Copper-bearing intra-uterine contraceptive devices. Requirements, tests

Copper-bearing intra-uterine contraceptive devices. Requirements, tests

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1   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.