ISO 25841:2014

INTERNATIONAL ISO
STANDARD 25841
Second edition
2014-01-15
Female condoms — Requirements and
test methods
Préservatifs féminins — Exigences et méthodes d’essai
Reference number
©
ISO 2014
© ISO 2014
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Published in Switzerland
ii © ISO 2014 – All rights reserved

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Quality verification . 3
5 Design . 4
5.1 General . 4
5.2 Product insertion feature . 4
5.3 Retention features . 5
5.4 Lubrication . 5
5.5 Dimensions . 5
5.6 Risk assessment . 6
6 Barrier properties . 6
7 Biocompatibility . 7
8 Clinical (human use) investigations . 7
9 Bursting volume and pressure . 8
9.1 Minimum values. 8
9.2 Sampling and requirements . 9
10 Tests for stability and shelf-life . 9
10.1 General . 9
10.2 Procedure for determining shelf-life by real-time stability studies . 9
10.3 Procedure for estimating shelf-life based upon accelerated stability studies . 9
11 Freedom from holes .10
12 Visible defects.10
13 Packaging and labelling .10
13.1 Package integrity .10
13.2 Packaging .10
13.3 Labelling .10
13.4 Inspection .12
14 Data sheets.13
Annex A (normative) Sampling plans intended for assessing compliance of a continuing series of
lots of sufficient number to allow the switching rules to be applied .14
Annex B (informative) Sampling plans intended for assessing compliance of isolated lots .15
Annex C (normative) Determination of lubricant mass for individual female condom containers 16
Annex D (normative) Determination of female condom length .18
Annex E (normative) Determination of female condom width .19
Annex F (normative) Determination of female condom thickness .20
Annex G (normative) Testing for female condom package integrity .21
Annex H (normative) Determination of barrier properties using the bacteriophage method .23
Annex I (normative) Determination of bursting volume and bursting pressure .28
Annex J (normative) Testing for holes .30
Annex K (normative) Determination of shelf-life by real-time stability studies .36
Annex L (informative) Guidance on conducting and analysing accelerated ageing studies .38
Bibliography .41
iv © ISO 2014 – All rights reserved

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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 157, Non-systemic contraceptives and STI barrier
prophylactics.
This second edition cancels and replaces the first edition (ISO 25841:2011), which has been technically
revised.
Introduction
A female condom is a sheath that completely lines the vaginal canal and is designated to be retained
in the vagina during sexual intercourse and after withdrawal of the penis to prevent pregnancy and
transmission of sexually transmitted infections (STIs).
A female condom is distinguished from a male condom in that it is retained in the vagina after withdrawal
of the penis. The external component of the device can provide some coverage to the external female
genitalia. Non-porous, intact, polymer films can be effective barriers to human immunodeficiency virus
(HIV), to other infectious agents responsible for the transmission of STls, and to spermatozoa. Female
condoms made from polymer films can be effective for contraceptive purposes and in the prevention of
STI transmission. To be effective, it is essential that female condoms completely line the vaginal canal,
be free from holes and defects, have adequate physical properties so as not to break during use, are
correctly packaged to protect them during storage, and are correctly labelled to facilitate their use.
To be safe, it is essential that the female condom and any lubricant, additive, dressing, individual
packaging material, or powder applied to it neither contain nor liberate substances in amounts that are
toxic, sensitizing, locally irritating, or otherwise harmful under normal conditions of storage or use.
Female condoms are non-sterile medical devices, but manufacturers are advised to take appropriate
precautions to minimize microbiological contamination of the product during manufacturing and
packaging. To ensure high quality products, it is essential that female condoms be designed and
produced under a good quality management system. Reference can be made, for example, to ISO 9000,
ISO 9001, ISO 9004, ISO 13485, and ISO 14971. To estimate the shelf-life of any new or modified female
condom, manufacturers conduct stability tests before the product is placed on the market. This ensures
that manufacturers have adequate data to support shelf-life claims and that these data are available
for review by regulatory authorities, test laboratories, and purchasers. They are also intended to limit
the need for third parties to conduct long-term stability studies. Real-time shelf-life studies are also
initiated, but not necessarily completed, prior to placing the product in the market.
