ISO/DIS 11948-1

Urine-absorbing aids

Aides pour absorption d'urine

Standards Content (sample)

DRAFT INTERNATIONAL STANDARD ISO/DIS 11948-1
ISO/TC 173/SC 3 Secretariat: SIS
Voting begins on: Voting terminates on:
2005-11-23 2006-04-24

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION

Urine-absorbing aids —
Part 1:
Whole-product testing
Aides pour absorption d'urine —
Partie 1: Essais portant sur le produit entier
[Revision of first edition (ISO 11948-1:1996)]
ICS 11.180.20

In accordance with the provisions of Council Resolution 15/1993 this document is circulated in

the English language only.

Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est distribué

en version anglaise seulement.

To expedite distribution, this document is circulated as received from the committee secretariat.

ISO Central Secretariat work of editing and text composition will be undertaken at publication

stage.

Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du

secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au

Secrétariat central de l'ISO au stade de publication.

THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE

REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.

IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT

INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO

WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
© International Organization for Standardization, 2005
---------------------- Page: 1 ----------------------
ISO/DIS 11948-1
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 notice

This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted

under the applicable laws of the user's country, neither this ISO draft nor any extract from it may be

reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying,

recording or otherwise, without prior written permission being secured.

Requests for permission to reproduce should be addressed to 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 [e-mail]
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii ISO 2005 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/DIS 11948-1
Contents Page

Foreword................................................................................................................................................ iv

Introduction ............................................................................................................................................ v

1 Scope.......................................................................................................................................... 1

2 Normative references.................................................................................................................. 1

3 Term and definition..................................................................................................................... 1

4 Test methods .............................................................................................................................. 1

4.1 Principle...................................................................................................................................... 1

4.2 Sampling and pre-conditioning of test samples.......................................................................... 1

4.3 Test conditions ........................................................................................................................... 2

4.4 Reagent....................................................................................................................................... 2

4.4.1 Test liquid ................................................................................................................................... 2

4.5 Apparatus ................................................................................................................................... 2

4.5.1 Reservoir .................................................................................................................................... 2

4.5.2 Drainage screen.......................................................................................................................... 2

4.5.3 System for introducing the drainage screen containing the sample into and out of the

reservoir...................................................................................................................................... 3

4.5.4 Drainage tray............................................................................................................................... 3

4.5.5 Balance ....................................................................................................................................... 3

4.6 Test procedure ............................................................................................................................ 3

4.7 Calculation and results .............................................................................................................. 5

4.8 Test report.................................................................................................................................. 5

Bibliography ........................................................................................................................................... 9

© ISO 2004 – All rights reserved iii
DRAFT 2005
---------------------- Page: 3 ----------------------
ISO/DIS 11948-1
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 11948-1 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 (11948-1:1996), of which has been technically

revised.

ISO 11948 consists of the following parts, under the general title Urine-absorbing aids:

¾ Part 1: Whole-product testing
iv © ISO 2004 – All rights reserved
DRAFT 2005
---------------------- Page: 4 ----------------------
ISO/DIS 11948-1
Introduction

The method described in this part of ISO 11948 was selected from those used in the ISO Pad Leakage

Project, in which a variety of disposable urine-absorbing aids were tested in various ways in the laboratory

and by a user population of about 100 heavily incontinent persons, the majority of whom were non-ambulatory

adult females residing in hospitals or nursing homes in eight different countries. The applicability of the

method to other groups (e.g. babies or ambulatory adults) or to other classes of product (e.g. reusable or

non-body worn) is unknown (see Biblipgraphy, references [1] and [2]).

The method measures the maximum absorption capacity of the absorbing material in the entire

urine-absorbing aid. The method is validated for predicting the performance of products whose absorbing

materials are uniform in composition and absorbing properties, but it overestimates the amount of urine these

products hold in actual use. The method has not been validated for predicting performance of urine-absorbing

aids whose absorbent cores are designed to be non-uniform in composition and absorbing properties.

Urine-absorbing aid user performance is affected by many other factors in addition to absorption capacity,

such as: the pressure on the product; the posture of the user (e.g. sitting, standing, moving, lying down); the

flow rate at which the user loses urine; and how well the product is put on. From user trials, urine-absorbing

aid performance is also known to be affected by composition and design features such as shaping, profiling,

and composition of the absorbent core, elastication and the kind of fixation system used to keep the product

close to the body. This method does not differentiate these product features.
© ISO 2004 – All rights reserved v
DRAFT 2005
---------------------- Page: 5 ----------------------
DRAFT INTERNATIONAL STANDARD ISO/DIS 11948-1
Urine-absorbing aids — Part 1: Whole-product testing
1 Scope

This part of ISO 11948 specifies a method for determining the maximum absorption capacity of the absorbent

material of bodyworn urine-absorbing aids.

Other methods for measuring absorption capacity examine aspects are outside the scope of this part of

ISO11948.
2 Normative references

The following normative documents contain provisions which, through reference in this text, constitute

provisions of this International Standard. For dated references, subsequent amendments to, or revisions of,

any of these publications do not apply. However, parties to agreements based on this International Standard

are encouraged to investigate the possibility of applying the most recent editions of the normative documents

indicated below. For undated references, the latest edition of the normative document referred to applies.

Members of ISO and IEC maintain registers of currently valid International Standards.

ISO 3696:1987, Water for analytical laboratory use – Specification and test methods.

ISO 5725-2, Accuracy (trueness and precision) of measurement methods and results – Part 2: Basic method

for the determination of repeatability and reproducibility of a standard measurement.

ISO 6353-2:1983, Reagents for chemical analysis - Part 2: Specifications - First series.

3 Term and definition

For the purposes of this part of ISO 11948, the following term and definition apply.

3.1
urine-absorbing aid
product containing material for the purpose of absorbing urine
4 Test methods
4.1 Principle

The urine-absorbing aid is weighed dry, soaked in test liquid, drained, and weighed wet. Subtraction of the dry

mass from the wet mass gives the absorption capacity.
4.2 Sampling and pre-conditioning of test samples

Urine-absorbing aids shall be selected and removed randomly from the packing. The samples shall be

unfolded, and then conditioned using one of the following procedures, a) or b):
© ISO 2004 – All rights reserved 1
DRAFT 2005
---------------------- Page: 6 ----------------------
ISO/DIS 11948-1

a) Samples may be conditioned in an atmosphere of 23°C ± 2°C and 50 % ± 5 % relative humidity for at

least 12 h and no more than 36 h prior to testing.

b) By agreement of the parties involved in the testing, samples may be conditioned in the ambient

temperatures of an office environment at a relative humidity within the range 25 % to 55 % for a time

period between 4h and 24 h.

Samples shall not be exposed to temperatures or relative humidity outside those specified in b) at any time

after removal from their packing.
4.3 Test conditions
Urine-absorbing aids shall be tested under the conditions specified in 4.2.
4.4 Reagent
4.4.1 Test liquid
o o

The concentration of NaCI = 9,0 g/l ± 0,1 g/l prepared at 23 C ± 2 C, comprising grade 3 distilled

...