SIST EN ISO 15621:2026

SLOVENSKI STANDARD
01-maj-2026
Nadomešča:
SIST EN ISO 15621:2017
Absorbenti za urin, blato in/ali oboje v izdelkih za inkontinenco - Splošne smernice
za ovrednotenje (ISO 15621:2026)
Absorbent incontinence products for urine, faeces, or both - General guidelines on
evaluation (ISO 15621:2026)
Saugfähige Inkontinenzhilfen für Urin und /oder Stuhl - Allgemeine Richtlinien für die
Evaluierung (ISO 15621:2026)
Produits d'incontinence pour l'absorption d’urine et/ou de matières fécales - Directives
générales d'évaluation (ISO 15621:2026)
Ta slovenski standard je istoveten z: EN ISO 15621:2026
ICS:
11.180.20 Pripomočki pri stomi in Aids for incontinence and
inkontinenci ostomy
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 15621
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2026
EUROPÄISCHE NORM
ICS 11.180.20 Supersedes EN ISO 15621:2017
English Version
Absorbent incontinence products for urine, faeces, or both
- General guidelines on evaluation (ISO 15621:2026)
Produits d'incontinence absorbants pour l'urine, les Saugfähige Inkontinenzprodukte für Urin und/oder
matières fécales ou les deux - Lignes directrices Stuhl - Allgemeine Richtlinien für die Evaluierung (ISO
générales pour l'évaluation (ISO 15621:2026) 15621:2026)
This European Standard was approved by CEN on 13 January 2026.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15621:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 15621:2026) has been prepared by Technical Committee ISO/TC 173 "Assistive
products" in collaboration with Technical Committee CEN/TC 293 “Assistive products and accessibility”
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 September 2026, and conflicting national standards
shall be withdrawn at the latest by September 2026.
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.
This document supersedes EN ISO 15621:2017.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 15621:2026 has been approved by CEN as EN ISO 15621:2026 without any modification.

International
Standard
ISO 15621
Fourth edition
Absorbent incontinence products
2026-02
for urine, faeces, or both — General
guidelines on evaluation
Produits d'incontinence absorbants pour l'urine, les matières
fécales ou les deux — Lignes directrices générales pour
l'évaluation
Reference number
ISO 15621:2026(en) © ISO 2026
ISO 15621:2026(en)
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 15621:2026(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Evaluation requirements . 2
4.1 General .2
4.2 User-related factors.2
4.2.1 General .2
4.2.2 Quality of life . .2
4.2.3 Independence or assistance .2
4.2.4 Nature of incontinence .3
4.2.5 End user characteristics .3
4.2.6 Activities .4
4.2.7 Individual needs .4
4.2.8 Product handling .4
4.3 Product-related factors .4
4.3.1 General .4
4.3.2 Freedom from leakage .5
4.3.3 Freedom from odour leakage . .5
4.3.4 Skin health .5
4.3.5 Comfort and fit .6
4.3.6 Discretion .6
4.4 Usage-related factors .6
4.4.1 Ergonomics .6
4.4.2 Needs of caregiver .7
4.4.3 Information supplied .7
4.4.4 Laundry facilities .7
4.4.5 Disposal facilities .7
4.4.6 Sustainability and environment .7
4.4.7 Product safety .8
4.4.8 Total cost .8
4.5 Evaluation methods .8
4.5.1 General .8
4.5.2 Testing in the laboratory .9
4.5.3 Testing in user trials .9
4.5.4 Combined approach .9
4.5.5 Interpretation of test results .9
4.5.6 Sample size .10
Bibliography .11

iii
ISO 15621:2026(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 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, in collaboration with the European Committee for Standardization (CEN)
Technical Committee CEN/TC 293, Assistive products and accessibility, in accordance with the Agreement on
technical cooperation between ISO and CEN (Vienna Agreement).
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 Bibliography.
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
ISO 15621:2026(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
incontinence or faecal incontinence, or both, 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. pads, all-in-ones, pull-ons) and their characteristics (e.g. design to secure
leakage security and maintaining skin health);
— cost;
— environmental impact.
Currently, there is a limited amount of published data on these factors. This document 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 and interpretation of test results.
There are a number of stakeholders who can 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 and for them. Practical, in-use suitability is best determined by testing products with the
individual end user.
Other standards that can be useful for evaluating absorbent incontinence products and performing user
trials include
— ISO 6658,
— ISO 9999,
— ISO 11948-1,
— ISO 16021, and
— ISO 22748.
v
International Standard ISO 15621:2026(en)
Absorbent incontinence products for urine, faeces, or both —
General guidelines on evaluation
1 Scope
This document is applicable for evaluating absorbent incontinence products for urine, faeces, or both for
adults and children. It provides a context for the procedures described in other International Standards and
for published testing procedures. General factors relating to incontinence products and their usage are also
addressed.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 22748, Absorbent incontinence products for urine and/or faeces — Product type names and illustrations
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
absorbent incontinence product
product containing absorbent material to contain urine, faeces, or both when the wearer experiences
incontinence
3.2
absorption capacity
amount of liquid that can be absorbed by an absorbent incontinence product (3.1) under specified conditions
3.3
acquisition speed
time taken for a specified amount of liquid to be absorbed into an absorbent incontinence product (3.1) under
specified conditions
3.4
end user
person who wears an absorbent incontinence product (3.1)
3.5
caregiver
person who assists users with applying and changing incontinence products
Note 1 to entry: Caregivers can be paid staff or family/friends.

ISO 15621:2026(en)
3.6
absorbent product with sensors
absorbent incontinence product (3.1) including sensors used to monitor the saturation of the product to
indicate when it might need changing, assist with care planning, or both
3.7
retention capacity
amount of liquid that is retained by an absorbent incontinence product (3.1) after all unbound liquid has been
removed under specified conditions
3.8
rewet
amount of liquid that escapes from an absorbent incontinence product (3.1) when it is exposed to external
forces or pressure under specified conditions
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. 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).
Users of this document shall refer to ISO 22748 for terms, pictures and examples of the product types
discussed in this document.
NOTE 1 Preferred term can vary in different context and countries.
NOTE 2 It can be helpful to prepare for an evaluation by consulting the international classification ISO 9999:2022,
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.
4.2.2 to 4.2.8 list key assessment factors related to the end user as discussed in Reference [9]. 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
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

ISO 15621:2026(en)
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
need assistance.
The ease of putting absorbent incontinence products on and taking them off should be considered, especially
[8]
for users with one or more of the following: reduced mobility, reduced dexterity, cognitive impairment,
reliance on caregivers.
If end users can change products themselves, they will be more independent, preserving their dignity, as well
as reducing care costs. Product types which end users can apply and remove themselves, should be favoured,
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, faeces or both leaked will be important factors in
selecting appropriate products. A frequency volume chart (FVC) or a bladder diary covering at least 24 h
[9]
and a “pad test” (leakage test) can 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 or to assist with care planning, or
both.
Some people lose only small quantities of urine on infrequent occasions, in which case an absorbent
incontinence product with more limited absorption capacity can be adequate. Others can 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 can 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 can 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
The particular characteristics and activities of individual end users should be considered in selecting
products most appropriate to their needs.
Some products work with only male anatomy or only female anatomy, while some are suitable for either.
Body shape or size (e.g. height, body mass index, waist and thigh measurements) can influence the comfort
and effectiveness of a product. As morphology of users can range from very low weight to extremely obese
individuals, Product
...