ISO/TR 24484:2023

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 2023
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ii
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
iii
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
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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
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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.
iv
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 shoul
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