ISO 11615

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Logo of the German Institute for Standardization DIN ISO 11615
Area Medical informatics
title Drug Identification - Data elements and structures used to identify drugs for the exchange of officially approved drug information
Latest edition 12012-10
ISO 11615

ISO 11615: 2012 is a standard of the International Organization for Standardization (ISO) that describes data elements, structures and relationships between data elements for the identification and detailed representation of medicinal products . Together with the other standards of this group of standards (IDMP), it is possible to describe and identify drugs throughout their entire life cycle. The aim of this standard is also to enable the exchange of regulatory data and thus the identification of drugs. This is important for pharmacovigilance , regulatory and other activities.

The standard was developed in the working group WG6 (Pharmacy) of the Technical Committee ISO TC 215 Health Informatics .

Other relevant standards

The ISO 11615: 2012 standard belongs to a group of five standards for the identification of medicinal products (IDMP) . Further standards are

  • ISO 11616: 2012 - Pharmaceutical products
  • ISO 11240: 2012 - units of measure
  • ISO 11239: 2012 - Catalogs for dosage forms, dosage units, application types and containers
  • ISO 11238: 2012 - Substance information

The entire group of standards was developed for use in medicinal products for human use.

Individual evidence

  1. ↑ a b International Organization for Standardization : Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information . Retrieved July 25, 2014.
  2. ↑ International Organization for Standardization : Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information . Retrieved October 26, 2012.
  3. ↑ International Organization for Standardization : Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement . Retrieved October 26, 2012.
  4. ↑ International Organization for Standardization : 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 . Retrieved October 26, 2012.
  5. ↑ International Organization for Standardization : Health Informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances . Retrieved October 26, 2012.