FprEN ISO 15621

SLOVENSKI STANDARD
oSIST prEN ISO 15621:2025
01-februar-2025
Absorbenti za urin in/ali blato v izdelkih za inkontinenco - Splošne smernice za
ovrednotenje (ISO/DIS 15621:2024)
Absorbent incontinence products for urine and/or faeces - General guidelines on
evaluation (ISO/DIS 15621:2024)
Saugfähige Inkontinenzhilfen für Urin und /oder Stuhl - Allgemeine Richtlinien für die
Evaluierung (ISO/DIS 15621:2024)
Produits d'incontinence pour l'absorption d’urine et/ou de matières fécales - Directives
générales d'évaluation (ISO/DIS 15621:2024)
Ta slovenski standard je istoveten z: prEN ISO 15621
ICS:
11.180.20 Pripomočki pri stomi in Aids for incontinence and
inkontinenci ostomy
oSIST prEN ISO 15621:2025 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 15621:2025
oSIST prEN ISO 15621:2025
DRAFT
International
Standard
ISO/DIS 15621
ISO/TC 173/SC 3
Absorbent incontinence products
Secretariat: SIS
for urine and/or faeces — General
Voting begins on:
guidelines on evaluation
2024-12-27
ICS: 11.180.20
Voting terminates on:
2025-03-21
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
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POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 15621:2024(en)
oSIST prEN ISO 15621:2025
DRAFT
ISO/DIS 15621:2024(en)
International
Standard
ISO/DIS 15621
ISO/TC 173/SC 3
Absorbent incontinence products
Secretariat: SIS
for urine and/or faeces — General
Voting begins on:
guidelines on evaluation
ICS: 11.180.20
Voting terminates on:
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
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TO SUBMIT, WITH THEIR COMMENTS,
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NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION.
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 15621:2024(en)
ii
oSIST prEN ISO 15621:2025
ISO/DIS 15621:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 General terms .1
3.2 Product types .2
4 Evaluation requirements . 5
4.1 General .5
4.2 User-related factors.5
4.2.1 General .5
4.2.2 Quality of life . .5
4.2.3 Independence or assistance .6
4.2.4 Nature of incontinence .6
4.2.5 End user characteristics .6
4.2.6 Activities .7
4.2.7 Individual needs .7
4.2.8 Handling products .7
4.3 Product-related factors .7
4.3.1 General .7
4.3.2 Freedom from leakage .8
4.3.3 Freedom from odour leakage . .8
4.3.4 Skin health .8
4.3.5 Comfort and fit .9
4.3.6 Discretion .9
4.4 Usage-related factors .9
4.4.1 Ergonomics .9
4.4.2 Needs of caregiver .10
4.4.3 Information supplied .10
4.4.4 Laundry facilities .10
4.4.5 Disposal facilities .10
4.4.6 Sustainability and environment .10
4.4.7 Product safety .11
4.4.8 Total cost .11
4.5 Evaluation methods .11
4.5.1 General .11
4.5.2 Testing in the laboratory .11
4.5.3 Testing in user trials . 12
4.5.4 Combined approach . 12
4.5.5 Interpretation of test results . 12
4.5.6 Sample size . 13
Bibliography . 14

iii
oSIST prEN ISO 15621:2025
ISO/DIS 15621:2024(en)
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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO [had/had not] received notice of
(a) patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of 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 www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 173, Assistive products, Subcommittee SC 3,
Aids for ostomy and incontinence.
This fourth edition cancels and replaces the third edition (ISO 15621:2017), which has been technically
revised.
The main changes are as follows:
— updated terms and definitions
— terminology has been harmonized with ISO 22748;
— updated reference list.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
oSIST prEN ISO 15621:2025
ISO/DIS 15621:2024(en)
Introduction
Incontinence is a set of diseases that affects between 4 % and 8 % of the population or the lives of
approximately 425 million people worldwide. Absorbent products can help people affected by urinary and/
or faecal incontinence to live an independent and dignified life. There are many absorbent incontinence
products 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 products, for example:
— the particular needs of the end user (e.g. the nature and severity of their incontinence);
— the needs of assisting caregivers (e.g. ergonomics in the design of the product);
— the design of the products (e.g. inserts, all-in-ones, pull-ons), their characteristics (e.g. design to secure
leakage security and maintaining skin health)
— cost;
— and environmental impact.
Currently, there is a limited amount of published data on these factors. ISO 15621 gives guidance for
evaluating absorbent incontinence products so that informed choices can be made. It describes the needs
of people with incontinence, 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, care providers, nursing home managers, prescribers, caregivers, manufacturers,
suppliers, sick funds, insurance companies and end users themselves. 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 anatomy,
age, the nature and severity of incontinence, mobility, dexterity, cognitive status, 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 products and performing user
trials include
— ISO 6658,
— ISO 9999,
— ISO 11948-1, and
— ISO 16021,
— ISO 22748,
v
oSIST prEN ISO 15621:2025
oSIST prEN ISO 15621:2025
DRAFT International Standard ISO/DIS 15621:2024(en)
Absorbent incontinence products for urine and/or faeces —
General guidelines on evaluation
1 Scope
This document gives guidelines for evaluating absorbent incontinence products for urine and/or faeces for
adults and children. 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 terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1 General terms
3.1.1
absorbent incontinence product
product containing absorbent material to absorb/contain urine and/or contain faeces when the wearer
experiences incontinence
3.1.2
absorption capacity
amount of liquid that can be absorbed by an absorbent incontinence product (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 product (3.1.1)
under specified conditions
3.1.4
end user
person who wears an absorbent incontinence product (3.1.1)
3.1.5
caregiver
person who assists user(s) with applying and changing incontinence products
Note 1 to entry: Caregivers may be paid staff or family/friends

