摘要
IEC 61010-2-101适用于预期用作体外诊断(IVD)医用目的,包括自测IVD医用目的的设备。为了更好地理解和使用IEC 61010-2-101:2015国际标准,本研究介绍了该标准的背景,以及2015版与2002版在技术要求上的主要变化。
IEC 61010-2-101 applies to equipment intended for in vitro diagnostic(IVD)medical purposes,including self-test IVD medical purposes.In order to understand and use this standard,the backgrounds and mainly changes in technical requirements of the 2015 and 2002 editions are presented in this paper.
作者
李妍达
Li Yanda(Beijing Institute of Medical Device Testing,Beijing 101111,China)
出处
《医疗装备》
2019年第9期35-36,共2页
Medical Equipment
关键词
安全要求
体外诊断
医用设备
使用说明
Safety requirements
In vitro diagnostic
Medical equipment
Instructions for use
