ISO 16021:2024
(Main)Absorbent incontinence products for urine and/or faeces — Basic principles for evaluation of single-use adult products from the perspective of users and caregivers
Absorbent incontinence products for urine and/or faeces — Basic principles for evaluation of single-use adult products from the perspective of users and caregivers
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.
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
Le présent document donne des lignes directrices et des exigences relatives à la conception et la conduite d’une évaluation des produits absorbants à usage unique pour l’incontinence des adultes. Il donne des lignes directrices et des exigences sur la création d’outils de collecte des données. Il propose notamment un cadre permettant de sélectionner et d’enregistrer les opinions que les utilisateurs et les soignants peuvent émettre quant à l’acceptabilité des produits. De plus, un journal du produit est décrit. Il permet de quantifier les paramètres d’utilisation du produit, notamment la durée d’utilisation, la masse d’urine absorbée par le produit et la gravité des éventuelles fuites. Le présent document ne couvre pas la comparaison directe entre les produits d’après des paramètres statistiques. Il ne fournit pas non plus de lignes directrices sur la mesure de l’efficacité clinique des produits. Celles-ci sont disponibles dans l’ISO 14155.
General Information
Relations
Standards Content (Sample)
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 2024
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Published in Switzerland
ii
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
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
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
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, it lists the primary
issues which should be considered in creating a protocol, along with guidelines on how to address them.
A record of the decisions made on these issues should be included in the evaluation report (see Clause 8).
NOTE Lists of issues that can be considered in writing questionnaires and other documentation are provided,
but users of this document are cautioned against using any of them exactly as found here without first verifying their
usefulness for the intended study.
4.2 Selection of products
The products or product types to be evaluated should be selected. Samples should be obtained from multiple
production batches in order to randomize the selection and reduce the impact of atypical results emanating
from e.g. a faulty batch.
4.3 Selection of users
A group of users appropriate to the product to be evaluated should be selected in accordance with the
manufacturers' intended use, as described in their technical documentation.
The severity of users’ incontinence should be matched to the absorbency of the product(s) as declared by the
manufacturer.
NOTE 1 In order to make a good match between users and products it can be useful to establish the absorption
requirements of potential evaluators by weighing their used products over a period of several days. It will usually be
possible to estimate the product absorption capacity an evaluator needs by weighing 10 or more of each user’s used
products.
Sample populations should be of distinct end-user groups. Users should be chosen from either institutions or
home settings, but not both in the same evaluation since practices, requirements and priorities often differ.
It is recommended to select either users who manage their own incontinence or those who rely on the help
of a caregiver(s), but not a mix in the same evaluation.
NOTE 2 Users in their own homes can manage their incontinence independently or rely on help from caregivers.
Clear inclusion and exclusion criteria for recruiting users or caregivers should be written. Such criteria can
include the age and sex of users and levels of mobility, mental acuity and severity of incontinence.
The user selection criteria should be well-defined and strictly adhered to while recruiting.
NOTE 3 Narrow inclusion criteria ensure homogeneous test populations leading to simpler data analysis but they
make recruitment of suitable evaluators (testers) more difficult.
4.4 Sample size
The number of users contributing to the study should be decided after taking into consideration the end-use
of the data and the time and resources available.
NOTE Large numbers will provide more reliable data, but a large study consumes more resources.
Those wishing to make statistically robust comparisons between different products should con
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