对制造商保留的其他批次器械进行检测
Testing of device from other lot batch retained by manufacturer
- 上级条目
- 原因调查和调查类型
- 层级
- 4 级
定义
调查采用了对报告的不良事件中可疑器械以外的另一批次器械进行相关的经验测试，以支持确定不良事件的可能原因。这包括没有指定批号/批次的设备。使用制造商保留的设备进行测试（即未装运）。相关测试通常基于最新相关标准中描述的用于评估安全性和性能的测试方法。
The investigation employed relevant empirical testing of the device of another lot or batch than that of the suspected device in the reported adverse event in order to support the identification of possible causes for the adverse event. This includes devices without a lot/batch designation. Testing was performed using the device retained by the manufacturer (i.e. was not shipped). Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.
索引词 可用于检索该条目的同义词与别名
- 对制造商保留的其他批次器械进行检测
英文词条（1）
- Testing of device from other lot batch retained by manufacturer
后组配轴 Postcoordination
该条目未定义后组配轴，直接使用上面的编码即可。后组配是在主干编码之后追加侧别、具体解剖部位、严重程度、病因等细节的可选组合方式，不是必填项。