EN ISO 16021:2024

SLOVENSKI STANDARD
01-junij-2024
Absorpcijski izdelki za inkontinenco urina in/ali blata - Osnovna načela
vrednotenja izdelkov za odrasle za enkratno uporabo z vidika uporabnikov in
negovalcev (ISO 16021:2024)
Absorbent incontinence products for urine and/or faeces - Basic principles for evaluation
of single-use adult products from the perspective of users and caregivers (ISO
16021:2024)
Urinaufsaugende Hilfsmittel - Grundprinzipien für die Bewertung von Einmalgebrauchs-
Hilfsmitteln für inkontinente Erwachsene aus der Sicht von Anwendern und Pflegekräften
(ISO 16021:2024)
Produits d'incontinence pour l'absorption d'urine et/ou de matières fécales - Principes de
base pour l'évaluation des produits à usage unique pour adultes par les utilisateurs et les
soignants (ISO 16021:2024)
Ta slovenski standard je istoveten z: EN ISO 16021:2024
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 16021
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2024
EUROPÄISCHE NORM
ICS 11.180.20 Supersedes EN ISO 16021:2000
English Version
Absorbent incontinence products for urine and/or faeces -
Basic principles for evaluation of single-use adult products
from the perspective of users and caregivers (ISO
16021:2024)
Produits d'incontinence pour l'absorption d'urine Urinaufsaugende Hilfsmittel - Grundprinzipien für die
et/ou de matières fécales - Principes de base pour Bewertung von Einmalgebrauchs-Hilfsmitteln für
l'évaluation des produits à usage unique pour adultes inkontinente Erwachsene aus der Sicht von
par les utilisateurs et les soignants (ISO 16021:2024) Anwendern und Pflegekräften (ISO 16021:2024)
This European Standard was approved by CEN on 25 August 2023.

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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16021:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 16021:2024) 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 October 2024, and conflicting national standards shall
be withdrawn at the latest by October 2024.
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 16021:2000.
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 16021:2024 has been approved by CEN as EN ISO 16021:2024 without any modification.

International
Standard
ISO 16021
Second edition
Absorbent incontinence products
2024-03
for urine and/or faeces — Basic
principles for evaluation of single-
use adult products from the
perspective of users and caregivers
Reference number
ISO 16021:2024(en) © ISO 2024
ISO 16021:2024(en)
© ISO 2024
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 16021:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Creating the evaluation protocol . 2
4.1 Questionnaires .2
4.2 Selection of products.2
4.3 Selection of users .2
4.4 Sample size .3
4.5 E valuation period .3
4.6 Product evaluation strategy .3
5 Data-gathering tools . 3
5.1 Data requirements .3
5.2 Demographic data .4
5.3 Product evaluation data .4
5.3.1 Product evaluation questionnaire .4
5.3.2 Product diary .5
5.4 Product description data .5
5.5 Other documentation.5
6 User trial procedure . . 5
6.1 Pilot studies .5
6.2 Preparations .5
7 Data collection . . 6
7.1 Demographic data .6
7.2 Product performance data .6
7.2.1 Product evaluation questionnaire .6
7.2.2 Product change diary .6
7.3 User withdrawal . .6
7.4 Product description data .7
7.5 Other documentation.7
8 E v a lu at ion r ep or t . 7
Bibliography .11

iii
ISO 16021:2024(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 document 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 second edition cancels and replaces the first edition (ISO 16021:2000), which has been technically
revised.
The main changes are as follows:
— clarified the scope;
— added references to new relevant standards;
— updated reference list;
— terminology has been harmonized with ISO 22748.
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 16021:2024(en)
Introduction
This document provides basic principles for conducting user evaluations of single-use, body-worn urine-
absorbing products for adult incontinent users, their caregivers, or both. It gives guidance for users or
caregivers in evaluating products in actual use and can be used for comparing products. EDANA has provided
[4]
useful guidelines on the evaluation of baby diapers many of which apply equally to absorbent products for
adult incontinence. Whether a user evaluation or a clinical investigation is planned, it is important to check
if ethics committee approval will be required.
The comparison of user evaluation data obtained from evaluating several products is statistically complex
and highly dependent upon the information desired from the evaluation, the differences between or among
products, and the size of the user population used in the evaluation, to mention only three important factors.
Direct comparison between products based on statistical parameters is not covered by this document.
This document is based upon an extensive body of data and experimentation on the ways in which evaluation
of incontinence products by users can be done to gain useful information on the acceptability of products for
a variety of purposes. Selected references are given in the Bibliography as an aid to the user of this document
in applying it to particular situations of interest.

v
International Standard ISO 16021:2024(en)
Absorbent incontinence products for urine and/or faeces —
Basic principles for evaluation of single-use adult products
from the perspective of users and caregivers
1 Scope
This document provides guidelines and requirements for designing and conducting an evaluation of single-
use adult incontinence absorbing products. It provides guidelines and requirements on creating data
collection tools. In particular, it provides a framework for eliciting and recording the views of users and
their carers on the acceptability of products. In addition, a product diary is described which can help to
quantify some parameters of product use, such as wear times, the mass of urine absorbed by the product
and the severity of any leakage from it.
This document does not cover direct comparison between products based on statistical parameters, neither
does it provide guidelines on measuring the clinical efficacy of products; that is available in ISO 14155.
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
caregiver
person who assists user(s) with applying and changing absorbent incontinence products (3.5)
Note 1 to entry: Caregivers can be paid staff or family/friends.
3.2
ethics committee
body whose role is to protect the interests of evaluation subjects ‒ particularly in institutions ‒ by inspecting
proposed evaluation protocols
Note 1 to entry: Ethics committee permission is normally required before an evaluation can begin.
3.3
evaluation centre coordinator
person in charge of the evaluation in a given centre
3.4
principal investigator
person in overall charge of an evaluation

ISO 16021:2024(en)
3.5
product
body-worn absorbent product intended to aid incontinent persons
Note 1 to entry: Further information regarding products and product types is given in ISO 22748.
3.6
product type
group of similar products (3.5) provided by a manufacturer or supplier which have similar construction, but
which differ from one another in such details as size or absorbency level
3.7
user
person who wears the product(s) (3.5) subject to evaluation
4 Creating the evaluation protocol
4.1 Questionnaires
This evaluation employs a series of questionnaires designed to collect users'/caregivers' observations and
opinions on aspects of the acceptability of a product, or several products, over an agreed period of time.
Further questionnaires are used to ascertain the age and health of the user, the severity of their incontinence
and other relevant background information.
The information entered on the questionnaires is processed for each user and each product tested at the end
of the evaluation period and is used to produce a report on the acceptability of each product in terms of the
level of satisfaction of the users.
This document does not provide a standard protocol, since objectives for running evaluations, user
populations, evaluation sites, products, and specific data of interest vary widely. Instead,
...