7

ISO7720, ISO7721

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SLLSEP3A – NOVEMBER 2016 – REVISED DECEMBER 2016

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6.7 Regulatory Information

DW package devices certified according to VDE, CSA, UL, and TUV; All other certifications are planned.

VDE

CSA

UL

CQC

TUV

Certified according to

DIN V VDE V 0884-10

(VDE V 0884-10):2006-

12

Certified under CSA

Component Acceptance

Notice 5A, IEC 60950-1,

and IEC 60601-1

Certified according to UL

1577 Component

Recognition Program

Plan to certify according to

GB4943.1-2011

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

Maximum repetitive peak

isolation voltage, 1414

Maximum surge isolation

Reinforced insulation per

CSA 60950-1-07+A1+A2

and IEC 60950-1 2nd Ed.,

voltage (pollution degree 2,

material group I);

DW-16: Single

D-8: Single protection,

DW-16: Reinforced

Insulation, Altitude

≤ 5000

m, Tropical Climate, 400

voltage;

D-8: Basic Insulation,

Altitude

≤ 5000 m, Tropical

maximum working voltage

insulation per EN 61010-

1:2010 (3rd Ed) up to

working voltage of 600

2 MOPP (Means of Patient

Protection) per CSA 60601-

1:14 and IEC 60601-1 Ed.

working voltage

insulation per EN 60950-

1:2006/A11:2009/A1:2010/

A12:2011/A2:2013 up to

working voltage of 800

Certificate number:

40040142

Master contract number:

220991

File number: E181974

Certification planned

Client ID number: 77311