ISO/TS 19844:2016 保健信息学 医药产品的标识 物质管制信息的唯一标识和交换用数据元与结构的实施指南

标准编号：ISO/TS 19844:2016

中文名称：保健信息学 医药产品的标识 物质管制信息的唯一标识和交换用数据元与结构的实施指南

英文名称：Health informatics — Identification of medicinal products — Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances

发布日期：2016-12

标准范围

ISO/TS 19844:2016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提供了定义物质和特定物质的概念框架，以及在ISO IDMP标准中分配唯一标识符的概念框架。ISO 11238描述了定义和区分物质的一般概念，以及物质信息结构的高级模型。本文件详细解释了每种类型或分组的物质信息，对ISO 11238实施的元素逐一描述，以及各种物质和特定物质的示例。本文件的第二版涉及ISO 11238和附件A、B、C、D、E、F、G和H中定义的指定物质的第1组至第3组。预计ISO 11238中定义的指定物质第4组将在本文件的后续版本中讨论。本文件附件中可能包含一些通常属于特定物质类别4的信息。这些信息虽然没有定义物质或特定物质组1，但可能对区分物质至关重要。本文件阐述了以下内容:·定义物质和指定物质组1至3所需的数据元素；·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类商业规则-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。ISO/TS 19844:2016未涉及以下内容:·数据管理的业务流程；·实施特定的数据信息系统（例如关系数据库模式）；·物质的规范性信息传递标准；·保持受控词汇；·应使用的特定全局标识符系统；·物质的命名标准。

ISO/TS 19844:2016 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 second 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 and H. 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 may be covered in the Annexes of this document. This information, although not defining of either a Substance or a Specified Substance Group 1, may 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.

ISO/TS 19844:2016 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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