Because female condoms are a relatively new class of devices and designs of female condoms vary
considerably, clinical investigations in humans are necessary to continue to build evidence of safety and
efficacy. These investigations enable an assessment of the overall performance of internal and external
retention features, failure modes, safety, and effectiveness of female condoms. This International
Standard represents minimal requirements and test methods and acknowledges that new designs can
require further due rigour of retention and other features as well as additional definition of specifications
and test methods by the manufacturer.
All these issues are addressed in this International Standard.
vi © ISO 2014 – All rights reserved

INTERNATIONAL STANDARD ISO 25841:2014(E)
Female condoms — Requirements and test methods
1 Scope
This International Standard specifies the minimum requirements and test methods for female condoms,
which are supplied to consumers for contraceptive purposes, assisting in the prevention of sexually
transmitted infections.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 2859-1:1999, Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by
acceptance quality limit (AQL) for lot-by-lot inspection
ISO 4074, Natural rubber latex male condoms — Requirements and test methods
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 10993-11, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 14155 (all parts), Clinical investigation of medical devices for human subjects
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
3 Terms and definitions
For the purposes of this document, the terms and definitions 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
[SOURCE: ISO 2859-1:1999, 3.1.26]
3.2
consumer package
package intended for distribution to a consumer, containing one or more individual container(s) of
female condoms
3.3
date of manufacture
date of formation of the female condom sheath or the date the female condoms are packed in their
individual containers provided, in the latter case, a maximum period of bulk storage is specified and
shelf-life studies have been conducted on female condoms that have been subjected to the maximum
bulk storage period
3.4
expiry date
date at the end of the shelf-life
3.5
female condom
sheath that completely lines the vaginal canal and is designed to be retained in the vagina during sexual
intercourse to prevent pregnancy and STIs
3.6
identification number
number, or combination of numerals, symbols, or letters used by a manufacturer on consumer packages
to uniquely identify the lot numbers of individual female condoms contained in that package, and from
which it is possible to trace those lots through all stages of manufacturing, packaging, and distribution
Note 1 to entry: Whenever the consumer package contains only one kind of female condom, the identification
number can be the same as the lot number. However, if the consumer package contains several different types of
female condoms, for instance, female condoms of different shapes or colours, the identification number is different
from the lot number.
3.7
individual container
primary package containing a single female condom
3.8
inspection level
relationship between lot size and sample size
[SOURCE: ISO 2859-1:1999, 10.1]
3.9
lot
collection of female 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, common
equipment, and packed with the same lubricant and any other additive or dressing in the same type of
individual container
Note 1 to entry: This International Standard does not specify the size of a lot; however, it is possible for a purchaser
to do so as part of the purchasing contract. Attention is drawn to the difficulties that can be associated with
the distribution and control of very large lots. The recommended maximum individual lot size for production is
500 000 female condoms.
3.10
lot number
number or combination of numerals, symbols, or letters used by the manufacturer to identify a lot of
individually packaged female condoms, and from which it is possible to trace that lot through all stages
of manufacture up to packaging
3.11
lot test
test to assess the conformity of a lot
Note 1 to entry: A lot test can be limited to include only those parameters that can change from lot to lot.
2 © ISO 2014 – All rights reserved

3.12
non-visible hole
hole in a female condom that is not visible under normal or corrected vision, but is detected by a suitable
water leak test
Note 1 to entry: Leakage during testing can be detected, for instance, by rolling a female condom on absorbent
paper.
Note 2 to entry: Suitable tests are specified in this International Standard.
3.13
sampling plan
specific plan that 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)
3.14
shelf-life
time from date of manufacture to the claimed expiry date during which condoms are required to conform
to specified requirements
3.15
total clinical failure
sum of female condoms that clinically break or slip, or are associated with misdirection, invagination, or
any additional failure mode(s) identified in the risk assessment which results in reduction of the female
condom protective function
Note 1 to entry: Total clinical failure rate is calculated by dividing the number of female condoms with a clinical
failure by the number of female condoms used during sexual intercourse.
