PD CEN ISO/TS 20440:2023
Health informatics. Identification of medicinal products. Implementation guidelines for ISO 11239 data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of…
发布时间:2023-04-30 实施时间:


药品识别是药品管理和监管的重要环节,也是保障公众健康和安全的重要手段。药品识别需要对药品的剂型、剂量单位和药品标识符进行准确的识别和管理。为了实现药品识别的准确性和效率,ISO 11239提出了一系列数据元素和结构,用于规范药品剂型、剂量单位和药品标识符的信息交换。PD CEN ISO/TS 20440:2023提供了ISO 11239数据元素和结构的实施指南,以便药品制造商、药品分销商、药品监管机构和其他涉及药品识别的组织更好地管理药品信息。

该标准的实施需要遵循ISO 11239数据元素和结构的规范,包括药品剂型、剂量单位和药品标识符的命名、编码和格式等方面。同时,该标准还提供了药品识别的实施和维护的指南,包括药品信息的收集、存储、更新和共享等方面。药品制造商、药品分销商和药品监管机构可以根据该标准的指南,更好地管理药品信息,提高药品识别的准确性和效率。

该标准的实施可以带来以下好处:
1.提高药品识别的准确性和效率,减少药品管理和监管中的错误和漏洞;
2.促进药品信息的共享和交流,提高药品管理和监管的协同效应;
3.提高公众对药品的信任和满意度,保障公众健康和安全。

总之,PD CEN ISO/TS 20440:2023是一项关于健康信息学的标准,旨在提供药品识别的实施指南,以便在药品剂型、剂量单位和药品标识符的规范信息交换中使用ISO 11239数据元素和结构。该标准的实施可以帮助药品制造商、药品分销商和药品监管机构更好地管理药品信息,提高药品识别的准确性和效率,从而更好地保障公众健康和安全。

相关标准
ISO 11239:2012 Health informatics -- Identification of medicinal products -- Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
ISO 11615:2012 Health informatics -- Identification of medicinal products -- Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
ISO 11238:2012 Health informatics -- Identification of medicinal products -- Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
ISO 11240:2012 Health informatics -- Identification of medicinal products -- Data elements and structures for the unique identification and exchange of regulated information on substances
ISO 11241:2012 Health informatics -- Identification of medicinal products -- Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation and routes of administration