ISO 11239:2023 保健信息学 医药产品的标识 对制药剂量形式、表示单位、管理与包装路线等管制信息的唯一标识和交换用数据元与结构

标准编号：ISO 11239:2023

中文名称：保健信息学 医药产品的标识 对制药剂量形式、表示单位、管理与包装路线等管制信息的唯一标识和交换用数据元与结构

英文名称：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 pres

发布日期：2023-06

标准范围

本文件规定:—？信息交换所需的数据元素、结构和数据元素之间的关系，其唯一且确定地识别药物剂型、呈现单位、给药途径和与药品相关的包装项目（容器、封闭件和给药装置）；—？将单个概念翻译成不同语言的机制，这是信息交换的一个组成部分；—？用于概念的版本化以跟踪其演变的机制；—？帮助地区当局以协调和有意义的方式将现有的地区术语映射到使用本文件创建的术语的规则。

This document specifies:

—     the data elements, structures and relationships between the data elements required for the exchange of information, which uniquely and with certainty identify pharmaceutical dose forms, units of presentation, routes of administration and packaging items (containers, closures and administration devices) related to medicinal products;

—     a mechanism for the association of translations of a single concept into different languages, which is an integral part of the information exchange;

—     a mechanism for the versioning of the concepts in order to track their evolution;

—     rules to help regional authorities to map existing regional terms to the terms created using this document, in a harmonized and meaningful way.

标准预览图