Standards And Regulations; Table 4 Standards And Regulations - Varex Imaging Azure 3131Z Manual

Azure 3131Z - 4131Z Reference Manual
9.0

Standards and Regulations

The Azure 3131Z and 4131Z Ethernet X-ray detectors are designed to be compliant with the
requirements detailed in
accessories as listed in
invalid if any modifications to the product is made, or any portion thereof, without obtaining the
prior written authorization of Varex Imaging.
.
Table 4 Standards and Regulations
Standard
EN/IEC 60601-1:2006
+A1:2013/2005
+A1:2012
ANSI/AAMI ES60601-
1:2005 +A1:2021
CSA CAN/CSA-C22.2
EN/IEC 60601-1:14
EN/IEC 60601-1-2:2015
+A1:2021/2014
+A1:2020
93/42/EEC
2014/30/EU
The X-ray detector device is MDD Class IIa.
Note
A Declaration of Conformity has been filed for this product and available
Note
upon request by contacting Varex Imaging Corporation.
Table 4. All regulatory certificates are valid only if the original
Table 8 on page 11 are used. All regulatory certificates are rendered
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.
Medical Device Directive (EU MDD)
European Union Electromagnetic Compatibility Directive
www.vareximaging.com
Description
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