Overview

This standard has been prepared by Technical Committee ISO/TC 157 "Non-systemic contraceptives and STI barrier prophylactics", the secretariat of which is held by Malaysia, in collaboration with Technical Committee CEN/TC 285 "Non-active surgical implants" (secretariat: DIN, Germany) with the participation of German experts. At DIN, the German Institute for Standardization e. V., NA 063-01-04 AA "Kondome und Intrauterinpessare" ("Condoms and intra-uterine devices") of the Medical Standards Committee is responsible. This document specifies requirements and tests for single-use copper-bearing intra-uterine contraceptive devices (intra-uterine devices, IUD) and their insertion instruments. Intra-uterine contraceptive devices consisting only of a plastic body whose primary purpose is to release progestogens are not included in the scope of this standard. Some aspects of this International Standard can be applicable to medicated intra-uterine devices and intra-uterine devices that do not contain copper.

Document: references other documents

Responsible national committee

NA 176-04-10 AA - Condoms and intrauterine devices  

Responsible european committee

CEN/TC 285 - Non-active surgical implants