医用激光设备动物试验的决策与审评要求探讨

Discussion on the decision and evaluation requirements of animal experiment of medical laser equipment

医用激光设备是向人体靶组织输出能量的电气设备,动物试验是激光设备开展非临床/临床评价的重要手段之一,也可作为该类设备在临床试验前提供安全性和有效性的证据。本文通过参考现有医疗器械动物试验相关的法规、标准、指南,分析医用激光设备的作用机理;结合常见激光治疗设备的审评经验,概述了激光治疗设备决策开展动物试验研究的考量因素及规范要求;并举例分析了开展动物试验的目的、方案设计要求和评价指标;为医用激光治疗设备的动物试验研究提供参考,也可供该类医疗器械相关的技术审评人员及注册人员参考。

Medical laser equipment is an electrical equipment that outputs energy to human target tissues.Animal experiment is one of the important method for preclinical/clinical evaluation of laser equipment,and it can also be used as evidence of safety and effectiveness of such equipment before clinical trials.This article analyzes the mechanism of action of medical laser equipment by referring to existing regulations,standards,and guidelines related to animal experiment of medical equipment.Based on the evaluation experience of common laser therapy equipment,the factors and standard requirements for the decision making of animal experiments with laser therapy equipment were summarized.In addition,design requirements and evaluation indexes of animal tests were analyzed with examples.The purpose of this paper is to provide a reference for the animal experimental study of medical laser therapy equipment,as well as for the technical reviewers and registrants related to this medical device.