ISO/TR 24484:2023

Female condoms — Use of ISO 25841 and the quality management of female condoms

This document gives the essential principles in the application of ISO 25841. It outlines the details of elements applicable in quality management of female condoms as required by related normative standards, as referred in ISO 25841 and other relevant concepts. This document supplements the use of ISO 25841 and addresses quality management aspects to be considered during the development, manufacture, quality verification and procurement of female condoms. It encompasses the principles of quality management systems in design, manufacture, and delivery of female condoms with emphasis on their performance, safety and reliability. This document is applicable to female condoms made of natural rubber or synthetic rubber or synthetic polymers and the retention devices which form the integral components of female condoms. NOTE Female condoms made from either natural rubber latex or synthetic rubber or other synthetic polymeric materials are addressed in ISO 25841.

Préservatifs féminins — Utilisation de l'ISO 25841 et du management de la qualité des préservatifs féminins

General Information

• Status: Published
• Publication Date: 09-Jan-2023
• ICS: 11.200 - Birth control. Mechanical contraceptives
• Technical Committee: ISO/TC 157 - Non-systemic contraceptives and STI barrier prophylactics
• Drafting Committee: ISO/TC 157/WG 14 - Guidance on the use of condom standards
• Current Stage: 6060 - International Standard published
• Start Date: 10-Jan-2023
• Due Date: 01-Oct-2022
• Completion Date: 10-Jan-2023

Standards Content (Sample)

TECHNICAL ISO/TR
REPORT 24484
First edition
2023-01
Female condoms — Use of ISO 25841
and the quality management of female
condoms
Préservatifs féminins — Utilisation de l'ISO 25841 et du management
de la qualité des préservatifs féminins
Reference number
ISO/TR 24484:2023(E)
© ISO 2023

