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EVS-EN ISO 11238:2018

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2018)

General information

Valid from 16.08.2018
Base Documents
ISO 11238:2018; EN ISO 11238:2018
ICS Groups
35.240.80 IT applications in health care technology
Directives or regulations
None

Standard history

Status
Date
Type
Name
16.08.2018
Main
EVS-EN ISO 11238:2018
05.12.2012
Main
EVS-EN ISO 11238:2012
This document provides an information model to define and identify substances within medicinal products or substances used for medicinal purposes, including dietary supplements, foods and cosmetics. The information model can be used in the human and veterinary domain since the principles are transferrable. Other standards and external terminological resources are referenced that are applicable to this document.

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Standard monitoring
English (PDF 557 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