47
EN
GLISH
Elite
2
Mini XS Plus Rev.B
12.0 Specification Sheets (EN 12184 & ISO 7176-15)
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.
EN ISO 10993-5:2009
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
Standard
Definition / description
Test Dummy Weight
Medical Device
Regulation (EU)
2017/745
Applicable as mentioned in Appendix 1
EN 12182: 2012
Class B
Assistive products for persons with disability - General
requirements and test methods
-
-
Elite
2
Mini
136 kg
Elite
2
XS
Elite
2
Plus
170 kg
EN 12184: 2014
Class B
Electrically powered wheelchairs, scooters and their chargers -
Requirements and test methods
-
-
Elite
2
Mini
136 kg
Elite
2
XS
Elite
2
Plus
170 kg
ISO 7176-8: 2014
Requirements and test methods for impact, static and fatigue
strengths
N/A
N/A
ISO 7176-9: 2009
Climate tests for electric wheelchairs
N/A
N/A
ISO 7176-14: 2008
Requirements and test methods for control systems for electric
wheelchairs
N/A
N/A
ISO 7176-16: 2012
Requirements for resistance to ignition of upholstered parts
N/A
N/A