本文件规定了开发与预期药物用途一致的药物相关问题知识库的要求，用于基于规则的临床决策支持系统（CDSS），如选择原始数据源的标准以及开发和维护药物安全规则或临床规则的质量标准。它还描述了如何开发知识库的过程、知识库开发人员要考虑的主题，并就如何做到这一点给出了指导。 本文件提供了开发知识库的指导方针: -制定规则，以加强在与毒品有关的问题上的决定和行动，使之符合预期的毒品用途； -其可以被所有类型的医疗保健专业人员使用，例如那些开处方、分配、施用或监测药物的人；-可用于各种护理环境，包括慢性和急性护理、初级和专科护理； -这是一个由专家评估的证据/实践基础规则库； -其意在与医药产品词典结合使用； -其知识以规则结构化，因此用于基于规则的CDS类型。 本文件不包含: -描述知识库的确切内容，即开发规则过程的结果。 -提供临床决策支持系统的要求，该软件使用与患者数据相结合的知识库，并将规则的结果呈现给医疗保健专业人员。这些要求在ISO/DTS 22703[1]中有描述。 -给出非药物知识库的要求。本文件中要求的某些方面本质上是一般性的，适用于其他类型的知识库，但本文件并未解决非药物知识库的所有要求。 [1]正在准备中。出版时的阶段:ISO/DTS 22703。

This document specifies the requirements for developing a knowledge base for drug-related problems that cohere with the intended drug use, to be used in rule-based clinical decision support systems (CDSS), such as the criteria for selecting a raw data source and the quality criteria for the development and maintenance for the rules or clinical rules for drug safety. It also describes the process of how to develop a knowledge base, the topics to be considered by the developers of a knowledge base, and it gives guidance on how to do this. This document gives guidelines for the development of a knowledge base: — with rules to enhance decisions and actions in drug-related problems that cohere with the intended drug use; — which can be used by all kinds of healthcare professionals, such as those who prescribe, dispense, administer or monitor medicines; — which can be used in every care setting, including chronic and acute care, primary and specialized care; — which is a repository of evidence/practice bases rules, assessed by experts; — which is meant to be used in conjunction with a medicinal product dictionary; — whose knowledge is structured in rules and therefore to be used in the type of rule-based CDSS. This document does not: — describe the exact content of a knowledge base i.e. the outcome of the process of developing rules. — provide the requirements for a clinical decision support system, the software that uses the knowledge base combined with the patient's data, and presents the outcome of the rules to the healthcare professional. These requirements are described in ISO/DTS 22703[1]. — give the requirements for non-medication knowledge bases. Some aspects of the requirements in this document are general in nature and applicable to other kinds of knowledge bases, but this document does not address all of the requirements of non-medication knowledge bases. [1] Under preparation. Stage at the time of publication: ISO/DTS 22703.