IEC60601-1-2 第四版新的医疗EMC标准


IEC60601-1-2 第四版新的医疗EMC标准

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 Test3th ed criteria4th ed criteriaEnhanced 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:

NameTypeInput VoltageWattsVoutEfficiencyIngress ProtectionMOOPMOPP60601-1-4th Ed.IEC 62368-1Dimensions (mm)
GT-41134-W2-TABWall Plug-in120V~/60Hz66 VVIP40
GTM41076-06VV-QA 2MOPPWall Plug-in100-240V~, 50-60 Hz65-30 VMeets/Exceeds for MedicalIP52 Option43.5* 74.0* 35.3
GTM41134-WWVV-FOpen Frame/Internal100-240V~, 50-60 Hz63.3-48 VN/A84.5*41.5*17.0
GTM41134-WWVV-FWT2Open Frame/Internal100-240V~, 50-60 Hz65 VN/A84.5*41.5*17.0
GTM96060-06VV-QWall Plug-in100-240V~, 50-60 Hz63.3-48 VVIIP5243.5*74.0*36.8
GTM46101-WWVV-X.X-USBWall Plug-in100-240V~, 50-60 Hz105-5.5 VVIIndoor Use41.0 x 71.0 x 31.5
GTM46101-WWVV-X.X-USB1AWall Plug-in100-240V~, 50-60 Hz105-5.5 VVIIndoor Use41.0 x 70.0 x 35.1
GTM46161-16V.V-USBWall Plug-in100-240V~, 50-60 Hz165-5.5 VVIIndoor Use41.0 x 71.0 x 31.5
GTM46161-16V.V-USB1AWall Plug-in100-240V~, 50-60 Hz165-5.5 VVIIndoor Use41.0 x 71.0 x 31.5
GTM46161-16V.V-USB2AWall Plug-in100-240V~, 50-60 Hz165-5.5 VVIIndoor Use41.0 x 70.0 x 35.1
GTM46161-16V.V-USBCWall Plug-in100-240V~, 50-60 Hz165-5.5 VVIIndoor Use41.0 x 70.0 x 35.1
GTM41080-18VV-FOpen Frame/Internal100-240V~, 50-60 Hz185-48 VVIPX084.5*41.5*21.6
GTM41080-18VV-FOpen Frame/Internal100-240V~, 50-60 Hz185-48 VVIPX074*44*34
GTM96180-18VV H/MWall Plug-in100-240V~, 50-60 Hz183-48 VVIIP4274*43.5*36.8
GTM96180-18VV-T2Desktop/External100-240V~, 50-60 Hz185-48 VVIIP42(L)87x(W)47x(H)32mm
GTM96180-18VV-T2ADesktop/External100-240V~, 50-60 Hz185-48 VVIIP42(L)87x(W)47x(H)32mm
GTM96180-18VV-T3Desktop/External100-240V~, 50-60 Hz185-48 VVIIP42(L)87x(W)47x(H)32mm
GTM96180-18VV-T3ADesktop/External100-240V~, 50-60 Hz185-48 VVIIP42(L)87x(W)47x(H)32mm
GTM41060-25VV-FW-IMOpen Frame/Internal100-240V~, 50-60 Hz253-48 VMeets/Exceeds for Medical98*50*28
GTM96250-25VV-R2Wall Plug-in+Desktop Combination100-240V~, 50-60 Hz255-48 VVIIP41, IP52 Option available(L)101.73x(W)46.47x(H)38.2mm
GTM91120-30VV-FOpen Frame/Internal100-240V~, 50-60 Hz305-48 VV101.6x50.8x22.30
GTM91120-30VV-F (PCB Mounted)Open Frame/Internal100-240V~, 50-60 Hz3012-24 VV101.6x50.8x22.30
GTM91120-30VV-FWOpen Frame/Internal100-240V~, 50-60 Hz305-48 VV101.6x50.8x22.30
GTM91120-30VV-FW (PCB Mounted)Open Frame/Internal100-240V~, 50-60 Hz305-48 VV101.6x50.8x22.30
GTM91120-30VV-P2Potted/Encapsulated in plastic housing100-240V~, 50-60 Hz305-48 VV102*46*37
GTM91120-30VV-P2(SR with NA Plug 2 pin)Potted/Encapsulated in plastic housing100-240V~, 50-60 Hz305-48 VVIP68
GTM91120-30VV-P3Potted/Encapsulated in plastic housing100-240V~, 50-60 Hz305-48 VVIP68102*46*37
GTM91120-30VV-P3 (SR with EU Plug 3 pin)Potted/Encapsulated in plastic housing100-240V~, 50-60 Hz305-48 VVIP68
GTM91120-30VV-P3 (SR with NA Plug 3 pin)Potted/Encapsulated in plastic housing100-240V~, 50-60 Hz305-48 VVIP68
GTM91120-30VV-T2Wall Plug-in+Desktop Combination100-240V~, 50-60 Hz305-48 VVIP40 (cord), IP52(R-blades)(L)101.77x(W)47.47x(H)36.7
