IEC60601-1-2 第四版新的医疗EMC标准

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IEC60601-1-2 第四版新的医疗EMC标准

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60601-1的EMC部分60601-1-2现在是第三版本。但从2017年4月开始，新的认证或重新认证医疗器械，需要满足更严格的第四版标准。所以很多医疗器械制造商现在就倾向于使用符合第4版EMC的设计。

EMC标准包括辐射和干扰两部分，第四版的辐射部分和第三部基本一致，不过要注意的是辐射标准是CISPR11 B级（传导和辐射）和61000-3-2（谐波）B级。

下列表格列举了第三版和第四版的一些差别，同时标注了Globtek新一代产品GTM96系列电源产品在该规格上的参数。

美国FDA设了转换日期为2017年4月1日，下面是他们网站上面的标准： http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=32630

60601-1-2 Immunity Test Level

Immunity Test	3th ed criteria	4th ed criteria	Enhanced GT EL6 GTM96XXX Family Product Capability
ESD 61000-4-2	6KV Contact 8KV Air	8KV Contact 15KV Air	10KV Contact 18KV Air
Radiated RF 61000-4-3	3V/m, 80-2500MHz, General Medical Equip 10V/m, 80-2500MHz, Life Support Equip	3V/m, 80-2500MHz, Professional Healthcare Facility 10V/m, 80-2500MHz, Home Healthcare Environment	Same as 4th ed Criteria
EFT 61000-4-4	2kV on AC input, 5KHz Repetition 3x -- to Line, Neutral and Earth	2kV on AC input, 100KHz Repetition 3x -- to Line, Neutral and Earth	4kV on AC input, 100KHz Repetition 3x -- to Line, Neutral and Earth
Surge (Lightning) 61000-4-5	2kV common mode, 1kV differential on AC lines (minimum 5 surges at each phase angle)	500V,1kV,2kV common mode, 500V,1kV differential on AC	500V,1kV,2kV,4kV common mode, 500V,1kV,2KV differential mode on AC input lines #
Conducted RF 61000-4-6	3Vrms, 0.15-80MHz on AC input	3Vrms, 0.15-80MHz on AC input	Same as 4th ed Criteria
Dips and Dropouts 61000-4-11	Dip to 40% for 5 cycles (100 ms) Dip to 70% for 25 cycles (500ms) Dropout to 5% for 10 ms Interrupt >95% for 5 sec	Dip to 0% for 1 cycles @ 0°phase angle Dip to 70% for 25/30 cycles @ 0° phase angle Dropout to 0% for 0.5 cycles @ 0°, 45°, 90°, 135° , 180°, 225°, 270° & 315° phase angles Interrupt 100% for 250/300 cycles-	Same as 4th ed Criteria
# GTM96060 Enhanced Surge capability limited to 1.5kV for differential mode

GlobTek products compliant with IEC 60601-1-2 4th edition:

Name	Type	Input Voltage	Watts	Vout	Efficiency	Ingress Protection	MOOP	MOPP	60601-1-4th Ed.	IEC 62368-1	Dimensions (mm)
GT-41134-W2-TAB	Wall Plug-in	120V~/60Hz	6	6 V	V	IP40			✔
GTM41076-06VV-QA 2MOPP	Wall Plug-in	100-240V~, 50-60 Hz	6	5-30 V	Meets/Exceeds for Medical	IP52 Option		✔	✔		43.5* 74.0* 35.3
GTM41134-WWVV-F	Open Frame/Internal	100-240V~, 50-60 Hz	6	3.3-48 V	N/A			✔	✔	✔	84.541.517.0
GTM41134-WWVV-FWT2	Open Frame/Internal	100-240V~, 50-60 Hz	6	5 V	N/A			✔	✔	✔	84.541.517.0
GTM96060-06VV-Q	Wall Plug-in	100-240V~, 50-60 Hz	6	3.3-48 V	VI	IP52		✔	✔	✔	43.574.036.8
GTM46101-WWVV-X.X-USB	Wall Plug-in	100-240V~, 50-60 Hz	10	5-5.5 V	VI	Indoor Use		✔	✔	✔	41.0 x 71.0 x 31.5
GTM46101-WWVV-X.X-USB1A	Wall Plug-in	100-240V~, 50-60 Hz	10	5-5.5 V	VI	Indoor Use		✔	✔	✔	41.0 x 70.0 x 35.1
GTM46161-16V.V-USB	Wall Plug-in	100-240V~, 50-60 Hz	16	5-5.5 V	VI	Indoor Use		✔	✔	✔	41.0 x 71.0 x 31.5
GTM46161-16V.V-USB1A	Wall Plug-in	100-240V~, 50-60 Hz	16	5-5.5 V	VI	Indoor Use		✔	✔	✔	41.0 x 71.0 x 31.5
GTM46161-16V.V-USB2A	Wall Plug-in	100-240V~, 50-60 Hz	16	5-5.5 V	VI	Indoor Use		✔	✔	✔	41.0 x 70.0 x 35.1
GTM46161-16V.V-USBC	Wall Plug-in	100-240V~, 50-60 Hz	16	5-5.5 V	VI	Indoor Use		✔	✔	✔	41.0 x 70.0 x 35.1
GTM41080-18VV-F	Open Frame/Internal	100-240V~, 50-60 Hz	18	5-48 V	V	IPX0	✔	✔	✔		84.541.521.6
GTM41080-18VV-F	Open Frame/Internal	100-240V~, 50-60 Hz	18	5-48 V	V	IPX0	✔	✔	✔		744434
GTM96180-18VV H/M	Wall Plug-in	100-240V~, 50-60 Hz	18	3-48 V	VI	IP42		✔	✔	✔	7443.536.8
GTM96180-18VV-T2	Desktop/External	100-240V~, 50-60 Hz	18	5-48 V	VI	IP42		✔	✔	✔	(L)87x(W)47x(H)32mm
GTM96180-18VV-T2A	Desktop/External	100-240V~, 50-60 Hz	18	5-48 V	VI	IP42		✔	✔	✔	(L)87x(W)47x(H)32mm
GTM96180-18VV-T3	Desktop/External	100-240V~, 50-60 Hz	18	5-48 V	VI	IP42		✔	✔	✔	(L)87x(W)47x(H)32mm
GTM96180-18VV-T3A	Desktop/External	100-240V~, 50-60 Hz	18	5-48 V	VI	IP42		✔	✔	✔	(L)87x(W)47x(H)32mm
GTM41060-25VV-FW-IM	Open Frame/Internal	100-240V~, 50-60 Hz	25	3-48 V	Meets/Exceeds for Medical			✔	✔		985028
GTM96250-25VV-R2	Wall Plug-in+Desktop Combination	100-240V~, 50-60 Hz	25	5-48 V	VI	IP41, IP52 Option available		✔	✔		(L)101.73x(W)46.47x(H)38.2mm
GTM91120-30VV-F	Open Frame/Internal	100-240V~, 50-60 Hz	30	5-48 V	V		✔	✔	✔		101.6x50.8x22.30
GTM91120-30VV-F (PCB Mounted)	Open Frame/Internal	100-240V~, 50-60 Hz	30	12-24 V	V		✔	✔	✔		101.6x50.8x22.30
GTM91120-30VV-FW	Open Frame/Internal	100-240V~, 50-60 Hz	30	5-48 V	V		✔	✔	✔		101.6x50.8x22.30
GTM91120-30VV-FW (PCB Mounted)	Open Frame/Internal	100-240V~, 50-60 Hz	30	5-48 V	V		✔	✔	✔		101.6x50.8x22.30
