ISO 7439:2002 PDF

Scope: This European Standard applies to single-use copper-bearing intra-uterine contraceptive devices and their insertion instruments. Intra-uterine contraceptive devices consisting only of a plastics body and intra-uterine contraceptive devices whose primary purpose is to release progestogens are not included in the scope of this standard. NOTE Some aspects of this standard can be applicable to medicated intra-uterine devices and intra-uterine devices that do not contain copper.

ISO 7439:2002 Referenced Document

EN 1441 Medical Devices - Risk Analysis
EN 540 Clinical Investigation of Medical Devices for Human Subjects Superseded by EN ISO 14155-1:2003
EN 980 Graphical Symbols for Use in the Labelling of Medical Devices*， 2003-04-01 Update
EN ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)*， 2020-11-30 Update

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