ISO 23409:2011

INTERNATIONAL ISO
STANDARD 23409
First edition
2011-02-15
Male condoms — Requirements and test
methods for condoms made from
synthetic materials
Préservatifs masculins — Exigences et méthodes d'essai pour les
préservatifs fabriqués en matières synthétiques

Reference number
©
ISO 2011
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©  ISO 2011
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ii © ISO 2011 – All rights reserved

Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
4 Quality verification .3
5 Lot size .4
6 Biocompatibility.4
7 Product claims.4
8 Design.4
9 Preclinical evaluation.5
10 Clinical (human use) investigations.6
11 Bursting volume and pressure .6
12 Freedom from holes.7
13 Stability and shelf-life .7
14 Visible defects .8
15 Package integrity for individual container.8
16 Packaging and labelling.8
17 Data sheet and test report .11
Annex A (normative) Sampling plans intended for assessing compliance of a continuing series of
lots with sufficient number to allow the switching rules to be applied .12
Annex B (informative) Sampling plans that are intended for assessing the compliance of isolated
lots .13
Annex C (normative) Determination of total lubricant for condoms in individual containers.14
Annex D (normative) Determination of length .16
Annex E (normative) Determination of width.18
Annex F (normative) Determination of thickness.19
Annex G (informative) Determination of barrier properties using the bacteriophage method.20
Annex H (normative) Determination of the bursting volume and pressure.24
Annex I (informative) Calibration of air inflation equipment for determination of burst volume and
pressure .27
Annex J (normative) Testing for holes .31
Annex K (normative) Determination of shelf-life by real-time stability tests.36
Annex L (informative) Guidance on conducting and analysing ageing studies .38
Annex M (normative) Tests for individual container integrity.40
Annex N (informative) Oven treatment for condoms made from synthetic materials .42
Bibliography.43

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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 23409 was prepared by Technical Committee ISO/TC 157, Non-systemic contraceptives and STI barrier
prophylactics.
iv © ISO 2011 – All rights reserved

Introduction
Synthetic condoms can be made from 100 % synthetic materials or a blend of synthetic materials and natural
rubber latex. The material(s) used in synthetic condoms should be validated as constituting a barrier to human
immunodeficiency virus (HIV), to other infectious agents responsible for the transmission of sexually
transmitted infections (STIs), and to spermatozoa. It is essential that the condoms fit the penis properly, remain
on the penis during use, are free from holes and have adequate physical strength so as not to break or tear
during use so that the condoms can be deemed to be effective for contraceptive purposes and in order to help
prevent the transmission of STIs. It is also important that they be correctly packaged so that they are
protected during storage and suitably labelled. All of these issues are addressed in this International Standard.
To be safe, it is essential that the condom and any lubricant, additive, marking materials, dressing, individual
packaging material or powder applied to it neither contain nor liberate substances in amounts that are toxic,
likely to produce allergies (sensitization), locally irritating or otherwise harmful under normal conditions of
storage and use.
Condoms are medical devices. To ensure high quality product, it is essential that condoms be produced under
[4]
a quality management system using design controls. Reference can be made, for example, to ISO 9001 , to
[8] [9]
ISO 14971, and to ISO 13485 . Additional guidance can be found in ISO 16038 .
Condoms are non-sterile medical devices; however, a clean environment is essential to minimize
microbiological contamination of the product during manufacturing and packaging.
Condoms can be of the designs given in the following terms, which are not intended to be exhaustive: smooth,
textured, parallel-sided, non-parallel-sided, plain-ended, reservoir-ended, dry, lubricated, transparent,
translucent, opaque, coloured, preshaped, welded or non-welded.
This International Standard specifies preclinical, clinical, and lot-by-lot physical requirement testing for
condoms made from synthetic materials, including condoms made from a blend of synthetic materials and
natural rubber latex. Application of lot-by-lot testing requirements becomes relevant only after the preclinical and
clinical requirements of this International Standard have been met.
