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Assessment of methods for finding hole in condoms

Objective

The aim of this project was to evaluate and compare methods for finding holes in condoms
by assessing the repeatability and reproducibility of each test and by comparing the effectiveness of the methods for finding holes.
RESULTS AND CONCLUSIONS
The main outcome of this project was that the Rolled Water Test and European Electrical Test confirmed by Rolled Water Test gave consistent results which were more reliable than the other three methods. There is no important difference between the results of the Rolled Water Test or the European Electrical Test confirmed by the Rolled Water Test in terms of repeatability and reproducibility or within the limits of our ability to determine, false positives or false negatives. Both tests should be permitted in standards with the choice made by individual laboratories.


EXPLOITATION PLANS AND ANTICIPATED BENEFITS
The major international condom standards, ISO4074 and EN600:1996 are both currently subject to revision. The revision of EN600:1996 has been delegated to ISO under the provisions of the Vienna agreement. The ISO committee, ISO/TC157 Mechanical Contraceptives, will carry out this work.

The results of this study will be disseminated to the ISO ( and European ) committees and will discussed in full at the next ISO/TC157 meeting in Paris in September 1997. The adoption of a revised ISO standard as a European standard has been made contingent upon the ISO committee taking fully into account the results and conclusions of the study.

The expected benefit of the study is that one or probably both the preferred test methods for holes identified by the study will be adopted in the next ISO standard and that consequently testing condoms for holes will become more consistent worldwide.

Most of the partners in the study are members of the ISO and European standards committees.
TECHNICAL DESCRIPTION
Two methods for finding holes are described in EN600: 1996, the recently approved harmonised European Standard for latex condoms. These are the Rolled Water Test where a condom is filled with water then rolled on absorbent paper, and the European Electrical Test where the condom is filled with electrolyte, immersed in a bath of electrolyte and then tested for electrical resistance. Positive results on the European Electrical Test have to be confirmed by a subsequent Rolled Water Test. Two other electrical tests are used, the Japanese Electrical Test and the RQTS test developed by J. Torres in Spain. Finally, the air burst test for condoms is regarded by some as a test for holes.

The comparative performance of all these tests has not been evaluated and neither has the repeatability of the measurements. The purpose of our study was to compare the tests across several European test laboratories, with tests repeated over a period of time using a consistent condom product.

The project was carried out in three phases. During the first phase, some test equipment and condoms for the study were made. During the second phase, a pilot study was conducted. The final phase was six full test rounds each lasting two months.

Funding Scheme

CSC - Cost-sharing contracts

Coordinator

LRC Products Ltd
Address
Cambridge Science Park Milton Road
CB4 4GZ Cambridge
United Kingdom

Participants (3)

INSTITUTE OF HEALTH CARLOS III
Spain
Address
Calle Sinesio Delgardo 6
28029 Madrid
LABORATOIRE NATIONAL D'ESSAIS
France
Address
Rue Gaston Boissier 1
75724 Paris
Österreichisches Institut für Biomedizinische Werkstofftechnik
Austria
Address
5,Franz-grill-strasse
1030 Wien