Regulatory Information
KONICA MINOLTA,
INC..……………..…………………………………………………………………………………………………
……………….………..81
009/(R)2012+A2:2010/(R)2012
MOD)
CAN/CSA-C22.2
No.60601-1:14
Medical electrical equipment – Part 1: General requirements
for basic safety and essential performance
ISO
15223-1:2016/
EN
ISO
15223-1:2016
Medical devices—Symbols to be used with medical device
labels, labeling and information to be supplied—Part 1:
General requirements
5.2. The compliance for each EMISSIONS and IMMUNITY standard or
test specified by IEC60601
‐
1
‐
2 standard
EMI Compliance Table
Emission
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
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
Radiated RF EM field
IEC 61000-4-3
3V/m
80MHz-2.7GHz
80% AM at 1kHz
Proximity fields from
RF
wireless
communications
equipment
IEC 61000-4-3
Refer to table “Proximity fields from RF
wireless communications equipment”
Rated power frequency
magnetic fields
IEC 61000-4-8
30A/m
50Hz or 60Hz
Proximity fields from RF wireless communications equipment
Test frequency
(MHz)
Band
(MHz)
Immunity test levels
Professional healthcare facility environment
385
380-390
Pulse modulation 18Hz, 27V/m