现行 YY 0845-2011
激光治疗设备 半导体激光光动力治疗机 激光治疗设备 半导体激光光动力治疗机 Laser therapeutic equipment—Diode laser equipment for photodynamic therapy
发布日期:2011-12-31
实施日期:2013-06-01
分类信息
研制信息

归口单位: 全国医用光学和仪器标准化分技术委员会(SAC/TC 103/SC 1)

起草单位: 国家食品药品监督管理局杭州医疗器械质量监督检验中心、 浙江省医疗器械检验所、 深圳市雷迈科技有限公司

起草人: 叶岳顺、 韩坚城、 杜毅、 杜堃

标准简介

本标准规定了半导体激光光动力治疗机的术语和定义、产品组成、基本参数、技术要求、试验方法和检验规则等要求。本标准适用于半导体激光光动力治疗机(以下简称治疗机),该治疗机采用特定波长的激光与光敏剂产生光化学作用,供临床单位进行光动力治疗

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最后更新时间 2025-09-02