EN ISO 15621:2017

Absorbent incontinence aids for urine and/or faeces - General guidelines on evaluation (ISO 15621:2017)

ISO 15621:2017 gives guidelines for evaluating absorbent incontinence aids for urine and/or faeces. It provides a context for the procedures described in other International Standards and published testing procedures. General factors relating to incontinence products and their usage are also addressed.

Saugfähige Inkontinenzhilfen für Urin und /oder Stuhl - Allgemeine Richtlinien für die Evaluierung (ISO 15621:2017)

Dieses Dokument enthält Leitfäden für die Bewertung saugfähiger Inkontinenzhilfsmittel für Urin und/oder Stuhl. Es bietet einen Kontext für Verfahren, die in anderen Internationalen Normen und veröffentlichten Prüfverfahren beschrieben sind. Ebenso werden allgemeine Faktoren bezüglich von Inkontinenz¬produkten und ihrer Verwendung angesprochen.

Aides à l'incontinence pour l'absorption d'urine et/ou de matières fécales - Directives générales d'évaluation (ISO 15621:2017)

L'ISO 15621:2017 fournit des lignes directrices pour évaluer les aides à l'incontinence pour l'absorption d'urine et/ou de matières fécales. Elle fournit un contexte pour les modes opératoires décrits dans d'autres Normes internationales et modes opératoires d'essais publiés. Les facteurs généraux concernant les produits pour incontinence et leur usage sont également examinés.

Absorbenti za urin in/ali blato v pripomočkih za inkontinenco - Splošne smernice za ovrednotenje (ISO 15621:2017)

Ta mednarodni standard podaja smernice za ovrednotenje lastnosti pripomočkov za absorbiranje urina in blata. Standard podaja kontekst za postopke, opisane v drugih mednarodnih standardih, in objavljene preskusne postopke. Obravnavani so tudi splošni dejavniki, ki vplivajo na pripomočke za inkontinenco in njihovo uporabo.

General Information

• Status: Published
• Publication Date: 11-Jul-2017
• Withdrawal Date: 30-Jan-2018
• ICS: 11.180.20 - Aids for incontinence and ostomy
• Technical Committee: CEN/TC 293 - Technical aids for disabled persons
• Drafting Committee: CEN/TC 293 - Technical aids for disabled persons
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 12-Jul-2017
• Completion Date: 12-Jul-2017
• Ref Project: SIST EN ISO 15621:2017 - Absorbent incontinence aids for urine and/or faeces - General guidelines on evaluation (ISO 15621:2017)

Relations

• Revised: FprEN ISO 15621 - Absorbent incontinence products for urine, faeces, or both - General guidelines on evaluation (ISO/FDIS 15621:2025)
• Effective Date: 20-Feb-2023

Overview

EN ISO 15621:2017 (ISO 15621:2017) provides general guidelines for evaluating absorbent incontinence aids for urine and/or faeces. It sets a framework to interpret laboratory tests and user trials, and addresses general factors affecting incontinence products and their use. The standard helps stakeholders make informed decisions about product selection, balancing performance, comfort and practical suitability for end users - an important consideration given incontinence affects an estimated 4–8% of the global population.

Key topics

• Scope & terminology
  • Definitions such as absorbent incontinence aid, absorption capacity and acquisition speed used to standardize evaluation language.
• User-related factors
  • Quality of life, independence vs. need for assistance, nature and severity of incontinence, mobility, dexterity, activities and individual preferences.
• Product-related factors
  • Freedom from leakage, odour control, skin health, comfort and fit, discretion and ease of handling.
• Usage-related factors
  • Ergonomics for users and carers, information/instructions, laundry and disposal considerations, environmental sustainability, safety and cost.
• Evaluation methods
  • Role of laboratory testing, structured user trials and combined approaches; guidance on interpretation of results and considerations such as sample size.