INTERNATIONAL STANDARD ISO 23409:2011(E)

Male condoms — Requirements and test methods for condoms
made from synthetic materials
1 Scope
This International Standard specifies the minimum requirements and the test methods applicable to male
condoms produced from synthetic materials or blends of synthetic materials and natural rubber latex which
are used for contraceptive purposes and to aid in the prevention of sexually transmitted infections.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 2859-1, Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by
acceptance quality limit (AQL) for lot-by-lot inspection
ISO 4074, Natural latex rubber condoms — Requirements and test methods
ISO/TR 8550 (all parts), Guidance on the selection and usage of acceptance sampling systems for inspection
of discrete items in lots
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15223 (all parts), Medical devices — Symbols to be used with medical device labels, labelling, and
information to be supplied
ISO 16037, Rubber condoms for clinical trials — Measurement of physical properties
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 2859-1 and the following apply.
3.1
acceptance quality limit
AQL
quality level that is the worst tolerable process average when a continuing series of lots is submitted for
acceptance sampling
[ISO 2859-1:1999, 3.1.26]
3.2
male condom
medical device, intended to cover and to be retained on the penis during sexual activity, used by consumers
for purposes of contraception and prevention of sexually transmitted infections
NOTE If a consumer can responsibly consider a device to be a male condom (due to its shape, packaging, etc.) it is
considered to be a male condom for the purposes of this International Standard.
3.3
consumer package
package, intended for distribution to a consumer, containing one or more individual containers of condoms
3.4
expiry date
date after which a condom is not suitable for use
3.5
identification number
number, or combination of numerals, symbols or letters, used by a manufacturer on consumer packages to
identify uniquely the lot numbers of individual condoms contained in that package, and from which it is
possible to trace those lots through all stages of manufacturing, packaging and distribution
NOTE When the consumer package contains only one type of condom, then the identification number can be the
same as the lot number. However, if the consumer package contains several different types of condoms, e.g. condoms
of different shapes or colours, then the identification number is different from the lot numbers.
3.6
individual container
primary package containing a single condom
3.7
inspection level
relationship between lot size and sample size
NOTE For a description, see ISO 2859-1:1999, 10.1.
3.8
lot
collection of condoms of the same design, colour, shape, size and formulation, manufactured at essentially
the same time, using the same process, raw materials of the same specifications and common equipment,
and packed with the same lubricant and any other additive or dressing in the same type of individual container
3.9
lot number
number, or combination of numerals, symbols or letters, used by the manufacturer to identify a lot of
individually packaged condoms, and from which it is possible to trace that lot through all the stages of
manufacture up to packaging
3.10
lot test
test to assess the conformity of a lot
NOTE A lot test may be limited to include only those parameters that can change from lot to lot.
3.11
non-visible hole
hole in a condom that is not visible under normal or corrected vision, but is detected by a suitable water leak
test or electrical test
NOTE Suitable tests are specified in this International Standard.
2 © ISO 2011 – All rights reserved

3.12
sampling plan
specific plan which indicates the number of units of product from each lot which are to be inspected (sample size
or series of sample sizes) and the associated criteria for determining the acceptability of the lot (acceptance and
rejection numbers)
3.13
shelf-life
period from date of manufacture, during which condoms are required to conform to specified requirements for
burst pressure, burst volume, freedom from holes, and pack integrity
NOTE Suitable requirements are specified in this International Standard.
3.14
synthetic material
any base material other than 100 % natural rubber latex that is used to make condoms
NOTE This term applies to both condoms made from all synthetic materials and to condoms made from synthetic and
latex blends.
3.15
visible hole
hole in the condom that is visible under normal or corrected vision before the condom is filled with water or
electrolyte during testing for freedom from holes
3.16
date of manufacture
date of sheath formation or the date the condoms are packed in their individual containers provided that, in the
latter case, a maximum period of bulk storage is specified and shelf-life studies have been conducted on
condoms that have been subjected to the maximum bulk storage period
3.17
visible defect (other than hole or tear)
broken, missing or severely distorted rim, and permanent creases with adhesion of the film
4 Quality verification
Condoms are mass produced articles manufactured in very large quantities. Inevitably, there is some variation
between individual condoms, and a small portion of condoms in each production run that might not meet the
requirements of this International Standard. Further, the majority of the test methods described in this
International Standard are destructive. For these reasons, the only practicable method of assessing
conformity with this International Standard is by testing a representative sample from a lot or series of lots.
