Designation: D 3492 – 03

Standard Specification for

Rubber Contraceptives (Male Condoms)1
This standard is issued under the fixed designation D 3492; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.

1. Scope E 691 Practice for Conducting an Interlaboratory Study to

1.1 This specification covers the minimum requirements for Determine the Precision of a Test Method4
individually packaged male condoms made from natural rubber 2.2 Other Document:
latex and intended for single use. This specification does not ANSI/MIL-STD 105E Sampling Procedures and Tables for
cover the specifications for lubricants or other dressing mate- Inspection by Attributes5
rials that may be applied to condoms except as noted in 3.2.
3. Materials and Manufacture
1.2 This specification is intended to assist buyers in obtain-
ing condoms of consistent quality. The safe and proper use of 3.1 Condoms shall be manufactured from natural rubber
condoms is excluded from the scope of this specification. latex conforming to Specification D 1076.
1.3 The applicability of this specification is as a design 3.2 The condoms and any dressing materials applied to
guideline and a reference test specification. It is not intended to them shall not liberate substances that are known to be toxic,
be a routine quality control specification for condom manufac- sensitizing, locally irritating, or otherwise harmful to the
turing operations. general population under normal conditions of use.
1.4 The annexes in this specification include important NOTE 1—Natural rubber latex products are known to cause irritation or
information, such as that on apparatus or materials, that is a sensitivity in a small proportion of the user population.
mandatory part of the specification but too detailed for inclu- NOTE 2—Condom lubricants that contain Nonoxynol 9 spermicide are
sion in the main text. known to cause irritation in a small proportion of the user population.
1.5 The appendixes in this specification contain information 4. Requirements
intended to provide guidance only and are not a mandatory part
of the specification. 4.1 General:
1.6 The values stated in SI units are to be regarded as the 4.1.1 Sampling—Samples will be selected randomly from
standard. The values given in parentheses are for information the defined “lot.” The sampling plan must conform to the
only. requirements listed in Table 1.
4.1.2 Sample Handling—To avoid inadvertent damage, op-
2. Referenced Documents erators must wear rubber gloves, finger cots, or other suitable
2.1 ASTM Standards: hand/finger covers and exercise reasonable caution in handling
D 412 Test Methods for Vulcanized Rubber and Thermo- the packet or condom in order to minimize the possibility of
plastic Elastomers—Tension2 damage during the testing procedure.
D 573 Test Method for Rubber—Deterioration in an Air 4.1.3 Process Controls—Manufacturers may use process
Oven2 control tests to determine condom properties. Finished con-
D 1076 Specification for Rubber—Concentrated, Ammonia doms shall be used for qualification and referee tests.
Preserved, Creamed, and Centrifuged Natural Latex2 4.1.4 Lot—A collection of condoms of the same design,
D 3078 Test Method for Determination of Leaks in Flexible color, shape, size, and formulation manufactured continuously,
Packaging by Bubble Emission3 using the same process, raw materials, or the same specifica-
D 3767 Practice for Rubber—Measurement of Dimensions2 tion, common equipment, and packaged with the same lubri-
D 4483 Practice for Determining Precision for Test Method cant and any other additives or dressing in the same type of
Standards in the Rubber and Carbon Black Industries2 individual container. The maximum lot size shall be 500 000
condoms.
4.2 Dimensions—Condoms shall meet the requirements
1
This specification is under the jurisdiction of ASTM Committee D11 on Rubber listed in Table 2.
and is the direct responsibility of Subcommittee D11.40 on Consumer Rubber
Products.
Current edition approved Aug. 10, 2003. Published Septemeber 2003. Originally
4
approved in 1976. Last previous edition approved in 1997 as D 3492–97. Annual Book of ASTM Standards, Vol 14.02.
2 5
Annual Book of ASTM Standards, Vol 09.01. Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
3
Annual Book of ASTM Standards, Vol 15.09. 4th Floor, New York, NY 10036.

Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.

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 D 3492 – 03
TABLE 1 Quality Inspection RequirementsA TABLE 4 Closed End Thickness
Characteristic Inspection Level AQL NOTE 1—All values in microns (0.001 mm).
Condom Material Average SrA SRB r C
RD
Dimensions S-2 4.0
Air burst properties I 1.5 A 77.2 0.4 3.9 1.1 11.0
Leakage I 0.25 B 82.2 0.7 6.0 2.1 16.7
Package C 114.4 1.3 8.7 3.5 24.3
Package integrity S-3 2.5 A
SR is within-laboratory standard deviation of the average (median/other
A
ANSI/MIL-STD 105E. function).
B
Sr is the between-laboratory standard deviation of the average (median/other
function).
TABLE 2 Dimensional Requirements C
r is the within-laboratory repeatability limit = 2.8 Sr.
D
Minimum Length, mm Maximum Width, mm Minimum Thickness, mm R is the between-laboratory reproducibility limit = 2.8 SR.
160 54 0.03

