Neuer EMC Standard nach IEC 60601-1-2 4th Edition


Die für den Sicherheits-Standard IEC 60601-1 relevante EMV Norm ist die 60601-1-2, zur Zeit in der 3. Edition. Ab April 2017 neu zugelassene sowie aktualisierte Zulassungen für medizinische Geräte müssen die höheren Anforderungen der sogenannten 4th Edition erfüllen. Aus diesem Grunde haben sich die meisten Hersteller von medizinischen Geräten dazu entschlossen, bereits heute ihre Produkte nach der 4th Edition zu qualifizieren.

Obwohl dieser EMV Standard beide Aspekte, sowohl Abstrahlung als auch Störfestigkeit medizinischer Geräte behandelt, bleiben die fundamentalen Anforderungen der 3rd Edition unverändert.

Die Störfestigkeitsanforderungen entsprechen Class B CISPR11 (Leitungsgebunden und abgestrahlt) sowie 61000-3-2 (Oberwellen Verordnung).

Die nachfolgende Tabelle zeigt die geänderten Anforderungen an die Störfestigkeitstest in Bezug auf die Änderung von der 3rd zur 4th Edition sowie zusätzlich die verbesserten Eigenschaften der neuen Globtek Netzgeräte-Serie GTM96 .

Nach der US-FDA Behörde gibt es eine Übergangsfrist bis zum 1. April 2017, weitere Details hierzu können auf der Webseite der Behörde eingesehen werden: 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 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 on AC

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

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)105.0x(W)50.0x(H)35.50mm
GTM96300-36VV-T2ADesktop/External100-240V~, 50-60 Hz365-54 VVIIP42, IP54 Option available(L)105.0x(W)50.0x(H)35.50mm
GTM96300-36VV-T3Desktop/External100-240V~, 50-60 Hz365-54 VVIIP42, IP54 Option available105x(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 VVI144.81*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
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~, 50-60Hz6513.2-48 VVIIP41117.5*53.5*34.2
GTM96600-65VV.V-P3Desktop/External100-240V~, 50-60Hz655-54 VVIIP41117.5*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 VVIna101.6 (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:

Information anfordern

Call
Email
💬
Text
💁
Chat
?
Request a Quote