Standards And Regulations - Vatech PaX-i Plus Manual

1. Introduction
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
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.
10
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.
PaX-i Plus / Insight Installation Manual