Equipment Standards; Equipment Class - Gendex GX CB-500 Service Manual

Cone beam volumetric tomography and panoramic dental imaging system
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Service Manual
Gendex GXCB-500

Equipment Standards

Equipment Class

13-8
Use only the interface cables provided with the System. Using other
interface cables may exceed the limits of Class B equipment,
pursuant to IEC 60601-1-2.
The System was tested and/or evaluated against and found
compliant to the following standards/requirements:
UL 60601-1
CSA C22.2 No. 601.1
JIS Z4701
JIS Z4703
JIS T0601
IEC/EN 60601-1
IEC/EN 60601-1-1
IEC/EN 60601-1-2
IEC/EN 60601-1-3
Protection against electric shock: Class I
Applied part has degree of protection against electric shock: Class B
Class of equipment against ingress of liquids: Ordinary Equipment,
IPX0
Radiated emissions: Class B
IEC/EN 60601-1-4
IEC/EN 60601-2-32
IEC/EN 60825-1JIS T0601
CE-MDD 93/42/EEC
LVFS 2003:11 (Swedish regulation,
transposing the MDD 93/42/EEC)
CMDCAS (Canadian Medical Device
Regulation)
ISO 10993-1:2003
ISO 14971:2000
G990710 30 June 2008

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