GOST 30324 35-2002 Medical electrical equipment Part 2 Particular requirements for the safety of blankets pads and mattresses intended for heating in medical use《医疗电气设备 第2部分 医用电热毯 .pdf

1、 2 , (I 60601-2-35:1996, D) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)30324.352002( 60601-2-35:1996), 1.092 . 1.22009 . , - . , , -, 1 - ()2 ()3 , (- 6 2002 . 22) : ( 3166) 00497 ( 3166) 00497 AMBYKZKGRUTJ 4 29 2012 . 1317- 30324.352002 ( 60601-2-35:1996) 1 2015 .5

2、IEC 60601-2-35:1996Medicalelectricalequipment Part2:Particular requirements for thesafetyofblankets,padsand mattresses, intended for heating in medical use ( . 2. - , ).C (D). 50267.3599 ( 60601-2-3596)6 - , - . () . , - - , 2014 -, II 30324.352002 . .11 .12 23 .25 .36 , 3 . 517 .519 5 . .621 .6 . 6

3、36 6 . 7 . .742 744 , , , , , , .746 .849 .8 . .850 .851 10 . ; .1152 .11 . 1254 1256 1557 , .1659 16 101 .18 102 .18 103 18 104 .19 105 19 106 . . . 20 107 20 107 .21 108 .22 L () , .23 () .24 () .27 () , ( ) 28 DD() , ( ) .29 () 30III 30324.352002 IEC 60601-2-35:1996 Medical electrical equipment P

4、art 2: Particular requirements for the safety of blankets,pads and mattresses, intended for heating in medical use ( . 2. , ), - 62D IEC 62 . , 30324.0, . - . , , *. - . :- , - ;- , - ;- , - . :- ;- , 2 , . , . , , , - , 101. , . ., ), ) . .IV 30324.352002 2 , Medical electrical equipment. Part 2. P

5、articular requirements for the safety of blankets, pads and mattresses intendedfor heating in medical use 20150101 . , :1 , :*1.1 , , , , 2.2.102, 2.2.106 2.2.107.2.2.103 , .2.2.104 , .2.2.105 , , .2.2.106 , .2.2.107 , , .2.2.108 - DD.2.2.109 - DD.2.10 , . , .1 30324.352002( 60601-2-35:1996) . .1.2

6、- , .1.3 ( 30324.0). , -. , - . , , ,.-, , , .*1.101 :- , ;- (. 30324.21);- (. 30324.19);- (. 30324.20).2 , :2.2 ()2.2.101 , , , , .2.2.102 , , .2.10.101 , , .2.12 2.12.101 R (. 101 101).3 :3.6 ) , , , - (. 3).2 30324.3520023.101 , , , - , , - . , , , IEC 60601-1-1.5 5.2 ) BF F.6 , , :6.1 ) :1) :-;-;- ;- , -,;- (. . ) ;2) ;3) , ;4) , ;5) , , , , ,;6) , , - , -, .*bb) , , - .) 30 , 50.101, .6.3 ) . 50.1 3 30324.352002) , -1(. 50.104 ).6.8 6.8.1 ( ) (. 6.1 - d) ) :- , 6.1 ) 6.1 );- 6.1 , - .6.8.2 *6.8.2 d) , , :