Itamar Medical Ltd.
Endo
PAT
TM
x Device
6
Operation Manual
STANDARD
#
13.
Medical electrical equipment - Part 1-6: General requirements
for basic safety and essential performance - Collateral
standard: Usability
EN 60601-1-6:2010
[the product was
developed according to:
IEC 60601-1-6:2010 +
AMD1:2013]
14.
Medical devices - Application of usability engineering to
medical devices
EN 62366:2008
[the product was
developed according to:
IEC 62366 : 2007 +
AMD1:2014 and IEC
62366-1 : 2015]
15.
Directive on the restriction of the use of certain hazardous
substances in electrical and electronic equipment
RoHS - Directive
2011/65/EU (RoHS 2)
