GB/T 21666-2025Absorbent incontinence aids for urine and/or faeces - General guidelines on evaluation (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 replaces GB/T 21666-2008 "General Guidelines for the Evaluation of Urine Absorption Assistive Devices" and is consistent with GB/T 21666-2008.

In addition to structural adjustments and editorial changes, the main technical changes are as follows.

--- Changed the scope of the document (see Chapter 1, Chapter 1 of the 2008 edition);

--- Added "General Terms" (see 3.1);

--- Added "Product Type" (see 3.2);

--- Changed the factors to be considered in the evaluation, and divided the factors to be considered into three groups (see 4.2, 4.3, 4.4, 3.2 of the 2008 edition);

--- Deleted the provisions of "inspection selection" (see 3.3 of the 2008 edition);

--- Added the provisions of "evaluation method" (see 4.5).

This document is equivalent to ISO 15621:2017 "General guidance for the evaluation of aids for the absorption of urine and feces for incontinence".

The following minimal editorial changes were made to this document.

--- Deleted the note of 4.4.5;

--- Deleted the information on product safety management of urine and feces absorption aids for incontinence in Europe and the United States in 4.4.7.

Introduction

Incontinence is a disease that affects 4% to 8% of the world's population, about 400 million people. Urine and fecal absorption aids can help patients with urinary and fecal incontinence live longer.

There are many urine and stool absorbent devices on the market that can help people stay dry and comfortable. Consumers can You can buy it at a pharmacy or supermarket, or from manufacturers or wholesalers through government procurement, but it may be difficult to choose a product that suits you.

There are many factors to consider when choosing an incontinence aid, such as.

---Specific needs of users (such as the type and severity of their incontinence);

--- Caregiver needs (such as ergonomics in product design);

--- The design of the auxiliary device (such as insertable diapers, one-piece diapers, elastic diapers), characteristics (such as absorption performance and ease of wearing) degree) and cost;

---Environmental factors.

Currently, there is a limited amount of published data on these factors. This document provides guidance on the evaluation of urine and faecal absorbent aids for incontinence.

This document describes the needs of people with incontinence and lists the most important issues for users of absorbent aids for incontinence and their caregivers.

The key factors are identified and the test methods/interpretation of test results are outlined.

Various stakeholders can benefit from using this document, such as purchasers within the healthcare system, nursing home managers, prescribers, caregivers, Manufacturers, suppliers, health funds, insurance companies and users. Each stakeholder often has different priorities and needs.

However, it is important to remember that the most important stakeholder is always the user. The user has different Different people have different needs depending on their height, mobility, flexibility, mental health, lifestyle and personal priorities.

Consider these factors in order to choose the most suitable product for the user.

Suitability for actual use is best determined by trial use of the product by the user.

Other criteria that may be helpful in evaluating incontinence aids and conducting user trials include.

---GB/T 10220 General principles of sensory analysis methodology;

---GB/T 16432 Classification and terminology of rehabilitation assistive devices;

---GB/T 21665 Urine absorption aids Evaluation of disposable adult incontinence urine absorption aids from the perspective of users and caregivers Basic principles of assistive devices;

---ISO 11948-1 Urine absorption aids Part 1: Inspection of the complete product.

Incontinence urine and stool absorption aids General Guidelines for Reviews

1 Scope

This document provides guidance on the evaluation of urine and feces absorbent aids for incontinence. It also provides information related to urine and feces absorbent aids for incontinence products and General factors related to its use.

2 Normative references

This document has no normative references.

3 Terms and definitions

The following terms and definitions apply to this document.