Technical Specifications; Applicable Norms / Standards - Sunrise Medical Quickie Teens Instructions For Use Manual

10.0 Technical specifications:

10.1 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.
Medical Device Regulation (EU)
2017/745
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 (2012) 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:
This seating system (when used in conjunction with
approved base) meets the crash test requirements
as described in ISO 7176-19
Wheelchairs – Part 19: Wheeled mobility devices for
use as seats in motor vehicles:
This seating system (when used in conjunction with
approved base) 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 flame equivalent.
Quickie Teens / Zippie Kids Seat Rev. B