EN ISO 15621:2017

Absorbent incontinence aids for urine and/or faeces - General guidelines on evaluation (ISO 15621:2017)

ISO 15621:2017 gives guidelines for evaluating absorbent incontinence aids for urine and/or faeces. It provides a context for the procedures described in other International Standards and published testing procedures. General factors relating to incontinence products and their usage are also addressed.

Saugfähige Inkontinenzhilfen für Urin und /oder Stuhl - Allgemeine Richtlinien für die Evaluierung (ISO 15621:2017)

Dieses Dokument enthält Leitfäden für die Bewertung saugfähiger Inkontinenzhilfsmittel für Urin und/oder Stuhl. Es bietet einen Kontext für Verfahren, die in anderen Internationalen Normen und veröffentlichten Prüfverfahren beschrieben sind. Ebenso werden allgemeine Faktoren bezüglich von Inkontinenz¬produkten und ihrer Verwendung angesprochen.

Aides à l'incontinence pour l'absorption d'urine et/ou de matières fécales - Directives générales d'évaluation (ISO 15621:2017)

L'ISO 15621:2017 fournit des lignes directrices pour évaluer les aides à l'incontinence pour l'absorption d'urine et/ou de matières fécales. Elle fournit un contexte pour les modes opératoires décrits dans d'autres Normes internationales et modes opératoires d'essais publiés. Les facteurs généraux concernant les produits pour incontinence et leur usage sont également examinés.

Absorbenti za urin in/ali blato v pripomočkih za inkontinenco - Splošne smernice za ovrednotenje (ISO 15621:2017)

Ta mednarodni standard podaja smernice za ovrednotenje lastnosti pripomočkov za absorbiranje urina in blata. Standard podaja kontekst za postopke, opisane v drugih mednarodnih standardih, in objavljene preskusne postopke. Obravnavani so tudi splošni dejavniki, ki vplivajo na pripomočke za inkontinenco in njihovo uporabo.

General Information

• Status: Published
• Publication Date: 11-Jul-2017
• Withdrawal Date: 30-Jan-2018
• ICS: 11.180.20 - Aids for incontinence and ostomy
• Technical Committee: CEN/TC 293 - Technical aids for disabled persons
• Drafting Committee: CEN/TC 293 - Technical aids for disabled persons
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 12-Jul-2017
• Completion Date: 12-Jul-2017
• Ref Project: SIST EN ISO 15621:2017 - Absorbent incontinence aids for urine and/or faeces - General guidelines on evaluation (ISO 15621:2017)

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2017
1DGRPHãþD
SIST ISO 15621:2016
$EVRUEHQWL]DXULQLQDOLEODWRYSULSRPRþNLK]DLQNRQWLQHQFR6SORãQHVPHUQLFH
]DRYUHGQRWHQMH,62
Absorbent incontinence aids for urine and/or faeces - General guidelines on evaluation
(ISO 15621:2017)
Hilfen zur Urinabsorption - Allgemeine Richtlinien für die Evaluierung (ISO 15621:2017)
Aides pour l'absorption d'urine - Directives générales d'évaluation (ISO 15621:2017)
Ta slovenski standard je istoveten z: EN ISO 15621:2017
ICS:
11.180.20 3ULSRPRþNLSULVWRPLLQ Aids for incontinence and
LQNRQWLQHQFL ostomy
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 15621
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2017
EUROPÄISCHE NORM
ICS 11.180.20
English Version
Absorbent incontinence aids for urine and/or faeces -
General guidelines on evaluation (ISO 15621:2017)
Aides à l'incontinence pour l'absorption d'urine et/ou Hilfen zur Urinabsorption - Allgemeine Richtlinien für
de matières fécales - Directives générales d'évaluation die Evaluierung (ISO 15621:2017)
(ISO 15621:2017)
This European Standard was approved by CEN on 28 May 2017.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15621:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 15621:2017) has been prepared by Technical Committee ISO/TC 173 “Assistive
products for persons with disability” in collaboration with Technical Committee CEN/TC 293 “Assistive
products for persons with disability” 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 January 2018, and conflicting national standards shall
be withdrawn at the latest by January 2018.
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.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 15621:2017 has been approved by CEN as EN ISO 15621:2017 without any modification.
INTERNATIONAL ISO
STANDARD 15621
Third edition
2017-06
Absorbent incontinence aids for urine
and/or faeces — General guidelines
on evaluation
Aides à l’incontinence pour l’absorption d’urine et/ou de matières
fécales — Directives générales d’évaluation
Reference number
ISO 15621:2017(E)
©
ISO 2017
ISO 15621:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
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[e-mail]
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ii © ISO 2017 – All rights reserved

ISO 15621:2017(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Evaluation requirements . 4
4.1 General . 4
4.2 User-related factors . 4
4.2.1 General. 4
4.2.2 Quality of life . 4
4.2.3 Independence or assistance . 4
4.2.4 Nature of incontinence . 4
4.2.5 End user characteristics . 5
4.2.6 Activities. 5
4.2.7 Individual needs . 5
4.2.8 Handling products . 6
4.3 Product-related factors . 6
4.3.1 General. 6
4.3.2 Freedom from leakage . 6
4.3.3 Freedom from odour leakage . 6
4.3.4 Skin health . 7
4.3.5 Comfort and fit . 7
4.3.6 Discretion . 7
4.4 Usage-related factors . 8
4.4.1 Ergonomics . 8
4.4.2 Needs of carer . . 8
4.4.3 Information supplied . 8
4.4.4 Laundry facilities . 8
4.4.5 Disposal facilities . 8
4.4.6 Sustainability and environment . 8
4.4.7 Product safety . . 9
4.4.8 Cost . 9
4.5 Evaluation methods . 9
4.5.1 General. 9
4.5.2 Testing in the laboratory . 9
4.5.3 Testing in user trials .10
4.5.4 Combined approach .10
4.5.5 Interpretation of test results .10
4.5.6 Sample size .11
Bibliography .12
ISO 15621:2017(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
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