GOST R IEC 62359-2011 Medical equipment General requirements for methods of determination of mechanical and thermal fields safe indices for medical ultrasonic diagnostic equipment《.pdf

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1、 623592011 IEC 62359:2010Ultrasonics Field characterization Test methods for the determinationof thermal and mechanical indices related to medical diagnosticultrasonic fields(IDT) 27 2002 . 184- , 1.02004 . 1 - - , 42 3 9 2011 . 114-4 62359:2010 , - (IEC 62359:2010 Ultrasonics Fieldcharacterization

2、Test methods for the determination of thermal and mechanical indices related to medicaldiagnostic ultrasonic fields). - 1.52004 ( 3.5). - , - 5 , - . - () . , , 2012 , - - II 6235920111 12 13 24 105 .115.1 115.2 .125.2.1 . . . 125.2.2 125.3 125.4 135.4.1 135.4.2 TIB 135.5 .145.5.1 .145.5.2 .155.6 .1

3、55.6.1 .155.6.2 .155.6.3 165.7 16 () .18 () , 1c1801.33 () 38 D () TI MI .39 () 62359 41 () .43 44III 623592011 Medical equipment. General requirements for methods of determination of mechanical and thermal fields safe indicesfor medical ultrasonic diagnostic equipment 201209011 :- , - ;- , - ;- , .

4、1 3 , -, ( / 2, 5, Ib), ( 10) . - , - , .2 MI 0,25 15 , TI 0,5 15 .3 , , 1 , 0,3 c2151c2151 1, , , - , 2.2 . - , - ( ). 60601-2-37 2-37: - (IEC 60601-2-37, Medical electrical equipment Part 2-37: Particular requirements for the basicsafety and essential performance of ultrasonic medical diagnostic a

5、nd monitoring equipment) 61157:2007 (IEC 61157:2007, Standard means forthe reporting of the acoustic output of medical diagnostic ultrasonic equipment)1 623592011 61161:2006 - (IEC 61161:2006, Ultrasonics Powermeasurement Radiation force balances and performance requirements) 61828:2001 (IEC 61828:2

6、001, Ultrasonics Focusing transducers Definitions andmeasurement methods for the transmitted fields) 62127-1:2007 1: 40 (IEC 62127-1:2007, Ultrasonics Hydrophones Part 1:Measurement and characterization of medical ultrasonic fields up to 40 MHz) 62127-2:2007 2: 40 (IEC 62127-2:2007, Ultrasonics Hydr

7、ophones Part 2:Calibration for ultrasonic fields up to 40 MHz) 62127-3:2007 3: - 40 (IEC 62127-3:2007, Ultrasonics Hydrophones Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz)3 , : 62127-1, 62127-2, 62127-3, 61157 61161. . / 2, 5, Ib - . , 10n(n ), - .3.1 c97,c2151c2151: , - - .

8、 .3.2 c1090,c2151c2151: , . .3.3 rp, : c92 ( - 62127-1). .3.4 , : , , , - ( 62127-1).1 . 3.4.1 3.4.2.2 , - .3.4.1 fawf: ( ), .1 , , - .2 6235920112 .3 , 3.4 .3.4.2 fawf: - f1 f2, , 3f1, 3 .1 - .2 , f10) (z =0).b) 70 , 25 .4.3, Y ( ), 1,0 , / (= 1)1 c1801.c) , .4.3.2 - , , , , 1 2, , 12, . - , .d) - (, 3D 4D ). / (- ) . 1 c1801 , , 1 . , 12, , - (, -), . TIS 1 c1801,c97(z) - 1 c1801, (. .2). TIB ( ) TIC ( ) . TIC , . - .4.1.4 (. .2). , -, 10 (. .2).4.1.6 TIS 1 c1801, c97(z) min (Ispta, c97(z)c21512, c97(z), .4.3.2, (.1) .2. , - 1 zb, ns. , - , . Pdeg 1, 12, 14, 23. .4.3.4.4.1.7