same day. Therefore, p = 10, q = 3, and n = 2. The measurement

4.2.1 Procedures for Dimensional Test: technique as defined in Practice D 3767 was used.
4.2.1.1 Length—Measure the length of the condom to the 4.2.1.5 Concept of r and R—If Sr and SR have been
nearest 1 mm, using the method described in Annex A1. calculated from a large enough body of data for test results that
4.2.1.2 Width—Measure to the nearest 0.5 mm the width of were averaged (medians/other function) form testing X number
the condom laid flat at a distance 30 6 5 mm from the open of specimens, the following definitions are applicable:
end. (a) Repeatability (r)—Comparing two test methods for the
4.2.1.3 Thickness—Measure the thickness of condoms dried same material obtained by the same operator using the same
at room temperature for a minimum of 16 h after any dressing equipment on the same day. The two test results should be
materials have been removed with water or isopropanol. judged not equivalent if they differ by more than the r value of
Measure the wall thickness at three points, 30 6 5 mm, 90 6 that material.
5 mm, and 150 6 5 mm from the closed end. The thickness (b) Reproducibility (R)—Comparing two test results for the
measuring device shall conform to that specified in Practice same material obtained by different operators using different
D 3767, Test Method A with the pressure of the foot thickness equipment on different days. The two test results should be
gage at 22 6 5 kPa. When a condom is textured, measure the judged not equivalent if they differ by more than the R value
thickness in the nontextured area. Report the measurements to for that material.
the nearest 0.01 mm.
(c) Any judgement in accordance with 4.2.1.4 and 4.2.1.5
4.2.1.4 Precision and Bias—This precision and bias has
would have an approximate 95 % (0.95) probability of being
been prepared in accordance with Practice D 4483. Refer to
correct.
this practice for terminology and other statistical details. The
There are no recognized standards by which to estimate bias
precision results in this precision and bias give an estimate of
of this test method.
the precision for this test method. The precision parameters
should not be used for acceptance or rejection of the material, 4.3 Tensile Properties—This part of the specification speci-
as this data is specific to this round robin and may not be fies a method for determining the breaking force, tensile
representative of other lots, materials or laboratories. Users of strength, and ultimate elongation of rubber contraceptives.
this test method should apply the principles outlined in Practice There are no breaking force, tensile strength, or elongation
D 4483 to their laboratory and materials or between specific requirements for condoms given in this specification.
laboratories. The principles of 4.2.1.5 would then be valid for 4.3.1 Procedures for Tensile Properties—breaking force,
such data. Tables 3 and 4 are based on an interlaboratory study tensile strength, and ultimate elongation. Test methods are
conducted in 2001 in accordance with Practice D 4483 involv- presented in Appendix X1 and Test Methods D 412.
ing three male latex condom materials (A–“thin”, B–regular, 4.3.1.1 As Is—Condoms that are less than 12 months old
C–“thicker”), ten laboratories, two locations on the condom and have not been subjected to accelerated aging.
(open end–150 mm from the shoulder, closed end–30 mm from 4.3.1.2 Accelerated Aging—Heat condoms to be aged in
the shoulder) with two replicates per location taken on the their primary packages at 70 6 2°C for 166 6 2 h in
accordance with Test Method D 573. Determine tensile prop-
TABLE 3 Open End Thickness erties not less than 16 h or not more than 96 h after heating.
Manufacturers may use process control tests to determine
NOTE 1—All values in microns (0.001 mm). suitable shelf life, but accelerated aging at 70°C for 166 h shall
Material Average SrA SRB r C
RD be used for qualification tests and referee tests.
A 61.8 0.8 5.3 2.3 14.8 4.3.2 Precision and Bias—The precision and bias associ-
B 62.2 0.8 4.6 2.3 12.8
C 80.8 1.0 7.0 2.7 19.6
ated with the tensile strength and ultimate elongation of male
A
condoms are as specified in Test Methods D 412.
SR is within-laboratory standard deviation of the average (median/other
function). 4.4 Air Burst Properties—Condoms shall conform to the
B
Sr is the between-laboratory standard deviation of the average (median/other requirements of 4.4.1 for pressure and 4.4.2 for volume.
function).
C
r is the within-laboratory repeatability limit = 2.8 Sr. 4.4.1 Pressure—When tested as described in Annex A2, the
D
R is the between-laboratory reproducibility limit = 2.8 SR. bursting pressure shall not be less than 1.0 kPa.

