This International Standard specifies requirements and tests for single-use copper-containing intrauterine contraceptive devices (IUDs) and their insertion devices. Intrauterine devices that consist only of a plastic body or whose primary purpose is the release of progestogens do not fall within the scope of this standard. NOTE Some aspects of this International Standard may also be applied to medicated intrauterine devices and non-copper intrauterine devices.
EN ISO 7439:2015 Referenced Document
EN 12011:1998 Instrumentation to Be Used in Association with Non-Active Surgical Implants - General Requirements
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 14155-1:2003 Clinical investigation of medical devices for human subjects - Part 1: General requirements
ISO 14630:2012 Non-active surgical implants - General requirements
ISO 14971:2007 Medical devices - Application of risk management to medical devices
ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
EN ISO 7439:2015 history
2023EN ISO 7439:2023 Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2023)
2015EN ISO 7439:2015 Copper-bearing contraceptive intrauterine devices - Requirements and tests
2011EN ISO 7439:2011 Copper-bearing contraceptive intrauterine devices - Requirements and tests
2009EN ISO 7439:2009 Copper-bearing intra-uterine contraceptive devices - Requirements, tests
2002EN ISO 7439:2002 Copper-Bearing Ints-Uterine Contraceptive Devices - Requirements, Tests ISO 7439:2002