Schweizerische Normen-Vereinigung

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
 N SN EN ISO 11239

Annotation

This International Standard 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 associated of translation 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 allow regional authorities to map existing regional terms to the terms crated using this International Standard, in harmonized meaningful way.

In addition, to support the successful application of this International Standard, references to standards concerned with identification of medicinal products (IDMP) and messaging for medicinal product information are provided as required.

Автоматический перевод:

Медицинская информатика - Идентификация лекарственных препаратов - Элементы данных и структуры для уникальной идентификации и обмена отрегулированной информацией о фармацевтических формах дозы, модулях представления, путей введения и упаковки