GOST IEC 60601-2-22-2011 Medical electrical equipment Part 2-22 Particular requirements for the basic safety and essential performance of surgical cosmetic therapeutic and diagnost.pdf

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1、 , () INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) 2-22 , , (IEC 60601-2-22:2007, IDT) 2013 IEC 60601-2-22 2011 IEC 60601-2-222011 II , 1.092 . 1.22009 . , . , , , 1 - () 2 () 3 , ( 40-2011 29 2011 .) : ( 3166) 00497 ( 3166) 00497 BY KZ KG RU 4 13 2011 . 1322- IEC 60601-

2、2-222011 1 2013 . 5 IEC 60601-2-22:2007 Medical electrical equipment Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment ( . 2-22. , , ). (IDT). . 60601-2-222008 6 ( ) . , . C, 2013 , IEC 60601-2-222011 V IEC

3、 60601-2-22:1995 IEC 60601-2-22:2007, , , IEC 60601-1 ( , 2005: . 1. ). . IEC 60601-1 IEC 60825-1. , . : - - ; - ; - , (, ), ; - , 3 , , . : - , (, 7 7.1, 7.2, .); - (, 7.1, 7.2 7.2.1 7). IEC 60601-2-222011 VI , . . , , , , - . , , , H /, 2. , : - , ; - , , ; - . * , , , , , AA . IEC 60601-2-222011

4、1 2-22 , , Medical electrical equipment. Part 2-22. Particular requirements for the basic safety and essential performance of surgical, cosmetic, therapeutic and laser equipment _ 2013 - 01 - 01 201.1 , 1 , : 201.1.1 : , , , , , , 3B 4 3.22 3.23 IEC 60825-1 ( ). IEC 60601-2-222011 2 . 1 3.49 IEC 608

5、25-1. 2 1; 1; 2; 2 3R , IEC 60825-1 IEC 60601-1. , . , , . , , , 7.2.13 8.4.1 . . 4.2 . , , , , . 201.1.2 : , , , . (IEC 60825-1) IEC 60601-2-222011 3 (IEC 60601-1). 201.1.3 : , 2 2 . IEC 60601-1-3 . 201.1.4 : IEC 60601 , , , . . IEC 60601-1 . . . : . . , . , IEC 60601-2-222011 4 , 101, AA, BB ., aa

6、), bb), . , , , 20x, x , 202 IEC 60601-1-2, 203 IEC 60601-1-3, . , , . ; , . IEC 60825-1, , , . IEC 60825-1, , . 201.2 2 , : : IEC 60825-1:2007 Safety of laser products Part 1: Equipment classification and requirements ( . 1. ) IEC 60947-3 Low-voltage switchgear and controlgear Part 3: Switches, IEC

7、 60601-2-222011 5disconnectors, switch-disconnectors and fuse-combination units ( . 3. , , ) IEC 61010-1 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1: General requirements ( , . 1. ) 201.3 , IEC 60601-1:2005, : : 201.3.101 (): () 1M, 2, 2M, 3R, 3B

8、(. 3.3 4 9 IEC 60825-1) 201.3.102 : , , . 201.3.103 : , , . 201.3.104 : , . 201.3.105 : (. 3.8 IEC 60825-1). 201.3.106 : , . IEC 60601-2-222011 6 201.3.107 1, 1, 2, 2M, 3R, 3B 4 : , , 3.41 3.18 3.23 IEC 60825-1. 201.3.108 : , , . 201.3.109 : , , , . 201.3.110 : / , , . , 4.7 IEC 60825-1. 201.3.111 : , (. 3.70 IEC 60825-1). 201.3.112 : , . , . () / . 3.73 IEC 60601-1. , . 201.3.113 : , . 201.3.114 : IEC 60601-2-222011 7, , . 3.72 IEC 60825-1. 201.3.115 : , , , , ,

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