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GB/T 21666-2025: Absorbent incontinence aids for urine and/or faeces - General guidelines on evaluation
Status: Valid GB/T 21666: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 21666-2025 | English | 354 |
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Absorbent incontinence aids for urine and/or faeces - General guidelines on evaluation
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GB/T 21666-2025
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| GB/T 21666-2008 | English | 174 |
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Urine-absorbing aids -- General guidance on evaluation
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GB/T 21666-2008
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PDF similar to GB/T 21666-2025
Basic data | Standard ID | GB/T 21666-2025 (GB/T21666-2025) | | Description (Translated English) | Absorbent incontinence aids for urine and/or faeces - General guidelines on evaluation | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.180 | | Word Count Estimation | 18,123 | | Date of Issue | 2025-02-28 | | Date of Implementation | 2025-06-01 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 21666-2025: Absorbent incontinence aids for urine and/or faeces - General guidelines on evaluation
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
GB/T 21666-2025 English version. Absorbent incontinence aids for urine and/or faeces - General guidelines on evaluation
ICS 11.180
CCSC30
National Standard of the People's Republic of China
Replace GB/T 21666-2008
Incontinence urine and stool absorption aids
General Guidelines for Reviews
General guidelines one valuation
(ISO 15621.2017, IDT)
Released on 2025-02-28
2025-06-01 Implementation
State Administration for Market Regulation
The National Standardization Administration issued
Table of Contents
Preface III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Evaluation Principles 3
4.1 General Principles 3
4.2 User-related factors 4
4.3 Product-related factors 5
4.4 Use-related factors 7
4.5 Evaluation Method 8
Reference 10
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.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is issued by the Ministry of Civil Affairs of the People's Republic of China.
This document is under the jurisdiction of the National Technical Committee for Standardization of Rehabilitation and Special Equipment for Persons with Disabilities (SAC/TC148).
This document was drafted by. National Rehabilitation Equipment Research Center, Cancer Hospital of Chinese Academy of Medical Sciences, Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
Hospital, Zhejiang Yiwei Medical Products Co., Ltd., and Coloplast (China) Medical Products Co., Ltd.
The main drafters of this document are. Liu Junling, Li Mingjie, Ma Lifang, Ma Fengling, Guo Huan, Fang Pengyue, Wang Xiangyu, Li Xinyue, Zhu Yunping,
Wang Jiajun and Lian Lian.
The previous versions of this document and the documents it replaces are as follows.
---First published in.2008 as GB/T 21666-2008;
---This is the first revision.
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.
3.1 General terms
3.1.1
incontinence absorbentincontinenceaid
Products containing absorbent materials that absorb urine and/or absorb/contain feces when the user is incontinent.
3.1.2
Absorption performanceabsorptioncapacity
The amount of liquid that can be absorbed by an incontinence absorbent aid (3.1.1) under specified conditions
3.1.3
absorption speed acquisitionspeed
The time required, under specified conditions, for a specified amount of liquid to be absorbed into an absorbent aid for incontinence (3.1.1)
3.1.4
end-user
People who wear incontinence absorbent aids.
3.1.5
caregiver
A person or organization that takes care of a person's daily life, such as dealing with incontinence.
3.1.6
retention capacity
The amount of liquid retained by an incontinent absorbent aid (3.1.1) under specified conditions after all liquid not absorbed by the adhesive has been removed.
3.1.7
Rewet
The amount of liquid that returns after overflow when an external force or pressure is applied to an incontinent absorbent aid (3.1.1) under specified conditions
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