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 (IEC 60601-1:2005/A1:2012): Medical electrical
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
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