ISO 23409:2011
(Main)Male condoms — Requirements and test methods for condoms made from synthetic materials
Male condoms — Requirements and test methods for condoms made from synthetic materials
ISO 23409:2011 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.
Préservatifs masculins — Exigences et méthodes d'essai pour les préservatifs fabriqués en matières synthétiques
General Information
Standards Content (Sample)
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 23409:2011(E)
©
ISO 2011
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ISO 23409:2011(E)
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ISO 23409:2011(E)
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
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ISO 23409:2011(E)
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.
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ISO 23409:2011(E)
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.
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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]
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ISO 23409:2011(E)
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.
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ISO 23409:2011(E)
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
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ISO 23409:2011(E)
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.
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ISO 23409:2011(E)
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
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ISO 23409:2011(E)
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.
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ISO 23409:2011(E)
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
s
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