标准编号：ISO/TS 19218-2:2012
中文名称：医疗器械 不良事件的分级编码结构 第2部分：评估代码
英文名称：Medical devices — Hierarchical coding structure for adverse events — Part 2: Evaluation codes
发布日期：2012-04
标准范围
This part of ISO 19218 specifies requirements for a hierarchical coding structure for characterizing the results of the analysis or evaluation of adverse events relating to medical devices. The codes are intended primarilyfor use by medical device manufacturers and regulatory authorities. They can also be used for coding the results of the analysis or evaluation of events other than those related to death or serious injury, as well as malfunctions that could lead to death or serious injury.This part of ISO 19218 is not intended to be used to decide whether or not an incident is reportable.
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