Practical applications

EN ISO 15621:2017 is a guidance document rather than a prescriptive test standard. Typical practical uses include:

• Helping manufacturers design and document product performance objectives (absorption, fit, odour control).
• Guiding clinical evaluators and research teams when planning user trials and interpreting in-use data.
• Informing healthcare procurement and purchasing decisions in hospitals, nursing homes and public health organizations.
• Assisting caregivers, prescribers and end users to select the most suitable incontinence products for individual needs.
• Supporting regulatory reviewers and insurers in assessing product claims and comparative evaluations.

Who benefits

• End users and family caregivers
• Clinicians, occupational therapists and continence advisors
• Product designers and quality engineers
• Procurement officers, nursing home managers and insurers

Related standards

EN ISO 15621:2017 is intended to be used alongside product-specific and test standards, for example:

• ISO 6658 (sensory / testing methods)
• ISO 9999 (classification of assistive products)
• ISO 11948-1 (urinary incontinence tests)
• ISO 16021 (user trial methodology)

EN ISO 15621:2017 provides the contextual guidance needed to evaluate incontinence products holistically - combining lab metrics like absorption capacity and acquisition speed with real-world usability and user-centred outcomes.

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2017
1DGRPHãþD
SIST ISO 15621:2016
$EVRUEHQWL]DXULQLQDOLEODWRYSULSRPRþNLK]DLQNRQWLQHQFR6SORãQHVPHUQLFH
]DRYUHGQRWHQMH,62
Absorbent incontinence aids for urine and/or faeces - General guidelines on evaluation
(ISO 15621:2017)
Hilfen zur Urinabsorption - Allgemeine Richtlinien für die Evaluierung (ISO 15621:2017)
Aides pour l'absorption d'urine - Directives générales d'évaluation (ISO 15621:2017)
Ta slovenski standard je istoveten z: EN ISO 15621:2017
ICS:
11.180.20 3ULSRPRþNLSULVWRPLLQ Aids for incontinence and
LQNRQWLQHQFL ostomy
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 15621
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2017
EUROPÄISCHE NORM
ICS 11.180.20
English Version
Absorbent incontinence aids for urine and/or faeces -
General guidelines on evaluation (ISO 15621:2017)
Aides à l'incontinence pour l'absorption d'urine et/ou Hilfen zur Urinabsorption - Allgemeine Richtlinien für
de matières fécales - Directives générales d'évaluation die Evaluierung (ISO 15621:2017)
(ISO 15621:2017)
This European Standard was approved by CEN on 28 May 2017.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15621:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 15621:2017) has been prepared by Technical Committee ISO/TC 173 “Assistive
products for persons with disability” in collaboration with Technical Committee CEN/TC 293 “Assistive
products for persons with disability” the secretariat of which is held by SIS.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by January 2018, and conflicting national standards shall
be withdrawn at the latest by January 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 15621:2017 has been approved by CEN as EN ISO 15621:2017 without any modification.
INTERNATIONAL ISO
STANDARD 15621
Third edition
2017-06
Absorbent incontinence aids for urine
and/or faeces — General guidelines
on evaluation
Aides à l’incontinence pour l’absorption d’urine et/ou de matières
fécales — Directives générales d’évaluation
Reference number
ISO 15621:2017(E)
©
ISO 2017
ISO 15621:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2017 – All rights reserved

ISO 15621:2017(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Evaluation requirements . 4
4.1 General . 4
4.2 User-related factors . 4
4.2.1 General. 4
4.2.2 Quality of life . 4
4.2.3 Independence or assistance . 4
4.2.4 Nature of incontinence . 4
4.2.5 End user characteristics . 5
4.2.6 Activities. 5
4.2.7 Individual needs . 5
4.2.8 Handling products . 6
4.3 Product-related factors . 6
4.3.1 General. 6
4.3.2 Freedom from leakage . 6
4.3.3 Freedom from odour leakage . 6
4.3.4 Skin health . 7
4.3.5 Comfort and fit . 7
4.3.6 Discretion . 7
4.4 Usage-related factors . 8
4.4.1 Ergonomics . 8
4.4.2 Needs of carer . . 8
4.4.3 Information supplied . 8
4.4.4 Laundry facilities . 8
4.4.5 Disposal facilities . 8
4.4.6 Sustainability and environment . 8
4.4.7 Product safety . . 9
4.4.8 Cost . 9
4.5 Evaluation methods . 9
4.5.1 General. 9
4.5.2 Testing in the laboratory . 9
4.5.3 Testing in user trials .10
4.5.4 Combined approach .10
4.5.5 Interpretation of test results .10
4.5.6 Sample size .11
Bibliography .12
ISO 15621:2017(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO’s adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: w w w . i s o .org/ iso/ foreword .html.
This document was prepared by ISO/TC 173, Assistive products for persons with disability, Subcommittee
SC 3, Aids for ostomy and incontinence.
This third edition cancels and replaces the second edition (ISO 15621:2011), which has been technically
revised.
iv © ISO 2017 – All rights reserved

