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
  • Assistive products for persons with disability. General requirements and test methods BS EN 12182
  • Flammability – ISO 16840-10, California Technical Bulletin 117-2013
  • PDAC cushion testing – Wheelchair cushion testing for USA Medicare/Medicaid reimbursement code
  • Certified compliant to EU Medical Devices Regulation 2017/745
  • 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.
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RESNA WC4-20

The Spex seating system complies with RESNA WC-4:2017, Section 20. Spex seating systems are designed only for use with wheelchair bases that have been successfully crash-tested to the frontal-impact requirements of RESNA WC-4:2017, Section 19.

Spex seating systems must be used on a wheelchair frame that provides four securement points and pelvic belt anchor points that conform to the requirements of RESNA WC-4:2017, Section 19. The seating system is designed to be occupied when the wheelchair is facing forward in motor vehicles.

When correctly installed, the following Spex products meet requirements of RESNA WC-4:2017, Section 20: Back Support, Seat Base, Cushion, Arm and Thigh Supports, Lateral Trunk Supports, Head Support. Any postural support device not intended for use as occupant restraint in motor vehicle transport may not provide occupant protection in a vehicle impact.

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.

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. Zygo Lo and Zygo Mid back supports.

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ISO 16840-4

Spex seating systems are designed 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. The seating system is designed to be forward-facing when used with a wheelchair base in a motor vehicle.

When correctly installed, the following Spex products meet requirements of ISO 16840-4:2009: Back Support, Seat Base, Cushion, Arm and Thigh Supports, Lateral Trunk Supports, Head Support. Any postural support device not intended for use as occupant restraint in motor vehicle transport may not provide occupant protection in a vehicle impact.

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. Zygo Lo and Zygo Mid back supports.

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