SIST EN ISO 16021:2001

Urine-absorbing aids - Basic principles for evaluation of single-use adult-incontinence-absorbing aids from the perspective of users and caregivers (ISO 16021:2000)

To provide guidelines for designing and conducting a user evaluation of single-use incontinence absorbing aids.

Urinaufsaugende Hilfsmittel - Grundprinzipien für die Bewertung von Einmalgebrauchs-Hilfsmitteln für inkontinente Erwachsene aus der Sicht von Anwendern und Pflegekräften (ISO/FDIS 16021:2000)

Diese Internationale Norm gibt Leitlinien zur Erarbeitung und Durchführung einer Bewertung urinaufsaugender Einmalgebrauchs-Hilfsmittel für inkontinente Erwachsene durch die Anwender. Sie bietet eine Anleitung für die Schaffung von Mitteln zur Datenerfassung. Im
Besonderen liefert sie ein Rahmenprogramm für die Befragung und Dokumentation der Ansichten von Anwendern und ihren Pflegekräften über die Leistung des Produkts. Zusätzlich werden ein wahlweises Verfahren für die Feststellung der Leistung gegen
Flüssigkeitsdurchtritt, der Tragezeiten der Produkte und der von ihnen aufgenommenen Urinmasse beschrieben. Ein direkter Vergleich zwischen Produkten auf der Grundlage statistischer Parameter ist nicht Bestandteil dieser Internationalen Norm.

Aides pour absorption d'urine - Principes de base pour l'évaluation des aides pour incontinents adultes par les utilisateurs et le personnel soignant (ISO/FDIS 16021:2000)

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.

Pripomočki za absorpcijo urina - Temeljna načela za ovrednotenje absorpcijskih pripomočkov za enkratno uporabo za odrasle, ki ne morejo zadrževati blata ali vode, z vidika uporabnikov in negovalcev

General Information

• Status: Withdrawn
• Publication Date: 31-Oct-2001
• Withdrawal Date: 10-Apr-2024
• ICS: 11.180.20 - Aids for incontinence and ostomy
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 09-Apr-2024
• Due Date: 02-May-2024
• Completion Date: 11-Apr-2024
• Ref Project: EN ISO 16021:2000 - Urine-absorbing aids - Basic principles for evaluation of single-use adult-incontinence-absorbing aids from the perspective of users and caregivers (ISO 16021:2000)

Relations

• Revised: SIST EN 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)
• Effective Date: 30-Mar-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2001
3ULSRPRþNL]DDEVRUSFLMRXULQD7HPHOMQDQDþHOD]DRYUHGQRWHQMHDEVRUSFLMVNLK
SULSRPRþNRY]DHQNUDWQRXSRUDER]DRGUDVOHNLQHPRUHMR]DGUåHYDWLEODWDDOL
YRGH]YLGLNDXSRUDEQLNRYLQQHJRYDOFHY
Urine-absorbing aids - Basic principles for evaluation of single-use adult-incontinence-
absorbing aids from the perspective of users and caregivers (ISO 16021:2000)
Urinaufsaugende Hilfsmittel - Grundprinzipien für die Bewertung von Einmalgebrauchs-
Hilfsmitteln für inkontinente Erwachsene aus der Sicht von Anwendern und Pflegekräften
(ISO/FDIS 16021:2000)
Aides pour absorption d'urine - Principes de base pour l'évaluation des aides pour
incontinents adultes par les utilisateurs et le personnel soignant (ISO/FDIS 16021:2000)
Ta slovenski standard je istoveten z: EN ISO 16021:2000
ICS:
11.180.20 9UHþNH]DEODWRLQXULQVNH Aids for ostomy and
YUHþNH incontinence
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

INTERNATIONAL ISO
STANDARD 16021
First edition
2000-11-01
Urine-absorbing aids — Basic principles for
evaluation of single-use adult-incontinence-
absorbing aids from the perspective of
users and caregivers
Aides pour absorption d'urine — Principes de base pour l'évaluation des
aides pour incontinents adultes par les utilisateurs et le personnel soignant
Reference number
ISO 16021:2000(E)
©
ISO 2000
ISO 16021:2000(E)
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ii © ISO 2000 – All rights reserved

ISO 16021:2000(E)
Contents Page
Foreword.iv
Introduction.v
1 Scope .1
2 Terms and definitions .1
3 Creating the evaluation protocol.2
4 Data-gathering tools.3
5 User trial procedure.5
6 Data collection .6
7 Evaluation report .7
Bibliography.11
ISO 16021:2000(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 16021 was prepared by Technical Committee ISO/TC 173, Technical systems and aids
for disabled or handicapped persons, Subcommittee SC 3, Aids for ostomy and incontinence.
iv © ISO 2000 – All rights reserved

