Standards And Regulations - Vatech Green X 12 Bedienungsanleitung

1. Imaging System Overview

Standards and Regulations

1.5
Standards
Green X 12 (Model: 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, AMD1:2013, IEC
60601-2-63:2012, AMD1:2017, AMD2:2021
▪ 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 (chinrest, bite and cover, nasal positioner and cover, ear rod and
cap, carpus plate).
12
This is class IIb equipment and obtained CE marking in
May 2017 for regulation compliance by the enacted
European Union`s MDR (Medical Device Regulation)
Green X 12 (Model: PHT-75CHS) User Manual
TM