GTM91120-30VV-T3AWall Plug-in+Desktop Combination100-240V~, 50-60 Hz305-48 VVIP40 (cord), IP52(R-blades)(L)101.77x(W)47.47x(H)36.7 mm
GTM96300-36VV-R2Wall Plug-in+Desktop Combination100-240V~, 50-60 Hz365-54 VVIIP40 (cord), IP52(R-blades)(L)101.73x(W)46.47x(H)38.2mm
GTM96300-36VV-R3AWall Plug-in+Desktop Combination100-240V~, 50-60 Hz365-54 VVIIP40 (cord), IP52(R-blades)(L)101.7x(W)46.47x(H)38.2mm
GTM96300-36VV-T2Desktop/External100-240V~, 50-60 Hz365-54 VVIIP42, IP54 Option available(L)107.2.0x(W)50.0x(H)35.50mm
GTM96300-36VV-T2ADesktop/External100-240V~, 50-60 Hz365-54 VVIIP42, IP54 Option available(L)107.2.0x(W)50.0x(H)35.50mm
GTM96300-36VV-T3Desktop/External100-240V~, 50-60 Hz365-54 VVIIP42, IP54 Option available107.2x(W)50.0x(H)35.0mm
GTM46402-40VV-x.x-QWall Plug-in100-240V~, 50-60 Hz405-48 VVIIndoor Use43.5 x 74.0 x 35.3
GTM43007-AWWVV-FOpen Frame/Internal100-240V~, 50-60 Hz605-48 VN/AN/A76.2x50.8x23.6 for 5V-14V models, 76.2x50.8x22.5 for 15V-48V modelsTop Diagram i
GTM43007-AWWVV-F (D3 without standoffs)Open Frame/Internal100-240V~, 50-60 Hz605-48 VN/AN/A76.2x50.8x23.6 for 5V-14V models, 76.2x50.8x22.5 for 15V-48V modelsTop Diagram i
GTM43007-AWWVV-FWOpen Frame/Internal100-240V~, 50-60 Hz605-48 VN/AN/A76.2x50.8x23.6 for 5V-14V models, 76.2x50.8x22.5 for 15V-48V models
GTM43007-AWWVV-FW (D2 without standoffs)Open Frame/Internal100-240V~, 50-60 Hz605-48 VN/AN/A76.2x50.8x23.6 for 5V-14V models, 76.2x50.8x22.5 for 15V-48V models
GTM43007-BWWVV-FOpen Frame/Internal100-240V~, 50-60 Hz605-48 VN/AN/A101.6x50.8x23.6 for 5V-14V models, 101.6x50.8x22.5 for 15V-48V models
GTM43007-BWWVV-FWOpen Frame/Internal100-240V~, 50-60Hz605-48 VN/AN/A101.6x50.8x23.6 for 5V-14V models, 101.6x50.8x22.5 for 15V-48V models
GTM43007-CWWVV-FOpen Frame/Internal100-240V~, 50-60 Hz605-48 VN/AN/A127x76.2x23.6
GTM43007-CWWVV-FWOpen Frame/Internal100-240V~, 50-60 Hz605-48 VN/AN/A127x76.2x23.6
GTM91099-60VV-P2Potted/Encapsulated in plastic housing100-240V~, 50-60 Hz605-48 VVIP68144.81*57.11*39.0
GTM91099-60VV-P3Potted/Encapsulated in plastic housing100-240V~, 50-60 Hz605-48 VV
GTM91099-60VV-P3(SR with NA Plug 3 pin)Potted/Encapsulated in plastic housing100-240V~, 50-60 Hz605-48 VV
GTM91099-60VV-T2Wall Plug-in+Desktop Combination100-240V~, 50-60 Hz605-48 VVIP42117.53*53.47*36.6
GTM91099-60VV-T3AWall Plug-in+Desktop Combination100-240V~, 50-60 Hz605-48 VVIP52, IP54 Option available117.53*53.47*36.6
GTM96600-60VV-P2(SR with NA Plug 2 pin)Potted/Encapsulated in plastic housing100-240V~, 50-60 Hz6036-48 VVIIP68144.81*57.11*39.0
GTM96600-60VV-P3(SR with NA Plug 3 pin)Potted/Encapsulated in plastic housing100-240V~, 50-60 Hz600 VVIIP68144.81*57.11*39.0
GTM96600-60VV.V-R2Wall Plug-in+Desktop Combination100-240V~, 50-60 Hz605-54 VVIIP40, IP54 Option available117.53*53.47*36.6
GTM96600-60VV.V-R3AWall Plug-in+Desktop Combination100-240V~, 50-60 Hz605-54 VVIIP40, IP54 Option available117.53*53.47*36.6
