ISO 25841-2017 amd1-2020 PDF

Full title and description

ISO 25841:2017/Amd 1:2020 — Female condoms — Requirements and test methods — Amendment 1. This document is an amendment to ISO 25841:2017 and contains technical and/or editorial changes that modify or clarify requirements and test procedures for female condoms supplied to consumers for contraceptive purposes and for assisting in the prevention of sexually transmitted infections (STIs).

Abstract

ISO 25841:2017 specifies minimum performance, design, packaging and labelling requirements and standardized test methods for female condoms. Amendment 1 (2020) provides updates and clarifications to the 2017 edition’s requirements and test procedures (the amendment document itself is one page and applies directly to the 2017 edition). Key performance tests include freedom from holes (leakage), burst volume and pressure, dimensional checks (length, width, thickness), package-seal integrity and sampling/acceptance levels; stability and shelf‑life testing are also addressed in associated guidance.

General information

• Status: Published (active amendment to ISO 25841:2017).
• Publication date: Amendment published April 2020 (effective date shown as 1 April 2020); base standard published August 2017 (3rd edition, confirmed 2023).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.200 — Birth control; mechanical contraceptives.
• Edition / version: ISO 25841 third edition (2017) with Amendment 1 (2020) — designation: ISO 25841:2017/Amd 1:2020.
• Number of pages: Amendment document: 1 page; base standard (ISO 25841:2017): 54 pages.

Scope

ISO 25841:2017 (as amended) applies to female condoms supplied to consumers for contraception and to help prevent STIs. The standard specifies minimum performance and safety requirements, methods for sampling and testing (including tests for freedom from holes, burst volume/pressure, dimensions and thickness, package integrity and labelling), and requirements for packaging and product information. The amendment updates the parent standard by clarifying or correcting specific clauses and test details.

Key topics and requirements

• Performance requirements: freedom from holes (low AQL), minimum burst volume and burst pressure thresholds, and limits for visible/critical defects.
• Test methods: water‑leakage/freedom‑from‑holes tests, air/burst tests (burst volume and pressure), dimensional measurements (length, width, thickness), tensile/physical property tests where applicable.
• Packaging and package‑seal integrity tests to ensure protection and shelf stability of individually packaged condoms.
• Sampling plans and acceptance criteria (sampling by lot with specified AQLs and inspection levels for different tests).
• Stability and shelf‑life considerations: accelerated and real‑time ageing studies appropriate to materials used, with requirements to demonstrate compliance over the claimed shelf life.
• Labelling and information: manufacturer identification, lot number, expiry date and consumer information as required for safe use.
• Risk control and change management: design or material changes require risk assessment (and possibly additional testing or clinical evaluation) to ensure continued safety and effectiveness.

Typical use and users

Primary users are manufacturers of female condoms, quality and regulatory affairs teams, independent testing and certification laboratories, national regulators and notified bodies, procurement agencies and public‑health organisations, and NGOs involved in sexual and reproductive health. The standard is used to specify product performance during design, production‑lot acceptance testing, prequalification/submission dossiers and post‑market surveillance.

Related standards

Standards commonly referenced alongside ISO 25841 include ISO 4074 (requirements and test methods for male condoms), ISO 10993 series (biocompatibility testing for medical devices), ISO 2859‑1 (sampling procedures for inspection by attributes), ISO 15223 (symbols for medical device labelling) and ISO 14971 (risk management for medical devices) for change control and risk assessment. These documents support testing, biocompatibility, sampling and regulatory processes used with female‑condom evaluation.

Keywords

female condom, contraceptive device, ISO 25841, amendment 2020, requirements, test methods, burst test, leakage test, package integrity, sampling, AQL, stability, labelling, STI prevention

FAQ

Q: What is this standard?

A: ISO 25841:2017 is an international standard that sets minimum requirements and standard test methods for female condoms; ISO 25841:2017/Amd 1:2020 is Amendment 1 published in April 2020 that updates or clarifies parts of the 2017 edition.

Q: What does it cover?

A: It covers design and performance requirements, lot sampling and acceptance criteria, and laboratory test methods (freedom from holes, burst tests, dimensional checks, package‑seal integrity, stability testing), plus requirements for packaging and labelling for female condoms supplied to consumers.

Q: Who typically uses it?

A: Manufacturers, product developers, quality and regulatory teams, independent test laboratories, national regulatory bodies, procurement agencies and public‑health organisations use the standard for product development, acceptance testing, regulatory submissions and prequalification processes.

Q: Is it current or superseded?

A: The 2017 edition of ISO 25841 remains the active base standard and was confirmed in ISO’s review process; Amendment 1 was published in April 2020. As of the most recent ISO lifecycle information the 2017 edition (with the 2020 amendment) remains published and active. Users should check ISO or their national SDO for any later revisions beyond 2020.

Q: Is it part of a series?

A: It is a standalone standard specific to female condoms, but it is commonly used together with other device and testing standards (for example ISO 4074 for male condoms, ISO 10993 for biocompatibility, ISO 2859‑1 for sampling and ISO 14971 for risk management) when specifying testing, safety and regulatory requirements.

Q: What are the key keywords?

A: Female condom, contraception, STI prevention, test methods, burst test, leakage test, package integrity, sampling, AQL, stability, labelling.