User's Manual

2/2020 CY-0090-018, Rev.A Page 40 of 49
9. 2 C omp li anc e De cla rat io n
IEC 60601-1:2014, 4th Edition Medical electrical equipment - Part 1:
General requirements for basic safety and
essential performance
IEC 60601-1-2: 2014, 4th Edition Medical electrical equipment - Part 1-2:
General requirements for basic safety and
essential performance - Collateral Standard:
Electromagnetic Compatibility -
Requirements and Tests
IEC 60601-1-6: 2010, 3rd Edition Medical electrical equipment - Part 1-6:
General requirements for safety - Collateral
Standard: Usability
IEC 60601-1-11: 2015 Medical electrical equipment - Part 1-11:
Collateral Standard: Requirements for
medical electrical equipment and medical
electrical equipment used in the home
healthcare environment
IEC 60601-2-10: 2012, 2nd Edition Medical electrical equipment - Part 2-10:
Particular requirements for basic safety and
essential performance of nerve and muscle
stimulators
CENELEC EN60601-1: 2006 Medical electrical equipment - Part 1:
General requirements for basic safety and
essential performance
AAMI ES60601-1: 2005 Medical electrical equipment - Part 1:
General requirements for basic safety and
essential performance
CSA C22.2 #60601-1: 2008, 3rd Edition Medical electrical equipment - Part 1:
General requirements for basic safety and
essential performance
9.3 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
 The e-vive™ device needs special EMC precautions and must be
installed and started according to the EMC information supplied
in this manual.