EN ISO 16021:2000
(Main)Urine-absorbing aids - Basic principles for evaluation of single-use adult-incontinence-absorbing aids from the perspective of users and caregivers (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)
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
Relations
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)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not
be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this
file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this
area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters
were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event
that a problem relating to it is found, please inform the Central Secretariat at the address given below.
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic
or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body
in the country of the requester.
ISO copyright office
Case postale 56 � CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.ch
Web www.iso.ch
Printed in Switzerland
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
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.