XE4S0
对用户返回的同一批次器械进行检测
Testing of device from same lot batch returned from user
- 上级条目
- 原因调查和调查类型
- 层级
- 4 级
定义
调查采用与报告的不良事件中可疑装置相同批次装置的相关经验测试，以支持确定不良事件的可能原因。该设备已从用户处退回。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 the same lot or batch as that of the suspected device in the reported adverse event in order to support the identification of possible causes for the adverse event. The device was returned from the user. 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
- 对用户返回的同一批次器械进行检测
英文词条（1）
- Testing of device from same lot batch returned from user
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。