ExoAtlet ExoAtlet-II - Applied Safety Standards

User’s Manual
http://www.exoatletasia.com
ExoAtlet
Ⓡ
II 17 / 84 Ver 1.0 (2019.03.29.)
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)