SIST ISO 15621:2016

INTERNATIONAL ISO
STANDARD 15621
Second edition
2011-02-15
Urine-absorbing aids — General
guidelines on evaluation
Aides pour l'absorption d'urine — Directives générales d'évaluation

Reference number
©
ISO 2011
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.

©  ISO 2011
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.org
Web www.iso.org
Published in Switzerland
ii © ISO 2011 – All rights reserved

Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Terms and definitions .1
3 Requirements.2
3.1 General summary .2
4 User-related factors.3
4.1 General .3
4.2 Quality of life.3
4.3 Independence or assistance .4
4.4 Nature of incontinence.4
4.5 End-user characteristics.4
4.6 Activities.4
4.7 Individual needs .5
4.8 Handling products.5
5 Product-related factors.5
5.1 General .5
5.2 Freedom from leakage .5
5.3 Freedom from odour leakage.5
5.4 Skin health .6
5.5 Comfort and fit.6
5.6 Discretion .7
6 Usage-related factors.7
6.1 Ergonomics.7
6.2 Needs of carer.7
6.3 Information supplied.7
6.4 Laundry facilities.7
6.5 Disposal facilities .7
6.6 Sustainability, environment .8
6.7 Product safety.8
6.8 Cost.8
7 Evaluation methods .8
7.1 General .8
7.2 Testing in user trials .8
7.3 Testing in the laboratory.9
7.4 The combined approach.9
7.5 Interpretation of test results.9
7.6 Sample size .10
Bibliography.11

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 2.
The main task of technical committees is to prepare International Standards. 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 document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 15621 was prepared by Technical Committee ISO/TC 173, Assistive products for persons with disability,
Subcommittee SC 3, Aids for ostomy and incontinence.
This second edition cancels and replaces the first edition (ISO 15621:1999), which has been technically
revised.
iv © ISO 2011 – All rights reserved

Introduction
This International Standard constitutes a general introduction to the methodology of evaluating urine-
absorbing aids of the type used by persons with incontinence. It should be read before undertaking the more
detailed test procedures described in other International Standards. It covers the general area of methodology
and is intended to:
a) describe the needs of the incontinent population;
b) list the most important factors for users and caregivers of absorbent incontinent products;
c) give guidance for how these factors can be evaluated;
d) give an overview of testing methodologies and interpretation of test results.
There are a number of stakeholders who will benefit from using this International Standard: purchasers within
healthcare systems, nursing home managers, prescribers, caregivers, manufacturers, suppliers, sick funds,
insurance companies and end-users. All these stakeholders have different priorities and different needs.
However, it is important to point out that the most important stakeholder is always the end-user. End-users
have different needs depending on gender, age, severity of incontinence, mobility, dexterity, mental health,
lifestyle, and personal priorities.
The basic knowledge from the perspective of needs of the user and clinical experience comes from the 4th
International Consultation on Incontinence (Reference [9]). It is recommended that Reference [9] be studied
thoroughly as it is an international consensus of great importance.
The purpose of evaluating products is to make a choice. An informed choice is preferable taking into account
the best information that is available. A number of factors are important when making choices, e.g. need,
performance, cost, and environmental factors. For many of these factors there is a lack of published data (see
Reference [9]). In Reference [9], there is a request for better tools that can be used in the evaluation of
incontinence products. The purpose of this International Standard is to give guidance on what is available and
what is not.
There are absorbent products of many types. There are different designs, e.g. inserts, all-in-ones, and pull-
ons. There are evidence-based data which can be used for choosing which type of absorbent product best
suits the need of an end-user (Reference [9]).
This International Standard provides guidance on selecting:
⎯ between type of product designs;
⎯ specific products within a type of design.
[8]
First of all there is the possibility of doing user trials. ISO 16021 provides the basic principles for making
such an evaluation. User trials are further discussed in 7.2.
When the product is not evaluated on users, it is recommended that the whole product be evaluated. The
[1]
principal methods available besides user trials are sensory analysis (see ISO 6658 ) and laboratory testing.
In sensory analysis, a panel of trained assessors use their senses to evaluate defined characteristics.
Laboratory testing is discussed further in 7.3.
[4]
The only published and validated laboratory test method so far is ISO 11948-1 , which measures the total
absorption capacity of products for heavy incontinence. Other methods are under development and will be
recommended when available.
INTERNATIONAL STANDARD ISO 15621:2011(E)

Urine-absorbing aids — General guidelines on evaluation
1 Scope
This International Standard gives general guidelines on the methodology of evaluating disposable urine-
absorbing aids, and provides a context for the procedures described in other International Standards or
published testing procedures. These products are also used for faecal incontinence, which is occasionally
mentioned.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
urine-absorbing aid
product containing material for the purpose of absorbing urine
2.2
end-user
person who is wearing an absorbent pad
2.3
caregiver
someone who is responsible for looking after another person
EXAMPLE A caregiver who is responsible for looking after a disabled, ill or very young person.
2.4
carer
individual who looks after another person
2.5
all-in-one
brief
urine-absorbing aid that is an adult-size version of a baby's diaper
NOTE An all-in-one usually has elasticated waist and legs and self-adhesive tabs.
2.6
insert
liner
shield
urine-absorbing aid held in place by close-fitting underwear or stretch mesh briefs
2.7
pull-on
protective underwear
disposable underwear
urine-absorbing aid similar to trainer pants for children, shaped like normal underwear
2.8
absorption capacity
amount of liquid that can be absorbed by a product
2.9
acquisition speed
rate with which the liquid is acquired and absorbed by the product
2.10
retention capacity
amount of liquid that is retained by the product when it is exposed to external forces or pressure
2.11
rewet
amount of liquid that leaves the product when it is exposed to external forces or pressure
3 Requirements
3.1 G
...