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ISO/TR 24484:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
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ISO/TR 24484:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Quality of design . 2
4.1 General . 2
4.2 Design input and design development . 2
4.2.1 General . 2
4.2.2 Barrier sheath . 3
4.2.3 Product insertion feature and retention feature . 3
4.2.4 Dressing materials . 4
4.2.5 Lubricants . 4
4.2.6 Biocompatibility . 4
4.2.7 Control of bioburden . 4
4.2.8 Packaging . 4
4.3 Design verification . 5
4.4 Design validation . 5
4.4.1 Evaluation of barrier properties . 5
4.4.2 Clinical (human use) investigations . 5
4.4.3 Stability studies and shelf-life claim . 5
4.5 Design output. 6
4.5.1 General . 6
4.5.2 Details of materials . 6
4.5.3 Specifications of the female condoms. 6
4.5.4 Supporting information . 7
4.5.5 Regulatory compliance . 7
4.6 Design transfer . 7
4.7 Validation and change controls . 7
5 Risk management . 7
6 Quality in manufacture . 8
7 Quality in testing .10
7.1 General . 10
7.2 Test equipment . 11
7.3 Sampling and testing: . 11
7.4 Training and competence of personnel in testing . 11
7.5 Review of results and reports: . 11
8 Quality in procurement .12
9 Handling and disposal of used female condoms .12
Bibliography .13
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ISO/TR 24484:2023(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing Technical Reports 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 of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 157, Non-systemic contraceptives and STI
barrier prophylactics.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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ISO/TR 24484:2023(E)
Introduction
A female condom is a sheath that completely lines the vaginal canal and is designed 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).
Female condoms that meet or exceed the requirements of ISO 25841 are effectively used for
contraceptive purposes and in the prevention of sexually transmitted infections (STIs). They have
adequate barrier properties, adequate physical properties so as not to break during use, are correctly
packaged to protect them during storage throughout the claimed shelf life and are correctly labelled to
facilitate their correct use.
ISO 25841 is a quality standard for female condoms, detailing the requirements for establishing
the baseline specifications and for testing the finished product for compliance to the predefined
specifications. It is applied by manufacturers, procurement agencies, regulatory bodies, and testing
laboratories.
ISO 13485 is a generic standard for quality management of medical devices and serves as the
requirement for regulatory compliance. The specific quality requirements for female condoms are
given in ISO 25841. This document is a document providing manufacturers, buyers, regulatory agencies
and third-party test laboratories, information relating to implementation and application of ISO 25841
and ISO 13485 in the quality management for manufacture of female condoms, and for purchasers to
develop appropriate purchase technical specifications and to verify that condoms delivered comply with
requirements of ISO 25841 and ISO 13485. This document outlines the importance of the requirements
of the quality management system based on ISO 13485 that are applied during all the stages of design
and development, production, supply, procurement, and post- production related to the complete life
cycle of female condoms.
Consistent quality of female condoms, as other medical devices, is achieved by implementation of
quality management system as per ISO 13485, which enables that quality is built into the product and
assured at every phase in the design, planning, production, procurement processes and post-production
activities. The requirements of ISO 13485 include implementation of the requirements ISO 14971 on
risk management during all the phases of manufacture.
Female condoms, being medical devices, are subject to regulatory controls by national and regional
regulatory agencies. The regulations address both the aspects of product approval and registration
and licensing controls on the manufacture and distribution of female condoms. Compliance with the
requirements of ISO 13485 and ISO 25841 are essential aspects which form the basis of regulatory
approvals.
The specific additional requirements of buyers and consumers are specifically given due consideration
when complying with the requirements of ISO 25841, as ISO 25841 is general by design, based on
the designs that are currently approved for marketing. There are also specific documented technical
specifications such as WHO UNFPA technical Specification on female condoms, which address the
requirements of projects and procurement for public distribution programs.
The designs of female condoms, which are currently available in the market or under development,
vary considerably with reference to the design of the sheath, the type of retention features, dressing
materials, lubricants, etc. Thus, the failure modes of each design of female condom could vary
significantly. Therefore, ISO 25841 requires that the efficacy and the safety of each design of female
condoms should be substantiated by
a) preclinical evaluations which would include standardization of physical properties, assessment of
barrier properties, tests for stability and shelf life and assessment of biocompatibility to ensure the
safety of materials that are used in the manufacture of female condoms and their components such
as sheath, retention features, dressing materials, lubricants, additives, residual processing aids,
etc. as prescribed in ISO 25841, and
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ISO/TR 24484:2023(E)
b) clinical investigations in humans to establish the efficacy and in vivo safety, as prescribed in
ISO 25841, ISO 29943-2, ISO 10993-1, ISO 10993-5 and ISO 10993-10 and if necessary, ISO 10993-3.
Though female condoms are non-sterile medical devices, manufacturers are recommended to
implement appropriate measures to minimize microbiological contamination of the product, by
exercising controls on the components used in the manufacture of female condoms, manufacturing
environment during manufacture of sheath, assembly of condoms and their packaging, manufacturing
