论文部分内容阅读
一、序言在凝聚现代高新技术成果的医疗器械中,以超声、X-CT、磁共振和核医学四大影像设备最为突出,其中又以B型超声诊断设备(B超)最为普及。国内对在用B超的检测始于20世纪90年代初,所检项目包括安全特性和性能特性,属于质量保证-质量控制检测行为。众所周知,医疗器械质量检测遵守的是技术标准,而B超标准中最重要的是国家强制性产品标准GB10152《B型超声诊断设备》,其中既规定了对安全
I. Preface In the medical devices that condense the achievements of modern high-tech, the four imaging devices such as ultrasound, X-CT, magnetic resonance and nuclear medicine are the most prominent, and the B-type ultrasound diagnostic device (B-ultrasound) is the most popular among them. The domestic tests on B-ultrasonography began in the early 1990s, and the seized items included the safety characteristics and performance characteristics, which belonged to quality assurance-quality control testing. As we all know, medical device quality inspection comply with the technical standards, and B-standard is the most important national compulsory product standards GB10152 “B-type ultrasound diagnostic equipment,” which provides for the safety