Standards And Regulations - VATECH Green X Handbuch

1. Imaging System Overview
1.4

Standards and Regulations

Standards
Green X (PHT-75CHS) 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

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.
4
This is Class IIb equipment and obtained CE marking in
April 2007 for regulations 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 regulations.
Green X (PHT-75CHS) User Manual