标准编号：ISO/TS 19844:2015
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：2015-12
标准范围
1 ScopeThis Technical Specification is used in the implementation of ISO 11238. This Technical Specification definessubstances 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 assigningunique identifiers in the context of the ISO IDMP standards. ISO 11238 describes general concepts for defining anddistinguishing substances and a high level model for the structuring of information for substances. This TechnicalSpecification provides detailed explanations of each type or grouping of substance information, an element-byelementdescription for implementation of ISO 11238, and examples for a variety of substances and specifiedsubstances.This first edition of the Technical Specification will only address substances, and Groups 1 to 3 of the specifiedsubstances as defined in ISO 11238 and Annexes A, B, C, and D. It is anticipated that specified substances Group 4,as defined in ISO 11238, will be addressed in a subsequent edition of this Technical Specification. Someinformation that would typically fall under specified substances Group 4 may be covered in the Annexes of thisTechnical Specification. This information, although not defining of either a substance or a specified substanceGroup 1, may be essential to distinguishing substances.This Technical Specification 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 Technical Specification 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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