Overview
ISO/TR 24484:2023 - “Female condoms - Use of ISO 25841 and the quality management of female condoms” is a technical report that explains how to apply ISO 25841 in conjunction with quality‑management principles for female condoms. It supplements ISO 25841 by outlining essential quality‑management elements to be considered during design, manufacture, testing, procurement and post‑production activities. The report emphasizes performance, safety and reliability for female condoms made from natural rubber, synthetic rubber or other polymeric materials, including their integral retention devices.
Key technical topics and requirements
- Design controls and verification/validation: Guidance on design input, design output, design transfer, design verification and design validation (including barrier properties, stability and clinical investigations).
- Material and biocompatibility considerations: Requirements for documenting materials, assessing biocompatibility and controlling additives, lubricants and dressing materials.
- Performance and barrier testing: Principles for assessing barrier effectiveness and physical properties as defined in ISO 25841.
- Shelf life and stability: Conducting stability studies to substantiate shelf‑life claims and appropriate storage conditions.
- Risk management: Integration of ISO 14971 risk‑management principles across product lifecycle to identify failure modes specific to different female condom designs.
- Manufacturing quality: Process controls, microbiological/bioburden considerations for non‑sterile devices, personnel hygiene and environmental controls.
- Testing and laboratory competence: Use of ISO/IEC 17025‑competent labs, sampling (e.g., ISO 2859‑1), test equipment calibration, personnel competence and result reporting.
- Procurement and regulatory alignment: How purchasers, procurement agencies and regulatory bodies can use ISO 25841 and ISO/TR 24484 to develop technical specifications, verify compliance and support regulatory approvals.
Practical applications - who uses this standard
- Manufacturers and product developers: To design, verify and validate female condom products and to implement quality systems during scale‑up.
- Quality and regulatory teams: To establish QMS practices consistent with ISO 13485 and to prepare regulatory submissions.
- Testing laboratories: To apply appropriate test methods, sampling plans and competence requirements referenced in ISO/TR 24484 and ISO 25841.
- Procurement agencies, NGOs and public health programs: To write purchase specifications, evaluate suppliers and verify delivered product compliance for distribution programs.
- Inspectors and auditors: For assessing manufacturing, testing and supply controls that affect safety, performance and shelf life.
Related standards
Keywords: ISO/TR 24484:2023, female condoms, ISO 25841, quality management, ISO 13485, risk management, barrier testing, shelf life, procurement, biocompatibility.
