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)
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)
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.
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)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 16021:2024
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
SIST EN ISO 16021:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 16021:2024
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SIST EN ISO 16021:2024
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.
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SIST EN ISO 16021:2024
EN ISO 16021:2024 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 16021:2024
EN ISO 16021:2024 (E)
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 Stan
...
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
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THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
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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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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 .
...
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