ISO 7439:2023

Name: ISO 7439:2023 — Copper-bearing contraceptive intrauterine devices — Requirements and tests
SKU: ISO 7439:2023
Price: 25 EUR
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Copper-bearing contraceptive intrauterine devices — Requirements and tests

Название (английский):

ISO 7439:2023

Copper-bearing contraceptive intrauterine devices — Requirements and tests

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 16
Дата публикации:: 4 апреля 2023 г.
Издание:: ISO IS 7439 edition 4 version 1
ICS:: 11.200

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Описание (английский):

This document specifies requirements and tests for single-use, copper-bearing contraceptive intrauterine devices (IUDs) and their insertion instruments. It is not applicable to IUDs consisting only of a plastics body or whose primary purpose is to release progestogens or other medicinal products. NOTE Some aspects of this document can be applicable to medicated intrauterine devices and IUDs not containing copper.

Abstract

Overview

Key topics and technical requirements

Scope and definitions: clear terms for IUDs, insertion instruments and thread (retrieval string).
Clinical performance: study design considerations (duration, population, sample size), metrics such as contraceptive efficacy, expulsion and discontinuation rates, and required investigation reporting and labeling.
Design attributes: requirements for shape, dimensions, copper components, thread and insertion instruments; tensile force, stability, viscoelastic properties and X‑ray detectability.
Materials and biocompatibility: material selection and biological evaluation referenced to ISO 10993‑1.
Design evaluation and tests: dimensional determination, tensile-force testing, elastic‑recovery (memory) tests, barium sulfate content and identification, pre‑clinical evaluation and detailed test reporting.
Manufacturing, sterilization and packaging: production controls, sterilization processes and packaging integrity tests (including cited ASTM methods).
Information and labeling: labelling of primary/secondary containers, instructions for health‑care providers and written information for clients after insertion.

Practical applications and users

ISO 7439:2023 is intended for:

Medical device manufacturers developing or producing copper‑bearing IUDs and insertion instruments (design verification, risk management, production control).
Regulatory and quality teams preparing submissions, clinical-evaluation plans and labeling to meet international expectations.
Test laboratories conducting physical, chemical and mechanical tests (tensile, memory, packaging integrity, X‑ray detectability).
Health‑care organizations and procurement evaluating device specifications, instructions for use and shelf‑life/packaging integrity.
Clinical researchers designing clinical investigations in line with ISO 14155 and the clinical‑performance guidance in ISO 7439.

Related standards (selected)

ISO 10993‑1 (biological evaluation of medical devices)
ISO 14155 (clinical investigation - good clinical practice)
ISO 14630 (non‑active surgical implants - general requirements)
ISO 14971 (risk management for medical devices)
ISO 15223‑1 (symbols for medical device information)
ASTM packaging integrity methods and relevant Pharmacopoeia references

Keywords: ISO 7439:2023, copper-bearing IUDs, intrauterine devices, insertion instruments, requirements and tests, clinical performance, packaging integrity, medical device standards.

Технические детали

Технический комитет: ISO/TC 157 - Non-systemic contraceptives and STI barrier prophylactics
SKU: ISO 7439:2023

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