ISO 11249-2018 PDF

Full title and description

St ISO 11249-2018 — Copper-bearing intrauterine contraceptive devices — Guidance on the design, execution, analysis and interpretation of clinical studies. This International Standard provides manufacturers, clinical investigators and regulators with guidance for planning, conducting, analysing and interpreting clinical investigations specifically for copper-bearing intrauterine devices (IUDs).

Abstract

ISO 11249:2018 gives recommendations on study design, conduct, statistical analysis and interpretation of results to determine the performance characteristics of new copper-bearing intrauterine contraceptive devices. It is intended to ensure scientific rigour and credible clinical evidence to support product development, post‑market evaluation and regulatory assessment, while noting that certain broader clinical trial administration issues (for example subject compensation, confidentiality and local ethics committee arrangements) are addressed in general clinical investigation standards such as ISO 14155.

General information

• Status: Published (International Standard).
• Publication date: February 2018 (2018-02).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.200 (Birth control; mechanical contraceptives).
• Edition / version: Edition 1 (2018).
• Number of pages: 23 pages (official ISO published document).

Scope

This document provides guidance specific to clinical investigations of single‑use, copper‑bearing intrauterine contraceptive devices. It covers design choices, selection of clinical endpoints, follow‑up duration, safety monitoring, data collection and statistical analysis necessary to evaluate device performance (e.g., contraceptive effectiveness, expulsions, adverse events). It is aimed at evidence generation for regulatory submissions and post‑market evaluations, and is to be used alongside general medical‑device clinical investigation standards (notably ISO 14155) where broader clinical trial governance topics are required.

Key topics and requirements

• Guidance on clinical study design tailored to copper‑bearing IUDs (prospective studies, cohort design, comparator considerations).
• Recommended clinical endpoints and performance measures (pregnancy rate, expulsion rate, device‑related adverse events and safety outcomes).
• Sample size and statistical analysis approaches appropriate for contraceptive device evaluation.
• Follow‑up schedules and duration sufficient to capture contraceptive effectiveness and medium‑term safety signals.
• Data collection, reporting and interpretation guidance to support regulatory/clinical decision making.
• Interaction with general GCP and clinical investigation requirements (referencing ISO 14155 for subject protection, consent, monitoring and broader trial conduct).
• Notes on limits of scope — administrative/ethical topics (compensation, confidentiality, local ethics arrangements) are not fully covered and require reference to general clinical investigation guidance.

Typical use and users

Primary users are medical device manufacturers and their clinical teams, contract research organizations (CROs) conducting device trials, principal investigators and clinical sites, regulatory bodies and notified/competent authorities assessing evidence for market access or post‑market surveillance, and conformity assessment bodies reviewing clinical evidence dossiers. The standard helps align study design and reporting to internationally accepted expectations for copper‑bearing IUDs.

Related standards

Key related documents to use alongside ISO 11249:2018 include ISO 14155 (Clinical investigation of medical devices for human subjects — Good clinical practice) for general GCP and trial conduct, and the device‑specific requirements and test methods standard ISO 7439 (Copper‑bearing contraceptive intrauterine devices — Requirements and tests). Users should consult these standards together when planning regulatory submissions or conformity assessments.

Keywords

copper-bearing intrauterine device; IUD; clinical investigation; contraceptive device; study design; clinical performance; statistical analysis; safety monitoring; ISO 11249; medical device clinical trials; good clinical practice.

FAQ

Q: What is this standard?

A: ISO 11249:2018 is an ISO International Standard that provides guidance for the design, execution, analysis and interpretation of clinical studies for copper‑bearing intrauterine contraceptive devices.

Q: What does it cover?

A: It covers clinical study design choices, endpoints, follow‑up, statistical analysis and interpretation specifically for copper‑bearing IUDs; it is intended to support credible evidence generation for manufacturers and regulators. Administrative GCP topics are covered in ISO 14155 and should be used together with ISO 11249.

Q: Who typically uses it?

A: Medical device manufacturers, clinical researchers, CROs, principal investigators, ethics committees (for study design input), regulatory reviewers and notified bodies involved in conformity assessment of contraceptive IUDs.

Q: Is it current or superseded?

A: ISO 11249:2018 is published and, per ISO lifecycle information, was reviewed and confirmed in recent review cycles and remains the current edition; ISO notes it is under review and an ISO/PRF (project) reference for 11249 has been indicated for future revision. Users should check the official ISO catalogue or their national standards body for any updates or replacement publications before use.

Q: Is it part of a series?

A: It is part of the family of standards on contraceptive intrauterine devices and clinical evaluation managed by ISO/TC 157. Related standards include ISO 7439 (requirements and tests for copper‑bearing IUDs) and broader clinical investigation standards such as ISO 14155.

Q: What are the key keywords?

A: Copper‑bearing IUD, intrauterine contraceptive device, clinical study guidance, contraceptive effectiveness, expulsions, adverse events, ISO 11249, clinical investigation, GCP.