iRay Technology Pluto0001X - 5.2 Guidance and Manufacturers Declaration for EMC

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Digital Intra-oral X-Ray Imaging System Pluto0001X /Pluto0002X User's Manual
IEC 60601-2-
65:2012+A1:2017
Medical electrical equipment - Part 2-65: Particular
requirements for the basic safety and essential
performance of dental intra-oral X-ray equipment
IEC 60601-1-
6:2010+A1:2013
Medical electrical equipment Part 1-6: General
requirements for basic safety and essential
performance — Collateral standard: Usability
CAN/CSA-C22.2
NO. 60601-1-
6:11+A1:2015
Medical electrical equipment Part 1-6: General
requirements for basic safety and essential
performance — Collateral standard: Usability
KS C IEC 60601-1-
6:2011
Medical electrical equipment Part 1-6: General
requirements for basic safety and essential
performance — Collateral standard: Usability
EN 60601-1-
6:2010+A1:2015
Medical electrical equipment Part 1-6: General
requirements for basic safety and essential
performance — Collateral standard: Usability
IEC 60601-1-2:2014 Medical electrical equipment – Part 1-2: General
requirements for basic safety and essential
performance– Collateral standard: Electromagnetic
disturbances– Requirements and tests
EN 60601-1-2:2015 Medical electrical equipment – Part 1-2: General
requirements for basic safety and essential
performance– Collateral standard: Electromagnetic
disturbances– Requirements and tests
EN 62304:2006/
AC:2008
Medical device software – Software life-cycle
processes
EN 62366:2008 Medical devices – Application of usability
engineering to medical devices
ISO 15223-1:2016 Medical devices-symbols to be used with medical
device labels, labeling and information to be
supplied–Part1:General requirements
5.2 Guidance and manufacture’s declaration for EMC
5.2.1 EMI Compliance Table
Emissions
Phenomenon Compliance Electromagnetic environment
RF emissions CISPR 11
Group 1, ClassB
Professional healthcare facility
environment