2
 D 3492 – 03
4.4.2 Volume—When tested as described in Annex A2, the TABLE 6 Burst Volume
bursting volume shall not be less than that as calculated by the NOTE 1—All values in dm3 units.
following equation: Condom Lots Average SrA SR B r C
RD
Vmin 5 0.00592~w 2! (1) A 37.3 4.6 5.4 13.0 15.3
B 30.5 3.3 3.9 9.3 11.1
where: C 38.4 5.2 6.0 14.7 16.9
Vmin = minimum burst volume in dm3, rounded to the nearest 1 dm3, D 37.9 5.6 6.3 15.7 17.9
and E 28.4 4.8 5.1 13.7 14.5
w = nominal flat width in millimetres of the shank portion of the F 37.8 6.1 6.6 17.2 18.8
condom measured 70 6 5 mm from the open end. A
Sr is the within-laboratory standard deviation of the average (median/other
NOTE 3—Cubic decimetre (dm3) is equivalent to litre (L). function).
B
SR is the between-laboratory standard deviation of the average (median/other
4.4.3 Precision and Bias: function).
C
r is the within-laboratory repeatability limit = 2.8 Sr.
4.4.3.1 Table 5 and Table 6 are based on an interlaboratory D
R is the between-laboratory reproducibility limit = 2.8 SR.
study conducted in 1992 in accordance with Practice E 691
involving six condom lots tested by six laboratories. For each
(c) Any judgement in accordance with 4.4.3.1 and 4.4.3.2
lot, all the samples were prepared at one source but the
would have an approximate 95 % (0.95) probability of being
individual specimens were prepared at the laboratories that
correct.
tested them. Each test result was the average of 80 individual
4.4.3.3 There are no recognized standards by which to
determinations. Each lab obtained two test results for each
estimate bias of this test method.
condom lot. (Warning—The explanations of r and R in 4.4.3.2
4.5 Leakage:
are only intended to present a meaningful way of considering
4.5.1 Criteria—Condoms that burst during the test or show
the approximate precision of this test method. The data in Table
any evidence of leakage in the test area, including seepage,
5 and Table 6 should not be rigorously applied to the
microdroplets, squirters, etc., not including leakage at a dis-
acceptance or rejection of condom lot, as those data are specific
tance of 25 mm (1 in.) or less from the open end, will be
to the round robin and may not be representative of other lots,
considered failures. The test method is described in Annex A3.
conditions, materials, or laboratories. Users of this test method
4.5.2 Precision and Bias—No statement is made concerning
should apply the principles outlined in Practice E 691 to
the precision or bias of determining leakage in condoms since
generate data specific to their laboratory and materials, or
the result states merely whether there is conformance to the
between specific laboratories. The principles of 4.4.3.2 would
criteria specified.
then be valid for such data.)
4.4.3.2 Concept of r and R—If Sr and SR have been 5. Packaging
calculated from a large enough body of data for test results that 5.1 Unless otherwise specified, packaging shall be in accor-
were averages (medians/other function) from testing X number dance with the manufacturer’s commercial practice.
of specimens, the following definitions are applicable: 5.2 Condom packages shall be tested in accordance with
(a) Repeatability (r)—Comparing two test methods for the Test Method D 3078 with the pressure reduced at least 50.8
same material obtained by the same operator using the same kPa (15 in. of Hg) below atmospheric pressure. The inspection
equipment on the same day. The two test results should be requirements of Section 10.2 of Test Method D 3078 are not
judged not equivalent if they differ by more than the r value for required. Package integrity requirements are stated in Table 1.
that material.
(b) Reproducibility (R)—Comparing two test results for the 6. Labeling
same material obtained by different operators using different 6.1 Each condom package (individual or retail) shall be
equipment on different days. The two test results should be marked legibly and include the name or trademark of the
judged not equivalent if they differ by more than the R value manufacturer.
for that material. 6.2 The retail package shall contain either the uncoded date
of manufacture or expiration date, which shall be marked as
such.
TABLE 5 Burst Pressure 6.3 The retail package may also contain information regard-
NOTE 1—All values in kPa units. ing the description of the condom (for example, nominal width,
Condom Lots Average SrA SR B rC RD length, texture, shape, etc.).
A 1.86 0.19 0.20 0.53 0.56 7. Storage
B 1.87 0.24 0.25 0.63 0.72
C 1.76 0.18 0.19 0.50 0.53 7.1 Condoms shall not be allowed to come into contact with
D 1.75 0.20 0.21 0.56 0.60 oil-based antiseptics, phenols and their derivatives, petroleum-
E 1.84 0.26 0.26 0.73 0.75
F 1.71 0.19 0.20 0.53 0.56 based products, or other material harmful to rubber.
A
Sr is the within-laboratory standard deviation of the average (median/other 7.2 Latex condoms should be stored in sealed containers in
function). dry areas at temperature below 40°C (104°F). Storage for short
B
SR is the between-laboratory standard deviation of the average (median/other periods of time above this temperature will not be harmful to
function).
C
r is the within-laboratory repeatability limit = 2.8 Sr. product. They should be kept away from direct sources of heat
D
R is the between-laboratory reproducibility limit = 2.8 SR. and ultraviolet light.

