Product Certifications And Classifications - biodex 058-800 Instructions For Use Manual

Product Certifications and Classifications

The Urology & Brachytherapy C-Arm Tables have received the following certifications, and
fall within the following classifications:
IEC60601-1:2005 (Third Edition) + CORR1:2006+Corr 2:2007 + A1:2012 (or IEC 60601-
●
1:2012 reprint)
ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010
●
CAN/CSA C22.2 No: 60601-1:14
●
CE Class I Non-measuring
●
FDA Class II Equipment
●
IEC 60601-2-46 Edition 3.0
●
Type B Applied Part
●
Electromagnetic Compatibility: This equipment complies with the Medical Equipment
●
IEC 60601-1-2:2014 EMC Standard.
Authorized European Community Representative:
Emergo Europe
Prinsessegracht 20
2514 AP, The Hague
The Netherlands
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