ISO 7439:2023 PDF

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. NOTE Some aspects of this document can be applicable to medicated intrauterine devices and IUDs not containing copper.

ISO 7439:2023 Referenced Document

ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 14630:2012 Non-active surgical implants - General requirements
ISO 14971 Medical devices - Application of risk management to medical devices
ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements

2023 ISO 7439:2023 Copper-bearing contraceptive intrauterine devices — Requirements and tests
2015 ISO 7439:2015 Copper-bearing contraceptive intrauterine devices - Requirements and tests
2011 ISO 7439:2011 Copper-bearing contraceptive intrauterine devices - Requirements and tests
2002 ISO 7439:2002 Copper-bearing intra-uterine contraceptive devices - Requirements, tests