Basic sampling plans are given in ISO 2859-1. Refer to ISO/TR 8550 for guidance on the selection of an
acceptance sampling system, scheme or plan for the inspection of discrete items in a lot. For testing purposes,
sampling shall be conducted by lot number, not by identification number.
When ongoing verification is required of the quality of condoms, it is recommended that, instead of
concentrating solely on evaluation of the final product, the party concerned also directs their attention to the
[3]
manufacturer's quality system. In this connection it should be noted that the ISO 9000 family and in
[8]
particular ISO 13485 cover the provision of an integrated quality system.
Sampling plans shall be selected to provide an acceptable level of consumer protection. Suitable sampling
plans are given in Annexes A and B.
a) Annex A describes sampling plans based on ISO 2859-1 and is most applicable to manufacturers or
purchasers assessing the conformity of a continuing series of lots. The full level of consumer protection
available depends upon the switch to tightened inspection if deterioration in quality is detected. The
switching rules cannot offer their full protection for the first two lots tested, but become progressively more
effective as the number of lots in a series increases. The sampling plans in Annex A are recommended
when five or more lots are being tested.
b) Annex B describes sampling plans, based on ISO 2859-1, that are recommended for the assessment of
isolated lots. The sampling plans in Annex B provide approximately the same level of consumer
protection as those given in Annex A when used with switching rules. It is recommended that these
sampling plans be used for the assessment of fewer than five lots, e.g. in cases of dispute, for referee
purposes, for type testing, for qualification purposes or for short runs of continuous lots.
c) Handling and storage conditions shall be documented before drawing the samples.
It is necessary to know the lot size in order to derive from ISO 2859-1 the number of condoms to be tested.
The lot size varies between manufacturers and is regarded as part of the process and quality controls used by
the manufacturer.
5 Lot size
The maximum individual lot size for production is 500 000.
Otherwise, this International Standard does not specify the size of a lot, but it is possible for a purchaser to do
so as part of the purchasing contract. Purchasers are encouraged to specify a lot size compatible with the
manufacturer's quality management system.
6 Biocompatibility
For any product which is new or which has undergone a significant change to the formulation or
manufacturing process, biocompatibility assessments shall be conducted in accordance with ISO 10993-1.
Testing for cytotoxicity according to ISO 10993-5, irritation according to ISO 10993-10, and sensitization
(delayed contact hypersensitivity) according to ISO 10993-10 shall be conducted. Many synthetic products
that have been established as safe, including condoms and medical gloves, can exhibit a positive cytotoxic
response when tested according to ISO 10993-5. While any cytotoxic effect can be of concern, it is primarily
an indication of potential for in vivo toxicity and a condom cannot necessarily be determined to be unsuitable
for use based solely on cytotoxicity data. The condom together with the any lubricant, additive, dressing
material, or powder applied to it shall be tested. Regulatory bodies might also specify specific local
requirements. Accredited laboratories shall be used for the testing. Regulatory bodies might require the results
to be interpreted by a qualified toxicologist or other suitably qualified expert. The biological assessment report
shall justify that the product is safe under normal conditions of use.
7 Product claims
Condoms meeting the requirements of this International Standard can be used for contraceptive purposes and
help protect against sexually transmitted infections. Manufacturers shall justify any additional claims made for
their products. If a manufacturer makes a claim relating to improved efficacy or safety then the claim shall be
substantiated by clinical investigation. Manufacturers shall make information justifying such claims available to
regulatory bodies, notified bodies, and consumer protection authorities.
8 Design
8.1 Retention mechanism
If a mechanism to retain the condom on the penis or an integral bead is required by the condom design, then
it shall comply with Clause 14.
4 © ISO 2011 – All rights reserved

8.2 Lubrication
If verification is required of the quantity of lubricant in a package, the method given in Annex C shall be used.
The criteria of compliance shall be as agreed between the parties concerned.
The method in Annex C also recovers part of the dressing powder on the condom. An allowance should be
made for this when manufacturers or purchasers specify lubricant levels.
8.3 Dimensions
8.3.1 Length
When tested according to the method given in Annex D, taking 13 condoms from each lot, no individual
measurement shall be below 160 mm.
