Standards And Regulations - Vatech EzRay Air Wall User Manual

1. General and Regulatory Information
1.5

Standards and Regulations

Standards:
The EzRay Air Wall (VEX-S300W) is designed and manufactured to meet the following
MEDICAL - APPLIED ELECTROMAGNETIC RADIATION EQUIPMENT

AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN
ACCORDANCE WITH
ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012),
CAN/CSA-C22.2 No. 60601-1 (2014), IEC 60601-1-3 (2008), IEC 60601-2-65
(2012)
21 CFR 1020.30 & 1020.31

ISO 13485

Classifications (IEC60601-1 6.1):
Protection against the ingress of water: Ordinary Equipment (IPX0). Protection against
electric shock: Class I equipment, Type B Applied Parts: Conehead
6
This is Class IIb equipment and obtained CE marking in April
2007 for regulations compliance by the revised European
Union's MDD (Medical Devices Directive) 93/42 EEC.
This equipment received the UL certification mark in
accordance with ANSI/AAMI, CAN/CSA-C22.2 No. 60601-1
regulations.
EzRay Air Wall (VEX-S300W) User Manual