ISO 16021:2000(E)
Introduction
This International Standard provides basic principles for conducting user evaluation of single-use, body-worn urine-
absorbing aids by adult incontinent users, their caregivers, or both. It gives guidance in the understanding of
product performance in actual use and hence can be used when making purchasing or reimbursement decisions,
or both, from among a variety of products whose performance characteristics vary.
The focus of this International Standard is on the basic principles, which should be considered for evaluation of a
single product in actual use. Where several products are to be evaluated, the procedure suggested should be
applied to each, although the exact evaluation protocol used might vary, based on the unique characteristics of
each product, the population of users being used for the evaluation, or both.
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 International Standard.
It is essential that those wishing to make statistically robust comparisons between different products consult a
medical statistician for advice on, for example, the number of evaluation subjects they should recruit and
randomizing the order of evaluating different products.
This International Standard draws on a French national standard [Q34-019: Méthoded'essaiauporter pour les
articles d'hygiène infantile, féminine et de l'incontinence (articles à usage unique)] and the protocols for
incontinence product evaluation developed by the Continence Products Evaluation Network at University College
London, England.
This International Standard 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 product performance 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 9949-1, Urine absorbing aids — Vocabulary — Part 1: Conditions of urinary incontinence.
� ISO 9949-2, Urine absorbing aids — Vocabulary — Part 2: Products.
� ISO 9949-3, Urine absorbing aids — Vocabulary — Part 3: Identification of product types.
� ISO 11948-1, Urine-absorbing aids — Part 1: Whole-product testing.
� ISO 11948-2, Urine-absorbing aids — Part 2: Determination of short-time liquid release (leakage) under
conditions of light incontinence and low pressure.
� ISO 15621, Urine-absorbing aids — General guidance on evaluation.
INTERNATIONAL STANDARD ISO 16021:2000(E)
Urine-absorbing aids — Basic principles for evaluation of single-
use adult-incontinence-absorbing aids from the perspective of
users and caregivers
1 Scope
This International Standard provides guidelines for designing and conducting a user evaluation of single-use adult-
incontinence-absorbing aids. 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 product performance. In addition, an
optional approach for establishing the leakage performance and wear times of products and the mass of urine in
them is described.
This International Standard does not cover direct comparison between products based on statistical parameters.
2 Terms and definitions
For the purposes of this International Standard, the following terms and definitions apply (in alphabetical order).
2.1
caregiver
person who assists user(s) with applying and changing incontinence products
NOTE Caregivers may be paid staff or family/friends.
2.2
ethics committee
body whose role is to protect the interests of evaluation subjects — particularly in institutions — by inspecting
proposed evaluation protocols
NOTE Ethics committee permission is normally required before an evaluation can begin.
2.3
evaluation centre coordinator
person in charge of the evaluation in a given centre
2.4
principal investigator
person in overall charge of an evaluation
2.5
product
body-worn absorbent product intended to aid incontinent persons
NOTE Further information regarding products and product types is given in ISO 9949-2 and ISO 9949-3.
2.6
product line
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
ISO 16021:2000(E)
2.7
user
person who wears the product(s) subject to evaluation
3 Creating the evaluation protocol
3.1 Questionnaires
This evaluation employs a series of questionnaires designed to collect users'/caregivers' observations and opinions
on aspects of the performance of an incontinence 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 performance of each product in terms of the level of
satisfaction of the users.
This International Standard 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 7).
NOTE Some lists of issues to be considered in writing questionnaires and other documentation are provided, but users of
this International Standard are cautioned against using any of them exactly as found here without first verifying their usefulness
for the intended study.
3.2 Selection of products
The products (2.5) or product lines (2.6) 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.
3.3 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 sales literature.
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 may be useful to establish the absorption
requirements of potential evaluators by weighing their used pads over a period of several days.
Sample populations should be of distinct end-user groups. Users should be chosen from either institutions or home
settings but not both since practices, requirements and priorities often differ.
NOTE 2 Users in their own homes may manage their incontinence independently or rely on help from caregivers. It is
advisable to select either users who manage their own incontinence or those who rely on the help of a caregiver(s), but not a
mix.
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.
It is essential that the user selection criteria are well-defined and are 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.
2 © ISO 2000 – All rights reserved

ISO 16021:2000(E)
3.4 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 consult a medical
statistician for advice on the number of test subjects, the collection of data and randomizing the order of testing
different products.
3.5 Evaluation period
The time period over which the product will be evaluated should be decided. Sufficient time should be given to
allow users/caregivers to get used to the product and form an opinion on its performance. However, the time should
not be so long that interest wanes, especially if several products are to be evaluated by the same user/caregiver.
NOTE An evaluation period of one or two weeks per product usually works well.
3.6 Product evaluation strategy
If more than one product is to be evaluated by a chosen user group, it is essential that the order of testing the
products varies amongst members.
NOTE This is generally easier in the community than in institutions where it is often impractical for different residents on
the same ward to be using different product lines at the same time. However, test order can be varied between institutions and
wards if more than one is involved.
Where an entire group of products in a product line (e.g. of different absorbency levels or to fit different body sizes)
is being evaluated, the criteria to be employed in deciding which product(s) within a given product line each user
will evaluate should be decided. Where multiple product lines are being evaluated, these criteria should be applied
consistently to all the product lines evaluated.
4 Data-gathering tools
4.1 Data requirements
The following information/documents are included in the data-gathering tools:
� demographic data;
� a product performance questionnaire (an example of the information to be included is given in Table 1);
� a pad change diary;
� product description data;
� a short-form protocol (an example of the information to be included is given in Table 2);
� a user information sheet (an example of the information to be included is given in Table 3);
� consent and assent forms (an example of the information to be included is given in Table 4);
� a pro forma letter to a user's general practitioner (an example of the information to be included is given in
Table 5);
� a user withdrawal form (an example of the information to be included is given Table 6).
ISO 16021:2000(E)
4.2 Demographic data
A demographic data form for recording information appropriate to the user group should be created. The form can
cover such details as: age, sex, mental acuity, mobility, degree and frequency of incontinence, place of res
...