Abstract

Manufacturers, consumers, and regulators use various water test methods to test the integrity of the barrier offered by natural rubber latex condoms. The purpose of this study is to analyze three alternative water test methods and determine which is the best method for detecting holes in condoms. Three types of holes (laser, acupuncture, and 28 gage insulin needles), approximating defects that occur in condoms, were placed in condoms and then into equal size test sets for testing by six laboratories for the purpose of evaluating the three alternative methods: the ASTM method, the ISO/FDA method, and the CSI/FHI method. Each method shares a hang portion for 1 min, and then uses a different form of manipulation; either elevate (ASTM), roll (ISO/FDA), or squeeze (CSI/FHI). The interlaboratory study data indicate the CSI/FHI is the most sensitive method for locating holes in condoms, becoming more sensitive as the defect approaches the closed end.

Issue Section:
Research Papers
Keywords:
condoms, water test methods, holes, natural rubber latex

References

1.
Pinkerton
,
S.D.
 and
Abramson
,
P.R.
, “
Effectiveness of Condoms in Preventing HIV Transmission
,”
Social Science Medicine
 0277-9536, Vol.
44
, No.
9
,
1997
, pp.
1303
–
1312
.
Google Scholar
Crossref
Search ADS
PubMed
 
2.
Albert
A.E.
,
Warner
,
D.L.
,
Hatcher
,
R.A.
,
Trussell
,
J.
, and
Bennett
C.
, “
Condom Use Among Female Commercial Sex Workers in Nevada's Legal Brothels
,”
American Journal of Public Health
 0090-0036, Vol.
85
, No.
11
,
11
1995
, p.1514.
3.
Anderson
,
J.E.
,
Brackbill
,
R.
, and
Mosher
,
W.D.
, “
Condom Use for Disease Prevention Among Unmarried U.S. Women
,”
Family Planning Perspectives
 0014-7354, Vol.
28
, No.
1
, pp.
25
–
39
, Jan./Feb., 1996.
Crossref
Search ADS
PubMed
 
4.
Steiner
,
M.J.
,
Taylor
,
D.J.
,
Feldblum
,
P.J.
, and
Wheeless
,
A.J.
, “
How Well Do Male Condoms Work? Pregnancy Outcomes During One Menstrual Cycle of Use
,”
Contraception
 0010-7824, Vol.
62
, No.
6
, December, 200, pp.
15
–
19
.
PubMed
 
5.
Coulter
,
E.
,
The Improved Method for the Examination of Rubber Prophylactics
, (
Chicago District
),
U.S. Food and Drug Administration
,
09
08
1951
.
6.
Center for Disease Control, Morbidity and Mortality Weekly Report
, Vol.
37
, No. 9, 11 March, 1988, pp.
133
–
137
.
7.
ASTM D 3492-02
Standard Specification for Rubber Contraceptives (Male Condoms)
Annual Book of ASTM Standards
, Vol.
09.02
,
2003
and
ISO 4074:2002 Natural Latex Rubber Condoms, Requirements and Test Methods, International Standards Organization
, Feb.15, 2002.
8.
Das
,
Bigyani
 and
Myers
,
M.R.
, “
Virus Transmission Through Compromised Synthetic Barriers
,”
Journal of Biomechanical Engineering
 1369-703X, Vol.
123
,
10
2001
, pp.
513
–
518
.
Google Scholar
Crossref
Search ADS
PubMed
 
9.
“
Acute HIV Infection Transmits Greater Risk
,”
AIDS Alert
, Vol.
17
, No.
7
,
07
2002
, pp.
87
–
88
.
PubMed
 
10.
Kerr
,
L.N.
,
Boivin
,
W.S.
,
Hamilton
,
S.L.
,
Mailhot
,
S.A.
,
O'Malley
,
L.G.
,
Boyd
,
S.M.
, et al, “
Comparison of ISO/FDA and ASTM Condom Water Leak Test Methods
,”
Journal of Testing and Evaluation
 0090-3973, Vol.
29
, No.
2
,
03
2001
, pp.
192
–
198
.
11.
ASTM E 1601-98
Practice for Conducting an Interlaboratory Study to Evaluate the Performance of an Analytical Method
,
Annual Book of ASTM Standards
, Vol.
03.05
,
2003
.
12.
Kerr
,
L.N.
,
Chaput
,
M.P.
,
Boyd
,
S.M.
,
Galevi
,
E.A.
, and
Millward
,
P.A.
, “
Characterization and Creation of Defects in Condoms
,”
Journal of Testing and Evaluation
 0090-3973,
03
2001
, Vol.
29
, No.
2
, pp.
214
–
219
.
13.
Rosner
,
B.
,
Fundamentals of Biostatistics
, 3rd ed.,
1990
.
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