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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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 de
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