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

This document specifies a test method to evaluate the effects of liquid cleaners and disinfectants on the properties of waterproof coated textiles that are used as the protective outer surface of assistive products for tissue integrity (APTIs). The test method is not applicable to outer surfaces of APTIs that are not sufficiently drapeable. The test addresses degradation by pure chemical contact time only, it does not address degradation by other factors, such as abrasion.

This document provides guidance around best practices for cleaning, disinfecting and caring for the polyurethane covers for assistive products for tissue integrity when lying down (APTIs) where the covers are designed to protect the internal components of the APTI from damage. Adherence to this guidance will extend the operational life of the APTI and its tissue integrity performance. This document gives guidance for cleaning and disinfecting by manual means only. This document is not intended to give guidance related to the efficacy of the cleaning and disinfection procedures.

This document lists the terminology and common test methods used by manufacturers and laboratories to quantify the performance of a foam material. It also and gives information to users or buyers of these products to make an educated assessment of the relevance of the physical characteristics between various products offered to them. This document summarizes/gives information about the tests for — polyurethane foams – typically polyether (polyether polyurethane foam) or polyester based (polyester polyurethane foam) – produced by either slabstock (slabstock foam) or moulded foam process, and — latex foams produced by either the Dunlop process or Talalay process. The physical properties addressed in this document are a) resilience, b) hysteresis, c) support/SAG factor, d) density, e) hardness, f) compression set, g) tensile strength, h) tear strength, i) air flow/permeability, j) resistance to fatigue, and k) microbial resistance. NOTE The test methods presented in this document do not necessarily simulate conditions of use in practice. The use of resulting data is therefore restricted to a broad comparative assessment between different foam products. This document addresses only the characterization and performance of foam materials used in APTIs. It does not address the design, construction method or other factors relating to the final clinical efficiency of the product. Test methods for characterizing the physical properties of any coverings, or the effects of any coverings on the physical properties of the foams, are not addressed in this document.

This part of ISO 20342 specifies conditions and test methods for the durability of assistive products for tissue integrity (APTI) when lying down additional to ISO 20342-1. This document is applicable to APTIs, such as mattresses and overlays, and includes single patient multiple use products. This document does not apply to single use products. NOTE It is intended to help differentiate the durability characteristics between APTIs. It is not intended for determining overall performance or for ranking or scoring of such APTIs.

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.