5.11 Safety-Related Certifications

DW package certifications are complete; DWW package certifications completed for UL and TUV and planned

for VDE, CSA, and CQC.

Table 5-4. Regulatory Information

VDE

CSA

UL

CQC

TUV

Certified according to

DIN V VDE V

0884-10 (VDE V

0884-10):2006-12 and

DIN EN 60950-1 (VDE

0805 Teil 1):2011-01

Approved under CSA

Component Acceptance

Notice 5A, IEC 60950-1

and IEC 60601-1

Recognized under

UL 1577 Component

Recognition Program

Certified according to

GB 4943.1-2011

Certified according to

EN 61010-1:2010 (3rd Ed) and

EN 60950-1:2006/A11:2009/

A1:2010/A12:2011/A2:2013

Reinforced insulation

Maximum transient

isolation voltage, 8000

VPK;

Maximum repetitive peak

isolation voltage, 2121

VPK (DW), 2828 VPK

(DWW);

Maximum surge isolation

voltage, 8000 VPK

Reinforced insulation per

CSA 60950-1-07+A1+A2

and IEC 60950-1 2nd Ed.,

800 VRMS (DW package)

and 1450 VRMS (DWW

package) max working

voltage (pollution degree

2, material group I);

Single protection, 5700

VRMS

Reinforced Insulation,

Altitude ≤ 5000 m,

Tropical Climate, 250

VRMS maximum working

voltage

5700 VRMS Reinforced insulation

per EN 61010-1:2010 (3rd Ed)

up to working voltage of 600

VRMS (DW package) and 1000

VRMS (DWW package)

2 MOPP (Means of

Patient Protection) per

CSA 60601-1:14 and IEC

60601-1 Ed. 3.1,

250 VRMS (354 VPK)

max working voltage (DW

package)

5700 VRMS Reinforced insulation

per EN 60950-1:2006/A11:2009/

A1:2010/A12:2011/A2:2013 up

to working voltage of 800 VRMS

(DW package) and 1450 VRMS

(DWW package)

Certificate number:

40040142

Master contract number:

220991

File number: E181974

Certificate number:

CQC15001121716

Client ID number: 77311

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