Certificates

Declaration of Conformity
For the following equipment：
Product Name: Medical Type Switching Power Supply
Model Designation: MFM/MPM-15/20-X(X=3.3,5,12,15,24)
is herewith confirmed to comply with the requirements set out in the Council Directive, the following standards
were applied：
RoHS Directive (2011/65/EU)、(EU)2015/863
MDD Directive (93/42/EEC)
EN60601-1:2006+A11+A1+A12
TUV certificate No：TA50391964
EMI (Electro-Magnetic Interference)
Conducted emission / Radiated emission
EN55011:2016/A1:2017
Class B
Harmonic current
EN61000-3-2:2014
Voltage flicker
EN61000-3-3:2013
EMS (Electro-Magnetic Susceptibility)
EN60601-1-2:2015
ESD air
EN61000-4-2:2009
Level 4 15KV
ESD contact
EN61000-4-2:2009
Level 4 8KV
RF field susceptibility
EN61000-4-3:2006+A1:2008+A2:2010
Level 3 10V/m(80MHz-2.7GHz)
RF field susceptibility
EN61000-4-3:2006+A1:2008+A2:2010
Table 9 9~28V/m (385MHz~5.78GHz)
EFT bursts
EN61000-4-4:2012
Level 3 2KV/100KHz
Surge susceptibility
EN61000-4-5:2014
Level 3 1KV/Line-Line
Conducted susceptibility
EN61000-4-6:2014
Level 3 10V
Magnetic field immunity
EN61000-4-8:2010
Level 4 30A/m
Voltage dip, interruption
EN61000-4-11:2004 100% dip 1 periods 30% dip 25 periods 100% interruptions 250 periods
Note:
A component power supply will be installed into final equipment. Since EMC performance will be affected by the complete
installation, the final equipment manufacturers must re-qualify EMC Directive on the complete installation again.
For guidance on how to perform these EMC tests, please refer to TDF (Technical Documentation File)..
This Declaration is effective from serial number EB9xxxxxxx
Person responsible for marking this declaration：
MEAN WELL Enterprises Co., Ltd.
(Manufacturer Name)
No.28, Wuquan 3rd Rd., Wugu Dist., New Taipei City 24891, Taiwan
(Manufacturer Address)
Johnny Huang/Manager, Certification Center：
Alex Tsai/Director, Marketing Department：
(Name / Position) (Signature)
(Name / Position) (Signature)
Taiwan
Jul. 22nd, 2019
(Place)
(Date)
Version：2