ISO 25841:2017/Amd 1:2020
(Amendment)Female condoms - Requirements and test methods - Amendment 1
Female condoms - Requirements and test methods - Amendment 1
Préservatifs féminins — Exigences et méthodes d'essai — Amendement 1
General Information
- Status
- Published
- Publication Date
- 31-Mar-2020
- Technical Committee
- ISO/TC 157 - Non-systemic contraceptives and STI barrier prophylactics
- Drafting Committee
- ISO/TC 157/WG 18 - Female condoms and diaphragms
- Current Stage
- 6060 - International Standard published
- Start Date
- 01-Apr-2020
- Due Date
- 23-Apr-2020
- Completion Date
- 01-Apr-2020
Relations
- Effective Date
- 25-Dec-2021
Overview
ISO 25841:2017/Amd 1:2020 is an important amendment to the international standard that specifies requirements and test methods for female condoms. Developed by ISO Technical Committee ISO/TC 157, focused on non-systemic contraceptives and STI barrier prophylactics, this amendment introduces vital updates that enhance quality assurance and testing protocols for female condoms. The standard ensures consistency, safety, and effectiveness in the manufacturing and performance evaluation of female condoms, supporting global health initiatives and users' protection.
This amendment clarifies measurement terms, refines test method verification processes, and expands requirements for packaging and product performance testing. It reflects ISO's commitment to harmonized international standards that support public health and safety.
Key Topics
Nominal Dimensions Update
The amendment replaces broad language concerning product sizing with specifically defined nominal width and nominal length of female condoms to improve clarity in manufacturing and quality control.Test Method Verification (Annex G.2.7 & Annex K.4)
New subclauses introduce a rigorous verification procedure for test methods using hypodermic syringe needles (0.25 mm to 0.35 mm diameter). This procedure ensures that:- Holes can be consistently and precisely made in packaging and condoms.
- The integrity of testing equipment and methods is maintained.
- Faulty needles are detected and replaced to guarantee reliable test results.
Quality Assurance Protocols
The standard details inspection processes post-test, emphasizing the importance of confirming needle penetration through materials to validate testing effectiveness.Packaging Integrity Testing
Verification now includes checks on individual condom containers, enhancing the reliability of barrier protection until use.
Applications
Manufacturers of Female Condoms
Use this amendment to ensure products meet updated size specifications and pass enhanced test method verifications, confirming product safety and regulatory compliance.Quality Assurance Laboratories
Implement the newly specified test verification steps to validate the testing process, preventing false negatives in condom integrity tests.Regulatory Bodies & Health Organizations
Reference ISO 25841:2017/Amd 1:2020 for setting product approval criteria and confirming adherence to global safety standards for female condoms.Healthcare Providers & Educators
Gain confidence in recommending female condoms that comply with verified international testing standards, promoting safer sexual health options.
Related Standards
ISO 25841:2017 (Third Edition)
The base international standard providing comprehensive requirements and test methods for female condoms.ISO/IEC Directives, Part 1 & Part 2
Framework documents detailing the procedures and editorial rules followed in the creation and amendment of ISO standards.ISO/TC 157 Standards on Barrier Contraceptives
Additional standards addressing other types of barrier contraceptives and prophylactic devices.ISO 13485
Quality management systems specific to medical devices, relevant for manufacturers and testing labs applying this standard.
Keywords: ISO 25841:2017/Amd 1:2020, female condoms, contraceptive standards, test method verification, packaging integrity, condom size requirements, quality assurance, non-systemic contraceptives, STI barrier prophylactics, international standards, hypodermic needle testing.
Frequently Asked Questions
ISO 25841:2017/Amd 1:2020 is a standard published by the International Organization for Standardization (ISO). Its full title is "Female condoms - Requirements and test methods - Amendment 1". This standard covers: Female condoms - Requirements and test methods - Amendment 1
Female condoms - Requirements and test methods - Amendment 1
ISO 25841:2017/Amd 1:2020 is classified under the following ICS (International Classification for Standards) categories: 11.200 - Birth control. Mechanical contraceptives. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 25841:2017/Amd 1:2020 has the following relationships with other standards: It is inter standard links to ISO 25841:2017. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 25841:2017/Amd 1:2020 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 25841
Third edition
2017-08
AMENDMENT 1
2020-04
Female condoms — Requirements and
test methods
AMENDMENT 1
Préservatifs féminins — Exigences et méthodes d'essai
AMENDEMENT 1
Reference number
ISO 25841:2017/Amd.1:2020(E)
©
ISO 2020
ISO 25841:2017/Amd.1:2020(E)
© ISO 2020
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ii © ISO 2020 – All rights reserved
ISO 25841:2017/Amd.1:2020(E)
Foreword
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