Standards And Regulations - VATECH Green X 18 Handbuch

Standards and Regulations

1.4
Standards
TM
Green X 18
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, AMD1:2013, IEC 60601-2-63:2012, AMD1:2017
• 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
Green X 18 TM (Model: PHT-75CHS) User Manual
(Model: PHT-75CHS) is designed and developed to comply with the
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.
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,
AMD1:2013, IEC 60601-2-63:2012, AMD1:2017
1. Imaging System Overview
3