Standards And Regulations - Vatech EzRay Air VEX-P300 User Manual

1.5

Standards and Regulations

Standards:
The VEX-P300 is designed and manufactured to meet the following standards:
▪ IEC/EN 60601-1, IEC/EN 60601-1-2, IEC/EN 60601-1-3, IEC/EN 60601-2-65
▪ X-RAY EQUIPMENT for DENTAL INTRA-ORAL RADIOGRAPHY VEX-P300
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: Conehead
EzRay Air (Model: VEX-P300) User Manual
1. General and Regulatory Information
The CE symbol grants this equipment complies with the
European Directive for Medical Devices 93/42/EEC as
amended by 2007/47/EC as a class IIb device.
7