标准编号：ISO/TS 19218-1:2011
中文名称：医疗器械 不良事件的分级编码结构 第1部分：事件型代码
英文名称：Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes
发布日期：2011-05
标准范围
This part of ISO/TS 19218 specifies requirements for a hierarchical coding structure for describing adverseevents relating to medical devices. The codes are intended for use by medical device users, manufacturers,regulatory authorities, health care facilities and other organizations. The codes can be used for coding eventsthat are not related to death or serious injury, or malfunctions that could lead to death or serious injury.This part of ISO/TS 19218 is not intended to be used to decide whether an incident is reportable or not.
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