GOST R IEC 62353-2013 Medical electrical equipment Recurrent test and test after repair of medical electrical equipment《医疗电气设备 医用电气设备周期性测试和修理后测试》.pdf

1、 623532013 IEC 62353:2007Medical electrical equipment Recurrent test and test after repair of medicalelectrical equipment(IDT) 1 - ,42 011,3 -82013.1534-4 62353:2007 - . (IEC 62353:2007 Medical electrical equipment Recurrent test and test after repair ofmedicalelectricalequipment).- ,5 1.02012 ( 8).

2、 ( 1 ) , -.()- .,- (gost.ru),2014 , -II 6235320131 , .11.1* .11.2 22 23 24 .64.1* .64.2 ,.74.3* 85* .85.1 .85.2 .85.3 85.4 196 .196.1 196.2 20() .21() .26() - 29D() 31() 60601-132F() 35G() .36() 3738 39III 623532013- , (MEME). 60601-1 - . 1. . - ME ME . . (*) - , , . :- , , - ;- , , , , ;- ;- , 2 ,

3、. :- , ;- , , ;- - .IV 623532013 Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment 201501011 , , 1.1 * , ( ME ME ) ME ME , 60601-1 2 , , ME ME ( ). , 60601-1, . , 60601-1 2. , ME ME . :- : , , - : , ME ME , . . MEME- . , ME ME . , , , - , , . - . . -

4、-. . , . F.1 623532013 1.2 - , , : ME ME .2 . - . ( ). 60364-7-710 . 7-710. . (IEC 60364-7-710, Electrical installations ofbuildings Part 7-710: Requirements for special installations or locations Medical locations) 60417 (IEC 60417, Graphicalsymbols for use on equipment) 61010-1 , - . 1. (IEC 61010

5、-1, Safety requirements forelectrical equipment for measurement, control, and laboratory use Part 1: General requirements) 61010-2-010 , . 2-010. - (IEC 61010-2-010, Safety requirements for electrical equipment formeasurement, control and laboratory use Part 2-010: Particular requirements for labora

6、tory equipment forthe heating of materials) 61010-031 , - . 031. - (IEC 61010-031, Safety requirements for electrical equipment formeasurement, control and laboratory use Part 031: Safety requirements for hand-held probe assemblies forelectrical measurement and test) 61140 . - (IEC 61140, Protection

7、 against electric shock Common aspects for installation and equipment) 61557-1 1000 1500 . , . 1. (IEC 61557-1, Electrical safety in low voltage distribution systemsup to 1000 V a.c. and 1500 V d.c. Equipment for testing, measuring or monitoring of protectivemeasures Part 1: General requirements)3 :

8、 , 60601-1, .3.1 (accessible conductive part): ME , , , .3.2 (accessory): , :- ;- ;- ;- , - . 60601-1, 3.33.3 (accompanying document): , ME, ME 2 623532013 , . 60601-1, 3.43.4 (applied part): ME , ME ME .3.5 (applied part leakage current): , .3.6 I (class I): , - , - , . 60601-1, 3.143.7 II (class I

9、I):, - , - , , . 60601-1, 3.153.8 (detachable power supply cord): , . 60601-1, 3.213.9 (earth leakage current): , - . 60601-1, 3.253.10 (electrical safety): , , - 60601-1. (. 14971, 2.24).3.11 (equipment leakage current): , .3.12 () F ( F) F-type isol ated (floating) applied part (herein F-type applied part): , ME , , , -,- . 60601-1, 3.293.13 (functional connection): , , , . ( ) . 60601-1, 3.333.14 (inspeksion): .3.15 (internal electrical power source): -, , - . , , .