oSIST prEN ISO 16021:2023
(Main)Urine-absorbing products - Basic principles for evaluation of single-use adult-incontinence products from the perspective of users and caregivers (ISO/DIS 16021:2023)
Urine-absorbing products - Basic principles for evaluation of single-use adult-incontinence products from the perspective of users and caregivers (ISO/DIS 16021:2023)
Urinaufsaugende Hilfsmittel - Grundprinzipien für die Bewertung von Einmalgebrauchs-Hilfsmitteln für inkontinente Erwachsene aus der Sicht von Anwendern und Pflegekräften (ISO/DIS 16021:2023)
Produits pour l'absorption d'urine - Principes de base pour l’évaluation des produits d'incontinence adulte à usage unique par les utilisateurs et les soignants (ISO/DIS 16021:2023)
La présente Norme internationale donne des lignes directrices utiles pour la conception et la conduite d'une évaluation des aides pour absorption pour incontinence pour adultes à usage unique. Elle donne des lignes directrices pour la création d'outils de collecte des données. Elle propose notamment un cadre permettant de sélectionner et d'enregistrer les opinions que les utilisateurs et le personnel soignant peuvent émettre quant aux performances du produit. En outre, elle décrit une approche facultative permettant d'établir les caractéristiques d'étanchéité, la durée d'utilisation des produits et la masse d'urine supportée. La présente Norme internationale ne traite pas de la comparaison directe de plusieurs produits à partir des paramètres statistiques.
Izdelki za absorpcijo urina - Temeljna načela za ovrednotenje izdelkov za enkratno uporabo za odrasle, ki ne morejo zadrževati blata ali urina, z vidika uporabnikov in negovalcev (ISO/DIS 16021:2023)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 16021:2023
01-julij-2023
Izdelki za absorpcijo urina - Temeljna načela za ovrednotenje izdelkov za enkratno
uporabo za odrasle, ki ne morejo zadrževati blata ali urina, z vidika uporabnikov in
negovalcev (ISO/DIS 16021:2023)
Urine-absorbing products - Basic principles for evaluation of single-use adult-
incontinence products from the perspective of users and caregivers (ISO/DIS
16021:2023)
Urinaufsaugende Hilfsmittel - Grundprinzipien für die Bewertung von Einmalgebrauchs-
Hilfsmitteln für inkontinente Erwachsene aus der Sicht von Anwendern und Pflegekräften
(ISO/DIS 16021:2023)
Produits pour l'absorption d'urine - Principes de base pour l’évaluation des produits
d'incontinence adulte à usage unique par les utilisateurs et les soignants (ISO/DIS
16021:2023)
Ta slovenski standard je istoveten z: prEN ISO 16021
ICS:
11.180.20 Pripomočki pri stomi in Aids for incontinence and
inkontinenci ostomy
oSIST prEN ISO 16021:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 16021:2023
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oSIST prEN ISO 16021:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 16021
ISO/TC 173/SC 3 Secretariat: SIS
Voting begins on: Voting terminates on:
2023-05-01 2023-07-24
Urine-absorbing products — Basic principles for
evaluation of single-use adult-incontinence products from
the perspective of users and caregivers
ICS: 11.180.20
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
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oSIST prEN ISO 16021:2023
ISO/DIS 16021:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 16021
ISO/TC 173/SC 3 Secretariat: SIS
Voting begins on: Voting terminates on:
Urine-absorbing products — Basic principles for
evaluation of single-use adult-incontinence products from
the perspective of users and caregivers
ICS: 11.180.20
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
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© ISO 2023
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NATIONAL REGULATIONS.
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© ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
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oSIST prEN ISO 16021:2023
ISO/DIS 16021:2023(E)
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 Evaluation 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 . 4
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 Evaluation report . 7
Bibliography .10
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oSIST prEN ISO 16021:2023
ISO/DIS 16021:2023(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 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 second edition cancels and replaces the first edition (ISO 16021:2000), which has been technically
revised.
The main changes are as follows:
— Clarified that the recommendation in the standard is related to guidance for users and caregivers
evaluating products and not for producers evaluating performance which require a clinical
investigation
— Adding connection to new relevant standards
— Updated reference list
— Terminology has been harmonised with ISO 16021 to be consistent with ISO 22748 (new since
ISO 16021 was first written). For example, we replaced "pad" with "absorbent product" since - in
ISO 16021 - "pad" refers to a specific type of absorbent product.
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.
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oSIST prEN ISO 16021:2023
ISO/DIS 16021:2023(E)
Introduction
This document provides basic principles for conducting user evaluations of single-use, body-worn
urine-absorbing products 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.
The focus of this document is on the basic principles which should be considered in evaluating products
to determine their acceptability in actual use.). EDANA has provided useful guidelines on the evaluation
of baby diapers (Guidelines for the Testing of Baby Diapers, EDANA, Brussels, 2016) many of which
apply equally to absorbent products for adult incontinence. Whether a user evaluation or a clinical
investigation is planned, it is vital to check if ethics committee approval will be required.
The comparison of user evaluation data obtained in 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.
It is essential that those wishing to make statistically robust comparisons between different products
consult a statistician for advice on, for example, the number of evaluation subjects they should recruit
and randomizing the order of evaluating different products.
This document is based upon an extensive body of data and experimentation on the ways in which
evaluation of incontinence products by users may 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 International Standard in applying it to particular situations of interest.
ISO 16021 should be read in conjunction with the following related International Standards for Urine-
absorbing aids:
— ISO 22748:2021 Absorbent incontinence products for urine and/or faeces — Product type names
and illustrations
— ISO 15621, Absorbent incontinence aids for urine and/or faeces — General guidelines on evaluation
— ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice
— EDANA Guidelines for the Testing of Baby Diapers Version 2.0 – April 2016
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oSIST prEN ISO 16021:2023
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oSIST prEN ISO 16021:2023
DRAFT INTERNATIONAL STANDARD ISO/DIS 16021:2023(E)
Urine-absorbing products — Basic principles for
evaluation of single-use adult-incontinence products from
the perspective of users and caregivers
1 Scope
This document provides guidelines for designing and conducting an evaluation of single-use adult
incontinence absorbing products. It provides guidance 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 guidance on measuring the clinical efficacy of products: that is available in
ISO 14155 Clinical investigation of medical devices for human subjects – Good clinical practice.
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 incontinence products
Note 1 to entry: Caregivers may 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
1
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oSIST prEN ISO 16021:2023
ISO/DIS 16021:2023(E)
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 variant
group of similar products provided by a manufacturer/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) 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 8).
NOTE Some lists of issues to 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 (3.5) or product variants (3.6) to be evaluated should be selected. Consideration should be
given to obtaining samples from multiple production batches in order to randomize the selection and
reduce the impact of atypical results emanating from, say, a faulty batch.
4.3 Selection of users
A group of users appropriate to the product to be e
...
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