转化ISO 7439:2015含铜宫内节育器 技术要求与试验方法标准的解析  

Conversion of ISO 7439:2015 Copper-bearing Contraceptive Intrauterine Devices——Requirements and Tests Standard Analysis

作　　者：钱心依 QIAN Xinyi(Shanghai Institute of Medical Device Testing,Shanghai,201318)

机构地区：[1]上海市医疗器械检验研究院,上海市201318

出　　处：《中国医疗器械杂志》2022年第1期88-90,共3页Chinese Journal of Medical Instrumentation

摘　　要：介绍转换ISO 7439:2015的强制性国家标准《含铜宫内节育器技术要求与试验方法》的基础内容,阐述了在转换过程中,结合实际中国含铜宫内节育器市场情况,对标准的部分条款修改的原因。它作为强制性基础通用标准,对生产IUD的厂商具有指导意义,能促进产品质量提高。This paper introduces the basic content of the compulsory national standard ISO 7439:2015 Copperbearing 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.

关 键 词：铜宫内节育器 标准 试验 

分 类 号：F203[经济管理—国民经济]