ISO/TR 19969:2018

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
• ICS: 11.200 - Birth control. Mechanical contraceptives
• Technical Committee: ISO/TC 157 - Non-systemic contraceptives and STI barrier prophylactics
• Drafting Committee: ISO/TC 157/WG 10 - Burst requirements
• Current Stage: 6060 - International Standard published
• Start Date: 08-Oct-2018
• Completion Date: 13-Dec-2025

Relations

• Consolidated By: ISO 11839:2021 - Machinery for forestry - Thrown object guard - Test method and performance criteria
• Effective Date: 06-Jun-2022

Overview

ISO/TR 19969:2018 provides laboratory guidance on sample handling and preparation for two key male condom quality tests: determination of bursting volume and pressure and testing for freedom from holes. The technical report focuses on standardized procedures to minimize handling damage that can produce false failures or inconsistent results. It is intended for laboratory use only (not for end-user instructions).

Key topics

• Scope and purpose
  • Guidance to improve reproducibility of mechanical and leak testing for male condoms.
  • Supports testing performed against ISO 4074 and ISO 23409.
• General precautions
  • Use of protective gloves (seamless medical examination gloves recommended); remove jewellery and avoid long/sharp fingernails.
  • Open individual containers by tearing (do not use scissors or sharp instruments).
  • Test samples promptly after unpackaging - preferably within 1 hour, definitely within 4 hours to reduce environmental damage (UV, ozone).
• Bursting volume and pressure
  • Verify pressure transducer range and calibration before testing.
  • Ensure the rod/mandrel surface is smooth, undamaged, and contaminant-free.
  • Unroll condoms evenly onto the mandrel using both hands with minimal stretching; set clamping device carefully to avoid knocks or slippage.
• Freedom-from-holes (water/electrical leak test)
  • Two recommended unrolling methods to reduce micro-damage (finger-ring method and two-finger expansion method).
  • Inspect visually for defects per ISO 4074/23409; remove temporary creases by gently trapping air (without stretching).
  • Attach condoms to mount with both hands, stretching no more than required (not more than 100% as noted).
  • Use coloured absorbent paper (single piece, free from joints/foreign matter) when rolling samples for water leakage inspection.
• Handling after test
  • Remove and handle wet specimens gently to avoid contact damage and false hole creation; avoid excessive rubbing when wiping water drops.

Applications

• Quality control and assurance laboratories performing condom mechanical and leak tests.
• Manufacturers and R&D teams validating product performance and sample-preparation protocols.
• Conformity assessment bodies and regulatory testing facilities seeking standardized, reproducible test preparation methods.
• Interlaboratory comparison studies and accreditation bodies focused on test repeatability and precision.

Related standards

• ISO 4074 - Natural rubber latex male condoms - Requirements and test methods
• ISO 23409 - Male condoms - Requirements and test methods for condoms made from synthetic materials

Keywords: ISO TR 19969, condom testing, sample handling, bursting volume, bursting pressure, freedom from holes, water leakage test, ISO 4074, ISO 23409, laboratory guidance, condom quality.

Standards Content (Sample)

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 2018
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii © ISO 2018 – All rights reserved

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
Foreword
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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).
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.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

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.
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.
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
...