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 D 3492 – 03
8. Quality Assurance 9. Keywords
8.1 When specified in the contract or purchase order, the 9.1 condoms; contraceptives; prophylactic; rubber
supplier is responsible for the performance of all inspection
requirements.

ANNEXES

(Mandatory Information)

A1. DETERMINATION OF LENGTH

A1.1 Purpose A1.4.2 Put the condom over the mandrel and let it hang
A1.1.1 Annex A1 specifies a method of determining the freely, stretched only by its own mass.
length of rubber condoms. A1.4.3 Note, to the nearest millimetre, the length of the
condom as indicated on the scale outside the open end of the
A1.2 Principle
condom.
A1.2.1 Free hanging of the unrolled condom over a gradu-
ated mandrel (Fig. A1.1) and observation of its length, the teat A1.5 Test Report
excluded.
A1.5.1 Report the following information:
A1.3 Equipment
A1.5.1.1 Identification of the sample,
A1.3.1 A mandrel with a scale divided into millimetres and A1.5.1.2 Length noted in accordance with A1.4.3, and
having the dimensions shown in Fig. A1.1.
A1.5.1.3 Date of testing.
A1.4 Procedure
A1.4.1 Unroll the condom and smooth out the wrinkles
resulting from the condom having been rolled up.

4
 D 3492 – 03

FIG. A1.1 Mandrel for Determining Length of Condom

5
 D 3492 – 03

A2. AIR BURST TESTING OF CONDOMS

A2.1 Principle pressure within the condom and not at the air inlet line
A2.1.1 A constant length of condom is inflated with air, and pressure, which may be different.
the volume and pressure at the moment of bursting is recorded. A2.2.2 Suitable mount for clamping the condom to the
apparatus without damaging or stretching the condom. The
A2.2 Equipment mount shall be equipped with a rod of sufficient length to
A2.2.1 Apparatus capable of inflating the condom with ensure that the length of condom tested, excluding reservoir (if
clean, oil-free air at a specified rate and provided with any), is 150 6 3 mm. The rod shall terminate in a smooth
equipment for measuring volume inside the condom to an sphere 25 mm in diameter for hanging the unrolled condom
accuracy of 5 % and pressure inside the condom to an accuracy when fixed to the apparatus. Examples of suitable mounts are
of 2 %, respectively. It must be configured to measure the shown in Fig. A2.1 and Fig. A2.2. Additional information

NOTE 1—Other designs for a mechanical clamp system are feasible. This drawing is intended only as an example of one of the possibilities. In any
design of this type of system the important criteria are:
(1) Pressure tap configured such that there is no pressure drop between the condom and the pressure tap.
(2) Length of condom that is free to expand is 150 6 3 mm.
(3) Sphere at top of length limiter is 25.0 6 0.2 mm diameter.
(4) Clamping ring does not pull condom down the cylinder as it is lowered.
FIG. A2.1 Example of Condom Mount for Air Inflation Testing—Mechanical Clamp

6
 D 3492 – 03

NOTE 1—Other designs for an air-operated clamp system are feasible. This drawing is intended only as an example of one of the possibilities. In any
design of this type of system the important criteria are:
(1) Pressure tap configured such that there is no pressure differential between the condom and the pressure tap.
(2) Length of condom that is free to expand is 150 6 3 mm.
(3) Sphere at top of length limiter is 25.0 6 0.2 mm diameter.
(4) Expansion cuff deflates to a diameter such that the condom rolls freely over it.
FIG. A2.2 Example of Condom Mount for Air Inflation Testing—Air-Inflated Cuff

related to the validation of the air burst testing apparatus is temperature conditions prevailing at the opening that leads into the
provided in Appendix X2. condoms.
A2.3.4 If the condom leaks, discontinue the test. In the
A2.3 Procedure analysis of the test results, such behavior does not constitute a
A2.3.1 Carry out the test under controlled conditions of sample test. Replace the sample if this occurs.
temperature (25 6 5°C). A2.3.5 If the condom does not leak, measure and record the
A2.3.2 Unroll the condom onto the rod without stretching, bursting volume in cubic decimetres rounded to the nearest 0.5
but ensure that the condom is draped smoothly. Place the dm3, and the bursting pressure in kilopascals rounded to the
unrolled condom on the mount. Seal it to the system and ensure nearest 0.1 kPa.
that air cannot leak through the seal or from the system during
inflation. A2.4 Test Report
A2.3.3 Inflate the condom with air at a constant rate of 0.4 A2.4.1 Include at least the following particulars in the test
to 0.5 dm3/s (24 to 30 dm3/min). report:
NOTE A2.1—The flow rate referred to is that under pressure and A2.4.1.1 Identification of sample,

