ISO 25841:2011
(Main)Female condoms — Requirements and test methods
Female condoms — Requirements and test methods
ISO 25841:2011 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.
Préservatifs féminins — Exigences et méthodes d'essai
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INTERNATIONAL ISO
STANDARD 25841
First edition
2011-07-15
Female condoms — Requirements and
test methods
Préservatifs féminins — Exigences et méthodes d'essai
Reference number
ISO 25841:2011(E)
©
ISO 2011
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ISO 25841:2011(E)
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ISO 25841:2011(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
4 Quality verification .3
5 Design.4
6 Barrier properties .6
7 Biocompatibility.6
8 Clinical (human use) investigations .7
9 Bursting volume and pressure .8
10 Tests for stability and shelf-life .8
11 Freedom from holes .9
12 Visible defects .9
13 Packaging and labelling.10
14 Data sheets .12
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.13
Annex B (informative) Sampling plans intended for assessing compliance of isolated lots .14
Annex C (normative) Determination of lubricant mass for individual female condom containers.15
Annex D (normative) Determination of female condom length.17
Annex E (normative) Determination of female condom width .18
Annex F (normative) Determination of female condom thickness .19
Annex G (normative) Testing for female condom package integrity.20
Annex H (normative) Determination of barrier properties using the bacteriophage method.22
Annex I (normative) Determination of bursting volume and bursting pressure .27
Annex J (normative) Testing for holes .29
Annex K (normative) Determination of shelf-life by real-time stability studies .35
Annex L (informative) Guidance on conducting and analysing accelerated ageing studies .37
Bibliography.39
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ISO 25841:2011(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 25841 was prepared by Technical Committee ISO/TC 157, Non-systemic contraceptives and STI barrier
prophylactics.
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ISO 25841:2011(E)
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), 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 manufacture 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 on 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.
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INTERNATIONAL STANDARD ISO 25841:2011(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 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 2859-1:1999, 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 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 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, definition 3.1.26]
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ISO 25841:2011(E)
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 transmission of sexually transmitted infections
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 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
NOTE For description, see 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 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 A lot test can be limited to include only those parameters that can change from lot to lot.
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ISO 25841:2011(E)
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 Leakage during testing can be detected, for instance, by rolling a female condom on absorbent paper.
NOTE 2 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 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 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 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 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
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ISO 25841:2011(E)
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 may 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.
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ISO 25841:2011(E)
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 may 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
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ISO 25841:2011(E)
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.
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
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ISO 25841:2011(E)
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 manufactur
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