Overview

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 that 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 (adjustable included) or as a whole integrated system. This document does not apply to medical beds. 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 addresses the combination of a full body support surface and an adjustable mattress support platform (slatted frame). 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 9999:2022: - assistive products for decubitus prophylaxis while lying down; - assistive products for repositioning and turning; - positioning cushions, pads, and systems; - bedding. This document does not apply to beds used for medical purposes. This document does not apply to lying support surfaces used in combination with incubators or operating/surgical tables. The standard differs from DIN EN ISO 20342-1 (VDE 0750-2-52-1):2020-03 as follows: a) the scope has been clarified; b) Clause 2 has been updated; c) Clause 3 has been updated; d) subclause 7.3 on V-shaped openings has been amended; e) subclause 7.7 and Table 4 have been amended (with regard to surface temperature); f) the bibliography has been updated. This document covers a range of different surfaces for lying support. It also covers assistive products primarily intended for decubitus prophylaxis, for changing a lying position, or for maintaining a lying position. It also addresses the combination of a full body support surface and an adjustable mattress support platform (slatted frame). It also covers safety and performance test methods to ensure protection against injuries to the user.

Responsible national committee

DKE/K 805 - Apparate zur therapeutischen Unterstützung  

Responsible european committee

CEN/TC 293 - Assistive products and accessibility  

Responsible international committee

ISO/TC 173/WG 11 - Assistive products for tissue integrity