3.16
visible hole
hole or tear in the female condom that is visible under normal or corrected vision
3.17
visible defect
other than a visible hole, broken, missing, or severely distorted retention feature, permanent crease
with adhesion of the film, or unintentional adhesion of the film to retention feature, including defect
particles from female condoms or other materials embedded in the female condom wall
4 Quality verification
Female condoms are produced in large quantities. Inevitably, there is some variation between individual
female condoms. A small proportion of female condoms in each production run might not meet the
requirements in this International Standard. Furthermore, the majority of the test methods described
in this International Standard is 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 identified in ISO 2859-1. See 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. Handling and storage
conditions shall be documented before drawing the samples.
Sampling plans shall be selected to provide an acceptable level of consumer protection. Suitable sampling
plans are given in Annexes A and B.
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 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.
Annex B describes sampling plans, based on ISO 2859-1, which are recommended for the assessment of
isolated lots. It is recommended that these sampling plans be used for the assessment of fewer than five
lots, for example in cases of dispute, for referee purposes, for type testing, for qualification purposes, or
for short runs of continuing series of lots.
It is necessary to know the lot size in order to derive from ISO 2859-1 the number of female condoms to
be tested. The lot size varies among manufacturers and is regarded as part of the process and quality
controls used by the manufacturer.
Instead of concentrating solely on evaluation of the final product, the design and manufacture of
the female condoms shall conform to the appropriate requirements of ISO 13485, which include the
following:
a) controls in the work environment to ensure product safety;
b) focus on risk-management activities and design transfer activities during product development;
c) specific requirements for inspection and traceability for implantable devices;
d) specific requirements for documentation and validation of processes for sterile medical devices;
e) specific requirements for verification of the effectiveness of corrective and preventive actions.
5 Design
5.1 General
Female condoms shall be designed to prevent pregnancy and STIs during vaginal intercourse. A female
condom is distinguished from a male condom in that it is retained in the vagina after insertion. A female
condom can be made from natural rubber latex (NRL) or synthetic materials.
The design of a new female condom shall take into consideration the following design aspects:
a) product insertion into the vagina;
b) product retention during sexual intercourse or penile removal;
c) penile misdirection during sexual intercourse;
d) safe product removal after sexual intercourse.
5.2 Product insertion feature
Designs for female condoms shall include either a feature or tool to aid in the proper insertion and
deployment of the female condom or methods for insertion of the female condom without such additional
aids.
The insertion feature design, materials, and/or method shall be evaluated for function as part of design
validation and clinical evaluation of the finished female condom device described in Clause 8.
The insertion feature materials shall be evaluated for biocompatibility (irritation, sensitization,
cytotoxicity, and acute systemic cytotoxicity) as an integrated feature of the finished female condom
device in accordance with Clause 7.
Manufacturers shall identify specifications and test methods as appropriate to verify the design and
to ensure the quality and consistency of components and materials used for each insertion feature.
Examples of specifications the manufacturer should consider include critical dimensions, durometer,
stiffness, and density.
4 © ISO 2014 – All rights reserved

5.3 Retention features
Designs for female condoms shall incorporate intra-vaginal retention features to retain the female
condom within the vagina during sexual intercourse and permit safe withdrawal after use. Intra-vaginal
retention features can be affixed on or placed within the sheath. Examples of intra-vaginal retention
mechanisms include, but are not limited to, elastomeric rings and open or closed cell foam components.
Designs for female condoms shall incorporate external retention features to keep the open end of the
female condom open during sexual intercourse, prevent misdirection of penis, and prevent female
condom invagination. External retention features include, but are not limited to, annular, triangular, or
other-shaped components affixed to the open end of the female condom.
Retention feature designs, materials, and/or methods shall be evaluated for function as part of design
validation and clinical evaluation of the finished female condom device described in Clause 8. They shall
also be evaluated in this manner to ensure the features stay affixed to the sheath or are retained within
the sheath so that they remain intact during sexual intercourse and during product withdrawal, such
that the features are completely removed from the vagina when the female condom is removed from the
vagina.
Retention feature materials shall be evaluated for biocompatibility (irritation, sensitization, and
cytotoxicity) as an integrated feature of the finished female condom device in accordance with Clause 7.
Manufacturers shall identify specifications and test methods as appropriate to verify the design and
to ensure the quality and consistency of components and materials used for each retention feature.
Examples of specifications the manufacturer should consider include critical dimensions, durometer,
stiffness, and density.
