990400 Rev C 2010 May 1
Product Information
14-7
Equipment Standards
The System was tested and/or evaluated against and found
compliant to the following standards/requirements:
UL 60601-1 IEC 60601-2-28
CSA C22.2 No. 601.1 EN 980
JIS Z4701 EN/ISO 13485
JIS Z4703 IEC/EN 60601-2-32
JIS T0601 IEC/EN 60825-1
IEC/EN 60601-1 CE-MDD 93/42/EEC
IEC/EN 60601-1-1 LVFS 2003:11 (Swedish regulation,
transposing the MDD 93/42/EEC)
IEC/EN 60601-1-2 CMDCAS (Canadian Medical Device
Regulation)
IEC/EN 60601-1-3 ISO 10993-1
IEC/EN 60601-1-4 ISO 14971
IEC 60601-2-7
Equipment Class
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
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