Standards And Regulations - Vatech EzRay Air W User Manual

1. General and Regulatory Information
1.5

Standards and Regulations

Standards:
The VEX-S300W is designed and manufactured to meet the following standards:
IEC 60601-1, IEC/EN 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-65,

IEC 62366
X-RAY EQUIPMENT for DENTAL INTRA-ORAL RADIOGRAPHY VEX-S300W

IEC 60601-2-65:2012
CAN/CSA-C22.2 No. 60601-1:14, CAN/CSA-C22.2 No. 60601-1-3:09, CAN/CSA-

C22.2 No. 60601-1-6:11, CAN/CSA-C22.2 No. 60601-2-65:15, CAN/CSA-IEC
62366:14
ANSI/AAMI ES60601-1:2005 / (R)2012, AND A1:2012, C1:2009 / (R)2012 AND

A2:2010 / (R)2012 (Consolidated text - edition 3.1)
ISO 13485

21 CFR 1020.30 & 1020.31

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: Cone head
6
The CE symbol grants this equipment compliance with the
European Directive for Medical Devices 93/42/EEC as
amended by 2007/47/EC as a class IIb device.
EzRay Air W (Model: VEX-S300W) User Manual