8.3.2 Width
When tested by the method given in Annex E, measuring at the narrowest part of the condom in the range of
20 mm to 50 mm from the open end, taking 13 condoms from each lot, no measurement of the width shall
deviate from the nominal width stated by the manufacturer by more than ±2 mm.
Where the design of the condom is such that this measurement cannot be made reliably or the narrowest
point within the first 50 mm from the open end of the condom is at the bead, the method of measurement shall
be provided by the manufacturer.
8.3.3 Thickness
If verification is required of the thickness of a condom, the thickness, determined in accordance with the
method given in Annex F, shall be equal to the claimed thickness, subject to a tolerance of:
a) ±0,008 mm for condoms with thickness less than 0,05 mm;
b) ±0,01 mm for condoms with thickness between 0,05 mm and 0,08 mm;
c) ±0,015 mm for condoms with thickness greater than 0,08 mm.
9 Preclinical evaluation
A risk analysis of the product shall be conducted in accordance with ISO 14971. The analysis shall identify
safety and efficacy concerns, and shall address at least the areas where the risks are in excess of those
encountered with natural rubber latex condoms conforming to ISO 4074.
The barrier properties of the condom shall be established by viral penetration studies using simulated use
conditions and a suitable surrogate virus, e.g. bacteriophage phiX 174. Viral penetration properties shall be
compared with those of a latex condom that meets the requirements of ISO 4074. A suitable procedure for
conducting these studies is given in Annex G. The number of test condoms exhibiting leakage of virus
−6
suspension fluid above the detection limit of 2 ¯ 10 ml should not be significantly worse than for the control
latex condom. Appropriate statistical procedures may be used to analyse the results using a 95 % confidence
interval.
Biocompatibility for the finished product and its components shall be established in accordance with the
relevant clauses of ISO 10993-1, ISO 10993-5, and ISO 10993-10. Condoms are a surface device with
repeated contact with mucosa and possibly compromised tissue surfaces. The tests shall indicate whether the
device produces cytotoxicity, sensitization, or mucosal irritation. It is possible for additional testing, e.g. for
[6]
systemic toxicity in accordance with ISO 10993-11 , to be required, depending upon the nature of the
materials used or to meet local regulatory requirements. If there is a likelihood of systemic absorption of any
components or residuals, mutagenicity testing shall be performed. Regulatory bodies can require the results to
be interpreted by a qualified toxicologist or suitably qualified scientist. The biological assessment report shall
justify that the product is safe under normal conditions of use.
All data generated in these investigations shall be available to regulatory authorities on request.
The manufacturer shall obtain, and make available on request from regulatory authorities, toxicity data on all
the additives and residual monomers, residual solvents and known impurities resulting from the manufacture
of the condom. Suitable material safety data sheets are to be supplied as requested for materials used in the
manufacture of products in compliance with this International Standard.
10 Clinical (human use) investigations
The manufacturer shall conduct a randomized controlled clinical investigation comparing the synthetic condom
to a control condom made from natural rubber latex.
a) Clinical investigations in humans shall be conducted in accordance with local regulatory requirements, as
well as ISO 14155.
b) The clinical failure rate (combined slippage and breakage rates) of the synthetic condom shall be non-
inferior to the clinical failure rate of the control condom made from natural rubber latex.
c) In order to demonstrate non-inferiority the upper limit of the one-sided 95 % confidence interval for the
test condom clinical failure rate minus the control condom clinical failure rate shall be less than or equal to
2,5 %.
The limit shall be calculated using a method that accounts for the unique characteristics of data such as:
1) each study participant may contribute data from more than one condom use;
2) very low event rates.
d) For the control condom, the clinical failure rate shall be less than 4,0 %.
e) The control condom shall be made from natural rubber latex and shall conform to ISO 4074.
f) The physical properties of the natural rubber control condom shall be determined in accordance with
ISO 16037.
[10]
NOTE See ISO 29943-1 .
For products in the market prior to the publication of this International Standard, manufacturers may use data
from existing clinical investigations. Information on the studies shall be made available to regulatory and
governmental authorities upon request.
