Conversion of ISO 7439:2015 Copper-bearing Contraceptive Intrauterine Devices - Requirements and Tests Standard Analysis / 中国医疗器械杂志

ABSTRACT

This paper introduces the basic content of the compulsory national standard ISO 7439:2015 Copper-bearing contraceptive intrauterine devices--Requirements and tests standard analysis, and expounds the reasons for revising part of the standard during the conversion process according to the actual market situation of intrauterine contraceptive device containing copper in China. As a compulsory basic universal standard, it has a guiding significance for the manufacturers of IUD and can promote the improvement of product quality.