GB/T 44426.1-2024Assistive products for tissue integrity when lying down - Part 1: General requirements (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1: Structure and drafting rules for standardization documents" Drafting.

This document is part 1 of GB/T 44426 "Assistive devices for protecting tissue integrity while lying down". GB/T 44426 has been published.

The following parts.

--- Part 1: General requirements.

This document is modified to adopt ISO 20342-1:2022 "Assistive devices for protecting tissue integrity during lying down - Part 1: General requirements".

This document has the following structural adjustments compared to ISO 20342-1:2022.

---4.6~4.8 corresponds to 4.7~4.9 of ISO 20342-1:2022.

The technical differences between this document and ISO 20342-1:2022 and their reasons are as follows.

--- Modified the term "rehabilitation aids/assistive devices" (see Chapter 3, Chapter 3 of ISO 20342-1:2022), and ISO 9999:2022 is aligned;

--- Modified the general requirements (see 4.1, 4.1 of ISO 20342-1:2022), deleted the item "Clinical evaluation" (see ISO 20342-1.

2022) and the related terms "clinical evaluation" (see 3.8 of ISO 20342-1:2022) and "clinical study" (see 3.9 of ISO 20342-1:2022) and the normative reference document ISO 14155 to adapt to the current status of my country's rehabilitation assistive device industry;

--- Replace IEC 62366-1 with the normative reference YY/T 1474 (see 4.4.1), and replace IEC 60601-1-6 with YY/T 9706.106 (see 4.4.1), ISO 20417 replaces EN1041 (see 5.1.1, 5.1.7), YY/T 0466.1 replaces ISO 15223-1 (see 5.1.7), GB/T 3785.1 replaces IEC 61672-1 (see 5.4, 5.5), GB/T 3768 replaces ISO 3746 (see 5.4, 5.5), GB/T 16404 replaces ISO 9614-1 (see 5.4, 5.5), GB/T 17248.3 replaces ISO 11202 (see 5.5), GB/T 3785.2 replaces IEC 61672-2 (see 5.5), YY9706.108 replaces IEC 60601-1-8 (see 5.6), GB/T 5169.16 replaces IEC 60695-11-10 (see 6.3), YY9706.252 replaces IEC 60601-2-52 (see 7.1), GB/T 42062 replaces ISO 14971 (see 7.3), GB 9706.1-2020 replaces IEC 60601-1:2005 AMD1.2012 AMD2.2020 (see 7.6, 7.7, 8.1), YY9706.235 replaces IEC 60601-2-35 (see 7.7), YY9706.102 replaces IEC 60601-1-2 (see 8.1, 8.2.1, 8.2.3), YY9706.111 replaces IEC 60601-1-11 (see 8.1), GB 4824 replaces CISPR11 (see 8.2.2), GB 17625.1 replaces IEC 61000-3-2 (see 8.2.2), GB/T 17625.2 replaces IEC 61000-3-3 (see 8.2.2), GB/T 17626.3 replaces IEC 61000-4-3 (see 8.2.3), GB/T 17626.8 replaces IEC 61000-4-8 (see 8.2.4), GB/T 4208 replaces IEC 60529 (see 8.3), GB/T 16754 replaces ISO 13850 (see 8.6), GB/T 16886.1 replaces ISO 10993-1 (see 9.1), YY/T 0771.1 replaces ISO 22442-1 (see 9.2) to adapt to my country's technical conditions.

The following editorial changes were made to this document.

--- Deleted the footnotes (see 5.1.8, 5.6, 7.7 of ISO 20342-1:2022);

--- Deleted informative appendices A, B, C and notes referring to the contents of the appendix in the entries (see 4.1, 5.1.6, 6.1, 8.2.4, 9.1).

Introduction

In different application environments (such as institutional care and home care), assistive devices for preserving tissue integrity (APTI) have been used in maintaining body position, preventing it plays a significant role in preventing and treating pressure injuries (pressure sores). ISO plans to develop a series of standards to promote the quality improvement of APTI.

There are three standards, namely ISO 20342-1, ISO 20342-7, and ISO 20342-10, and some other standards are still under development.

