摘要
介绍了2018年青海省B型超声诊断设备的现场抽检情况,分析了B型超声诊断设备在检验过程中涉及到的2个标准GB 10152—2009《B型超声诊断设备》和YY/T 0162.1—2009《医用超声设备档次系列第1部分:B型超声诊断设备》的联系与区别,指出了GB 10152—2009标准适用于检验B型超声诊断设备的关键性能指标,能更全面地判断仪器是否满足型式检验要求,而YY/T 0162.1—2009标准侧重于评判仪器是否能达到某种档次的指标要求,为B型超声诊断设备的质量监管提供了参考。
The on-site sampling of B-type ultrasonic diagnostic equipment in Qinghai Province in 2018 was introduced.The connection and difference of two standards involved in the inspection of B-type ultrasonic diagnostic equipment were analyzed,including GB 10152—2009"B mode ultrasonic diagnostic equipment"and YY/T 0162.1—2009"Medical ultrasound equip-ment class series—Part 1:B mode ultrasonic diagnostic equipment".It's pointed out that GB 10152—2009 standard was applicable to test the key performance indicators of B-type diagnostic ultrasound equipment and comprehensively determine whether the instrument met the type inspection requirements,while YY/T 0162.1—2009 standard focused on judging whether the equipment could meet a certain grade of index requirements.References were provided for the quality supervision of B-type ultrasound diagnostic equipment.
作者
雷迪
王宸
任戬
孙晓宁
龙存林
张宏涛
海平
LEI Di;WANG Chen;REN Jian;SUN Xiao-ning;LONG Cun-lin;ZHANG Hong-tao;HAI Ping(Qinghai Provincial Drug Inspection and Testing Institute,NMPA Key Laboratory for Quality Control of TCM(Tibetan Medicine),Qinghai Key Laboratory of Modernization of Traditional Chinese and Tibetan Medicine,Xining 810016,China)
出处
《医疗卫生装备》
CAS
2022年第4期74-77,共4页
Chinese Medical Equipment Journal