oSIST prEN ISO 15621:2025
ISO/DIS 15621:2024(en)
3.1.6
absorbent product with sensors
absorbent product with sensors that are used to monitor the saturation of a product to indicate when it
might need changing and/or assist with care planning
3.1.7
retention capacity
amount of liquid that is retained by an absorbent incontinence product (3.1.1) after all unbound liquid has
been removed under specified conditions
3.1.8
rewet
amount of liquid that escapes from an absorbent incontinence product (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 product equipped with a fastener system that allows it to be secured to the body.
Note 1 to entry: An all-in-one usually has elastics surrounding the leg openings and/or self-adhesive tape
[SOURCE: ISO 22748:2021]
3.2.2
belted pad
absorbent incontinence product in which the absorbent core is mounted within a chassis, equipped with
a re-adjustable waist belt. The belt is designed to help with putting the pad on, especially in the standing
position
[SOURCE: ISO 22748:2021]
oSIST prEN ISO 15621:2025
ISO/DIS 15621:2024(en)
3.2.3
pad
insert
liner
shield
absorbent incontinence product held in place by separate elastic mesh briefs or other close-fitting underwear
[SOURCE: ISO 22748:2021]
3.2.4
pad for underwear
female pad
male pad
product designed to contain small amounts of urine, placed in wearers normal underwear, usually with an
adhesive strip to help secure it in place, often with a gender-specific shape
[SOURCE: ISO 22748:2021]
oSIST prEN ISO 15621:2025
ISO/DIS 15621:2024(en)
3.2.5
pull-on
pants
protective underwear
disposable underwear
absorbent incontinence pad designed to resemble normal underwear, may be especially for male or for
female users or a unisex product

3.2.6
male pouch
male incontinence wrap
absorbent incontinence pad for men, designed either to wrap around the penis or - in pocket form – to
contain the penis and sometimes the scrotum

3.2.7
male pad
absorbent incontinence pad for men, designed to be placed over the penis and scrotum, but not to surround them

oSIST prEN ISO 15621:2025
ISO/DIS 15621:2024(en)
3.2.8
unbacked pad
absorbent incontinence pad without waterproof backing or integral fastener system. It is either held in place
using a separate fastener system that includes waterproof backing, or used inside another absorbent product

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 may be helpful to prepare for an evaluation by consulting the international classification ISO 9999:2022,
[2]
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 [10]. These
assessment factors provide perspectives on how absorbent incontinence products 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 products, however, can have a positive impact on the quality of life of individuals suffering

oSIST prEN ISO 15621:2025
ISO/DIS 15621:2024(en)
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 products on their own. Many end users are unable to achieve independence in this regard and
will need assistance.
The ease of putting absorbent incontinence products on and taking them off should be considered, especially
[8]
for users with reduced mobility or dexterity and/or cognitive impairment and / or who rely on caregivers.
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 product types which end users can apply and
remove themselves, so maximising their independence and minimising the burden to caregivers, as well as
their associated costs.
4.2.4 Nature of incontinence
Determining the nature of someone’s incontinence and their suitability for different treatment and
management options is a normal part of the assessment process when someone presents with incontinence
problems. If the use of absorbent incontinence products 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
[10]
and a “pad test” (leakage test) may be useful tools to obtain valuable information about the incontinence.
In recent years, absorbent products with sensors have been developed with the purpose of monitoring the
saturation of the products to indicate when they might need changing and/or assist with care planning.
Some people lose only small quantities of urine on infrequent occasions, in which case an absorbent
incontinence product with more limited absorption capacity may be adequate. Others may lose a substantial
quantity of urine at a high flow rate and need a product which can rapidly absorb and distribute the urine
and retain it, under a variety of circumstances. Similar considerations apply to leakage of faeces, with the
added variable of the consistency of the faeces. The gender of the user may also be an important factor; some
products are designed specifically for men or for women.
The proximity and accessibility of toilet facilities can also influence the need for absorbent incontinence
products. Where only slight, or even no, clinical incontinence exists, products may still be required if toilet
facilities cannot be reached (easily and quickly enough) because of mobility, cognitive status or accessibility
problems.
4.2.5 End user characteristics
It is important to consider the particular characteristics and activities of individual end users in selecting
the product(s) most appropriate to their needs.
Some products work with just male anatomy or just female while some are suitable for either. Body shape
or size (e.g. height, body mass index, waist and thigh measurements) may influence the comfort and
effectiveness of a product. As morphology of users can range from very low weight to extremely obese
individuals, i
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