DTM160, DTM160-C8 Manual
External AC-DC Power Adapters, 160W
16. A
PPROVALS AND
R
EGULATORY
C
OMPLIANCES
CE
EU Declaration of Conformity includes Low-Voltage, EMC and RoHS Directive
UKCA
UK Declaration of Conformity includes Electrical Safety, EMC and RoHS Directive
UL 60601-1:ED3
UL Certificate
Recognized component for category QQHM2 and QQHM8 - Medical electrical
equipment
Applicable for US and Canada
E-File: E349607
IEC 60601-1.2005+A1
EN 60601-1:2006+A11+A1+A12
IEC 60601-1-6:2010+A1
EN 60601-1-6:2010+A1
IEC 62366:2007+A1
EN 62366:2008+A1
For DTM160:
Medical electrical equipment
Part 1: General requirements for basic safety and essential performance
Part 1-6: Collateral standard: Usability
Application of usability engineering to medical devices
TUEV Certificate TA 50558464 01
IEC 60601-1:2005+A1
EN 60601-1:2006+A11+A1+A12
IEC 60601-1-6:2010+A1
EN 60601-1-6:2010+A1
IEC 60601-1-11:2015
EN 60601-1-11:2015
IEC 62366:2007+A1
EN 62366:2008+A1
For DTM160-C8:
Medical electrical equipment
Part 1: General requirements for basic safety and essential performance
Part 1-6: Collateral standard: Usability
Part 1-11: Collateral Standard: Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare environment
Application of usability engineering to medical devices
TUEV Certificate TA 50558455 01
IEC/BS/EN 62368-1
Compliant with safety requirements for audio/video, information and communication
technology equipment
ErP Directive
Compliant with EU Regulation 2019/1782 (Ecodesign requirements for external power
supplies)
DoE Level
Compliant with the US DoE Level VI specification
REACH Directive
Directive 1907/2006/EU of the European Parliament and the Council of June 1st, 2007
regarding the Registration, Evaluation, Authorisation and Restriction of Chemicals
(REACH)
All parameters are typical values specified at nominal input voltage, nominal output load, 25°C ambient and after a 5 minutes run-in time unless
otherwise noted. The information presented in this document is believed to be accurate and reliable and may change without notice.
For additional information, please visit
https://product.tdk.com/en/power/dtm
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DOC-ID: 260933 – Issue 1