Technical Specifications; Applicable Norms / Standards - Sunrise Medical QUICKIE Sedeo Pro Instructions For Use Manual

9.0 Technical specifications:

9.1 Applicable norms / standards

This product complies with the regulations and guidelines for medical aids
and carries a CE symbol.
The product meets the requirements and standards below. These are checked by
independent institutions.
EU Guideline 2017/745 EEC
EN 12182 (2012) Class B
EN 12184 (2014) Class B
ISO 7176-8: 2014
ISO 7176-9
ISO 7176-14
ISO 7176-16: 2012
ISO 7176-19 (2008)
Dahl Docking
ISO 7176-19 (2008)
EN-ISO10993-5: 2009
EN 1021 1&2
38
Applicable as mentioned in table 1
The requirements from EN12182 (2014) as
mentioned in EN 12184 (2014).
Assistive products for persons with disability –
General requirements and test methods.
Electrically powered wheelchairs, scooters and
their chargers – Requirements and test methods.
Requirements and test methods for impact,
static and fatigue strengths.
Climate tests for electric wheelchairs.
Requirements and test methods for control
systems for electric wheelchairs.
Requirements for resistance to ignition of
upholstered parts.
Wheelchairs – Part 19: Wheeled mobility devices
for use as seats in motor vehicles:
Sedeo Pro meets the crash test requirements as
described in ISO 7176-19
Wheelchairs – Part 19: Wheeled mobility devices
for use as seats in motor vehicles:
Sedeo Pro meets the crash test requirements as
described in ISO 7176-19
Biological evaluation of medical devices.
Assessment of the ignitability of upholstered
furniture. Ignition source: smouldering cigarette/
match lame equivalent.
Sedeo Pro Rev.B