ISO 12505-1:2014

INTERNATIONAL ISO
STANDARD 12505-1
First edition
2014-02-15
Skin barrier for ostomy aids — Test
methods —
Part 1:
Size, surface pH and water-absorbency
Barrière cutanée pour appareillages stomiques — Méthodes
d’essai —
Partie 1: Taille, pH de surface et absorbance d’eau
Reference number
ISO 12505-1:2014(E)
©
ISO 2014

---------------------- Page: 1 ----------------------
ISO 12505-1:2014(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2014
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
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 2014 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 12505-1:2014(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Evaluation of skin barriers . 2
4.1 General . 2
4.2 General conditions of test . 2
4.3 Measurement of size . 2
4.4 Measurement of surface pH . 7
4.5 Water absorbency test . 8
4.6 Test report .10
Bibliography .12
© ISO 2014 – All rights reserved iii

---------------------- Page: 3 ----------------------
ISO 12505-1:2014(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 be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 173, Assistive products for persons with disability,
Subcommittee SC 3, Aids for ostomy and incontinence.
ISO 12505 consists of the following parts, under the general title Skin barrier for ostomy aids — Test
methods:
— Part 1: Size, surface pH and water-absorbency
— Part 2: Wet-integrity and adhesive strength
iv © ISO 2014 – All rights reserved

---------------------- Page: 4 ----------------------
ISO 12505-1:2014(E)

Introduction
Skin barriers are made to seal the ostomy bag to the skin and stay on, protecting the peristomal skin
from excrements and secretion, and keeping the skin physiology intact by absorbing or permeating
sweat.
The skin characteristics vary from person to person, and the products behave differently from each
other depending on type of stoma, purpose of use, atmosphere, and other environmental factors, care
techniques, the user’s way of daily living etc. These make the testing situation complex and a number
of test methods have been developed — laboratory and clinically based. But despite the efforts and
improvements made, there are still problems for the user of the products — trial and error can still be
the prime method to find an adequate product.
The problem that we primarily focus upon is the possibility for the users — purchasers, professional
staffs, persons with stoma etc. — to rationally evaluate the products and the test methods used.
The skin barrier is an important part of an ostomy product. It protects the peristomal skin and holds
the ostomy bag in place. Skin barriers shall be flexible, erosion-resistant, skin-friendly, and having
adhesion properties that allows the bag to stay in place and be removed. Skin barriers are manufactured
in a number of shapes and degrees of convexity and flexibility. Understanding how skin barriers are
designed and work will help to provide ostomy patients or consumers with the best products.
The properties of skin barriers differ and there is a need to evaluate them properly. Skin barriers can be
evaluated by either clinical trials or by laboratory test methods. Clinical trials are not covered here but
in other International Standards. Laboratory test methods found in other International Standards were
not developed for skin barriers but for industrial tapes. Methods found elsewhere differ by manufacturer,
consumer, and medical professional.
The test methods found in this International Standard covers the evaluation of size, pH, and absorption.
The methods have been specifically designed for skin barriers for ostomy products.
© ISO 2014 – All rights reserved v

---------------------- Page: 5 ----------------------
INTERNATIONAL STANDARD ISO 12505-1:2014(E)
Skin barrier for ostomy aids — Test methods —
Part 1:
Size, surface pH and water-absorbency
1 Scope
This part of ISO 12505 specifies test methods dealing with a face plate of skin barriers for ostomy aids.
It does not cover medical properties (cytotoxicity, sensitization, irritation/intracutaneous reactivity,
buffering effect, microbiological effects, etc).
The test methods do not individually or collectively define or recommend a product of a specific design,
style or size, and do not recommend medical affairs such as treatment, nursing, etc.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 554:1976, Standard atmospheres for conditioning and/or testing — Specifications
ISO 7886-1:1993, Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO 10523:2008, Water quality — Determination of pH
ISO 24214:2006, Skin barrier for ostomy aids — Vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions in ISO 24214 and the following apply.
3.1
surface pH
value obtained with a glass electrode pH meter in the skin-contacting part of skin barrier in moisturized
condition
3.2
water absorbency
possibility which allows water in the skin barrier
3.3
sample
small trial sheet representing a whole product of skin barrier, including test specimen that is a single
typical part or example taken from the trial sheet as test piece
3.4
linear dimension
straight shortest distance between any two points selected on the sample
© ISO 2014 – All rights reserved 1

---------------------- Page: 6 ----------------------
ISO 12505-1:2014(E)

4 Evaluation of skin barriers
4.1 General
This part contains the following tests/measurements:
a) measurement of sizes;
b) measurement of surface pH;
c) water absorbency test.
4.2 General conditions of test
4.2.1 Standard conditions of test place: Follow ISO 554:1976; preferred standard test conditions shall
be temperature (23 ± 2) °C and relative humidity (50 ± 5) %. If not available, state conditions used in the
test report.
4.2.2 Pretreatment of a sample: The sample is left under the conditions in 4.2.1 for 24 h or more.
4.2.3 Accuracy requirement/rounding of test results: The results shall be rounded and expressed by
number of digits as shown in Table 1.
Table 1 — Rounding method of test results
Test items Test results obtained
Size: Length, width, and diameter (mm) Integer number position in all
     Thickness (mm) One digit after decimal point
Surface pH One digit after decimal point
2
Water absorbency (mg/cm ) Integer number position
4.3 Measurement of size
4.3.1 Principle
Following description of shape, length and width or diameter of the skin barrier is measured using a
scale ruler. The area of the skin barrier can be calculated, if necessary. The diameter of the precut or
starter hole and the flange can be measured and also the maximum diameter to which the hole can be
cut if applicable. The thickness of the skin barrier is measured using a thickness gauge. Measurements
shall always be performed in 3 samples to take the average.
4.3.2 Apparatus
4.3.2.1 Scale ruler, capable of measuring to the nearest 1 mm.
Alternatively, a caliper can be used. For diameter measurements, a diameter gage can also be used.
4.3.2.2 Thickness gage, dial indicator capable of measuring to the nearest 0,1 mm having a flat surface
of 8 mm diameter and capable of exerting a pressure of 12 kPa (0,6 N) on the object measured.
It is recommended to have a flat surface of (8 ± 1) mm, but the actual diameter shall be measured with
a precision of 0.1 mm.
To obtain 12 kPa pre
...