SIST ISO 15621:2016
Urine-absorbing aids -- General guidelines on evaluation
Urine-absorbing aids -- General guidelines on evaluation
This International Standard gives general guidelines on the methodology of evaluating disposable urineabsorbing
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.
Aides pour l'absorption d'urine -- Directives générales d'évaluation
Pripomočki za absorpcijo urina - Splošne smernice za ovrednotenje
Ta mednarodni standard podaja splošne smernice za metodologijo ovrednotenja pripomočkov za absorpcijo urina za enkratno uporabo ter zagotavlja kontekst za postopke, opisane v drugih mednarodnih standardih ali objavljenih preskusnih postopkih. Te izdelke je mogoče uporabljati tudi za fekalno inkontinenco, kar je občasno tudi omenjeno.
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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 15621:2011(E)
©
ISO 2011
---------------------- Page: 1 ----------------------
ISO 15621:2011(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.
COPYRIGHT PROTECTED DOCUMENT
© 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
---------------------- Page: 2 ----------------------
ISO 15621:2011(E)
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
© ISO 2011 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 15621:2011(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 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
---------------------- Page: 4 ----------------------
ISO 15621:2011(E)
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.
© ISO 2011 – All rights reserved v
---------------------- Page: 5 ----------------------
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
© ISO 2011 – All rights reserved 1
---------------------- Page: 6 ----------------------
ISO 15621:2011(E)
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 General summary
It is essential to define the need for an evaluation. Different clauses of this International Standard are useful in
different situations. There are different factors and priorities depending on the aim of the evaluation. Individual
assessment and choice of products differ from an evaluation aiming at groups of users and this influences the
process of evaluation.
The amount of evaluation workload also differs with different purposes. An evaluation with the purpose to
identify unacceptable products is smaller than an evaluation with the purpose to differentiate between a
number of products with similar characteristics.
[2]
A helpful starting point in the process is to use the international classification ISO 9999:— .
[2]
NOTE ISO 9999:— , contains a revised clause on incontinence.
The user related factors, Clause 4, are the starting point of any evaluation. These factors are further described
in the 4th International Consultation on Incontinence (Reference [9]).
The product-related factors, Clause 5, are the factors more related to the actual performance of the product.
Usage-related factors are described in Clause 6.
Evaluation methods are described in Clause 7.
The following factors are addressed by this International Standard:
a) user-related factors:
⎯ quality of life,
⎯ independence or assistance,
⎯ nature of incontinence,
⎯ end-user characteristics,
⎯ activities,
⎯ individual needs,
⎯ handling products;
2 © ISO 2011 – All rights reserved
---------------------- Page: 7 ----------------------
ISO 15621:2011(E)
b) product-related factors:
⎯ freedom from leakage,
⎯ freedom from odour leakage,
⎯ skin health,
⎯ comfort and fit,
⎯ discretion;
c) usage-related factors:
⎯ ergonomics,
⎯ needs of caregivers,
⎯ information supplied,
⎯ disposal facilities,
⎯ laundry facilities,
⎯ sustainability and environment,
⎯ product safety,
⎯ cost;
d) evaluation methods:
⎯ testing in user trials,
⎯ testing in the laboratory,
⎯ the combined approach,
⎯ interpretation of test results,
⎯ sample size.
4 User-related factors
4.1 General
The needs of the individual end-user shall always be the most important aspects when evaluating products.
The following is a list of key assessments factors for end-user assessment from Reference [9].
4.2 Quality of life
All forms of incontinence can cause isolation, depression and physiological problems, and can significantly
impact the social and work-related aspects of the sufferer's and their family's life. Absorbent products can
have a positive impact on the quality of life of individuals suffering from incontinence, allowing users to
maintain their sense of dignity and enabling them to get out, work, take part in social activities, and lead a full
and satisfying life.
© ISO 2011 – All rights reserved 3
---------------------- Page: 8 ----------------------
ISO 15621:2011(E)
4.3 Independence or assistance
The most important goal is to give people the ability to live an independent life. An important aspect of this for
an individual is being able to access toilet facilities and to manage incontinence and toileting. Independence is
made possible when the end-user is able to access appropriate facilities and take care of the change of the
absorbent product on his/her own. However, many end-users may not be independent in this regard and need
assistance.
