机构地区: 广东省医疗器械质量监督检验所,广东广州510663
出 处: 《中国医疗器械信息》 2017年第16期18-21,共4页
摘 要: 该文对比GB9706.1-2007和YY0668-2008,发现两本标准有关患者电缆除颤效应防护的标记要求存在矛盾,通过对照两本标准相应的英文标准,确认GB9706.1与IEC60601-1的要求不完全一致;通过临床场景分析,论证如何标记才能对医护人员起到警示作用;通过查阅新版IEC60601-1有关要求及国内转化标准审批稿,确定标准发展的趋势,最终认为GB9706.1-2007相应标准要求存在瑕疵。 This paper compared GB9706.1-2007and YY0668-2008,found these two standard about the marking requirement for defibrillation-proof PATIENT cable exists contradictions,through check these two standard corresponding of English standard,confirmed the requirements in GB9706.1and IEC60601-1are not completely consistent;through clinical scene analysis,argument how mark to warning medical personnel;through check out new IEC60601-1about requirements and the domestic into standard approval draft,determine standard development of trend,eventually obtained the conclusion that GB9706.1-2007corresponding standard Request flawed.