User's Manual

6. Regulatory Information
66 iRay Technology Co., Ltd..
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
6.2 Guidance and manufacture’s declaration for EMC
6.2.1 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
Class A
Professional healthcare facility environment
Voltage fluctuations
and flicker
IEC 61000-3-3
Compliance
Professional healthcare facility environment
6.2.2 EMS Compliance Table
 Enclosure Port
Phenomenon Basic EMC
standard
Immunity test levels
Professional healthcare facility environment
Electrostatic
Discharge
IEC 61000-4-2 ±8 kV contact
±2kV, ±4kV, ±8kV, ±15kV air