GTM91120-30VV-P2	Potted/Encapsulated in plastic housing	100-240V~, 50-60 Hz	30	5-48 V	V		✔		✔		1024637
GTM91120-30VV-P2(SR with NA Plug 2 pin)	Potted/Encapsulated in plastic housing	100-240V~, 50-60 Hz	30	5-48 V	V	IP68	✔	✔	✔
GTM91120-30VV-P3	Potted/Encapsulated in plastic housing	100-240V~, 50-60 Hz	30	5-48 V	V	IP68	✔		✔		1024637
GTM91120-30VV-P3 (SR with EU Plug 3 pin)	Potted/Encapsulated in plastic housing	100-240V~, 50-60 Hz	30	5-48 V	V	IP68	✔		✔
GTM91120-30VV-P3 (SR with NA Plug 3 pin)	Potted/Encapsulated in plastic housing	100-240V~, 50-60 Hz	30	5-48 V	V	IP68	✔	✔	✔
GTM91120-30VV-T2	Wall Plug-in+Desktop Combination	100-240V~, 50-60 Hz	30	5-48 V	V	IP40 (cord), IP52(R-blades)	✔		✔		(L)101.77x(W)47.47x(H)36.7
GTM91120-30VV-T3A	Wall Plug-in+Desktop Combination	100-240V~, 50-60 Hz	30	5-48 V	V	IP40 (cord), IP52(R-blades)	✔	✔	✔		(L)101.77x(W)47.47x(H)36.7 mm
GTM96300-36VV-R2	Wall Plug-in+Desktop Combination	100-240V~, 50-60 Hz	36	5-54 V	VI	IP40 (cord), IP52(R-blades)		✔	✔	✔	(L)101.73x(W)46.47x(H)38.2mm
GTM96300-36VV-R3A	Wall Plug-in+Desktop Combination	100-240V~, 50-60 Hz	36	5-54 V	VI	IP40 (cord), IP52(R-blades)		✔	✔	✔	(L)101.7x(W)46.47x(H)38.2mm
GTM96300-36VV-T2	Desktop/External	100-240V~, 50-60 Hz	36	5-54 V	VI	IP42, IP54 Option available		✔	✔	✔	(L)107.2.0x(W)50.0x(H)35.50mm
GTM96300-36VV-T2A	Desktop/External	100-240V~, 50-60 Hz	36	5-54 V	VI	IP42, IP54 Option available		✔	✔	✔	(L)107.2.0x(W)50.0x(H)35.50mm
GTM96300-36VV-T3	Desktop/External	100-240V~, 50-60 Hz	36	5-54 V	VI	IP42, IP54 Option available		✔	✔	✔	107.2x(W)50.0x(H)35.0mm
GTM46402-40VV-x.x-Q	Wall Plug-in	100-240V~, 50-60 Hz	40	5-48 V	VI	Indoor Use		✔	✔	✔	43.5 x 74.0 x 35.3
GTM43007-AWWVV-F	Open Frame/Internal	100-240V~, 50-60 Hz	60	5-48 V	N/A	N/A		✔	✔	✔	76.2x50.8x23.6 for 5V-14V models, 76.2x50.8x22.5 for 15V-48V modelsTop Diagram i
GTM43007-AWWVV-F (D3 without standoffs)	Open Frame/Internal	100-240V~, 50-60 Hz	60	5-48 V	N/A	N/A		✔	✔	✔	76.2x50.8x23.6 for 5V-14V models, 76.2x50.8x22.5 for 15V-48V modelsTop Diagram i
GTM43007-AWWVV-FW	Open Frame/Internal	100-240V~, 50-60 Hz	60	5-48 V	N/A	N/A		✔	✔	✔	76.2x50.8x23.6 for 5V-14V models, 76.2x50.8x22.5 for 15V-48V models
GTM43007-AWWVV-FW (D2 without standoffs)	Open Frame/Internal	100-240V~, 50-60 Hz	60	5-48 V	N/A	N/A		✔	✔	✔	76.2x50.8x23.6 for 5V-14V models, 76.2x50.8x22.5 for 15V-48V models
GTM43007-BWWVV-F	Open Frame/Internal	100-240V~, 50-60 Hz	60	5-48 V	N/A	N/A		✔	✔	✔	101.6x50.8x23.6 for 5V-14V models, 101.6x50.8x22.5 for 15V-48V models
