XE1XT
模型变异检测
Testing of model variant
- 上级条目
- 原因调查和调查类型
- 层级
- 4 级
定义
调查采用了与报告的不良事件有关的装置模型变体的相关经验测试,以支持通过合理性推理确定不良事件的可能原因。型号变体与实际设备不同,但与相关设备具有相同的特征。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 a model variant of the device involved in the reported adverse event in order to support the identification of possible causes for the adverse event through plausibility reasoning. A model variant is not identical to the actual device, but shares relevant characteristics with the device involved. 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
- 模型变异检测
英文词条(1)
- Testing of model variant
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。