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3.7. Applied safety standards
IEC 60601-1:2012
Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance
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 60601-1-6:2016
Medical electrical equipment – Part 1-6: General requirements
for safety – Collateral standard :
IEC 62304:2008
EN 62304:2006/AC:2008
Medical device software - Software life-cycle processes
IEC 62366:2007
EN 62366:2008
Medical devices - Application of usability engineering to
medical devices
EN ISO 15223-1:2016
Medical devices - Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1:
General requirements
EN 50581:2012
Technical documentation for the assessment of electrical and
electronic products with respect to the restriction of
hazardous substances
IEC 62321:2008
Electrotechnical products - Determination of levels of six
regulated substances (lead, mercury, cadmium, hexavalent
chromium, polybrominated biphenyls, polybrominated
diphenyl ethers)