Compliance

Compliance

Below is a list of testing standards and compliance that Spex Seating has achieved...

  • Motor vehicle transportation - Crash testing to RESNA WC4-20 and ISO 16840-4 Wheelchair Seating Systems for Use in Motor Vehicles
  • Usability engineering EN 62366 - Medical devices. Application of usability engineering to medical devices
  • Risk Management – ISO 14971 - Application of risk management to medical devices
  • Assistive products for persons with disability. General requirements and test methods BS EN 12182
  • Flammability – ISO 7176-16, California Technical Bulletin 117-2013,
  • Biocompatibility/ cytotoxicity – ISO 10993-1,5
  • PDAC cushion testing - Wheelchair cushion testing for USA Medicare/Medicaid reimbursement code
  • Certified compliant to EU Medical Devices Regulation 2017/745
  • Spex registration in HMV (Germany public health insurance)
  • Clinical evaluation to MEDDEV 2.7.1, rev 4 (literature based)
  • ISO 16840-3: 2015  Wheelchair seating – Part 3: Determination of static, impact and repetitive load strengths for postural support devices.

 

RESNA WC4-20

The Spex Seating System complies with RESNA WC-4:2012, Section 20. Spex is designed only for use with wheelchair frames that have been successfully crash tested to the frontal-impact requirements of RESNA WC-4:2012, Section 19.

Spex Seating Systems must be used on a wheelchair frame that provides four securement points and pelvicbelt anchor points that conform to the requirements of RESNA WC-4:2012, Section 19.

Spex components that are WC20 certified for use during motor vehicle transportation include: Backrest, Grid-Base Seat Pan, Cushion, Thigh & Arm Supports, Trunk Supports and Head Support. The seating system is designed to be occupied when the wheelchair is facing forward in motor vehicles.

The seating system has been designed to accommodate the proper use of vehicle-anchored belt restraints and the ratings of the seating systems with regard to a) ease of properly positioning vehicle-anchored belt restraints on the wheelchair passenger, and b) the degree to which proper positioning of belt restraints can be achieved.

 

ISO 16840-4

Spex Seating is intended only for use with wheelchair bases tested as part of a complete wheelchair system that conforms to the performance requirements of ISO 7176-19.

Spex Seating Systems must be used on a wheelchair base that provides securement points that conform to the design requirements of ISO 7176-19. Components that are ISO 16840-4 certified for use during motor vehicle transportation include: Backrest, Grid-Base Seat Pan, Cushion, Thigh & Arm Supports, Trunk Supports and Head Support. The seating system is designed to be forward facing when used with a wheelchair base in a motor vehicle.

A wheelchair tiedown and occupant restraint system (WTORS) that conforms to the requirements of ISO 10542-1 must be used during wheelchair transportation with this seating system.
When tested in accordance with Annex D of ISO 16840-4 with regard to accommodating vehicle-anchored occupant restraints, Spex Seating achieved an overall score of 16 out of 16, and a rating of A (Good).

 

Note: Back supports that are lower than the user's shoulder height are not certified and not recommended for transport in a vehicle. e.g. Vigour Lo and Vigour Mid back supports.