5.4 Lubrication
The design of a female condom can include lubrication in any of the following manners:
a) lubricant pre-applied directly on the packaged female condom as supplied;
b) lubricant supplied in a separate container for application to the female condom by the user;
c) both pre-applied and as a separate container.
The type and amount of lubricant is unique to each female condom design. The manufacturer shall
specify the range for the mass of lubricant consistent with the mass of lubricant used in the clinical
trial described in Clause 8. When tested in accordance with the method given in Annex C, taking 13
female condoms from each lot, no female condom lubricant mass measurement shall be outside of the
manufacturer’s specified range.
Manufacturers shall identify specifications and test methods as appropriate to verify the design and to
ensure the quality and consistency of the lubricant. Examples of specifications the manufacturer should
consider include viscosity.
5.5 Dimensions
5.5.1 Length
The length of a female condom is unique to each design. The manufacturer shall specify a nominal value
and the range for the length of female condoms consistent with the length of the female condoms used
in the clinical trial described in Clause 8. When tested in accordance with the method given in Annex D,
taking 13 female condoms from each lot, no female condom length measurement shall be outside of the
manufacturer’s specified range.
5.5.2 Width
The width of a female condom is unique to each design. The manufacturer shall specify the range for the
width of the female condom consistent with the width of the female condoms used in the clinical trial
described in Clause 8. When tested in accordance with the method given in Annex E, taking 13 female
condoms from each lot, no female condom width measurement shall be outside of the manufacturer’s
specified range.
5.5.3 Thickness
The thickness of a female condom is unique to each design. The range for the thickness of the female
condom shall be specified by the manufacturer, based upon the female condoms that are used in the
clinical trials. When tested by the method given in Annex F, taking 13 female condoms from each lot, no
female condom thickness measurement shall be outside of the manufacturer’s specified range (from the
clinical trials).
5.6 Risk assessment
5.6.1 A risk assessment for the product shall be conducted in accordance with ISO 14971. The assessment
shall identify all potential failure modes for the device as well as any other safety and efficacy concerns.
Failure modes identified in the risk analysis shall be compared to those listed in 5.6.2. In addition to these
known failure modes, any new failure modes shall be assessed in the design and execution of any pre-
clinical or clinical investigations of the female condom. Manufacturers shall make the results of the risk
assessment available to regulatory authorities.
5.6.2 The following are definitions of known female condom failure modes.
a) Clinical breakage is defined as breakage during sexual intercourse or during withdrawal of the
female condom from the vagina. Clinical breakage is breakage with potential adverse clinical
consequences. The clinical breakage rate is calculated by dividing the number of female condoms
reported to have broken during sexual intercourse or during withdrawal by the number of female
condoms used during sexual intercourse.
NOTE Total breakage is defined as the sum of all female condom breakages at any time before, during, or
after sexual intercourse. It includes both clinical breakages and non-clinical breakages. The total breakage
rate is calculated by dividing the total number of female condoms that broke by the number of female condom
packages opened.
b) Slippage is defined as an instance when a female condom slips completely out of the vagina during
sexual intercourse. The slippage rate is calculated by dividing the number of female condoms that
slipped by the number of female condoms used during sexual intercourse.
c) Misdirection is defined as vaginal penetration whereby the penis is inserted between the female
condom and the vaginal wall. The misdirection rate is calculated by dividing the number of reported
events of misdirection by the number of female condoms used during sexual intercourse.
d) Invagination is defined as an instance when the external retention feature of the female condom
is partially or fully pushed into the vagina during sexual intercourse. The invagination rate is
calculated by dividing the number of events of invagination by the number of female condoms used
during sexual intercourse.
6 Barrier properties
The barrier properties of the female condom shall be established by viral penetration studies using
a suitable surrogate virus, for example bacteriophage phi-X 174. When tested in accordance with the
method given in Annex H, viral penetration properties shall be compared with those of a male latex
condom that meets the requirements of ISO 4074.
6 © ISO 2014 – All rights reserved

7 Biocompatibility
Biocompatibility for the finished product and its components shall be established. The female condom,
together with any lubricant, additive, dressing material, or powder applied to it, shall be tested as well
as all retention or insertion devices, whether affixed or removable. Accredited laboratories shall be used
for the testing.