7
 D 3492 – 03
A2.4.1.2 Bursting volume and bursting pressure of each A2.4.1.3 Date of testing.
condom tested, and

A3. LEAKAGE TEST

A3.1 Test Principle the inner surface of the condom. Allow the condom to hang
A3.1.1 Experience has shown that the water leak test is most freely for not less than 1 min. Inspect the entire surface of the
sensitive when the condom is filled while hanging vertically, its water-filled area of the condom for evidence of leakage.
top is closed off, and the condom is moved into horizontal A3.3.2.4 Close off the top of the condom.
positions and squeezed while it is examined for leaks. A3.3.2.5 Force the water to the top of the condom in a ball,
(Fig. A3.2), examining all surfaces. Maintaining the ball of
A3.2 Test Apparatus water, force the water back to the closed end (Fig. A3.3). Use
A3.2.1 A filling apparatus with a suitably smooth-finished the water to inflate the reservoir end of the condom, expanding
funnel fixture whose design permits the condom under test to it fully (Fig. A3.4).Care should be used not to over-distend the
hang unsupported, that is, with the closed end not touching the reservoir end during squeezing. Turn the condom in an upward
surface below while being filled with water, should be used. position to check for holes. Take the water back to the top of
the condom to examine the entire length for holes (Fig. A3.5).
A3.3 Procedure Upon completion of the examination, the condom may be
A3.3.1 A properly trained and qualified operator will wear snapped or rolled off the mandrel (Fig. A3.6).
gloves or finger cots while conducting this test.
NOTE A3.1—Recent surveys of the marketplace have found products
A3.3.2 A properly trained and qualified operator will:
within the scope of this specification that will not readily contain the 300
A3.3.2.1 Carefully remove the condom from the package, cm3 of water as required for this test. To evaluate these products for
being sure to hold the condom while it is still inside the leakage, manual extension of the condom should be used to allow filling
package in such a manner that during the opening of the with the 300 cm3.
package, the packaging material does not damage or cut the
condom. Remove the condom, and if rolled, unroll the condom A3.3.2.6 If leakage is noted in the upper region of the
to its fullest length. condom near the rim, mark the spot. Remove the condom from
A3.3.2.2 Carefully stretch the condom’s rim and affix the funnel fixture. Empty the water. Measure the distance from
(place) it on the filling apparatus (Fig. A3.1.) the marked spot of the leak to the rim.
A3.3.2.3 Fill each condom to be tested with 300 6 10 cm3
of water whose temperature is not less than 10°C nor greater A3.4 Interpretation of Results
than 40°C. Gently tap the condom to remove air bubbles from A3.4.1 See 4.5.1.

FIG. A3.1 Leakage Test: Step 1

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 D 3492 – 03

FIG. A3.2 Leakage Test: Step 2

FIG. A3.3 Leakage Test: Step 3

FIG. A3.4 Leakage Test: Step 4

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 D 3492 – 03

FIG. A3.5 Leakage Test: Step 5

FIG. A3.6 Leakage Test: Step 6

APPENDIXES

(Nonmandatory Information)

X1. PREPARATION AND TESTING OF RING-STYLE TEST SPECIMENS FOR THE TENSILE TESTING OF CONDOMS

X1.1 Purpose use of guides for the selected sample cutting equipment to
X1.1.1 The purpose of Appendix X1 is to provide informa- ensure the condom is placed at right angles to the cutting die is
tion on the preparation of the ring-type tensile specimens recommended. In addition, the region selected for cutting
supplementary to that provided in Test Methods D 412. Expe- should be inspected carefully prior to cutting to ensure that the
rience with the tensile testing of condoms has resulted in resulting ring specimen is free of film flaws.
several refinements to the methods of specimen preparation
described in Test Methods D 412. It has been demonstrated X1.3 Equipment
during interlaboratory studies of this test procedure that the X1.3.1 Die—A device having parallel cutting edges spaced
hand or mallet cutting of specimens, as allowed by Test 20 6 0.1 mm apart and having a length of at least 70 mm
Methods D 412, results in consistently lower tensile strength designed so that the cutting edges may be replaced or honed
values and considerably greater experimental variability. periodically to maintain the die’s sharpness.
X1.3.2 Cutter—A mechanical press or other apparatus that
X1.2 General ensures that the die’s cutting edges will move in a straight
X1.2.1 The importance of cutting properly prepared ring- vertical direction to the anvil (cutting surface).
type test specimens for the tensile testing of condoms cannot be
NOTE X1.1—Experience has shown that a mechanical press operating
overemphasized. Every effort must be made in the training of at a minimum vertical cutting speed of not less than 500 mm/s (20 in./s)
personnel and the selection of equipment to ensure that the test and constructed so that the die may be attached to the arbor will result in
specimen is clean cut and that the cut across the width of the more uniform specimens. As an alternative, a mallet and die can be used
condom is made at a right angle to the condom’s length. The for sample cutting. However, this method is not recommended since the