operations and health and hygiene of personnel.
It is important that properties of female condoms are maintained throughout the shelf life to ensure
their safety and efficacy. ISO 25841 requires that the shelf life of any new or significantly modified
female condom should be estimated by conducting stability studies as per ISO 25841 and, based on
such studies, the appropriate storage conditions should be prescribed. The review of data of the shelf
studies is important for granting product approvals and for awarding purchasing requirements.
This document also addresses how to deal with other important issues not directly covered by
ISO 25841, but related to effective implementation of quality management system in manufacture of
female condoms which will conform to the specifications of ISO 25841.
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TECHNICAL REPORT ISO/TR 24484:2023(E)
Female condoms — Use of ISO 25841 and the quality
management of female condoms
1 Scope
This document gives the essential principles in the application of ISO 25841. It outlines the details
of elements applicable in quality management of female condoms as required by related normative
standards, as referred in ISO 25841 and other relevant concepts.
This document supplements the use of ISO 25841 and addresses quality management aspects to be
considered during the development, manufacture, quality verification and procurement of female
condoms. It encompasses the principles of quality management systems in design, manufacture, and
delivery of female condoms with emphasis on their performance, safety and reliability.
This document is applicable to female condoms made of natural rubber or synthetic rubber or synthetic
polymers and the retention devices which form the integral components of female condoms.
NOTE Female condoms made from either natural rubber latex or synthetic rubber or other synthetic
polymeric materials are addressed in ISO 25841.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes references for 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 9000, Quality management systems — Fundamentals and vocabulary
ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 14971, Medical devices — Application of risk management to medical devices
ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
ISO 25841, Female condoms — Requirements and test methods
ISO 29943-2, Condoms — Guidance on clinical studies — Part 2: Female condoms, clinical function studies
based on self-reports
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 2859-1, ISO 9000, ISO 13485,
ISO 14971, ISO/IEC 17025, ISO 25841 and ISO 29943-2 apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
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ISO/TR 24484:2023(E)
4 Quality of design
4.1 General
Female condoms essentially comprise of the following components: sheath, which is made of natural
rubber latex or synthetic rubber or other synthetic polymer material with an external retention device
(retention feature) and where applicable, an internal retention device (product insertion feature).
The dimensions of the barrier sheath and insertion features may vary depending on the proprietary
designs, which have been validated for their safety and efficacy. The lubricant used in the female
condoms also vary with the design of the manufacturers. Because of such a wide variety of the design
and the materials, the unique features and characteristics specific design are detailed in the product
Data sheet (see 4.5).
The following features/characteristics have been listed in ISO 25841:
a) product insertion into the vagina;
b) product retention and prevention of slippage during sexual intercourse or penile removal;
c) penile misdirection during sexual intercourse;
d) invagination of the female condom during sexual intercourse;
e) safe product removal after sexual intercourse;
f) safety of all materials used in the construction of the female condom including the risk of any
interaction between the materials;
g) impermeability of the film to microorganisms;
h) risk of breakage of the female condom during insertion, use and withdrawal.
4.2 Design input and design development
4.2.1 General
The requirements of design and development as prescribed in ISO 13485 are applicable in the design
and development of female condoms. When the design and development activities relating to female
condoms conform with the requirements of ISO 13485, the dimensions and shape of the female condoms
and their components are appropriate for the anatomy and physiology of female and male reproductive
organs and are proven to be functionally suitable for the efficacy of female condoms. Survey of clinical
literature supported with laboratory scale development and evaluation of several prototypes enables
that the female condom design fulfils the above criteria. Currently, several types of designs having
shapes such as tubular, dome shaped, cylindrical, etc. with different types, material of construction
and geometry of the external and internal retention features are available. The designs of the female
condoms are not limited to the above and several innovative designs are under development. The
designs of female condoms are mostly patented. While evaluating the options, it is important that the
basis of evaluation takes into consideration the following potential failure modes listed in ISO 25841:
1) acute failure event;
2) clinical breakage;
3) non-clinical breakage;
4) total breakage;
5) clinical slippage;
6) clinical misdirection;
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ISO/TR 24484:2023(E)
7) clinical invagination;
8) total clinical failure;
9) total female condom failure.
In addition to the given failure modes, other potential new failure modes which are identified during the
risk assessment of design and development also play a vital role in development and validation of the
design. It is quite possible that during the initial controlled clinical evaluations, additional information
on the suitability of the designs will be available to be used for progressing further the development
of the designs. Due to anthropometric variations of male and female reproductive organs, the optimal
designs can have a range of dimensions and shape of the female condoms. The data sheets and labels
of female condoms depict the essential features of dimensions and design of the specific type of female
condoms.