Since the female condom is in repeated contact with surface mucosa and possibly compromised tissue
surfaces, the testing shall be conducted to demonstrate that the materials are neither cytotoxic nor
cause sensitization, mucosal irritation, or acute systemic cytotoxicity in accordance with the relevant
clauses of ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11, respectively. If there is a likelihood
of systemic absorption of any components or residuals, mutagenicity testing shall be performed.
Regulatory bodies can require that the results be interpreted by a qualified toxicologist. The biological
assessment report shall justify that the product is safe under normal conditions of use. All data generated
in these evaluations shall be made available to regulatory authorities on request.
The manufacturer shall also obtain, and make available on request from regulatory authorities,
toxicity data on all the additives and residual monomers, solvents, and known impurities used in the
manufacture of the female condom subject to this International Standard. Suitable material safety data
sheets shall be supplied on request for materials used in the manufacture of products conforming with
this International Standard.
8 Clinical (human use) investigations
8.1 Clinical investigations of female condoms in humans shall be conducted in accordance with ISO 14155
(all parts), and are intended to be conducted with a future International Standard on functionality studies
of acute failure events based on self-reports.
NOTE Clinical investigations can also be subject to local regulatory requirements.
8.2 In order to assess the safety and effectiveness of a new female condom design, a contraceptive
effectiveness study shall be conducted. The study design shall be adequate to allow the 6-month
pregnancy rate to be computed using life table methods with at least 100 women years of data (e.g.
200 women completing 6 months). The 12-month pregnancy rate can be extrapolated from the 6-month
data providing it is made clear that the value obtained is an estimate and the method of extrapolation is
documented. The study should also measure all the rates of all failure modes identified in Clause 5.
8.3 New female condom designs that are sufficiently similar to a design that is already approved
and marketed can claim exemption from the requirement of 8.2. If a new female condom design and
specifications are sufficiently similar to those of a marketed device and that marketed device has a known
pregnancy rate established from a clinical effectiveness study, the manufacturer can refer to the estimated
pregnancy rate of the marketed device instead of conducting a contraceptive effectiveness study on the
new device. If there is no suitable control female condom available in the market with an established
pregnancy rate, then the manufacturer can use an alternative female condom that has been evaluated
directly against a device with an established pregnancy rate as the control.
To claim exemption from the requirements of 8.2, the following requirements shall be met:
a) The manufacturer shall conduct a risk analysis in accordance with 5.6.
b) The manufacturer shall establish that the new female condom design and specifications are
sufficiently similar to those of a marketed female condom, after assessing the impact of each
difference in dimension, material, insertion, and retention feature or method, on the incidence of
each failure mode described in 5.6.2, on the incidence of new failure modes, and on the efficacy of
the female condom in preventing pregnancy and STI transmission. To be considered sufficiently
similar to a marketed device, the risk analysis shall demonstrate that the new female condom can
be expected to have the same failure modes as the marketed device and no new failure modes or
other risk factors. Manufacturers shall make the results of this assessment available to regulatory
authorities.
c) The manufacturer shall conduct a randomized controlled clinical investigation comparing the new
female condom to a control female condom and the following.
1) The control female condom shall meet the bursting volume and pressure, freedom from holes,
and visible defects requirements of Clauses 9, 11, and 12, and shall have a known pregnancy
rate established from a clinical effectiveness study. If there is no suitable control female condom
available in the market with an established pregnancy rate, then the manufacturer can use an
alternative female condom that has been evaluated directly against a device with an established
pregnancy rate as the control.
2) The total clinical failure rate of the new female condom shall be shown to be non-inferior to the
total clinical failure rate of the control female condom.
3) The upper bound of the 95 % one-sided confidence interval for the new female condom total
clinical failure rate minus the control female condom total clinical failure rate shall be less than
or equal to 3 %.
4) The bound shall be calculated using a method that accounts for the unique characteristics of
data such as
i) each study participant can contribute data from more than one female condom use, and
ii) possibly low event rates.
5) The control female condom total clinical failure rates shall not be lower than 1 %.
