GOST R IEC 60601-2-46-2014 Medical electrical equipment Part 2-46 Particular requirements for the basic safety and essential performance of operating tables《医疗电气设备 第2-46部分 手术台基本安全和.pdf

1、 2-46 IEC 60601-2-46:2010Medical electrical equipment Part 2-46: Particular requirements for the basicsafety and essential performance of operating tables(IDT) 60601-2-4620141 ( -) -, 42 411 - , 3 4 2014 . 498-4 60601-2-46:2010 . 2-46. - (IEC 60601-2-46:2010 Medical electricalequipment Part 2-46: Pa

2、rticular requirements for the basic safety and essential performance of operatingtables). - - , 5 1.02012 ( 8). ( 1 ) , -. () . , - (gost.ru) , 2014 , - - II 60601-2-462014201.1 , 1201.2 .2201.3 3201.4 .3201.5 3201.6 3201.7 , 4201.8 4201.9 , . . . 4201.10 6201.11 .6201.12 .7201.13 .7201.14 (PEMS) 72

3、01.15 .7201.16 7201.17 7202 . 7 G () .9 AA () .10 () 12 13 60601-2-462014III . - 60601-1:2005 . 1. (IEC 60601-1:2005,Medical electrical equipment Part 1: General requirements for basic safety and essential performance), - . -. - . - 1). , , - , . - . (*), , , - .1) . General guidance and rationale (

4、. . ), Particular guidance and rationale (. . ).IV 60601-2-462014 2-46 Medical electrical equipment. Part 2-46. Particular requirements for the basic safety and essential performanceof operating tables 20150601201.1 , 1 1), :201.1.1 : , - , , , , . . 4.2 . :- ;- ;- ;- ;- ;- ;- ;- . / , .201.1.2 : ,

5、201.3.2032), .201.1.3 : , 2 - 201.2 .1) 60601-1:2005 . 1. (IEC 60601-1:2005, Medical electrical equipment Part 1: Generalrequirements for basic safety and essential performance) ( ).2) . 201.3.201, 201.3.203.1 60601-2-462014 60601-1-2 202. 60601-1-3, 60601-1-8 60601-1-10 . 60601-1, .201.1.4 : 60601

6、, -, - , . - . 60601-1 . - . 201 (, 201.1 - 1 ) 20, () () - (, 202.4 4 60601-1-2, 203.4 4 - 60601-1-3 . .). - :- , - ;- , ;- , - ., , , -, 201.101. , - 3.1 3.139, 201.3.201. , BB . ., - ), bb) . ., , , - , 20, () () , 202 60601-1-2, 203 60601-1-3 . . , , . -, ; , .201.2 2 , : 60601-1-2:2007 . 1-2. -

7、 . . - . (IEC 60601-1-2:2007, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard:Electromagnetic compatibility Requirements and tests): 60601-2-2 . 2-2. - (IEC 60601-2-2, Medical electricalequipment Part 2-2: Particular requirem

8、ents for the basic safety and essential performance of highfrequency surgical equipment and high frequency surgical accessories)2 60601-2-462014201.3 60601-1, : .:201.3.201 (MOBILE OPERATING TABLE): - , .201.3.202 (NORMAL POSITION): - , .201.3.203 (OPERATING TABLE): , - . - , / - .201.3.204 (TEMPORARY USE): - 24 .201.3.205 (TRANSPORTER): , - , , , .1 , .2 .201.3.206 (TRENDELENBURG POSITION): , , .201.4 4 , :201.4.3 : , :- - , , .201.4.7 : :- () / .101 , - .102 , - (), .201.5 5 .201.6 6 .3 60601-2-462014201.7 ,