ISO 15621:2017(E)
Introduction
Incontinence is a set of diseases that affects between 4 % and 8 % of the population or the lives of
approximately 400 million people worldwide. Absorbent aids can help people affected by urinary and/or
faecal incontinence to live an independent and dignified life. There are many absorbent incontinence
aids on the market that can help persons to stay dry and comfortable. They can be purchased at
pharmacies or supermarkets by consumers or via public procurement from producers or wholesalers,
but selecting the right product can be difficult.
There are many factors to consider when choosing absorbent incontinence aids, for example:
— the particular needs of the end user (e.g. the nature and severity of their incontinence);
— the needs of an assisting carer (e.g. ergonomics in the design of the product);
— the design of the aids (e.g. inserts, all-in-ones, pull-ons), their characteristics (e.g. absorption
capacity and ease of putting on) and cost;
— environmental factors.
Currently, there is a limited amount of published data on these factors. ISO 15621 gives guidance for
evaluating absorbent incontinence aids so that informed choices can be made. It describes the needs of
the incontinent population, lists the most important factors for end users and caregivers and gives an
overview of testing methodologies/interpretation of test results.
There are a number of stakeholders who could benefit from using this document, e.g. purchasers within
healthcare systems, nursing home managers, prescribers, caregivers, manufacturers, suppliers, sick
funds, insurance companies and end users. These stakeholders often have different priorities and
different needs. However, it is important to remember that the most important stakeholder is always
the end user. End users have different needs depending on, for example, their gender, age, the nature
and severity of incontinence, mobility, dexterity, mental health, lifestyle, and personal priorities. These
factors should be taken into account when the most appropriate products are being chosen by/for them.
Practical, in-use suitability is best determined by testing products with the individual end user.
Other standards that might be useful for evaluating absorbent incontinence aids and performing user
trials include
— ISO 6658,
— ISO 9999,
— ISO 11948-1, and
— ISO 16021.
INTERNATIONAL STANDARD ISO 15621:2017(E)
Absorbent incontinence aids for urine and/or faeces —
General guidelines on evaluation
1 Scope
This document gives guidelines for evaluating absorbent incontinence aids for urine and/or faeces. It
provides a context for the procedures described in other International Standards and published testing
procedures. General factors relating to incontinence products and their usage are also addressed.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1 General terms
3.1.1
absorbent incontinence aid
product containing absorbent material to absorb urine and/or absorb/contain faeces when the wearer
is suffering incontinence
3.1.2
absorption capacity
amount of liquid that can be absorbed by an absorbent incontinence aid (3.1.1) under specified conditions
3.1.3
acquisition speed
time taken for a specified amount of liquid to be absorbed into an absorbent incontinence aid (3.1.1)
under specified conditions
3.1.4
end user
person who uses an absorbent incontinence aid (3.1.1)
3.1.5
carer
person or organization who helps someone to perform their tasks of daily living, such as managing
their incontinence
3.1.6
retention capacity
amount of liquid that is retained by an absorbent incontinence aid (3.1.1) after all unbound liquid has
been removed under specified conditions
ISO 15621:2017(E)
3.1.7
rewet
amount of surplus that escapes from an absorbent incontinence aid (3.1.1) when it is exposed to external
forces or pressure under specified conditions
3.2 Product types
3.2.1
all-in-one
brief
slip
absorbent incontinence aid (3.1.1) in which the absorbent core is mounted within a chassis, equipped
with re-adjustable fixation system, which allows it to be secured to the body without the help of
additional fixation systems
Note 1 to entry: An all-in-one usually has elastics surrounding the leg shape and self-adhesive tapes.
3.2.2
belted product
absorbent incontinence aid (3.1.1) in which the absorbent core is mounted within a chassis, equipped
with re-adjustable waist belt
3.2.3
pad
insert
liner
shield
absorbent incontinence aid (3.1.1) held in place by elastic mesh briefs or to be used inside another
absorbent product to supplement absorption capacity (3.1.2)
Note 1 to entry: There is a wide range of pads designed for different amounts of urine leakage. Some products are
designed mainly for urine leakage while others are designed also for faecal leakage.
2 © ISO 2017 – All rights reserved