GTM43007-BWWVV-FW	Open Frame/Internal	100-240V~, 50-60Hz	60	5-48 V	N/A	N/A		✔	✔	✔	101.6x50.8x23.6 for 5V-14V models, 101.6x50.8x22.5 for 15V-48V models
GTM43007-CWWVV-F	Open Frame/Internal	100-240V~, 50-60 Hz	60	5-48 V	N/A	N/A		✔	✔	✔	127x76.2x23.6
GTM43007-CWWVV-FW	Open Frame/Internal	100-240V~, 50-60 Hz	60	5-48 V	N/A	N/A		✔	✔	✔	127x76.2x23.6
GTM91099-60VV-P2	Potted/Encapsulated in plastic housing	100-240V~, 50-60 Hz	60	5-48 V	V	IP68		✔	✔		144.8157.1139.0
GTM91099-60VV-P3	Potted/Encapsulated in plastic housing	100-240V~, 50-60 Hz	60	5-48 V	V			✔	✔
GTM91099-60VV-P3(SR with NA Plug 3 pin)	Potted/Encapsulated in plastic housing	100-240V~, 50-60 Hz	60	5-48 V	V			✔	✔
GTM91099-60VV-T2	Wall Plug-in+Desktop Combination	100-240V~, 50-60 Hz	60	5-48 V	V	IP42		✔	✔		117.5353.4736.6
GTM91099-60VV-T3A	Wall Plug-in+Desktop Combination	100-240V~, 50-60 Hz	60	5-48 V	V	IP52, IP54 Option available		✔	✔		117.5353.4736.6
GTM96600-60VV-P2(SR with NA Plug 2 pin)	Potted/Encapsulated in plastic housing	100-240V~, 50-60 Hz	60	36-48 V	VI	IP68		✔	✔		144.8157.1139.0
GTM96600-60VV-P3(SR with NA Plug 3 pin)	Potted/Encapsulated in plastic housing	100-240V~, 50-60 Hz	60	0 V	VI	IP68		✔	✔		144.8157.1139.0
GTM96600-60VV.V-R2	Wall Plug-in+Desktop Combination	100-240V~, 50-60 Hz	60	5-54 V	VI	IP40, IP54 Option available		✔	✔		117.5353.4736.6
GTM96600-60VV.V-R3A	Wall Plug-in+Desktop Combination	100-240V~, 50-60 Hz	60	5-54 V	VI	IP40, IP54 Option available		✔	✔		117.5353.4736.6
GTM96600-60VV.V-T2	Desktop/External	100-240V~, 50-60Hz	60	5-54 V	VI	IP41		✔	✔		117.553.534.2
GTM96600-60VV.V-T2A	Desktop/External	100-240V~, 50-60Hz	60	5-54 V	VI	IP41		✔	✔		117.553.534.2
GTM96600-60VV.V-T3	Desktop/External	100-240V~, 50-60Hz	60	5-54 V	VI	IP41		✔	✔		117.553.534.2
GTM96600-60VV.V-T3A	Desktop/External	100-240V~, 50-60Hz	60	5-54 V	VI	IP41		✔	✔		117.553.534.2
GTM96600-65VV-P2(SR with fixed Plug 2 pin)	Potted/Encapsulated in plastic housing	100-240V~, 50-60 Hz	60	0 V	VI	IP68		✔	✔		144.8157.1139.0
GTM96605-GEN2-R2	Desktop/External	100-240V~, 50-60Hz	60	0 V	VI			✔	✔	✔
GTM96605-GEN2-R3A	Desktop/External	100-240V~, 50-60Hz	60	0 V	VI			✔	✔	✔	117.5353.4736.6
GTM96605-GEN2-T2	Desktop/External	100-240V~, 50-60Hz	60	0 V	VI			✔	✔	✔
GTM96605-GEN2-T3	Desktop/External	100-240V~, 50-60Hz	60	0 V	VI			✔	✔	✔
GTM96600-65VV.V-P2	Desktop/External	100-240V~, 50-60Hz	65	5-54 V	VI	IP68		✔	✔		117.553.534.2
GTM96600-65VV.V-P3	Desktop/External	100-240V~, 50-60Hz	65	5-54 V	VI	IP68		✔	✔		117.553.534.2
GTM96600-65VV.V-R2	Wall Plug-in+Desktop Combination	100-240V~, 50-60 Hz	65	12-48 V	VI	IP40, IP54 Option available		✔	✔		117.5353.4736.6
