Standards And Regulations; Table 4 Standards And Regulations - Varex Imaging 2530C-G5 Manual

2530C-G5 X-ray Detector
8

Standards and Regulations

The X-ray detectors are designed to be compliant with the requirements detailed in
regulatory certificates are valid only if the original accessories are used. All regulatory certificates are
rendered invalid if any modifications to the Product are made, or any portion thereof, without
obtaining the prior written authorization of Varex Imaging.
Table 4 Standards and Regulations
Detector Standard
EN / IEC 60601-
1:2006+A2:2013 /
2005+A1:2012
ANSI/AAMI ES60601-
1:2005/(R)2012
CAN / CSA C22.2 No.
60601-1-14
EN / IEC 60601-1-
2:2015+A1:2021 /
2014+A1:2020
93/42/EEC
2017/745
Note
MDD Class IIA
A Declaration of Conformity has been filed for this product and is available upon
Note
request by contacting Varex Imaging
4
Medical Electric Equipment Part 1: General Requirements for Basic Safety
and Essential Performance (ED. 3.1.)
Medical Electrical Equipment – Part 1: General Requirements for Basic
Safety and Essential Performance.
Medical Electrical Equipment, Part 1 General Requirements for Basic Safety
and Essential Performance.
Medical Electrical Equipment Part 1-2: General Requirements for Basic
Safety and Essential Performance Collateral Standard: Electromagnetic
Compatibility 4th ed.
European Union Medical Device Directive (MDD)
European Union Electromagnetic Compatibility Directive
Description
Table 4 below. All