GB/T 44426 "Assistive devices for protecting tissue integrity when lying down" aims to improve the quality and reliability of APTI and provide a reference for its production and inspection it is intended to provide a basis for its use and is composed of 9 parts.

--- Part 1: General requirements. The purpose is to specify lying protection organizations in different application environments (such as institutional care, home care) General requirements and test methods for assistive devices that protect tissue integrity (APTI) and assistive devices that guide lying and protect tissue integrity the production and testing of pressure tools (APTI) plays an important role in protecting user safety and preventing and treating pressure injuries.

--- Part 2: Microclimate. The purpose is to provide microclimate characteristics such as APTI heat dissipation and water vapor dissipation under specified test conditions.

Test method.

--- Part 3: Strength and impact. The purpose is to specify the requirements and procedures for APTI strength and impact tests.

--- Part 4: Durability. The purpose is to specify the test method for APTI durability.

--- Part 5: Resistance to cleaning and disinfection. The purpose is to provide tests to evaluate the resistance of APTI to cleaning and disinfection by liquid chemical disinfectants method.

--- Part 6: Horizontal stiffness. The purpose is to specify the test method for APTI horizontal stiffness.

--- Part 7: Properties, characteristics and performance of foams. The purpose is to provide terminology used by manufacturers and laboratories to quantify foam properties.

and common test methods.

--- Part 8: Pressure distribution. The purpose is to describe the ability of APTI to redistribute pressure and to specify the test method for pressure distribution.

methods, reporting of results, and the clinical significance of the results.

--- Part 10: Cleaning, disinfection and care guidance for polyurethane covers. The purpose is to provide guidance on cleaning, disinfection and care A practical guide to APTI polyurethane covers.

Assistive devices for lying down to protect tissue integrity Part 1: General requirements

1 Scope

This document specifies assistive devices for preserving tissue integrity (APTI) for lying down in different application settings (e.g. institutional care, home care).

Related general requirements and test methods.

This document applies to the requirements for the safety of APTIs that remain in position during recumbency, and for the prevention and treatment of pressure injuries.

The kit includes a range of different lying support surfaces which can be used in combination with an appropriate support platform (including adjustable) or as a complete set.

Use as a system.

This document does not apply to medical beds (including mattress support platforms).

This document also includes assistive devices that are primarily used to change lying position to preserve tissue integrity and assistive devices used to maintain lying position.

This document does not apply to lying support surfaces used in conjunction with incubators or operating tables.

This document covers combinations of full body support surfaces and adjustable mattress support platforms. It also includes safety and performance test methods to ensure that users Protect from harm.

This document specifies the requirements and test methods for APTI in the following categories of ISO 9999:2022.

043306 Assistive devices for lying down to protect tissue integrity, including but not limited to.

---Mattresses and mattress covers for the prevention of pressure injuries;

---Mattress covers for pressure damage prevention mattresses.

123103 Sliding and turning aids, including but not limited to devices that utilize sliding or turning techniques to change a person's position or orientation.

The only products included are those that are intended for lying down and remain in place as part of a lying support surface. These products include.

---Sliding products can slide in one direction and lock in the other direction;

--- Sheets and mattresses made of flexible materials with low friction;

---Fabric sold by the meter, can be cut to size according to repositioning needs;

---Power turning products.

Does not include sliding panels unless the product is intended to remain in place.

090706 Fixing pillows, fixing pads and fixing systems, including but not limited to.

---Leg fixator;

---Arm fixator;

---Multi-purpose body binder.

181215 Bedding articles, including but not limited to bed sheets.

2 Normative references

The contents of the following documents constitute essential clauses of this document through normative references in this document.

For referenced documents without a date, only the latest version (including all amendments) applies to this document.

This document.

GB/T 3768 Acoustics Sound Pressure Method for Determination of Sound Power Level and Sound Energy Level of Noise Sources Using a Simple Measuring Surface Enveloped Above the Reflecting Surface Law (GB/T 3768-2017, ISO 3746:2010, IDT) GB/T 3785.1 Electroacoustic sound level meter Part 1: Specification (GB/T 3785.1-2023, IEC 61672-1:2013, IDT)