欧美医用激光产品标准对比分析

European and American Medical Laser Products Standards:Comparison and Analysis

欧洲采用的国际电工委员会(IEC)标准和美国采用的食品药品监督管理局属下的器械和放射保健中心(CDRH)标准是两大主要的激光标准体系。通过对比分析两大医用激光标准,总结两者的差异和联系,为我国医用激光产品标准的制定和修订提供借鉴。

The International Electrotechnical Commission （IEC） standards applying in Europe and the Center for Devices and Radiological Health（CDRH） standards using in America are the two main laser standards systems. Through comparison and analysis on the European and American medical laser products standards,the differences and connections are presented to provide some references for compiling and revising the medical laser products standards of our country.