Standards And Regulations - VTech EzRay Air Portable User Manual

1. General and Regulatory Information
1.5

Standards and Regulations

Standards:
The device is designed and manufactured to meet the following standards:
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)
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 II equipment,
Type B Applied Parts: Round Cover, Rectangular Cover, Rotating Rectangular Cover
10
This is Class IIb equipment and obtained CE marking in
April 2007 for regulation 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 regulation.
EzRay Air Portable (Model: VEX-P300) User Manual