ISO 15621:2017(E)
3.2.4
pad for underwear
female pad
male pad
absorbent incontinence aid (3.1.1) to be placed in underwear with, for example, an adhesive strip
Note 1 to entry: Compared to pad/insert/liner/shield (3.2.3) pads for underwear are usually smaller products,
often with gender-specific shape and designed for lower amount of urine.
3.2.5
pull-on
pants
protective underwear
disposable underwear
absorbent incontinence aid (3.1.1) shaped and designed to resemble normal underwear designed
especially for male or female users or as unisex products
Note 1 to entry: A pull-on can be applied like a normal underwear.
ISO 15621:2017(E)
4 Evaluation requirements
4.1 General
The details of how an evaluation is conducted and the factors that it needs to focus on will vary
depending on, for example, the needs and priorities of the end users, their caregivers, the organization
providing the products, etc. It will also depend on the purpose of the evaluation: for example, if the
priority is to exclude poorly performing products, or to distinguish between products with broadly
similar characteristics, the specific questions will differ.
But, whatever the nature and purpose of an evaluation, the factors to be considered can be usefully
divided into the three groups: user-related factors (see 4.2), product-related factors (see 4.3), and
usage-related factors (see 4.4).
NOTE It can be helpful to prepare for an evaluation by consulting the international classification
[2]
ISO 9999:2016, Code 09 30 .
4.2 User-related factors
4.2.1 General
The needs of the individual end user are of utmost importance and, therefore, should always be the
primary focus when evaluating products.
The following is a list of key assessment factors related to the end user as discussed in Reference [9]. These
assessment factors provide perspectives on how absorbent incontinence aids can benefit the end user.
4.2.2 Quality of life
All forms of incontinence can cause isolation, depression and physiological problems and can
significantly damage the social and work-related aspects of the sufferer’s life and that of their family.
Absorbent incontinence aids, however, can have a positive impact on the quality of life of individuals
suffering from incontinence by helping them to maintain their sense of dignity and enabling them to
leave home, to work, to take part in social activities and to live a full and satisfying life.
4.2.3 Independence or assistance
The most important goal is to give people the ability to live as independent a life as possible. An
important aspect of this is to be able to access toilet facilities and to manage incontinence and toileting.
Independence is made possible when the end user is able to access appropriate facilities and change
their absorbent incontinence aids on their own. Many end users may not be able to achieve independence
in this regard and will need assistance.
The ease of putting absorbent incontinence aids on and taking them off should be considered, especially
[8]
for caregivers and for incontinent end users with reduced mobility or dexterity . If end users can
change products themselves, they will be more independent, preserving their dignity, as well as
reducing care costs. It is, therefore, important to favour products that support independence.
4.2.4 Nature of incontinence
During the normal assessment process of the individual with incontinence problems, the nature of
their incontinence and their suitability for different treatment and management options are assessed.
If the use of absorbent incontinence aids is indicated, the frequency and timing (e.g. day or night) of
incontinence events and the amount of urine and/or faeces leaked will be important factors in selecting
appropriate products. A frequency volume chart (FVC) or a bladder diary covering at least 24 h and a
[9]
“pad test” (leakage test) may be useful tools to obtain valuable information about the incontinence .
In recent years, several electronic diapers have been developed with the purpose to automatically map
4 © ISO 2017 – All rights reserved

ISO 15621:2017(E)
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