User's Manual

Regulatory Information
iRay Technology Co. Ltd. 77
performance — Collateral standard: Usability
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
IEC 62133:2012
Secondary cells and batteries containing
alkaline or other non-acid electrolytes –
Safety requirements for portable sealed
secondary cells, and for batteries made
from them, for use in portable applications
EN 62220-1:2004
Medical electrical equipment – Characteristics of
digital X-ray imaging devices–Part 1:
Determination of the detective quantum
efficiency
EN 62304:2006/AC:2008
Medical device software – Software life-cycle
processes
EN 62366:2008
Medical devices – Application of usability
engineering to medical devices
ANSI/AAMI ES60601-1:2005+ Amendment 1:2012+ Amendment
2:2010
Medical Electrical Equipment – Part 1: General
requirements for safety and essential
performance
CAN/CSA C22.2 No. 60601-1-14
Medical Electrical Equipment – Part 1: General
requirements for safety and essential
performance
ISO 15223-1:2016
Medical devices-symbols to be used with
medical device labels, labeling and information
to be supplied–Part1:General requirements
6.3 Guidance and manufacture’s declaration for EMC
6.3.1 EMI Compliance Table
 Emissions
Phenomenon
Compliance
Electromagnetic environment
RF emissions
CISPR 11
Group 1, Class B
Professional healthcare facility environment
Harmonic distortion
IEC 61000-3-2
Professional healthcare facility environment