BS EN ISO 11239:2023 - TC | 30 Jun 2023 | BSI Knowledge
Standard
BS EN ISO 11239:2023
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
Current
•
Published:
1 Scope
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.
Product Details
Descriptors
Management
Product information
Exchange
Identification methods
Data elements
Structures
Technical regulations
Drugs
Dose (drug)
ICS Codes
35.240.80 IT applications in health care technology