ISO 12505-2:2016

Skin barrier for ostomy aids — Test methods — Part 2: Wet integrity and adhesive strength

ISO 12505-2:2016 specifies test methods dealing with face plates of skin barriers for ostomy aids. ISO 12505-2:2016 does not cover medical properties (cytotoxicity, sensitization, irritation/intracutaneous reactivity, buffering effect, microbiological effects, etc.).

Barrière cutanée pour appareillages stomiques — Méthodes d'essai — Partie 2: Résistance des adhésifs et intégrité une fois mouillés

General Information

• Status: Published
• Publication Date: 18-Oct-2016
• ICS: 11.180.20 - Aids for incontinence and ostomy
• Technical Committee: ISO/TC 173/SC 3 - Aids for ostomy and incontinence
• Drafting Committee: ISO/TC 173/SC 3 - Aids for ostomy and incontinence
• Current Stage: 9093 - International Standard confirmed
• Completion Date: 13-Sep-2022

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 12505-2
First edition
2016-10-15
Skin barrier for ostomy aids — Test
methods —
Part 2:
Wet integrity and adhesive strength
Barrière cutanée pour appareillages stomiques — Méthodes
d’essai —
Partie 2: Résistance des adhésifs et intégrité une fois mouillés
Reference number
ISO 12505-2:2016(E)
©
ISO 2016

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ISO 12505-2:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
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ii © ISO 2016 – All rights reserved

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ISO 12505-2:2016(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Evaluation of skin barriers . 1
Bibliography .12
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ISO 12505-2:2016(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 World Trade Organization (WTO) principles in the
Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.
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
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ISO 12505-2:2016(E)

Introduction
Skin barriers are made to seal the ostomy bag to the skin and stay on, protecting the peristomal skin
from stoma effluent 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, 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, based on laboratory and clinical testing. But despite the efforts and improvements
made, there are still problems for the user of the products; trial and error may still be the prime method
to find an adequate product.
The problem that we primarily focus upon is the ability 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 are flexible, erosion-resistant, skin-friendly and have adhesion
properties that allow the bag to stay in place during use and be removed following use. 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
for adhesive products were not developed for skin barriers but for industrial tapes. The test methods
found in this part of ISO 12505 cover the evaluation of wet integrity and adhesion. The methods have
been specifically designed for skin barriers for ostomy aids.
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INTERNATIONAL STANDARD ISO 12505-2:2016(E)
Skin barrier for ostomy aids — Test methods —
Part 2:
Wet integrity and adhesive strength
CAUTION — These test methods may not provide design information as there may be no direct
relationship between laboratory test results and functional requirements. Data shall not be
interpreted as applying to clinical use of the skin barrier because of variations in the skin and in
the user’s pouching techniques.
1 Scope
This part of ISO 12505 specifies test methods dealing with face plates of skin barriers for ostomy aids.
This part of ISO 12505 does not cover medical properties (cytotoxicity, sensitization,
irritation/intracutaneous reactivity, buffering effect, microbiological effects, 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 24214, Skin barrier for ostomy aids — Vocabulary
ISO 12505-1, Skin barrier for ostomy aids — Test methods — Part 1: Size, surface pH and water-absorbency
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 24214, ISO 12505-1 and the
following apply.
3.1
wet integrity
ability of a skin barrier to maintain its physical form when exposed to fluid
3.2
adhesive strength
force required to peel a skin substitute from the surface of a skin barrier specimen
3.3
specimen
single typical part or example taken from the trial sample sheet as a test piece
4 Evaluation of skin barriers
4.1 General
This part contains the following tests/measurements:
Wet integrity test and adhesive strength (resistance upon removal) test.
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ISO 12505-2:2016(E)

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. The test methods,
however, shall be utilized for the market need to fulfil the product property of the skin barrier.
4.2 General conditions of test
4.2.1 Standard conditions of test place: The preferred standard test conditions shall be a temperature of
(23 ± 2) °C and a relative humidity of (50 ± 5) %. If not available, state the used conditions 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
a
Test items Test results obtained
Wet-integrity (mm) One digit after decimal point
Adhesive-strength (N/cm) Two digits after decimal point
a
Integer number position in all.
4.3 Wet integrity
4.3.1 Principle
Because skin barriers absorb water, deform and collapse over time, the test is used to measure such
reaction as the swelling and/or erosion in simulated use. It is measured at the centre of the skin barrier
where a stoma hole of 25 mm diameter is punched out, under the influence of physiological saline
solution, which is rotated by using a magnetic stirrer process in 24 h incubation at 37 °C. Such change is
observed as discoloration of erosion/swelling around the centre hole and defined as follows.
— Inner diameter (D1) of the hole after test > 25 mm = outward erosion.
— Inner diameter (D1) of the hole after test < 25 mm = inward swelling.
— Outer diameter (D2) = the outer edge of the discoloured area = collapsed border.
4.3.2 Apparatus
4.3.2.1 Test solution, saline or 0,9 % NaCl solution. Test solution shall be pre-warmed to 37 °C.
4.3.2.2 Stirrer table, magnetic stirrers (4.3.2.3) being able to run from 300 rpm to 600 rpm. Rotation
speeds shall be within calibration specifications.
1)
4.3.2.3 Magnetic stirrer, glass-coated, 8 mm diameter × 40 mm length. Do not use Teflon-coated
stirrers in order to reduce wear and to prevent the washed-out adhesive from sticking to the bar.
4.3.2.4 Plastic container/cup, translucent, 365 ml in capacity, 95 mm in diameter.
4.3.2.5 Lid to cup, translucent, 95 mm in diameter, with an 8 mm diameter centre hole and a 2 mm
diameter air vent.
1) Teflon is an example of a suitable product available commercially. This information is given for the convenience
of users of this document and does not constitute an endorsement by ISO of this product.
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ISO 12505-2:2016(E)

