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EVS-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 (ISO 11239:2023)

General information

Valid from 03.07.2023
Base Documents
ISO 11239:2023; EN ISO 11239:2023
ICS Groups
35.240.80 IT applications in health care technology
Directives or regulations
None

Standard history

Status
Date
Type
Name
03.07.2023
Main
EVS-EN ISO 11239:2023
05.12.2012
Main
EVS-EN ISO 11239:2012
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.

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Standard monitoring
English (PDF 680 KB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English