GTM96600-65VV.V-R3A	Wall Plug-in+Desktop Combination	100-240V~, 50-60 Hz	65	12-48 V	VI	IP40, IP54 Option available		✔	✔		117.5353.4736.6
GTM96600-65VV.V-T2	Desktop/External	100-240V~, 50-60Hz	65	5-48 V	VI	IP41		✔	✔		117.553.534.2
GTM96600-65VV.V-T3	Desktop/External	100-240V~, 50-60Hz	65	5-48 V	VI	IP41		✔	✔		117.553.534.2
GTM41133-90VV-x.x-F	Open Frame/Internal	100-240V~, 50-400Hz	90	12-48 V	V			✔	✔		1846225
GTM41133-90VV-x.x-T2	Desktop/External	100-240V~, 50-60 Hz	90	12-48 V	V	IP21		✔	✔		149.38 x 62.6 x 33.5 +/-1.0
GTM96900P90VV.V-T2	Desktop/External	100-240V~, 50-60 Hz	90	12-54 V	VI	IP41			✔	✔	149.38 x 62.6 x 33.5 +/-1.0
GTM96900P90VV.V-T3	Desktop/External	100-240V~, 50-60Hz	90	12-54 V	VI	IP41		✔	✔	✔	149.3 x 62.8 x 34.0 +/-1.0
GTM96900P90VV.V-T3A	Desktop/External	100-240V~, 50-60Hz	90	12-54 V	VI	IP41		✔	✔	✔	149.38 x 62.6 x 33.5 +/-1.0 mm
GTM961200P120VV.V-T2	Desktop/External	100-240V~, 50-60 Hz	120	12-54 V	VI	IP41		✔	✔	✔	149.3062.8034.00
GTM961200P120VV.V-T3	Desktop/External	100-240V~, 50-60 Hz	120	12-54 V	VI	IP41		✔	✔	✔	149.3062.8034.00
GTM961600PWWWVV.V-T2	Desktop/External	100-240V~, 50-60 Hz	160	12-36 V	VI	IP41		✔	✔		176.57440
GTM961600PWWWVV.V-T3	Desktop/External	100-240V~, 50-60 Hz	160	12-54 V	VI	IP41		✔	✔		176.57440
GTM961600PWWWVV.V-T3A	Desktop/External	100-240V~, 50-60 Hz	160	12-36 V	VI	IP41		✔	✔		176.57440
GTM961800PWWWVV.V-T2	Desktop/External	100-240V~, 50-60 Hz	180	12-54 V	VI	IP41		✔	✔		176.57440
GTM961800PWWWVV.V-T2A	Desktop/External	100-240V~, 50-60 Hz	180	12-54 V	VI	IP41		✔	✔		176.57440
GTM961800PWWWVV.V-T3	Desktop/External	100-240V~, 50-60Hz	180	12-54 V	VI	IP41		✔	✔		176.57440
GTM961800PWWWVV.V-T3A	Desktop/External	100-240V~, 50-60 Hz	180	15-54 V	VI	IP41		✔	✔		176.57440
GTM962250PWWWVV.V-F	Open Frame/Internal	100-240V~, 50-60 Hz	225	12-54 V	VI	N/A		✔	✔	✔	101.6 (L) x 50.8 (W) x 31.0 (H)
GTM962250PWWWVV.V-FL	Open Frame/Internal	100-240V~, 50-60 Hz	225	12-54 V	VI	na		✔	✔	✔	103.5 (L) x 62.3 (W) x 40.0 (H)
GTM962500PWWWVV.V-CX	Open Frame/Internal	100-240V~, 50-60 Hz	250	15-35 V	VI	na		✔	✔		20363.541
GTM962500PWWWVV.V-F	Open Frame/Internal	100-240V~, 50-60 Hz	250	12-54 V	VI	na		✔	✔		20363.541
GTM962500PWWWVV.V-FL	Open Frame/Internal	100-240V~, 50-60 Hz	250	12-54 V	VI	na		✔	✔		20363.541

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IEC60601-1-2 第四版新的医疗EMC标准

60601-1-2 Immunity Test Level

GlobTek products compliant with IEC 60601-1-2 4th edition:

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