标准摘要
[中文适用范围]: 本文件规定了一次性含铜宫内节育器 (IUD) 及其插入器械的要求和测试。 它不适用于仅由塑料体组成或其主要目的是释放孕激素或其他药品的宫内节育器。 注:本文件的某些方面可适用于不含铜的药物宫内节育器和宫内节育器。 [外文原描述]: This document specifies requirements and tests for single-use, copper-bearing contraceptive intrauterine devices (IUDs) and their insertion instruments. It is not applicable to IUDs consisting only of a plastics body or whose primary purpose is to release progestogens or other medicinal products. NOTE Some aspects of this document can be applicable to medicated intrauterine devices and IUDs not containing copper.
英文名称Copper-bearing contraceptive intrauterine devices — Requirements and tests