Guidance on sample handling for determination of bursting volume and pressure, and testing for freedom from holes for male condom

This document gives guidance on the procedures for sample preparation for determining bursting volume and pressure and testing male condoms for freedom from holes.

Mode opératoire de préparation pour les méthodes d’essai d’éclatement et d’essai de résistance au trou des préservatifs de faible épaisseur

General Information

Status
Published
Publication Date
07-Oct-2018
Current Stage
6060 - International Standard published
Start Date
11-Sep-2018
Completion Date
08-Oct-2018
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ISO/TR 19969:2018 - Guidance on sample handling for determination of bursting volume and pressure, and testing for freedom from holes for male condom
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TECHNICAL ISO/TR
REPORT 19969
First edition
2018-10
Guidance on sample handling for
determination of bursting volume
and pressure, and testing for freedom
from holes for male condom
Mode opératoire de préparation pour les méthodes d’essai
d’éclatement et d’essai de résistance au trou des préservatifs de faible
épaisseur
Reference number
ISO/TR 19969:2018(E)
ISO 2018
---------------------- Page: 1 ----------------------
ISO/TR 19969:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018

All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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.
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Email: copyright@iso.org
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Published in Switzerland
ii © ISO 2018 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TR 19969:2018(E)
Contents Page

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

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

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

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

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Sample handling procedure for determining bursting volume and pressure .....................................2

5 Sample handling procedure for determining hole test ................................................................................................ 4

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

© ISO 2018 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/TR 19969:2018(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 of the voluntary nature of standards, 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 www .iso

.org/iso/foreword .html.

This document was prepared by Technical Committee ISO/TC 157, Non-systematic contraceptive and STI

barrier prophylactics.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2018 – All rights reserved
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ISO/TR 19969:2018(E)
Introduction

Recent analyses of male condom samples from different manufacturers that have failed the freedom

from holes test suggest that some of the holes observed in the samples are caused by damage when

the samples are being prepared for testing in the laboratory. There have also been reports of incorrect

results when testing condoms for bursting volume and pressure caused by poor handling of the

condoms, for example by excessively stretching the samples when mounting them on the burst testing

apparatus. This leads to the development of a guidance for preparation procedures of test samples or

test pieces such as test for holes and bursting volume and pressure.

An interlaboratory study comparing the results for tests for freedom from holes and burst properties

from different laboratories has been completed. Thin natural rubber latex condoms and polyurethane

condoms were used in this study. The study identified various handling procedures that could lead to

incorrect results. Based on this study, a set of standardized handling procedures have been developed

to minimize the risk of incorrect results being obtained.

This document describes these standardized handling procedures which are designed to minimize

unintentional damage to the condoms during sample preparation and testing procedure in the

laboratory. It is expected for the procedures described in this document to improve the reproducibility

of test results between laboratories. This document helps improve the precisions of mechanical testing

for male condoms as specified in ISO 4074 and ISO 23409.

The guidance given in this document is intended for laboratory testing only. It is not intended for

condom users and should not be included in the instructions for use for condom users.

© ISO 2018 – All rights reserved v
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TECHNICAL REPORT ISO/TR 19969:2018(E)
Guidance on sample handling for determination of
bursting volume and pressure, and testing for freedom
from holes for male condom
1 Scope

This document gives guidance on the procedures for sample preparation for determining bursting

volume and pressure and testing male condoms for freedom from holes.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
individual container
primary package containing a single condom
3.2
lubricant

material which is applied to lubricate the surface of the condom and make it easier to unroll

3.3
protective gloves
gloves to protect the condom from handling damage
EXAMPLE Seamless gloves (e.g. non-sterile medical examination glove).
3.4
rod or mandrel
device used to support the condom during bursting volume and pressure
3.5
external clamping device
clamp which holds the condom to permit it to be inflated without leaking
3.6
coloured absorbent paper

water absorbing paper used during water leakage test to examine the condom sample is free from pinhole

Note 1 to entry: See 5.9 and Figure 1.
© ISO 2018 – All rights reserved 1
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ISO/TR 19969:2018(E)
a) Appropriate example b) Inappropriate example
adhesive tape stuck on the absorbent paper
Figure 1 — Coloured absorbent paper
3.7
mount
part of the water leakage testing dev
...

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