ISO 25841:2017/Amd 1:2020

Overview

ISO 25841:2017/Amd 1:2020 is an amendment to the international standard ISO 25841:2017, focused on female condoms. Developed by ISO/TC 157, this amendment introduces modifications and clarifications to requirements and test methods for female condom products. These enhancements help ensure proper product information, robust testing methods, and overall consumer safety. The standard supports manufacturers, regulators, and laboratories in improving product quality and reliability.

Key Topics

• Product Information Update
  The amendment requires manufacturers to clearly state the nominal width and nominal length of female condoms rather than referencing multiple sizes. This change improves labeling transparency and enables users and professionals to make informed decisions.

• Test Method Verification
  Clear procedures are now described for verifying the accuracy and reliability of test methods. Key requirements include:

  • Use of a hypodermic syringe needle (0.25 mm to 0.35 mm diameter) to make controlled penetrations in packaging and condom samples.
  • Visual confirmation that the needle fully penetrates both packs and condom material.
  • Immediate replacement of needles if they become blunt or fail to penetrate, to maintain test integrity.
  • Repeat testing with new needles if holes are not detected, ensuring no false negatives in test procedures.

• Documented Procedural Updates
  Amendments to Annex G and Annex K set out enhanced protocols for quality control, providing specific guidance on where and how to test finished products and packaging.

Applications

• Manufacturing Quality Control
  Female condom manufacturers use these clarified requirements and updated test methods to reinforce quality assurance in production. Accurate measurements and reliable test verification help reduce product failures and support market confidence.

• Product Regulatory Compliance
  Regulatory bodies reference the amended standard to assess compliance of female condom products with international health and safety benchmarks. The amendments facilitate easier and more consistent market approval processes.

• Laboratory Testing Procedures
  Laboratories tasked with evaluating female condom products benefit from the robust verification processes. The updated guidelines reduce the risk of undetected material flaws during permeability and integrity assessments.

• Procurement and Tenders
  Organizations procuring female condoms, such as health agencies and NGOs, can use ISO 25841:2017/Amd 1:2020 to specify quality requirements and ensure that suppliers meet the latest validated international standards.

Related Standards

Organizations and professionals working with ISO 25841:2017/Amd 1:2020 may also reference the following standards:

• ISO 25841:2017 – Female condoms - Requirements and test methods (the base standard updated by this amendment)
• ISO 4074 – Natural latex rubber condoms - Requirements and test methods
• ISO 23409 – Male condoms - Requirements and test methods for synthetic condoms
• Other ISO/TC 157 standards – Covering various non-systemic contraceptives and sexually transmitted infection (STI) barrier products

Practical Value

The latest amendment to ISO 25841:2017 provides practical improvements in the design, testing, and verification processes for female condoms. Manufacturers, laboratories, and healthcare providers gain from enhanced reliability and confidence in product performance, leading to safer and more effective sexual health products worldwide. Incorporating these changes aids compliance, supports consumer protection, and streamlines international market access.