Vatech PaX-i Plus

1. Introduction
10 PaX-i Plus / Insight Installation Manual
1.5 Standards and Regulations
Standards
PaX-i Plus / Insight (Model: PCH-30CS) is designed and developed to comply with
the following international standards and regulations:
 IEC 60601-1, IEC/EN 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-63
 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. 60601-2-63:15, CAN/CSA-IEC
62366:15
 ANSI/AAMI ES60601-1:2005 / (R)2012, AND A1:2012, A2:2010 / (R)2012
(Consolidated text - edition 3.1)
 21 CFR 1020.30, 31, 33
 NEMA Standard publication PS 3.1-3.18, 2008
This is Class IIb equipment and obtained CE marking in
April, 2007 for regulations compliance in accordance with
the revised European Union’s MDD (Medical Devices
Directive) 93/42 EEC.
This equipment received the CSA certification mark in
accordance with CAN/CSA C22.2 No.601.1 regulations.
Classifications (IEC 60601-1 6.1)
 Degree of protection against water ingress: Ordinary Equipment: IPX0
 Degree of protection against electric shock: Class 1 equipment, Type B Applied
Parts: Temple Supports, Chinrests and Bites.