SIST EN ISO 7439:2023 PDF

Name: SIST EN ISO 7439:2023 — Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2023)
SKU: SIST EN ISO 7439:2023
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Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2023)

Название (английский):

SIST EN ISO 7439:2023

Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2023)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 25
Дата публикации:: 21 августа 2023 г.
ICS:: 11.200
Технический комитет:: VAZ - Healthcare

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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

Похожие стандарты

Стандарты, упомянутые в описании

Overview - EN ISO 7439:2023 (Copper-bearing IUDs)

EN ISO 7439:2023 specifies requirements and tests for single‑use, copper‑bearing contraceptive intrauterine devices (IUDs) and their insertion instruments. Published in 2023 and adopted by CEN, this fourth‑edition standard supersedes EN ISO 7439:2015. It applies to non‑medicated, copper‑containing IUDs (single use) and excludes devices that are plastic‑only or whose primary purpose is drug (progestogen or other medicinal) release - although some clauses may be relevant to medicated IUDs.

Key topics and technical requirements

The standard defines design, testing and information requirements needed to demonstrate safe, effective performance. Major technical topics include:

Intended clinical performance: guidance on clinical performance parameters, study duration, population, sample size, contraceptive effectiveness, expulsion and discontinuation rates, and investigation reporting.

Design attributes: device shape, dimensions, tensile force (thread and component strength), stability, viscoelastic properties and X‑ray detectability.

Materials: requirements and considerations for copper components, polymer bodies and any radiopaque additives (e.g., barium sulfate content and identification tests are referenced).

Design evaluation and pre‑clinical testing: dimensional, mechanical and memory (elastic recovery) tests, plus pre‑clinical evaluations required prior to clinical use.

Manufacturing, inspection and quality verification: processes for production control, sampling, and verification of lot consistency.

Sterilization and packaging: requirements to ensure sterility, shelf‑life stability and protective packaging for single‑use devices.

Labelling and information: mandatory labelling of primary/secondary containers, instructions for healthcare providers, and written information intended for the client post‑insertion.

Practical applications

Guide design and development of copper IUDs and insertion instruments to meet regulatory expectations.

Define testing protocols for manufacturers to demonstrate mechanical integrity, sterility, dimensional accuracy and radiopacity.

Support regulatory submissions, conformity assessment and CE marking in CEN member countries.

Inform clinical investigators on endpoints and sample size considerations for performance studies.

Standardize labelling and patient information content for consistent clinical use and follow‑up.

SIST EN ISO 7439:2023 PDF

Abstract

Похожие стандарты

Overview - EN ISO 7439:2023 (Copper-bearing IUDs)

Key topics and technical requirements

Practical applications

Who should use this standard

Related standards (applicable)

Технические детали

ISO 7439:2023

Copper-bearing contraceptive intrauterine devices — Requirements and tests

ISO 7439:2015

Copper-bearing contraceptive intrauterine devices — Requirements and tests

SIST EN ISO 13485:2016/A11:2021

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)