玻璃体切割手术用眼内照明器的光辐射安全测试  

Optical Radiation Safety Testing of Endoilluminators for Vitrectomy

作　　者：彭建华 王敬涛 骆永洁 胡一平 黄涛 Peng Jianhua;Wang Jingtao;Luo Yongjie;Hu Yiping;Huang Tao(Zhejiang Institute of Medical Device Testing,Hangzhou Zhejiang 310018,China)

机构地区：[1]浙江省医疗器械检验研究院,浙江杭州310018

出　　处：《医疗装备》2023年第22期34-37,共4页Medical Equipment

基　　金：浙江省医疗器械检验研究院自立项科研项目(20220001)。

摘　　要：眼内照明器是玻璃体切割手术的必备仪器。国际标准ISO 15752:2010《眼科仪器眼内照明器光辐射安全的基本要求和试验方法》提出了眼内照明器的光辐射安全要求与试验方法。该标准要求试验需在纯水或盐溶液中进行,但并未明确具体的测试装置。为了填补这一空白,该研究分别基于辐照度法与光谱辐照度法研制了两种测试装置,并依据ISO 15004-2:2007《眼科仪器基本要求和试验方法第2部分:光危害防护》,选取加权视网膜辐照度、加权视网膜可见光和红外热辐照度作为参数,对眼内照明器进行光辐射安全评价。结果显示,两种装置测试结果较为一致,均满足ISO15752:2010的要求。As an essential instrument for vitrectomy,the optical radiation safety requirements and test methods for endoilluminators were proposed in the international standard ISO 15752:2010"Ophthalmic instruments,Endoilluminators,Requirements and test methods for optical radiation safety".According to this standard,the test needs to be conducted in pure water or salt solution,but the specific testing device is not specified.In order to fill this gap,two testing devices were developed in this study based on irradiance method and spectral irradiance method,respectively.In addition,according to ISO 15004-2:2007"Ophthalmic instruments,Requirements and test methods-Part 2:Protection against light hazards",weighted retinal irradiance,weighted retinal visible light,and infrared thermal irradiance were selected as parameters to evaluate the optical radiation safety of endoilluminators.The results showed that the test results of the two devices were consistent and met the requirements of ISO 15752:2010.

关 键 词：眼内照明器 光辐射安全 玻璃体切割手术 辐照度法 光谱辐照度法 

分 类 号：C40[社会学]