Continual survey of technical information and reports on post-market clinical follow up and surveillance
help keeping the design of the female condoms ‘state-of-the-art’ and minimize the risks of design and
safety issues due any adverse events reported.
The design input delineates the required specifications including the details of materials used, process
additives, residues that can potentially be left and the dimensions for the sheath, retention features,
material, composition, and amount for the lubricant, dressing materials, details of packaging materials
which is related to safe handling and storage of the female condom. The design input also includes
the required physical strength and elasticity of the barrier sheath and the other components in the
female condoms are appropriately built in them. While selecting the materials, due consideration is
given to potential presence of residual accelerators, nitrosamines, monomers of materials used, residue
of solvents used, degradation products generated during shelf life of female condoms and such other
chemical residues which could have impact on the safety and biocompatibility. These evaluations also
include properties of the materials of construction of retention features, any process additives such as
mould releasing agents, washing solvent residues, etc.
A method for determination of nitrosamines is available in ISO 29941.
When female condoms are made of natural rubber latex, the potential of latex allergy is also considered
and the manufacturing operations appropriately planned and implemented to reduce the potential of
latex allergy.
4.2.2 Barrier sheath
The barrier sheath or pouch is made of materials established to be safe and nontoxic for use in inserted
condition in contact with vaginal mucosal membrane. ISO 25841 requires that they should not liberate
any toxic chemicals or leave any toxic residues during storage and use. The pouch is usually of tubular
shape with the insertion features and retention features either attached to the sheath by fusing or as a
free component, by assembling process after the sheaths are manufactured. The female condom, in the
assembled form, is evaluated for compliance with the requirements of barrier properties according to
4.4.1.
4.2.3 Product insertion feature and retention feature
The insertion feature and retention feature may be produced by the manufacturer of female condoms
themselves or procured from approved vendors under a well-defined technical agreement. The
technical agreement covers the details of the material of construction such as:
— those of elastomers and open cell or closed cell sponges and design of these devices, which are
currently being used;
— the evaluations of compatibility of the materials used with the barrier sheath and the lubricant
which form the other integral parts of the female condoms;
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ISO/TR 24484:2023(E)
— conformance with the requirements of biocompatibility evaluations as per ISO 10993-1, ISO 10993-5,
ISO 10993-10, ISO 10993-23, and in addition ISO 10993-3, if necessary, when materials known for
negative effects in genotoxicity, carcinogenicity and reproductive toxicity are used in exceptional
cases if, for some reason.
During design and manufacture of these components, adequate consideration is given to ensure that
the geometry and design of these devices are fit for the purpose and they do not cause any injury to the
vaginal mucosa and skin of penis during use.
4.2.4 Dressing materials
The dressing powders are used essentially for providing a smooth surface and for avoiding stickiness
of the condom during storage and use. The dressing materials that are used are selected based
on the physical and chemical compatibility with the components of female condoms and overall
biocompatibility evaluation requirements of female condoms.
4.2.5 Lubricants
The female condoms contain lubricants which are chemically compatible with the other components of
the female condoms and comply with requirements of biocompatibility evaluations. Since the surface
area of female condoms is much larger than that of male condoms, the quantity of lubricant to cover
the entire surface of female condoms is much higher. The material and grade of the material such as
viscosity are important considerations that go in the selection of lubricant for female condoms. The
quantity of lubricant used varies for each design of female condoms. The ability of the lubricant to
migrate and cover the entire surface of the female condoms is also considered in the evaluation of the
lubricants.
During the use of female condoms, the need for additional lubricants may become necessary. The
additional lubricant may be supplied as companion sachet packs in a composite pack, by the manufacturer
of female condoms. In some cases, the use of stand-alone personal lubricants is also recommended. The
development of the design of female condoms includes the evaluation of compatibility of such additional
lubricants with the female condoms before including or recommending them for use with the female
condoms.
4.2.6 Biocompatibility
While designing the female condoms, the requirements of ISO 25841 for biocompatibility evaluation for
the female condoms and their components such as barrier sheath, insertion features, dressing materials,
lubricants, pigments and fragrances, if used, are considered and ensured that they are complied with.
4.2.7 Control of bioburden
The female condoms are nonsterile medical devices. However, since they come in contact with vaginal
mucosa and outer skin of penis, in order to minimize the potential of infection, it is essential that
they do not contain excessive microbial population and are free from pathogenic microbes such as
Staphylococcus aureus, Pseudomonas aeruginosa and Enterobacteriaceae, including Escherichia coli.
ISO 25841 recommends that the manufacturers control the total viable microbial counts and ensure
the absence of specific pathogens as above. In order to achieve this, manufacturers consider the
bioburden control aspects in the design and manufacturing stages. Some of the dressing materials such
as starch can be a good medium for proliferation of microbes. The assembly of female condom sheath
with the retention features is done usually by manual operation. Implementation of appropriate control
measures enable controlling the bioburden potentially caused by manua
...