11 Bursting volume and pressure
Manufacturers shall establish appropriate minimum pressure and volume limits for the specific condom based
on the airburst properties of the lot or lots used for the clinical trial. Determine the airburst properties of the lot
or lots used in the clinical study using a sample size of at least 2 000 condoms. If more than one lot was used
in the clinical study then the sample shall be drawn across all the lots, each individual lot being sampled
proportionally to its size. Set the minimum airburst limits at 80 % of the 1,5 percentile values of the airburst
volumes and pressures determined above.
6 © ISO 2011 – All rights reserved

For the purposes of this International Standard, the relevant percentile, x, shall be determined by ranking the
N data values and taking the value of the nth rank, where
Nx 1
n=+
100 2
rounded to the nearest integer (e.g. for N = 2 000, the lower 1,5 percentile is the 31st lowest value).
NOTE 1 Based on data supplied by manufacturers for both synthetic and natural rubber latex condoms, taking 80 % of
the 1,5 percentile values provides an adequate tolerance for the long-term lot-to-lot variability seen in normal manufacture.
For products in the market prior to the publication of this International Standard, manufacturers may use
existing specifications as established by their regulatory bodies for bursting properties, subject to those
specifications being consistent with the above requirements based on a representative sample of the product
tested at the time of the clinical trial. Information regarding the establishment of these values shall be made
available to regulatory and governmental authorities upon request.
[32]
NOTE 2 To ensure that the limits are appropriate, testing can be done by a laboratory accredited to ISO/IEC 17025 ,
by an accreditation body, or organization that is a member of the International Laboratory Accreditation Cooperation.
When tested using the methods given in Annex H, the bursting volumes and bursting pressures shall not be
less than the minimum values specified above. The compliance level shall be an acceptance quality limit
(AQL) of 1,5 for non-conforming condoms. A non-conforming condom is defined as a condom that fails the
requirements for volume, pressure or both, or any condom that exhibits obvious leakage.
12 Freedom from holes
When tested by the methods described in Annex J, the compliance level for each lot, for the sum of condoms
with visible and non-visible holes and tears, shall be an AQL of 0,25.
13 Stability and shelf-life
13.1 General
Manufacturers shall verify that the condoms comply with the requirements of Clauses 11, 12, and 15 until the
end of the shelf-life on the label. Shelf-life claims shall not exceed 5 years.
Data supporting shelf-life claims shall be made available to the appropriate regulatory authorities and direct
purchasers upon request.
Before compliance with this International Standard may be claimed, the manufacturer shall provide evidence
that:
a) a real-time study as described in 13.2 to determine shelf-life has commenced;
b) pending completion of the real-time study, shelf-life claims as described in 13.3 can be substantiated.
13.2 Procedure for determining shelf-life by real-time stability studies
After testing according to Annex K, the condom shall meet the requirements of Clauses 11, 12 and 15.
If the real-time data indicate a shorter shelf-life than that claimed on the basis of accelerated ageing (13.3),
the manufacturer shall notify the relevant regulatory authorities and direct purchasers. The manufacturer shall
change the shelf-life claims for the product to the one based on the real-time study. In no case shall the shelf-
life exceed 5 years.
For condoms placed on the market based on accelerated stability studies, real-time stability studies shall be
completed for the full period of the shelf-life claim.
13.3 Estimating shelf-life based upon accelerated stability studies
Pending the completion of real-time studies, manufacturers shall substantiate the original shelf-life claims.
Accelerated stability studies may be used for this purpose.
Further information on stability studies is provided in Annex L. Data generated from such studies should
support the claim that the condoms fulfil the requirements in Clauses 11, 12, and 15 for the duration of the
+5
shelf-life on the label at 30 °C.
−2
14 Visible defects
For visible defects as described in Annex J (J.2.3.3), the compliance level for each lot shall be an AQL of 0,4.
15 Package integrity for individual container
When an individual container comprising one or more flexible laminated films sealed together is tested in
accordance with Annex M, it shall pass the test. The compliance level for each test shall be an AQL of 2,5. An
AQL of 0,4 shall be applied to individual containers that have visibly open seals.
For other designs of individual containers, the manufacturer shall apply a suitable pack integrity test. The
compliance level for each test shall be an AQL of 2,5. The method given in Annex M may be used with
suitable adjustment to the level of vacuum applied. Details of the test method shall be provided on request.
