SIST EN 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 (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)
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.
Urinaufsaugende Hilfsmittel - Grundprinzipien für die Bewertung von Einmalgebrauchs-Hilfsmitteln für inkontinente Erwachsene aus der Sicht von Anwendern und Pflegekräften (ISO 16021:2024)
Dieses Dokument gibt Anleitungen und Anforderungen für die Gestaltung und Durchführung einer Bewertung von aufsaugenden Einmalgebrauchs-Hilfsmitteln für inkontinente Erwachsene. Es enthält Anleitungen und Anforderungen zur Erstellung von Methoden und Hilfsmitteln zur Datensammlung. Insbesondere bietet es einen Rahmen für die Erhebung und Aufzeichnung der Ansichten von anwendenden Personen und deren Pflegekräften über die Akzeptanz von Produkten. Darüber hinaus wird ein Produkttagebuch beschrieben, mit dessen Hilfe einige Parameter des Produktgebrauchs quantifiziert werden können, z. B. die Tragedauer, die vom Produkt aufgesaugte Urinmenge und das Ausmaß dessen Auslaufens.
Dieses Dokument umfasst nicht den direkten Vergleich von Produkten auf der Grundlage statistischer Parameter und bietet auch keine Anleitung zur Messung der klinischen Wirksamkeit von Produkten; diese ist in ISO 14155 enthalten.
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)
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.
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)
Ta dokument podaja smernice in zahteve za načrtovanje in izvedbo vrednotenja absorbcijskih izdelkov za inkontinenco za enkratno uporabo pri odraslih osebah. Zagotavlja smernice in zahteve v zvezi z ustvarjanjem orodij za zbiranje podatkov. Zlasti zagotavlja okvir za pridobivanje in beleženje mnenj uporabnikov ter njihovih negovalcev o sprejemljivosti izdelkov. Opisuje tudi dnevnik izdelka, ki je lahko v pomoč pri določanju nekaterih parametrov uporabe izdelka, kot so čas obrabe, masa urina, ki ga absorbira izdelek, in stopnja morebitnega prepuščanja.
Ta dokument ne zajema neposredne primerjave izdelkov na podlagi statističnih parametrov, niti ne zagotavlja smernic za merjenje klinične učinkovitosti izdelkov; te smernice so na voljo v standardu ISO 14155.
General Information
Relations
Standards Content (Sample)
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
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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
...
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