Page1of70医疗器械软件设计开发验证报告医疗器械软件设计开发验证报告记录编号：目 ODD 录 D第一部分总则......................................................................2一、概述.....................................................................2...二、验证方案...................................................................2.1、验证目的................................................................2.2、验证范围................................................................2.3、相关文件................................................................2.4、职责....................................................................2.5、验证条件................................................................3.6、验证方法................................................................3.7、验证合格标准及评价分析.................................................7.8、验证实施计划...........................................................7.9、验证周期...............................................................8.10、数据收集..............................................................8.第二部分测试确认..................................................................8一、功能性测试：..............................................................8.二、性能测试：................................................................9.三、可靠性和安全性测试.........................................................9四、用户场景测试..............................................................9.五、准确性测试................................................................1. 01 普通碱基测试.............................................................102 修饰碱基测试.............................................................163 兼并碱基测试.............................................................534 含 RNA 碱基测试........................................................595 含 mRNA 碱基测试.......................................................636 含特殊碱基 I 序...