16 Packaging and labelling
16.1 Packaging
Each condom shall be packed in an individual container. One or more individual containers may be packed in
other packaging such as a consumer package. The individual container, or consumer package or both, shall
protect the condom from environmental damage as is appropriate for the product. If condoms are supplied
directly to consumers in individual containers then the individual container shall be regarded as a consumer
package and shall meet all the labelling requirements.
Any marking medium, such as ink, used on a condom or any part of the package directly in contact with the
condom, shall not have a deleterious effect on the condom or be harmful to the user.
Individual containers and any other packaging shall protect the condom from damage during transport or
storage. Individual containers and any other packaging shall be designed in such a way that the package can
be opened without damaging the condom. The design of the individual container should facilitate easy
opening.
Manufacturers shall ensure that each lot complies with the established specification for packaging.
16.2 Labelling
NOTE National or other regulations relating to labelling, e.g. for latex allergy, which could be more stringent, can
apply.
16.2.1 Symbols
Any symbols used on packaging, information, and marketing materials shall meet the requirements of
ISO 15223.
8 © ISO 2011 – All rights reserved

16.2.2 Individual container
Each individual container shall be indelibly and legibly marked with at least the following information:
a) the identity of the manufacturer or distributor or, if permitted by local regulations, the registered brand or
trade mark;
b) the manufacturer's identifying reference for traceability (e.g. the lot number);
c) the expiry date (year and month) — the format of the year shall be in four digits and the format of the
month shall be in letters or two digits.
If the individual container is distributed outside a consumer pack within Europe then the CE Mark and address
of the manufacturer or European Authorized Representative shall be printed on the individual pack and the
requirements of 16.2.4 shall be met.
16.2.3 Consumer package
16.2.3.1 General. Where products are supplied for distribution in consumer packages, the packages shall
conform to the requirements of 16.2.3.2 and 16.2.3.3.
16.2.3.2 Consumer package exterior. The outside of the consumer package shall bear at least the
following information in at least one of the official languages of the country of destination or as stipulated
differently by that country or the purchaser and the seller:
a) a description of the condom, whether it is contoured or has a reservoir, and if it is coloured or textured;
b) the number of condoms contained in the consumer package;
c) the nominal width of the condom;
d) the name or trade name and address of the manufacturer and/or distributor, depending on national and
regional requirements;
e) the expiry date (year-month or month-year). If a consumer package contains condoms from different lots,
the earliest expiry date shall apply to all condoms;
f) a statement of storage instructions appropriate for the material used;
g) conditions that are impervious to light or other environmental conditions deleterious to the packaging of
the condom;
h) whether the condom is lubricated or dry — when a medicinal ingredient is added, it shall be identified and
its purpose indicated (e.g. spermicidal), and if the condom or lubricant is fragranced or flavoured, this
shall also be stated;
i) the manufacturer's identifying reference for traceability (e.g. the identification number/lot number) — if
different types of condoms, e.g. of different colours, are packaged together in the same consumer
package, the identification number on the consumer package shall allow the manufacturer to identify
uniquely the lot numbers of the individual condoms contained in that package, so that it is possible to
trace those lots through all stages of manufacture up to packaging;
j) a statement indicating the type of synthetic material used, and whether the material contains natural
rubber;
k) a statement indicating that the condom is for single use;
l) the number of this International Standard (ISO 23409:2010);
m) any other applicable warning as required;
n) if necessary, a statement alerting consumers to any potential allergic reactions as a result of product use.
