Foreword

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This document was prepared by Technical Committee ISO/TC 173, Assistive products, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 293, Assistive products and accessibility, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

A list of all parts in the ISO 20342 series can be found on the ISO website.

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Introduction

Assistive products for tissue integrity (APTIs) play an integral role in any care plan for the prevention and treatment of pressure injuries. They can make a difference in quality of life for any user with limited mobility. Since no one APTI is best for all users, a wide variety of APTIs, including mattresses, mattress overlays and integrated bed systems, are available in a broad array of materials. Choosing from this growing list of alternatives has become a daunting task for clinicians, care givers and users. Selecting from the available alternatives is further complicated by the lack of consistent information regarding APTI characteristics.

Clinicians, manufacturers, distributors and users all stand to benefit from the development of standardized procedures to evaluate the characteristics of APTI. Detailed information provided by standardized testing will help clinicians objectively match the characteristics of an APTI to the needs of individual users. Testing standards will also aid manufacturers by guiding new product development and in the redesign of existing products. Testing standards will promote quality assurance within the manufacturing process. Distributors too, will benefit by being able to clearly describe and compare products from multiple manufacturers. Lastly, users will benefit by having APTIs that truly support their needs.

This document includes the test methods for the evaluation of the durability of APTIs in the lying position in different application environments, such as hospitals, home care and institutions. Some of the devices can be used or reused in more than one application environment. This means that different test methods can be applied to the same APTI depending on the application environment. This document offers several test methods, not all of which are appropriate for all APTIs, and, therefore, the manufacturer should determine which are appropriate for their APTIs’ construction and use.

APTIs play a very important role in the prevention and treatment of pressure injuries. Healthcare workers implement prevention and treatment strategies, which include risk assessment, skin monitoring and repositioning. Guidance on the role of APTIs can be found in Reference [6].

1 Scope

This document specifies conditions and test methods for the durability of assistive products for tissue integrity (APTI) when lying down. These methods are additional to the ones in ISO 20342-1.

This document is applicable to both reactive and active APTIs, such as mattresses and overlays, and includes single-patient multiple-use products.

This document does not apply to single-use products.

NOTE This document 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.

2 Normative references

3 Terms and definitions

4 Common test equipment

4.1

4.2

5 Test method for determining the durability of an APTI placed on an articulated support platform

5.1 Principle

5.2 Test equipment − Test support platform

5.3 Test specifications

5.4 Procedure

5.5 Test report

6 Test method for determining the durability of an APTI to withstand user movement

6.1 Principle

6.2 Test equipment – Loading pad

6.3 Test specifications

6.4 Procedure

6.5 Test report

7 Test method for determining the durability of an APTI to withstand storage and operating environmental conditions

7.1 Principle

7.2 Test equipment − Environmental chamber

7.3 Test specifications

7.4 Procedure

7.5 Test report

8 Test method for determining the durability of an APTI to withstand user repositioning on an APTI toward the head end of a bed

8.1 Principle

8.2 Test equipment

8.3 Test specifications

8.4 Procedure

8.5 Test report

9 Test report

Bibliography

ISO 20342-4:2026

Assistive products for tissue integrity when lying down — - Part 4: Test methods for durability

Current

Published:

6 Feb 2026