10
 D 3492 – 03
quality of the sample produced is greatly affected by the skill of the such a manner that during the opening of the package, the
technician and the technique used. packing material does not damage or cut the condom.
X1.3.3 Anvil (Replaceable Cutting Surface)—The anvil X1.4.1.2 Carefully unroll the condom to its full length.
must be a flat surface large enough to support a replaceable X1.4.1.3 Cut off the reservoir portion at the shoulder area.
backing material that will permit the die to cut cleanly through For round end condoms, cut just below the round end.
the test specimen with minimal damage to the die’s cutting X1.4.1.4 Individually dip each lubricated condom into labo-
edge. The cutting die shall not cut over previous cutting scars ratory grade anhydrous isopropyl alcohol (IPA). For aqueous-
in the backing material. based lubricants, water can be used. The condom should be
held by the ring when dipping.
NOTE X1.2—Experience has shown that 3 mm (0.125 in.) thick high
density polyethylene (HDPE), polyvinylchloride (PVC), rubber, and X1.4.1.5 In a second container containing IPA or water,
polyethylene-coated cardboard are acceptable backing materials. Hard- again individually dip each condom (if necessary).
pressed cardboard also has been used successfully, but care must be taken X1.4.1.6 Subsequently dip each condom in an IPA/dressing
to ensure that the die cutting edge is not damaged. A wide variety of material slurry by submersion and gently mixing. Constant
materials produce good results if they meet the basic requirements of stirring of the slurry is required.
being smooth, flat, and firm. When cutting specimens, excessive penetra-
tion of the cutting surface should be avoided. If considerable penetration NOTE X1.3—All solutions must be changed when necessary.
is required to cut the sample, the cutting surface is not sufficiently firm or
the die is not sufficiently sharp. X1.4.1.7 Dry the condom (reservoir removed) using a
suitable apparatus (see X1.3.8) for a minimum of 15 min.
X1.3.4 Unrolling Mandrel—A device made of suitable Remove any excess dressing material by wiping.
material (smooth and cleanable) that will permit the condom to
X1.4.1.8 Lay the condoms flat on a bench top surface
be unrolled, if necessary, and sized so that the condom is not
covered with towels and allow to air dry at ambient tempera-
stretched during its removal.
ture for a minimum of 16 h. The condoms must be covered in
X1.3.5 Solvents—Water or isopropyl alcohol, or both, to be
some manner during this period.
used to remove lubricant, if required.
X1.3.6 Towel—A soft laboratory grade absorbent material NOTE X1.4—Steps X1.4.1.4 through X1.4.1.8 are applicable to lubri-
to be used to remove lubricant, if required. cated condoms only.
X1.3.7 Dressing Material—Virgin talc, corn starch or silica, X1.4.2 Ring Specimen Preparation—Lay the condom on
or both, (fragrance-free) to be used to assist drying and avoid the replaceable cutting surface, making sure that it is flat and
stickiness during handling and cutting. free of folds and wrinkles.
X1.3.8 Condom Drying Apparatus—An example of suitable
apparatus for drying the condom after removal of the lubricant NOTE X1.5—The cutting die shall not cut over the previous cutting
scars in the backing material.
is shown in Fig. X1.1.
X1.4.2.1 Smooth Surface Condoms—Cut the ring specimen
X1.4 Method in the region approximately 80 mm from the open end of the
X1.4.1 Condom Preparation: condom. Care should be taken to ensure that the cutting edges
X1.4.1.1 Carefully remove the condom from the package, of the die are parallel to the “width” of the condom and
being sure to hold the condom while still inside the package in perpendicular to the “length” of the condom.

NOTE 1—Oil-free, moisture-free compressed air supply.

NOTE 2—Suitable material, for example, glass.
NOTE 3—Reservoir removed.
FIG. X1.1 Condom Drying Apparatus