4.3.2.6 Punching tools, cutting two holes in lid (4.3.2.5); 8 mm and 2 mm in diameter, and cutting
out a 65 mm diameter plate (4.3.2.9) with an 8 mm diameter centre hole, a 65 mm outer diameter and
45 mm inner diameter ring of foam (4.3.2.11), and a 55 mm outer diameter and 25 mm inner diameter
ring-formed specimen of skin barrier.
4.3.2.7 Distance tube, fixing tube with a distance between the lid (4.3.2.5) and the plate (4.3.2.9). For
2)
example, Quick Star push-in fittings QSH-10-50 130726 by Festo Co.
4.3.2.8 Fasteners, auto cover clips, plastic (7 × 22) mm axis and 18 mm diameter head. The head shall
3)
not exceed 18 mm diameter. For example, Art.nr. 05009405 by Würth-Danmark A/S.
4.3.2.9 Mounting disc plate, APET (Amorphous Polyethylene Terephthalate) disk of 0,8 mm thickness,
4)
®
65 mm diameter with an 8 mm diameter centre hole (for example, Axpet by Bayer Material Science AG).
4.3.2.10 Insulating material, used between the bottom of the plastic container (4.3.2.4) and the
magnetic stirrer (4.3.2.3) to maintain the specified temperature constant and to keep the stirring function
intact. The material, thickness and shape are up to the test person (for example, fabric or expanded
polystyrene disk).
4.3.2.11 Waterproof ring-shaped foam, backed with adhesive, 65 mm diameter with a centre hole of
45 mm diameter, and used to prevent the outer rim of the skin barrier specimen from getting washed out
by the salt water. It can be any tape that is good enough to stay on the specimen during the testing period.
4.3.2.12 Measuring template, circles with diameters between 15 mm and 45 mm at 1 mm increments
printed on a transparent film, for measuring the inner and outer diameters after test. The diameters of the
circles on the template shall be measured using a calibrated measuring tool before the template is used.
4.3.2.13 Oven or incubator, having a circulating fan and capable of maintaining the temperature of the
test solution within an accuracy of ±0,75 °C and designed to distribute the air evenly throughout the oven
or incubator.
4.3.3 Procedures
See Figure 1.
a) Prepare the required mounting disc plate of 65 mm diameter with an 8 mm diameter centre hole,
the lid with an 8 mm diameter centre hole and a 2 mm diameter air vent hole, the adhesive foam
ring of 65 mm outer diameter/45 mm inner diameter, and the required skin barrier ring specimen
of 25 mm inner diameter/55 mm outer diameter, by punching out each hole.
b) Remove the release liner from the skin barrier specimen but not the backing; the removed side is
adhesive, and the adhesive side shall be attached to the disc plate.
c) Place the specimen on the mounting disc plate centred around the 8 mm diameter hole in an upside-
down position to avoid stretching of the adhesive, which could lead to non-circular centre holes
after testing.
d) Place the punched foam on top of the specimen centred around the outer edge.
2) Quick Star push-in fittings QSH-10-50 130726 is an example of a suitable product available commercially. This
information is given for the convenience of users of this document and does not constitute an endorsement by ISO
of this product.
3) Art.nr. 05009405 is an example of a suitable product available commercially. This information is given for the
convenience of users of this document and does not constitute an endorsement by ISO of this product.
®
4) Axpet is an example of a suitable product available commercially. This information is given for the convenience
of users of this document and does not constitute an endorsement by ISO of this product.
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ISO 12505-2:2016(E)

e) Assemble the lid and the disc plate of the specimen by using a distance tube and two auto clips at
each edge.
f) Place the magnetic stirrer in the cup and fill with 170 ml of pre-warmed 0,9 % NaCl solution. Use an
insulating material between the container bottom and the magnetic stirrer to control temperature
of the test sample constantly.
g) Attach the lid assembly to the cup.
NOTE 1 Ensure that the skin barrier specimen is placed correctly, meaning, its backing side or non-
adhesive side is faced toward the magnetic stirrer in the bottom of the plastic container.
h) Place 6 specimen cups on the stirrer table and adjust the speed to 400 rpm.
i) 6 containers with lid assembly shall be left on the stirrer table in the incubator for 24 h. It is
important to
...