ISO 7439:2023 銅含有避妊子宮内器具 — 要件とテスト | ページ 2

Foreword

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This document was prepared by Technical Committee ISO/TC 157, Non-systemic contraceptives and STI barrier prophylactics, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 285, Non-active surgical implants, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This fourth edition cancels and replaces the third edition (ISO 7439:2015), which has been technically revised.

The main changes are as follows:

• the subclause on clinical performance has been revised (see 5.2);
• the movable collar has been added in the subclause on insertion instrument (see 6.3.4);
• requirements for packaging integrity have been added;
• the instructions for health care providers have been amended in accordance with the"Family planning: A global handbook for providers"^[4];
• the requirement for stability in situ has been removed since there is no practical way of controlling it.

Introduction

Although every foreign object in the uterus exhibits a certain contraceptive effect, the method by which copper-bearing contraceptive intrauterine devices (IUDs) function is by the continuous release of copper ions. This interferes with some enzymatic functions, immobilizes sperm cells and inhibits fertilization.

The IUD is a highly effective contraceptive device with a long history of safe use. It can be used for many years, with a prompt return of fertility upon removal.

IUDs do not prevent sexually transmitted infections and condom use is recommended for those at risk.

IUDs containing copper are regarded as single use sterile medical devices implanted in the uterus. These medical devices are inserted and removed by trained and competent health care providers.

1 Scope

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.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminology databases for use in standardization at the following addresses:

Bibliography