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Standards Development
This document specifies requirements and a test method to assess the resistance to ignition by a smouldering cigarette equivalent of integrated or non-integrated components of a wheelchair intended to protect tissue integrity and/or provide postural support. The electrical ignition source is also a simulation of other potential sources of environmental ignition hazards.
The tests measure only the resistance to ignition of the items tested, and not the ignitability of the complete wheelchair. It gives an indication, but cannot guarantee, of the ignition behaviour of the assembled devices of a complete wheelchair.This document does not apply to resistance to ignition of structural parts of a wheelchair.
This document does not cover changes in resistance to ignition as a result of regular washing or use of the postural support devices.
This document allows for the separate testing of components of a wheelchair that are normally used in the horizontal plane (e.g. a seat cushion) from those normally used in the vertical plane (e.g. a back support).
This document describes testing an assembly of the composite of materials as used in the component. The results of the tests in this document do not give any indication of the resistance to ignition of any of the separate individual materials of the test sample.
NOTE 1 The intent of this document is primarily to address components that interface with the human body, such as cushions for positioning, or whose described purpose is that of protecting skin tissue against pressure, shear, and maceration related damage, as well as textile, foam, and plastic-based postural support devices.
Materials chosen are to comply with biocompatibility requirements and risk management guidance of ISO 10993–1, which includes consideration of cytotoxicity, sensitization, and irritation evaluations for devices making contact with the skin.
The pass criteria within this document have been set at a basic minimal level and are less severe than current requirements in some countries. Where practical, manufacturers are to use materials with superior resistance to ignition, when the overall risk analysis indicates the benefits outweigh any unintended harm, in accordance with ISO 14971.
NOTE 2 Requirements for the control of risks from sources of fire created by electrical and electronic components are included in ISO 7176-14.
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