Vatech Green 16 - Standards and Regulations

1. Introduction
Green 16/18 Installation Manual 11
English
1.5 Standards and Regulations
Standards
Green16/18 (PHT-65LHS) 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)
 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 following the
revised European Union’s MDD (Medical Devices
Directive) 93/42 EEC.
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)
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 cover, Nasal Positional and
cover, Ear Rod and cap, Carpus Plate)