www.recom-power.com

REV.: 1/2019

MED-5

DC/DC Converter

REM2

Series

SAFETY AND CERTIFICATIONS

Certificate Type (Safety)

Report / File Number

Standard

Medical Electric Equipment, General Requirements for Safety and Essential

Performance

E314885

CAN/CSA-C22.2 No. 60601-1:14, 3rd Edition, 2014

Medical Electric Equipment, General Requirements for Safety and Essential

Performance (CB scheme)

CB190124C12 001

IEC60601-1:2005, 3rd Edition + AM1:2012

Medical Electric Equipment, General Requirements for Safety and Essential

Performance

WD-SE-R-190048-A0

EN60601-1:2006 + A1:2013

Audio/Video, Information and Communication Technology Equipment -

Part1: Safety Requirements

WD-SE-R-180528-B0

IEC62368-1:2014, 2nd Edition

EN62368-1:2014 + AC:2015

RoHS2+

RoHS-2011/65/EU + AM-2015/863

EMC Compliance

Condition

Standard / Criterion

Medical Electrical Equipment Part 1-2: Electromagnetic Disturbances –

Requirements and Tests

WH-CE-E18083002

EN60601-1-2:2015

Industrial, Scientific and Medical Equipment - Radio Frequency

Disturbance Characteristics - Limits and Methods of Measurement

EN55011:2016 + A1:2017, Class B

Information Technology Equipment - Radio Disturbance

Characteristics - Limits and Methods of Measurement

with external filter

EN55032, Class B

ESD Electrostatic Discharge Immunity Test

Air ±2, 4, 8, 15kV

Contact ±2, 4, 6, 8kV

IEC61000-4-2, Criteria A

Radiated, Radio-Frequency, Electromagnetic Field Immunity Test

10V/m (80-2700MHz)

9, 27, 28V/m (several frequencies)

IEC61000-4-3, Criteria A

Fast Transient and Burst Immunity

DC Power Port: ±0.5, 1, 2kV

IEC61000-4-4, Criteria A

Surge Immunity

DC Power Port: ±0.5, 1kV

IEC61000-4-5, Criteria B

Immunity to Conducted Disturbances, Induced by Radio-Frequency Fields

DC Power Port: 3, 6V

IEC61000-4-6, Criteria A

Power Magnetic Field Immunity

50Hz, 30A/m

IEC61000-4-8, Criteria A

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