GTM96600-60VV.V-T2Desktop/External100-240V~, 50-60Hz605-54 VVIIP41117.5*53.5*34.2
GTM96600-60VV.V-T2ADesktop/External100-240V~, 50-60Hz605-54 VVIIP41117.5*53.5*34.2
GTM96600-60VV.V-T3Desktop/External100-240V~, 50-60Hz605-54 VVIIP41117.5*53.5*34.2
GTM96600-60VV.V-T3ADesktop/External100-240V~, 50-60Hz605-54 VVIIP41117.5*53.5*34.2
GTM96600-65VV-P2(SR with fixed Plug 2 pin)Potted/Encapsulated in plastic housing100-240V~, 50-60 Hz600 VVIIP68144.81*57.11*39.0
GTM96605-GEN2-R2Desktop/External100-240V~, 50-60Hz600 VVI
GTM96605-GEN2-R3ADesktop/External100-240V~, 50-60Hz600 VVI117.53*53.47*36.6
GTM96605-GEN2-T2Desktop/External100-240V~, 50-60Hz600 VVI
GTM96605-GEN2-T3Desktop/External100-240V~, 50-60Hz600 VVI
GTM96600-65VV.V-P2Desktop/External100-240V~, 50-60Hz655-54 VVIIP68117.5*53.5*34.2
GTM96600-65VV.V-P3Desktop/External100-240V~, 50-60Hz655-54 VVIIP68117.5*53.5*34.2
GTM96600-65VV.V-R2Wall Plug-in+Desktop Combination100-240V~, 50-60 Hz6512-48 VVIIP40, IP54 Option available117.53*53.47*36.6
GTM96600-65VV.V-R3AWall Plug-in+Desktop Combination100-240V~, 50-60 Hz6512-48 VVIIP40, IP54 Option available117.53*53.47*36.6
GTM96600-65VV.V-T2Desktop/External100-240V~, 50-60Hz655-48 VVIIP41117.5*53.5*34.2
GTM96600-65VV.V-T3Desktop/External100-240V~, 50-60Hz655-48 VVIIP41117.5*53.5*34.2
GTM41133-90VV-x.x-FOpen Frame/Internal100-240V~, 50-400Hz9012-48 VV184*62*25
GTM41133-90VV-x.x-T2Desktop/External100-240V~, 50-60 Hz9012-48 VVIP21149.38 x 62.6 x 33.5 +/-1.0
GTM96900P90VV.V-T2Desktop/External100-240V~, 50-60 Hz9012-54 VVIIP41149.38 x 62.6 x 33.5 +/-1.0
GTM96900P90VV.V-T3Desktop/External100-240V~, 50-60Hz9012-54 VVIIP41149.3 x 62.8 x 34.0 +/-1.0
GTM96900P90VV.V-T3ADesktop/External100-240V~, 50-60Hz9012-54 VVIIP41149.38 x 62.6 x 33.5 +/-1.0 mm
GTM961200P120VV.V-T2Desktop/External100-240V~, 50-60 Hz12012-54 VVIIP41149.30*62.80*34.00
GTM961200P120VV.V-T3Desktop/External100-240V~, 50-60 Hz12012-54 VVIIP41149.30*62.80*34.00
GTM961600PWWWVV.V-T2Desktop/External100-240V~, 50-60 Hz16012-36 VVIIP41176.5*74*40
GTM961600PWWWVV.V-T3Desktop/External100-240V~, 50-60 Hz16012-54 VVIIP41176.5*74*40
GTM961600PWWWVV.V-T3ADesktop/External100-240V~, 50-60 Hz16012-36 VVIIP41176.5*74*40
GTM961800PWWWVV.V-T2Desktop/External100-240V~, 50-60 Hz18012-54 VVIIP41176.5*74*40
GTM961800PWWWVV.V-T2ADesktop/External100-240V~, 50-60 Hz18012-54 VVIIP41176.5*74*40
GTM961800PWWWVV.V-T3Desktop/External100-240V~, 50-60Hz18012-54 VVIIP41176.5*74*40
GTM961800PWWWVV.V-T3ADesktop/External100-240V~, 50-60 Hz18015-54 VVIIP41176.5*74*40
GTM962250PWWWVV.V-FOpen Frame/Internal100-240V~, 50-60 Hz22512-54 VVIN/A101.6 (L) x 50.8 (W) x 31.0 (H)
GTM962250PWWWVV.V-FLOpen Frame/Internal100-240V~, 50-60 Hz22512-54 VVIna103.5 (L) x 62.3 (W) x 40.0 (H)
GTM962500PWWWVV.V-CXOpen Frame/Internal100-240V~, 50-60 Hz25015-35 VVIna203*63.5*41
GTM962500PWWWVV.V-FOpen Frame/Internal100-240V~, 50-60 Hz25012-54 VVIna203*63.5*41
GTM962500PWWWVV.V-FLOpen Frame/Internal100-240V~, 50-60 Hz25012-54 VVIna203*63.5*41

id:386 nr:

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