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 D 3492 – 03
X1.4.2.2 Textured Surface Condoms—Cut the ring speci- X1.4.5 Tensile Tester—Use a tensile tester with a range of
men in a region free of texture and at least 5 mm from the approximately 100 N and a speed of 8.5 6 0.8 mm/s (500
nearest texture or the rim. Care should be taken to ensure that mm/min). Use roller grips at least 20 mm in length and 15 6
the cutting edges of the die are parallel to the “width” of the 1 mm in diameter that rotate on low friction bearings. If
condom and perpendicular to the “length” of the condom. desired, rotate one roller grip mechanically at a rate of
X1.4.2.3 Form-fitting Condoms—Cut the ring specimen in a approximately one revolution in 6 to 10 s.
region free of shaping, that is, in a region in which the edges X1.4.6 Procedure—If necessary, lubricate the roller sur-
of the condom are parallel to and at least 5 mm from the end faces with any rubber lubricant, for example, silicon oil, talc,
of the shaping or the rim. Care should be taken to ensure that etc., that does not affect natural rubber. Place the specimen
the cutting edges of the die are parallel to the “width” of the over the rollers and start the tester. Record the force and
condom and perpendicular to the “length” of the condom. separation of roller centers at break.
X1.4.2.4 Other Styles of Condoms—Cut the ring specimen X1.4.7 Calculations:
in the region approximately 80 mm from the open end of the X1.4.7.1 Calculate the tensile strength as follows:
condoms, if free of texture or shaping, or in any other region
F F
consistent with the intent of forming a ring specimen that, T 5 2 WD 5 0.025 D (X1.1)
when tested, will yield information consistent with assessing
product quality. where:
X1.4.3 Inspection: T = tensile strength, MPa,
X1.4.3.1 Examine the ring specimens for evidence of dam- F = breaking force, N,
age, for example, nicks, or tears along the cut edges, or flaws W = width of ring, 20 mm, and
in the film. Discard any ring specimen determined to be D = mean single wall thickness, mm.
unsuitable and replace with a newly cut specimen from a X1.4.7.2 Calculate the elongation at break as follows:
freshly opened condom prepared as described in X1.4.1. ~2D 1 G 2 C!
X1.4.3.2 Condition all tensile test specimens, if not already E 5 100 C (X1.2)
conditioned, for not less than 3 h at 25 6 5°C and at 50 6 5 %
relative humidity. Test at 25 6 5°C. where:
X1.4.4 Dimensions of Tensile Specimen: E = elongation at break, %,
X1.4.4.1 For each specimen, measure the thickness to the D = distance between centers of rollers at break, mm,
G = circumference of one roller, mm, and
nearest 0.01 mm. Discard any specimen if the three measure-
C = circumference of the specimen, mm.
ments differ by more than 0.02 mm. Record the mean for the
thickness. X1.4.8 Test Report—Report the following information:
X1.4.4.2 Lay the specimen flat. For each specimen, measure X1.4.8.1 Identification of the sample,
the distance between the two folded edges to the nearest 0.5 X1.4.8.2 Breaking force, ultimate tensile strength, and elon-
mm. Multiply the measurement by 2 to obtain the circumfer- gation for each tested condom, and
ence of the ring specimen. X1.4.8.3 Date of testing.

X2. AIR INFLATION EQUIPMENT FOR THE DETERMINATION OF BURSTING VOLUME AND PRESSURE:
AN EXAMPLE OF SYSTEM CALIBRATION

X2.1 General second condom over the outside of the first condom and
X2.1.1 Due to the diversity of equipment used by different outside the clamping ring. Do not place the second condom
testing laboratories, it is not practical to define all calibration inside the clamp. Inflate the condom to at least 2.5 kPa and
procedures. However, a general outline (Fig. X2.1) of system observe whether the mark has moved. If there has been
calibration techniques and descriptions of some widely appli- movement of the mark away from the clamp, repair or replace
cable procedures are warranted in order to minimize interlabo- the clamp. If no slippage is seen, proceed to the inflation length
ratory variance. These checks should be carried out before new check (X2.3).
equipment is commissioned, after a modification or repair, and
periodically at pre-established intervals in accordance with X2.3 Inflation Length Check
good laboratory practice. X2.3.1 The specified length of condom to be inflated is 150
6 3 mm. To verify this length, mount a condom on each clamp.
X2.2 Clamp Slip Force Check Mark the condom with a fine-tipped felt pen as close as
X2.2.1 A clamp slip force test ensures that the condom possible to where it is gripped by the clamp. Remove the
length does not vary during inflation. Clamp slip force checks condom and place it on a standard length-measuring mandrel
should be carried out with standard, lubricated, untextured with a tip diameter of 25 mm. Read and record the length at the
condoms. mark. If any measurement is outside the range of 147 to 153
X2.2.2 Install a condom on the clamp and mark the condom mm, check the clamping mechanism to determine if the clamp
with a fine-tipped felt pen at the edge of the clamp. Place a is stretching or interfering with the condom. Make corrections,

