ISO 29943-1-2017 PDF

Full title and description

Condoms — Guidance on clinical studies — Part 1: Male condoms, clinical function studies based on self-reports. Guidance for the design, conduct, analysis and interpretation of clinical function studies that assess acute in‑use failure events (primarily clinical slippage and clinical breakage) for male condoms using participant self-reports.

Abstract

ISO 29943-1:2017 provides recommendations to help manufacturers, investigators and regulators plan and run clinical function studies for male condoms that evaluate real‑world performance during vaginal intercourse (not anal intercourse). The document focuses on study objectives, outcome measures (slippage, breakage and related events), study populations, test and control condoms, randomization and masking, data collection (individual condom use case report forms and interviews), pilot studies, basic statistical considerations and interpretation of results. It excludes many broader clinical trial administrative and ethical procedures (for which ISO 14155 and local regulations are referenced).

General information

• Status: Published (confirmed following ISO review; remains current).
• Publication date: 6 July 2017 (first edition).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.200 — Birth control. Mechanical contraceptives.
• Edition / version: Edition 1 (2017).
• Number of pages: 42 (ISO official publication).

Scope

This standard gives guidance for the design, execution, analysis and interpretation of clinical function studies of male condoms conducted in accordance with the requirements of the relevant product standards. Its scope covers comparisons of a new male condom with an established control condom during vaginal intercourse, with emphasis on documenting acute failure events (clinical slippage and clinical breakage) using participant self‑reports. The standard does not replace regulatory or ethical requirements and does not cover many administrative clinical trial elements (e.g., compensation, confidentiality, ethics committee procedures) addressed in ISO 14155 and local regulations.

Key topics and requirements

• Study objectives and primary outcome measures: definitions and measurement of clinical slippage, clinical breakage and other acute failure events.
• Risk assessment and pilot clinical studies to refine procedures and sample size assumptions.
• Design of clinical validation investigations: choice of control condom, randomization, allocation concealment and masking considerations.
• Selection and enrollment of study subjects, informed consent, inclusion/exclusion criteria and contraception requirements for participants.
• Instructions to participants, use of additional lubricant, condom distribution and interview/data collection schedules.
• Individual condom use case report forms (CRFs) and methods for collecting self‑reported data on each condom use episode.
• Basic analytical approaches for slippage/breakage rates, handling of missing or inconsistent self‑report data and interpretation of results for manufacturers and regulators.
• Limitations and exclusions: the document does not provide comprehensive guidance on ethics, compensation, or all regulatory submission requirements (see ISO 14155 and local regulations).

Typical use and users

Used by condom manufacturers and R&D teams planning clinical function studies; clinical investigators and contract research organizations (CROs) conducting condom performance trials; notified bodies, regulatory reviewers and public‑health researchers evaluating clinical performance evidence; and standardization or quality teams aligning clinical testing with ISO product requirements.

Related standards

Commonly referenced and complementary standards include ISO 29943-2 (Guidance for clinical studies for female condoms), ISO 23409 (requirements for male synthetic condoms and related testing), ISO 25841 (requirements for female condoms), ISO 14155 (clinical investigation of medical devices — good clinical practice) and product standards such as ISO 4074 (natural rubber latex male condoms). These documents are used together to define preclinical and clinical evaluation pathways and regulatory submission content.

Keywords

condom, male condom, clinical function study, self-report, slippage, breakage, clinical validation, ISO 29943-1:2017, contraception, clinical trial guidance, ISO 23409, ISO 14155

FAQ

Q: What is this standard?

A: ISO 29943-1:2017 is an ISO guidance document giving recommendations for designing, conducting, analysing and interpreting clinical function studies of male condoms based on participant self‑reports, with emphasis on acute failure events such as slippage and breakage.

Q: What does it cover?

A: It covers study objectives, outcome definitions, pilot studies, subject selection, test and control condom handling, randomization and masking considerations, data collection (individual condom use CRFs and interviews), basic analysis of slippage/breakage rates and interpretation of results for manufacturers and regulators. It does not address detailed ethics, compensation or all administrative trial procedures.

Q: Who typically uses it?

A: Condom manufacturers, clinical investigators and CROs, regulatory reviewers and notified bodies, quality and standards teams, and researchers conducting or evaluating condom performance studies.

Q: Is it current or superseded?

A: ISO 29943-1:2017 is the first edition published 6 July 2017. The ISO bibliographic record indicates the publication was reviewed and confirmed (five‑year review) and remains current following that review. Users should check the ISO catalogue or their national standards body for any amendments or later confirmations.

Q: Is it part of a series?

A: Yes — it is Part 1 of the ISO 29943 series (Part 2 covers female condoms: ISO 29943-2:2017). It is also intended to be used alongside related product and clinical standards such as ISO 23409, ISO 25841 and ISO 14155.

Q: What are the key keywords?

A: Male condom, clinical function study, self‑reports, slippage, breakage, clinical validation, ISO 29943-1, contraception, clinical study guidance.