ISO/TS 19218-1-2011 医疗设备.医疗设备.不良事件的层级编码结构.第1部分:事件类型编码

标准号：ISO/TS 19218-1-2011
中文标准名称：医疗设备.医疗设备.不良事件的层级编码结构.第1部分:事件类型编码
英文标准名称：Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes
标准类型：C30
发布日期：2011/5/15 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C30
国际标准分类号：03.120.10;11.040.01
适用范围：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.