ISO 11616
|
DIN ISO 11616 |
|---|---|
| Area | Medical informatics |
| title | Identification of pharmaceuticals - data elements and structures for the identification and exchange of pharmaceutical product labels |
| Latest edition | 12012-10 |
| ISO | 11616 |
ISO 11616: 2012 is a standard of the International Organization for Standardization (ISO), which describes different information levels for the identification of drugs or drug groups. It defines data elements, structures and relationships between data elements to identify pharmaceutical products. The aim of this standard is to enable the exchange of regulatory data and thus the identification of pharmaceuticals. 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 11616: 2012 standard belongs to a group of five standards for the identification of medicinal products (IDMP) . Further standards are
- ISO 11615: 2012 - Medicines
- 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
- ↑ a b 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.
- ↑ 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 October 26, 2012.
- ↑ 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.
- ↑ 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.
- ↑ 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.