Empatica EmbracePlus Instructions For Use Manual page 115

EmbracePlus laboratory testing
EmbracePlus has been subject to specific laboratory testing to assess its
safety, electromagnetic compatibility, usability and biocompatibility.
Tests have been performed according to the following standards:
● EN 60601-1:2006/A1:2013
equipment – Part 1: General requirements for basic safety and essential performance
● EN 60601-1-2:2015 (IEC 60601-1-2:2014): Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and tests
● IEC 60601-1-6:2010 + Amd1:2013: Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance - Collateral standard: Usability
● IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements
for basic safety and essential performance - Collateral standard: Requirements for
medical electrical equipment and medical electrical systems used in the home healthcare
environment
● IEC 62366-1:2015 Medical devices — Part 1: Application of usability engineering to
medical devices
● ISO 10993-1:2018 Biological Evaluation of Medical Devices - Part 1: Evaluation and
Testing within a risk management process
● EN ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for in vitro
cytotoxicity
(IEC 60601-1:2005/A1:2012): Medical electrical
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