4.4 Nature of incontinence
During the normal assessment process of the individual with incontinence problems, the nature of
incontinence is monitored as well as suitability for treatment and, for example, the type of absorbent product
needed. The frequency, volume, and flow rate of the incontinence influences product suitability. A frequency
volume chart (FVC) or a bladder diary during at least 24 h and a pad test (leakage test) can be useful tools to
obtain proper information about the incontinence (Reference [9]).
Some people lose only small quantities of urine on infrequent occasions, in which case a small urine-
absorbing aid is adequate. Others may lose a substantial quantity of urine when they experience an episode
of incontinence and need a urine-absorbing aid which can rapidly absorb, distribute, and retain the urine under
a variety of circumstances.
The proximity and accessibility of toilet facilities can influence the need for absorbent products. Where only
slight or even no clinical incontinence exists, products may still be required if toilet facilities cannot be reached
because of mobility or accessibility problems.
4.5 End-user characteristics
Many individual characteristics affect the choices that need to be made when choosing absorbent products.
End-users are different in many ways. Although the number of incontinent people increases with age,
incontinence is present in people of all ages. Incontinence is also present in people with no other disability, as
well as those with complex and profound disability.
A wide range of physical and mental impairments can restrict the ability to independently cope with
incontinence. Impaired mobility may make some product choices impractical or require toilet or clothing
modification to allow effective use of the product. Reduced dexterity — prob
...
SLOVENSKI STANDARD
SIST ISO 15621:2016
01-marec-2016
3ULSRPRþNL]DDEVRUSFLMRXULQD6SORãQHVPHUQLFH]DRYUHGQRWHQMH
Urine-absorbing aids -- General guidelines on evaluation
Aides pour l'absorption d'urine -- Directives générales d'évaluation
Ta slovenski standard je istoveten z: ISO 15621:2011
ICS:
11.180.20 9UHþNH]DEODWRLQXULQVNH Aids for ostomy and
YUHþNH incontinence
SIST ISO 15621:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST ISO 15621:2016
---------------------- Page: 2 ----------------------
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 15621:2011(E)
©
ISO 2011
---------------------- Page: 3 ----------------------
SIST ISO 15621:2016
ISO 15621:2011(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.
COPYRIGHT PROTECTED DOCUMENT
© 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
---------------------- Page: 4 ----------------------
SIST ISO 15621:2016
ISO 15621:2011(E)
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
© ISO 2011 – All rights reserved iii
---------------------- Page: 5 ----------------------
SIST ISO 15621:2016
ISO 15621:2011(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 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
---------------------- Page: 6 ----------------------
SIST ISO 15621:2016
ISO 15621:2011(E)
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.
© ISO 2011 – All rights reserved v
---------------------- Page: 7 ----------------------
SIST ISO 15621:2016
---------------------- Page: 8 ----------------------
SIST ISO 15621:2016
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
© ISO 2011 – All rights reserved 1
---------------------- Page: 9 ----------------------
SIST ISO 15621:2016
ISO 15621:2011(E)
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 General summary
It is essential to define the need for an evaluation. Different clauses of this International Standard are useful in
different situations. There are different factors and priorities depending on the aim of the evaluation. Individual
assessment and choice of products differ from an evaluation aiming at groups of users and this influences the
process of evaluation.
The amount of evaluation workload also differs with different purposes. An evaluation with the purpose to
identify unacceptable products is smaller than an evaluation with the purpose to differentiate between a
number of products with similar characteristics.
[2]
A helpful starting point in the process is to use the international classification ISO 9999:— .
[2]
NOTE ISO 9999:— , contains a revised clause on incontinence.
The user related factors, Clause 4, are the starting point of any evaluation. These factors are further described
in the 4th International Consultation on Incontinence (Reference [9]).
The product-related factors, Clause 5, are the factors more related to the actual performance of the product.
Usage-related factors are described in Clause 6.
Evaluation methods are described in Clause 7.