9 Bursting volume and pressure
9.1 Minimum values
Manufacturers shall establish appropriate minimum pressure and volume limits for the specific female
condom based on the airburst properties of the lot or lots used for the clinical trial.
For products in the market prior to the publication of this International Standard, manufacturers shall
comply with the procedure in 9.1 or can use existing specifications as established by their regulatory
bodies for bursting properties. The specifications shall be consistent with the requirements in 9.1 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.
The following procedure shall be used.
a) Determine the airburst properties of the lot or lots used in the clinical study using a sample size of
at least 2 000 female condoms. If more than one lot was used in the clinical study, the sample shall
be drawn across all the lots, each individual lot being sampled proportionally to its size.
b) Set the minimum airburst limits at 80 % of the 1,5 percentile values of the airburst volumes and
pressures determined above (see 9.1).
NOTE Based on the data supplied by the manufacturers for both synthetic and natural rubber male 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 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 n-th rank where n = Nx/100 + 1/2 rounded to the
nearest integer (e.g. for N = 2 000, the lower 1,5 percentile is the 31st lowest value).
8 © ISO 2014 – All rights reserved

9.2 Sampling and requirements
Whenever tested by the methods given in Annex I, the bursting volumes and bursting pressures shall not
be less than the minimum values established by the procedures described in 9.1. The compliance level
shall be an AQL of 1,5 for non-conforming female condoms. A non-conforming female condom is defined
as a female condom that fails the requirements for volume and/or pressure, or any female condom that
exhibits any leakage during airburst testing.
10 Tests for stability and shelf-life
10.1 General
Manufacturers shall verify that the female condoms conform to the airburst, freedom from holes, visible
defects, and labelling requirements of Clauses 9, 11, and 12 and 13.1 until the end of the labelled shelf-
life. Shelf-life claims shall not exceed 5 years.
Data supporting the shelf-life claims made by the manufacturer shall be made available to the appropriate
regulatory authorities and direct purchasers upon request.
Before a new or modified female condom design is placed in the market, the following requirements
shall be met.
a) A real-time stability study, as described in 10.2 to determine shelf-life, shall have commenced.
b) Pending completion of the real-time stability study, shelf-life shall be estimated as described in 10.3.
For existing designs on the market at the date of publication of this International Standard, real-time
+5
data in a form consistent with Annex K, at a temperature of (30 ) °C, shall be acceptable to verify the
−2
shelf-life claims.
10.2 Procedure for determining shelf-life by real-time stability studies
After testing in accordance with Annex K, the female condoms shall meet the requirements of Clauses 9,
11, and 12 and 13.1.
If the real-time data indicate a shorter shelf-life than that claimed on the basis of accelerated ageing
(see 10.3), the manufacturer shall notify the relevant regulatory authorities and direct purchasers. The
manufacturer shall change the shelf-life claim for the product to one based on the real-time stability
study. In no case shall shelf-life exceed 5 years. For female condoms placed on the market, real-time
stability studies shall be completed for the full period of the shelf-life claim.
10.3 Procedure for estimating shelf-life based upon accelerated stability studies
Pending the completion of real-time stability studies, accelerated stability studies shall be used to
+5
estimate the shelf-life. Shelf-life estimates shall be based on a mean kinetic temperature of (30 ) °C for
−2
all climatic conditions and can be carried out on female condoms from the same production lots as used
for real-time determination of shelf-life.
Several approaches to the analysis of accelerated-ageing data have been explored. However, at the
date of publication, no single method of analysis was sufficiently validated or widely used to justify its
designation as a standard method. The manufacturer can refer to ISO 11346 (Arrhenius testing) or use
other validated methods to conduct accelerated shelf-life studies. It is anticipated that as manufacturers
and regulatory agencies accumulate real-time data, a consensus method for the next revision of this
International Standard will be developed. Meanwhile, the results of accelerated-ageing data can be
analysed by a number of methods or as stipulated by the manufacturer’s regulatory authority.
NOTE Arrhenius testing cannot be applicable for some types of materials used for the manufacture of female
condoms.
Guidance on the conduct and analysis of accelerated ageing studies is provided in Annex L. Data generated
from such studies shall support the claim that the female condoms fulfil the requirements of Clauses 9,
+5
11, and 12 and 13.1 for the duration of the labelled shelf-
...