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    GOST R IEC 60601-2-2-2013 Medical electrical equipment Part 2-2 Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high.pdf

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    GOST R IEC 60601-2-2-2013 Medical electrical equipment Part 2-2 Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high.pdf

    1、2014 2-2 IEC 60601-2-2:2009Medical electrical equipment null Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories(IDT) 60601-2-2 2013 60601-2-22013II1 ( ) , 42 11 , 3 8 2013 . 13504 6060122:2009

    2、. 22. (IEC 6060122:2009 Medical electrical equipment Part 2 2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories). , 5 1.02012 ( 8). - ( 1 - ) , -. () - . , - (gost.ru) , 2014 , 60601-2-22013III201.1 ,

    3、.1201.2 2201.3 3201.4 5201.5 6201.6 ME ME 6201.7 , 6201.8 .10201.9 , ME ME .22201.10 .22201.11 22201.12 .24201.13 28201.14 (PEMS) 28201.15 .28201.16 31201.17 ME ME 31202 * . .31208 , 32 .33 A () 33 () , 49 () .55 55 60601-2-22013IV, , , . 606011:2005 . 1. ( ). . . (*) () , ., , , , , . , . . , , . /

    4、 , 2. : : ; : ; ( , ): . ; , 3 , . : , , ; , 7 () 7.1, 7.2 . .; ; , 7.1, 7.2 7.2.1 7. , . , . . . , , G / , 2. : , ; , , ; . , , http:/webstore.iec.ch , . : , , . 60601-2-22013 1 20150101201.1 , 1 1) :201.1.1 : , 201.3.222. 50 (, ). .201.1.2 : , 201.3.222.201.1.3 : , 2 201.2 . 6060112 6060118 202 20

    5、8 . 6060113, 60601110 606011112) . 606011 .201.1.4 : 60601 , , , , . .1) 606011:2005 . 1. ( ).2) 60601111:2010 . 1. . . , . 2-2 Medical electrical equipment. Part 22. Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgic

    6、al accessories 60601-2-220132 606011 . . 201 (, 201.1 1 ) 20x, x () () (, 202.4 4 6060112, 203.4 4 6060113 . .). :- ;- ;- ., , , , 201.101. , , 3.1 3.139, , 201.3.201. , . . aa), bb) . . , , , 20x, , , 202 6060112, 203 6060113 . . , . , , . , , , .201.2 . , 2, : 6060112:2007 . 12. . . (IEC 6060112:2

    7、007 Medical electrical equip ment Part 12: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and tests) 6060118:2006 . 18. . , (IEC 6060118:2006 Medi cal electrical equipment Part 18: General requirements for basic safety

    8、and essential performance Col lateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems): 6100043:2006 (EMC). 43. . (IEC 6100043:2006 Electromagnetic compatibility (EMC) Part 43: Testing and measurement tech niques Radiated, radiofrequency, electromagnetic field immunity test) 6100046:2003 (EMC) 4 6: . , (IEC 6100046:2003 Electromagnetic compatibility (EMC) Part 46: Testing and measurement tech niques Immunity to conducted disturbances, induced by radiofrequency fields) 60601-2-2


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