Overview - ISO 25841:2017 (Female condoms - Requirements and test methods)
ISO 25841:2017 is the international standard that defines the minimum requirements and test methods for female condoms supplied to consumers for contraception and STI (sexually transmitted infection) prevention. Published as the third edition in 2017, the standard addresses product design, barrier performance, biocompatibility, microbiological quality, packaging, labelling and stability/shelf‑life evaluation to ensure consistent safety and performance of female condoms.
Key technical topics and requirements
ISO 25841:2017 covers both design and verification, with normative and informative annexes that provide detailed test methods:
- Design and physical features: requirements for product insertion features, retention features, lubrication, and dimensional specifications (length, width, thickness) with defined tolerances.
- Barrier properties: methods to confirm non‑porous film performance and resistance to pathogen passage.
- Biocompatibility: evaluation per medical device biological testing principles to avoid toxic, sensitizing or irritating effects.
- Microbial contamination (bioburden): guidance for periodic monitoring and limits for total viable counts on finished products.
- Mechanical performance: bursting volume and pressure testing, freedom‑from‑holes inspections, and visible defect criteria to reduce clinical failure.
- Stability and shelf life: procedures for real‑time and accelerated stability studies and guidance for estimating shelf life.
- Packaging and labelling: individual container integrity tests, consumer labelling requirements, symbols and inspection protocols.
- Sampling and quality verification: sampling plans for lot inspection, including plans for isolated and continuing lots (annexes), and limits on maximum lot size.
- Clinical investigations: recommendations for human use studies to assess retention, failure modes and overall safety/effectiveness.
Normative references include ISO 4074 (male condoms), ISO 10993 series (biocompatibility), ISO 2859‑1 (sampling) and quality management standards such as ISO 9001 and ISO 13485.
Practical applications - who uses ISO 25841:2017?
- Female condom manufacturers - to design products that meet international safety and performance benchmarks and to define internal QC/test procedures.
- Test laboratories - to apply harmonized, reproducible test methods (burst, holes, bacteriophage barrier tests, packaging integrity).
- Regulatory authorities and procurement agencies - to assess conformity, approve products and verify shelf‑life claims.
- Public health organizations and NGOs - to select reliable products for distribution programs focused on contraception and STI prevention.
- Quality and regulatory affairs teams - to integrate requirements into quality management, risk assessment and labelling controls.
Related standards
- ISO 4074 - Natural rubber latex male condoms - requirements and test methods
- ISO 10993 series - Biological evaluation of medical devices
- ISO 2859‑1 - Sampling procedures for inspection by attributes
- ISO 9001, ISO 13485, ISO 14971 - Quality and risk management for medical devices
Using ISO 25841:2017 helps stakeholders ensure female condoms are consistently safe, effective and correctly labelled - supporting public health goals in contraception and STI prevention.
