本文件规定了药物安全警报系统的要求以及与警报系统供应商相关的主题。本文件适用于临床决策支持系统（CDSSs），无论这些系统是否为医疗设备。 本文件涉及: -？药物安全警告中使用的术语要求； -？选择药物安全警报系统知识库的要求； -？与药物安全警报系统相关的CDSSs适当功能的要求； -？药物安全警报显示要求； -？提高药物安全警报有效性的质量测量要求。 以下内容超出了本文件的范围: -？开发CDS的内容（基于规则的知识库）； -？开发用于在CDS中生成药物安全警报的算法； -？为CDS中的药物安全警报开发警报处理器。

This document specifies the requirements for medication safety alert systems and the topics which are relevant to alert system vendors. This document applies to clinical decision support systems (CDSSs) whether or not these are medical devices. This document addresses: —    requirements for terminology used in medication safety alerts; —    requirements for choosing a knowledge base for medication safety alert systems; —    requirements for the proper functionality of CDSSs as related to medication safety alert systems; —    requirements for medication safety alert display; —    requirements for quality measurements to improve the effectiveness of medication safety alerts. The following are out of the scope of this document: —    the development of content (rule-based knowledge base) for CDSS; —    the development of algorithms for generating medication safety alerts in CDSS; —    the development of alert processors for medication safety alerts in CDSS.