DANSK DSF/ISO/FDIS 20342-1 PDF

This document specifies general requirements and related test methods that are relevant to assistive products for tissue integrity (APTI) in the lying position in different application environments such as hospitals, home care and institutions. This document applies to the safety of APTI, which are intended to remain in situ during periods of lying, and to prevent and/or treat pressure injuries. This document covers a range of different lying support surfaces intended to be used in combination with the appropriate support platform or as a whole integrated system. This document also covers assistive products primarily intended for tissue integrity for changing a lying position and assistive products for maintaining a lying position. This document does not apply to lying support surfaces used in combination with incubators. This document addresses the combination of a full body support surface and an adjustable mattress support platform. It also covers safety and performance test methods to ensure protection against injuries to the user. This document specifies requirements and test methods for APTI within the following classifications of ISO 9999:2016: 04 33 06 Assistive products for tissue integrity when lying down such as but not limited to: – Mattresses and mattress overlays for pressure injury prevention; – Mattress coverings for pressure injury prevention mattresses. 12 31 03 Assistive products for sliding and turning such as but not limited to: Devices for changing position or direction of a person using sliding or turning techniques. The only products included are those intended to be used in a lying position and remain in situ as part of the lying support surface. They are the following: – sliding products that glide one way and lock the other way; – sheets and underlays in flexible materials with low friction; – fabric sold by the metre, cut as required for repositioning use; – powered turning product; This excludes sliding boards unless the product is intended to be left in situ. 09 07 06 Positioning pillows, positioning cushions and positioning systems such as but not limited to: – leg positioners, – arm positioners, and – multipurpose body positioners. 18 12 15 Bedding such as but not limited to: – draw sheets.