中国医疗设备
中國醫療設備
중국의료설비
CHINA MEDICAL EQUIPMENT
2015年
5期
137-138,141
,共3页
儿科群体%X射线设备%辐射剂量%辐射防护%上市前评估
兒科群體%X射線設備%輻射劑量%輻射防護%上市前評估
인과군체%X사선설비%복사제량%복사방호%상시전평고
pediatric patients%X-ray equipment%radiation dose%radiation prevention%pre-market assessment
常规X射线诊断、CT等成像设备广泛应用于儿科的放射成像,但在上市销售时制造商缺乏针对儿科群体的相应软硬件功能设置。因此,针对成人开发的X射线设备并非完全适用于儿科对象。本文综合了儿科群体相比成人有更高的辐射敏感性、儿科群体的辐射防护要求和X射线设备的监管要素,提出加强对儿科用X射线设备上市前评估的建议。
常規X射線診斷、CT等成像設備廣汎應用于兒科的放射成像,但在上市銷售時製造商缺乏針對兒科群體的相應軟硬件功能設置。因此,針對成人開髮的X射線設備併非完全適用于兒科對象。本文綜閤瞭兒科群體相比成人有更高的輻射敏感性、兒科群體的輻射防護要求和X射線設備的鑑管要素,提齣加彊對兒科用X射線設備上市前評估的建議。
상규X사선진단、CT등성상설비엄범응용우인과적방사성상,단재상시소수시제조상결핍침대인과군체적상응연경건공능설치。인차,침대성인개발적X사선설비병비완전괄용우인과대상。본문종합료인과군체상비성인유경고적복사민감성、인과군체적복사방호요구화X사선설비적감관요소,제출가강대인과용X사선설비상시전평고적건의。
Even though conventional X-ray equipment has been widely applied in radiation imaging for pediatric patients, lots of such equipment is marketed without regard to hardware and software features for pediatric use. And the X-ray equipment intended for adult patients is not fully applicable for pediatric patients. In view of pediatric patients’higher radio-sensitivity and radiation prevention requirements than adult patients as well as supervision factors of X-ray equipment, this paper raises the suggestion for strengthened pre-market assessment of X-ray equipment for pediatric patients.