013, IDT) 2014 IEC 61157 2013 II , 1.0 92 . 1.2 2009 . , . , , , 1 - - ( ) , 5 2 3 , (- 3 2013 . 62) : ( 3166) 004-97 ( 3166) 004-97 AM BY KG MD - RU TJ UZ 4 9 2014 . 783- IEC 611572013 1 2016

2、. 5 IEC 61157:2013 Standard means for the reporting of the acoustic output of medical diagnostic ultrasound equipment ( - ). - 1.5 2001 ( 3.6). - . (IDT) IEC 61157 2013 III 6 - , . () - - . , , 2014 -, - IEC 61157 2013 IV 1 . 1 2 1 3 , . 2 4 10 5 15 6 16 7 . 16 () . 17 () . 19 () 20 D () , 3 24 () (

3、 ) . 26 . 27 IEC 61157201 3 1 Medical electrical equipment. Devices for ultrasonic diagnostics. Requirements for the declaration of acoustic output parameters in technical documents 201601 01 1 - : - , - ; - ; - - . , -, , - . : - ; - ; - , . 2 : IEC 60050-801, International Electrotechnical Vocabul

4、ary Chapter 801: Acoustics and electroacoustics ( . 801. -) IEC 60050-802 International Electrotechnical Vocabulary Chapter 802: Ultrasonics (- . 802. ) IEC 61161, Ed 2: Ultrasonics Power measurement Radiation force balances and performance requirements. (. - ) IEC 62127-1, Ultrasonics Hydrophones P

5、art 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz. Amendment 1: 2013 (. . 1. - 40 . 1:2013) IEC 61157 2013 2 ISO 16269-6:2005, Statistical interpretation of data Part 6: Determination of statistical tolerance intervals ( . 6. -) ISO/IEC 98-3, Uncertainty of measuremen

6、 t- Part 3: Guide to the expression of uncertainty in measurement Geneva (GUM:1995) ( . 3. (GUM:1995) 3 , : , , IEC 61161 IEC 62127-1, D. , C.1 C .4. 3.1 () (acoustic output freeze): -, . 3.2 (acoustic pulse waveform): - , - , - . ( -) . IEC 62127-1, 3.1 3.3 rp, (acoustic repetition period): -, . IE

7、C 62127-1, 3.2 3.4 ( ), (acoustic frequency, acoustic-working frequency): , , , ( ) . 1 (. 3.4.1 3.4.2). 2 , . - . 3.4.1 fawf(zero-crossing acoustic-working frequency): n ( -), - n- . 1 n . 2 , - (), . 3 , 1. 4 - . IEC 62127-1, 1, 3.3.1 3.4.2 fawf (arithmetic-mean acous-tic-working frequency): f1 f2

8、, - , 3f1, 3 . 1 - . IEC 61157 2013 3 2 , f1 f2 . 3 f1 3f1, f2 , 3 - . IEC 62127-1, 3.3.2 3.5 BW, (bandwidth): f1 f2, - 3 . IEC 62127-1, 3.6 3.6 Ab6, Ab20, 2(beam area): , , , - (. 3) - . 1 , , , - ( ) . 2 -, : ) 3; b) , - . 3 , 0,25 0,01, 6 20 . 3.7 (beam axis): , , , , - . IEC 62127-1, 3.8 1 (. ). , , -. 2 -, : ) - - 3; b) , - . 3.8 (beam centrepoint): -, z. 3.9 (beamwidth midpoint): , - . 3.10 w6, w12, w20, (beamwidth): , , , ( - ) . 1 , : ) - , 2. b) , - . 2 , 6, 12 20 . -. IEC 61157 2013 4 IEC 62127-1, 3.11 3.11 (central scan line): - , -. 3.12 (external transducer aperture): - , -