This International Standard specifies requirements and tests for single-use, copper-bearing contraceptiveintrauterine devices (IUDs) and their insertion instruments.
EN ISO 7439:2011 Referenced Document
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*, 2018-08-01 Update
ISO 14155-1 Clinical investigation of medical devices for human subjects - Part 1: General requirements
ISO 14630:2008 Non-active surgical implants - General requirements
ISO 14971 Medical devices - Application of risk management to medical devices*, 2019-12-01 Update
ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements
EN ISO 7439:2011 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