ISO/TS 20443:2017 卫生信息学-药物产品的鉴定 识别和交换受管制的药品信息用ISO 11615数据元素和结构的执行指南

标准编号：ISO/TS 20443:2017

中文名称：卫生信息学-药物产品的鉴定 识别和交换受管制的药品信息用ISO 11615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 11615 data elements and structures for the unique identification and exchange of regulated medicinal produ

发布日期：2017-10

标准范围

ISO/TS 20443:2017定义了概念并描述了数据元素及其结构关系，这是药品唯一标识和详细描述所需的。综上所述，所有ISO IDMP标准（ISO 11615、ISO 11616、ISO 11238、ISO 11239和ISO 11240）都定义、描述并唯一标识了从批准到上市后更新或退出市场（如适用）供人类使用的受管制药品。此外，为了支持与医药产品的独特识别和特征描述有关的成功信息交换，描述了HL7通用产品模型（CPM）和结构化产品标签（SPL）消息的规范使用。ISO/TS 20443中包含了对医药产品信息使用其他相关标准的参考:2017年，支持成功的信息交流。

ISO/TS 20443:2017 defines concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products.Taken together, all ISO IDMP standards (ISO 11615, ISO 11616, ISO 11238, ISO 11239 and ISO 11240) define, characterise, and uniquely identify regulated Medicinal Products for human use from approval, to post-marketing and renewal or withdrawal from the market, where applicable.Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the normative use of HL7 common product model (CPM) and structured product labeling (SPL) messaging is described. References to the use of other relevant standards for Medicinal Product information are included in ISO/TS 20443:2017 to support successful information exchange.

标准预览图