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the condom height remains within 50 mm of the initial height,
proceed to the pressure check (see X2.6).
X2.6 Pressure Check
X2.6.1 Pressure gages or transducers should be checked
regularly against a reference meter. A convenient and accurate
reference is a water-tube manometer. The water in the manom-
eter should be clean and the zero should be checked prior to
each use.
X2.6.2 First check gage or transducer reading for zero.
Connect the manometer in parallel with the pressure gage or
transducer. Pressurize the system over the range of 0 to 3 kPa,
and compare the pressure of the gage or transducer to the
manometer.
X2.6.3 If the gage or transducer gives a reading within 0.05
kPa of the manometer, then the calibration is acceptable.
X2.7 Timer Check
X2.7.1 Stopwatches or electric timers should be checked
against nationally certified timers (for example, telephone
clocks or broadcast time signals).
X2.8 Air Flow Rate Check
X2.8.1 This check is to ensure that the air flow rate is within
the specifications 0.4 to 0.5 dm3/s (24 to 30 dm 3/min) when
ambient pressure or temperature changes.
X2.8.2 Calibration of air flow rate is most conveniently
carried out using a suitable variable area flowmeter (rotameter)
calibrated against a nationally or internationally certified dis-
placement flowmeter. Once the rotameter has been calibrated
against a known standard, the actual flow rate can be calculated
using the following equation:
NOTE X2.1—The rotameter must be placed at the air inlet to the
condom.

NOTE 1—Some items, such as leak checks, are a prerequisite to others,

such as volume and pressure checks, but others, such as timer check and
Q 5 qRΠPR 3 T
TR 3 P (X2.1)
inflation length check, can be done independently of most other checks.
FIG. X2.1 Systems Calibration Techniques where:
Q = actual air flow rate (dm3/s),
qR = reference air flow rate (dm3/s) obtained from certified
or replace the clamping mechanism, and then repeat the rotameter conversion chart,
inflation length check. If inflation length is within specifica- PR = reference absolute pressure (kPa) at the rotameter
tions, proceed to the cuff leak check (X2.4). inlet when the rotameter was calibrated against a
certified meter (sum of barometric pressure and gage
X2.4 Cuff Leak Check
inlet pressure),
X2.4.1 For systems having an inflated cuff, there is a TR = temperature (°K) of air flowing through the rotameter
possibility that air could leak from the cuff into the condom when it was calibrated against a certified meter,
while the cuff is still clamping effectively. P = absolute pressure (kPa) at the rotameter inlet when
X2.4.2 If there is an isolation valve between the cuff and the determining air flow rate (barometric pressure and
air supply, isolate the cuff and then observe to see that the cuff gage inlet pressure), and
is still inflated after 5 min. T = temperature (°K) of air passing through the rotameter
when determining air flow rate.
X2.5 System Leak Check
X2.5.1 Inflate two condoms one over the other to approxi- X2.9 Volume Check
mately 20 dm3 (about 40 s inflation time), and turn off the air X2.9.1 In-line Volume Meter—For systems equipped with
supply. Record the height of the condom. Recheck the height an in-line volume meter, the meter can be checked against a
after 10 min. If the change in height of the condom is over 50 rotameter or other certified volume meter.
mm, repeat the test with two other condoms. If there is still a X2.9.1.1 A rotameter can be placed in-line with the volume
significant height reduction, check the system for air leaks. If flowmeter, and the reading on the volume meter can be

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 D 3492 – 03
compared with the product of the true flow rate (as calculated X2.10 Verification of Automated Systems
in X2.8) and a fixed time of calibration, for example, 60 s. The
X2.10.1 On systems where results (for example, volume,
pressure at the inlet to the rotameter and at the volume
inflation time, and pressure) are recorded automatically, it is
flowmeter must be the same or a correction must be made
necessary to check that all parameters recorded are actually
(using the perfect gas law) for any expansion between the
those at the time of burst. This must be done for each test head
volume flowmeter and test head.
in the system.
X2.9.2 Air Flow Rate Multiplied by Time—For systems that
use air flow rate multiplied by time to determine the burst X2.10.2 Manually calculate the burst volume using the
volume, a correction factor must be used for the compressibil- calculation outlined in X2.9.2. A stopwatch should be used to
ity of the gas. The following equation will provide the actual record the inflation time to the nearest 0.1 s. Inflation time is
air volume inside the condom at the time of burst: defined as the period from which the air flow begins to inflate

S D
the condom to the burst moment. Compare the manually
Pbar
V 5 Qt P 1 P (X2.2) calculated burst volume to the automated burst volume. If the
bar burst
results are significantly different, the automated system infla-
where: tion time and flow rate calculation should be checked.
V = burst volume (dm3), X2.10.3 For systems using a volume flowmeter, the com-
Q = actual air flow rate (dm3/s) (see X2.6), puter output should be checked against the meter reading. The
t = time to burst (s), burst pressure should be manually recorded and compared
P bar = barometric pressure (kPa), and against the automated readout. If the pressure is significantly
Pburst = condom pressure at burst (kPa). different, refer to X2.6 for pressure check.

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