Vatech Smart Plus PHT-35LHS - Standards and Regulations

1. Introduction
10 Smart Plus (PHT-35LHS) Installation Manual
1.5 Standards and Regulations
Standards
Smart Plus is designed and developed to comply with the following international
standards and regulations:
 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 60601-2-63
(2012)
 21 CFR 1020.30, 31, 33
 NEMA Standard publication PS 3.1-3.18
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 UL certification mark in
accordance with ANSI/AAMI, CAN/CSA-C22.2 No.
60601-1 regulations.
Classifications (IEC 60601-1 6.1)
 The degree of protection against water ingress: Ordinary Equipment: IPX0
 The degree of protection against electric shock: Class 1 equipment, Type B
Applied Parts: Temple Supports, Chinrests, and Bites.