16.2.3.3 Instructions for use. The outside or the inside of the consumer package, or a leaflet contained
within the consumer package, shall bear at least the following instructions for use expressed in simple terms
and in at least one of the official languages of the country of destination, if possible supplemented by pictorial
representation of the major steps involved or as stipulated differently by that country:
a) the need to handle the condom carefully, including removal from the packaging in order to avoid damage
to the condom with fingernails, jewellery, etc.;
b) how and when to put on the condom; mention should be made that the condom should be placed on the
erect penis before any contact occurs between the penis and the partner's body so as to assist in the
prevention of sexually transmitted infections and pregnancy;
c) the need to stop and check if the user feels the condom slipping or tightening excessively on to the penis
because this can lead to breakage;
d) the need to withdraw the penis soon after ejaculation, while holding the condom firmly in place at the
base of the penis;
e) the need, if an additional lubricant is desired, to use the correct type of lubricant which is recommended
for use with the type of condom concerned;
f) the need to consult a doctor or pharmacist about the compatibility of topical medicines that might come in
contact with the condom;
g) advice to seek medical assistance as soon as possible, at least within 72 h should a condom leak or burst
during use;
h) advice that if the individual container is obviously damaged to discard that condom and use a new one
from an undamaged package;
i) instructions on how to dispose of the used condom;
j) a statement that the condom is for single use — if the condom is reused there might be an increased risk
of failure or infection;
k) the number of this International Standard (ISO 23409:2011);
l) the date of issue or the date of the latest revision of the instructions for use.
16.2.4 Condoms not distributed in consumer packages
For condoms that are distributed without a consumer package (e.g. in single foils or strips of foils), it is the
responsibility of the organization distributing the condoms to ensure that adequate information is supplied to
the user in accordance with local regulations. The individual condom containers shall comply with local
labelling requirements. If such condoms are for distribution in Europe, the labelling should be in accordance
[30] [31]
with the European Medical Device Directive 93/42/EEC as modified by 2007/47/EC .
This information may be in the form of leaflets, training sessions, posters, or additional packing added in the
distribution chain. For guidance on the content, see 16.2.3.2 and 16.2.3.3.
16.3 Inspection
For each lot, 13 consumer packages and 13 individual containers shall be inspected for conformity. All
inspected containers shall conform to the requirements of this International Standard.
Under certain conditions, it might be permissible for the manufacturer or distributor to correct faults associated
with packaging and labelling requirements and to resubmit the lot for further conformity testing. Examples
include insertion of missing instruction leaflets or the re-packaging of individual containers into entirely new
complete consumer packages before placing on the market.
10 © ISO 2011 – All rights reserved

If condoms of the same lot are packed into different consumer packages, then at least one consumer package
of each variant should be inspected. The number of packages inspected should not exceed 13, unless the
number of variants exceeds 13.
17 Data sheet and test report
17.1 Data sheet
The manufacturer shall make available to all interested parties a data sheet that contains, for each product
variant, at least the following information:
a) mean nominal dimensions (length, width, thickness);
b) airburst means and values for volume and pressure with limits based on testing according to Clause 11;
c) materials used in the construction of the condom;
d) nominal quantity and type of lubricant;
e) name and address of manufacturer and contractors (if appropriate);
f) reference to the clinical investigation conducted in accordance with Clause 10.
17.2 Test report
The test report shall contain at least the following information:
a) name and address of the test laboratory;
b) name and address of the client;
c) identification of the test report;
d) identification of the sample (sample size, lot number and lot size);
e) origin of the sample, date of the arrival of the sample in the laboratory, and who has taken the sample;
f) a reference to this International Standard (ISO 23409:2011) and the relevant annexes;
g) a listing of the minimum acceptance requirements for each applicable test (dimensions, freedom from
holes, airburst properties, package integrity, visible defects, quantity of lubricant, including measurements
and tolerances);
h) description of all deviations from this International Standard;
i) results according to the relevant annexes;
j) measurement error, if available;
k) date of the test report and the signature and title of the person(s) responsible for the report.
Normally it is recommended that condoms used in testing be destroyed after testing. Sometimes condoms
need to be kept to demonstrate particular problems. Thus it is important that the condoms be marked or
stored in such a way that unintentional use is prevented.
Annex A
(normative)
Sampling plans intended for assessing compliance of a continuing
series of lots with sufficient number to allow the switching rules
to be applied
A.1 Quality verification
When ongoing verification is required of the quality of condoms, it is suggested that, instead of concentrating
solely on evaluation of the final product, the party concerned also directs their attention to the manufacturer's
[3] [8]
quality system. In this connection it should be noted that the ISO 9000 family, and in particular ISO 13485 ,
covers the provision of an integrated quality system.
A.2 Sampling plans and compliance levels
If a party wishes to establis
...