The following factors are addressed by this International Standard:
a) user-related factors:
⎯ quality of life,
⎯ independence or assistance,
⎯ nature of incontinence,
⎯ end-user characteristics,
⎯ activities,
⎯ individual needs,
⎯ handling products;
2 © ISO 2011 – All rights reserved
---------------------- Page: 10 ----------------------
SIST ISO 15621:2016
ISO 15621:2011(E)
b) product-related factors:
⎯ freedom from leakage,
⎯ freedom from odour leakage,
⎯ skin health,
⎯ comfort and fit,
⎯ discretion;
c) usage-related factors:
⎯ ergonomics,
⎯ needs of caregivers,
⎯ information supplied,
⎯ disposal facilities,
⎯ laundry facilities,
⎯ sustainability and environment,
⎯ product safety,
⎯ cost;
d) evaluation methods:
⎯ testing in user trials,
⎯ testing in the laboratory,
⎯ the combined approach,
⎯ interpretation of test results,
⎯ sample size.
4 User-related factors
4.1 General
The needs of the individual end-user shall always be the most important aspects when evaluating products.
The following is a list of key assessments factors for end-user assessment from Reference [9].
4.2 Quality of life
All forms of incontinence can cause isolation, depression and physiological problems, and can significantly
impact the social and work-related aspects of the sufferer's and their family's life. Absorbent products can
have a positive impact on the quality of life of individuals suffering from incontinence, allowing users to
maintain their sense of dignity and enabling them to get out, work, take part in social activities, and lead a full
and satisfying life.
© ISO 2011 – All rights reserved 3
---------------------- Page: 11 ----------------------
SIST ISO 15621:2016
ISO 15621:2011(E)
4.3 Independence or assistance
The most important goal is to give people the ability to live an independent life. An important aspect of this for
an individual is being able to access toilet facilities and to manage incontinence and toileting. Independence is
made possible when the end-user is able to access appropriate facilities and take care of the change of the
absorbent product on his/her own. However, many end-users may not be independent in this regard and need
assistance.
4.4 Nature of incontinence
During the normal assessment process of the individual with incontinence problems, the nature of
incontinence is monitored as well as suitability for treatment and, for example, the type of absorbent product
needed. The frequency, volume, and flow rate of the incontinence influences product suitability. A frequency
volume chart (FVC) or a bladder diary during at least 24 h and a pad test (leakage test) can be useful tools to
obtain proper information about the incontinence (Reference [9]).
Some people lose only small quantities of urine on infrequent occasions, in which case a small urine-
absorbing aid is adequate. Others may lose a substantial quantity of urine when they experience an episode
of incontinence and need a urine-absorbing aid which can rapidly absorb, distribute, and retain the urine under
a variety of circumstances.
The proximity and accessibility of toilet facilities can influence the need for absorbent products. Where only
slight or even no clinical incontinence exists, products may still be required if toilet facilities cannot be reached
because of mobility or accessibility problems.
4.5 End-user characteristics
Many individual characteristics affect the choices that need to be made when choosing absorbent products.
End-users are different in many ways. Although the number of incontinent people increas
...
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Aides pour l'absorption d'urine -- Directives générales d'évaluationUrine-absorbing aids -- General guidelines on evaluation11.180.20YUHþNHAids for ostomy and incontinenceICS:Ta slovenski standard je istoveten z:ISO 15621:2011oSIST ISO 15621:2016en01-januar-2016oSIST ISO 15621:2016SLOVENSKI
STANDARD
oSIST ISO 15621:2016
Reference numberISO 15621:2011(E)© ISO 2011
INTERNATIONAL STANDARD ISO15621Second edition2011-02-15Urine-absorbing aids — General guidelines on evaluation Aides pour l'absorption d'urine — Directives générales d'évaluation
oSIST ISO 15621:2016
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oSIST ISO 15621:2016
ISO 15621:2011(E) © ISO 2011 – All rights reserved iii 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
oSIST ISO 15621:2016
ISO 15621:2011(E) iv © ISO 2011 – All rights reserved 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. oSIST ISO 15621:2016
ISO 15621:2011(E) © ISO 2011 – All rights reserved v 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. First of all there is the possibility of doing user trials. ISO 16021[8] 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 principal methods available besides user trials are sensory analysis (see ISO 6658[1]) 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. The only published and validated laboratory test method so far is ISO 11948-1[4], which measures the total absorption capacity of products for heavy incontinence. Other methods are under development and will be recommended when available. oSIST ISO 15621:2016
