ISO/TS 20451:2017 卫生信息学 药物产品的鉴定 识别和交换规范的药品产品信息用ISO 11616数据元素和结构的执行指南

标准编号:ISO/TS 20451:2017

中文名称:卫生信息学 药物产品的鉴定 识别和交换规范的药品产品信息用ISO 11616数据元素和结构的执行指南

英文名称:Health informatics — Identification of medicinal products — Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical

发布日期:2017-10

标准范围

ISO/TS 20451:2017定义了根据ISO 11616将药品与一组适当的PhPID关联所需的概念。药品标识符和元素是指药品监管机构指定的药品中的药品。ISO IDMP标准套件可适用于医药产品的标签外使用,但目前不在ISO/TS 20451:2017的范围内。参考ISO 11238、ISO 11239、ISO 11240、ISO 11615和HL7消息传递标准、HL7参考信息模型(RIM)、HL7 V3通用产品模型(CPM)和HL7 V3结构化产品标签(SPL)可适用于ISO/TS 20451中的药品信息:2017.

ISO/TS 20451:2017 defines the concepts required to associate pharmaceutical products with an appropriate set of PhPID(s) in accordance with ISO 11616.Pharmaceutical identifiers and elements are to represent pharmaceutical products as represented in a Medicinal Product as indicated by a Medicines Regulatory Authority. The suite of ISO IDMP standards can be applied to off-label usage of Medicinal Products, but is currently outside of the scope of ISO/TS 20451:2017.Reference to ISO 11238, ISO 11239, ISO 11240 and ISO 11615 and HL7 messaging standards, HL7 Reference Information Model (RIM), HL7 V3 Common Product Model (CPM) and HL7 V3 Structured Product Labelling (SPL) can be applied for pharmaceutical product information in the context of ISO/TS 20451:2017.

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