ISO/TS 19844:2018 卫生信息学 药品的标识 数据元素和结构ISO 11238的实施指南、用于唯一标识和交换有关物质的受管制信息

标准编号：ISO/TS 19844:2018

中文名称：卫生信息学 药品的标识 数据元素和结构ISO 11238的实施指南、用于唯一标识和交换有关物质的受管制信息

英文名称：Health informatics — Identification of medicinal products (IDMP) — Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated info

发布日期：2018-07

标准范围

本文件用于ISO 11238的实施。本文件根据物质的科学特性（即它们是什么）而不是其用途或生产方法来定义物质。ISO 11238为定义物质和特定物质以及在ISO IDMP标准的上下文中分配唯一标识符提供了概念框架。ISO 11238描述了定义和区分物质的一般概念以及物质信息结构化的高级模型。本文件提供了每种类型或每组物质信息的详细解释，ISO 11238实施的逐个元素描述，以及各种物质和特定物质的示例。该文件的第三版涉及ISO 11238和附件A、B、C、D、E、F、G、H、I、J和K中定义的特定物质的物质组1至3。预计ISO 11238中定义的第4组特定物质将在本文件的后续版本中讨论。本文件的附件涵盖了通常属于第4类特定物质的一些信息。该信息虽然没有定义物质或特定物质组1，但对于区分物质可能是必不可少的。本文件涉及以下内容:-定义物质和特定物质第1至第3组所需的数据要素；-ISO 11238中定义的数据元素的逻辑使用；-物质和特定物质第1至3组业务规则:-确定必要的数据元素，-根据ISO 11238区分和定义材料，-触发标识符的分配。本文档不涉及以下内容:-数据管理业务流程；-特定数据信息系统的实现(例如，关系数据库模式)；-物质的规范性信息标准；-控制词汇的维护；-应使用的特定全局标识符系统；-物质命名标准。

This document is used in the implementation of ISO 11238. This document defines substances based on their scientific identity (i.e. what they are) rather than on their use or method of production.ISO 11238 provides the conceptual framework for defining Substances and Specified Substances and for assigning unique identifiers in the context of the ISO IDMP standards. ISO 11238 describes general concepts for defining and distinguishing substances and a high-level model for the structuring of information for substances. This document provides detailed explanations of each type or grouping of substance information, an element-by-element description for implementation of ISO 11238, and examples for a variety of Substances and Specified Substances.This third edition of the document addresses Substances Groups 1 to 3 of the Specified Substances as defined in ISO 11238 and Annexes A, B, C, D, E, F, G, H, I, J and K. It is anticipated that Specified Substances Group 4, as defined in ISO 11238, will be addressed in a subsequent edition of this document. Some information that would typically fall under Specified Substances Group 4 is covered in the Annexes of this document. This information, although not defining of either a Substance or a Specified Substance Group 1, might be essential to distinguishing substances. This document addresses the following:- data elements necessary for defining Substances and Specified Substances Groups 1 to 3;- the logical use of data elements as defined in ISO 11238;- Substances and Specified Substances Groups 1 to 3 business rules for:

• - determining necessary data elements,
• - distinguishing and defining materials according to ISO 11238,
• - triggering the assignment of identifiers.

This document does not address the following:- business processes for data management;- implementation of a specific data information system (e.g. a relational database schema);- normative messaging standards for substances;- the maintenance of controlled vocabularies;- the specific global identifier system that should be used;- nomenclature standards for substances.

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