oSIST ISO 15621:2016
INTERNATIONAL STANDARD ISO 15621:2011(E) © ISO 2011 – All rights reserved 1 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 oSIST ISO 15621:2016
ISO 15621:2011(E) 2 © ISO 2011 – All rights reserved 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 General summary It is essential to define the need for an evaluation. Different clauses of this International Standard are useful in different situations. There are different factors and priorities depending on the aim of the evaluation. Individual assessment and choice of products differ from an evaluation aiming at groups of users and this influences the process of evaluation. The amount of evaluation workload also differs with different purposes. An evaluation with the purpose to identify unacceptable products is smaller than an evaluation with the purpose to differentiate between a number of products with similar characteristics. A helpful starting point in the process is to use the international classification ISO 9999:—[2]. NOTE ISO 9999:—[2], contains a revised clause on incontinence. The user related factors, Clause 4, are the starting point of any evaluation. These factors are further described in the 4th International Consultation on Incontinence (Reference [9]). The product-related factors, Clause 5, are the factors more related to the actual performance of the product. Usage-related factors are described in Clause 6. Evaluation methods are described in Clause 7. The following factors are addressed by this International Standard: a) user-related factors: ⎯ quality of life, ⎯ independence or assistance, ⎯ nature of incontinence, ⎯ end-user characteristics, ⎯ activities, ⎯ individual needs, ⎯ handling products; oSIST ISO 15621:2016
ISO 15621:2011(E) © ISO 2011 – All rights reserved 3 b) product-related factors: ⎯ freedom from leakage, ⎯ freedom from odour leakage, ⎯ skin health, ⎯ comfort and fit, ⎯ discretion; c) usage-related factors: ⎯ ergonomics, ⎯ needs of caregivers, ⎯ information supplied, ⎯ disposal facilities, ⎯ laundry facilities, ⎯ sustainability and environment, ⎯ product safety, ⎯ cost; d) evaluation methods: ⎯ testing in user trials, ⎯ testing in the laboratory, ⎯ the combined approach, ⎯ interpretation of test results, ⎯ sample size. 4 User-related factors 4.1 General The needs of the individual end-user shall always be the most important aspects when evaluating products. The following is a list of key assessments factors for end-user assessment from Reference [9]. 4.2 Quality of life All forms of incontinence can cause isolation, depression and physiological problems, and can significantly impact the social and work-related aspects of the sufferer's and their family's life. Absorbent products can have a positive impact on the quality of life of individuals suffering from incontinence, allowing users to maintain their sense of dignity and enabling them to get out, work, take part in social activities, and lead a full and satisfying life. oSIST ISO 15621:2016
ISO 15621:2011(E) 4 © ISO 2011 – All rights reserved 4.3 Independence or assistance
The most important goal is to give people the ability to live an independent life. An important aspect of this for an individual is being able to access toilet facilities and to manage incontinence and toileting. Independence is made possible when the end-user is able to access appropriate facilities and take care of the change of the absorbent product on his/her own. However, many end-users may not be independent in this regard and need assistance. 4.4 Nature of incontinence During the normal assessment process of the individual with incontinence problems, the nature of incontinence is monitored as well as suitability for treatment and, for example, the type of absorbent product needed. The frequency, volume, and flow rate of the incontinence influences product suitability. A frequency volume chart (FVC) or a bladder diary during at least 24 h and a pad test (leakage test) can be useful tools to obtain proper information about the incontinence (Reference [9]). Some people lose only small quantities of urine on infrequent occasions, in which case a small urine-absorbing aid is adequate. Others may lose a substantial quantity of urine when they experience an episode of incontinence and need a urine-absorbing aid which can rapidly absorb, distribute, and retain the urine under a variety of circumstances. The proximity and accessibility of toilet facilities can influence the need for absorbent products. Where only slight or even no clinical incontinence exists, products may still be required if toilet facilities cannot be reached because of mobility or accessibility problems. 4.5 End-user characteristics Many individual characteristics affect the choices that need to be made when choosing absorbent products. End-users are different in many ways. Although the number of incontinent people increases with age, incontinence is present in people of all ages. Incontinence is als
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