DIN Standards Committee Health Technologies
DIN CEN ISO/TS 19844
; DIN SPEC 13261:2017-12
Health informatics - Identification of medicinal products - Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances (ISO/TS 19844:2016); English version CEN ISO/TS 19844:2017, only on CD-ROM
Medizinische Informatik - Identifikation von Arzneimitteln - Implementierungsleitfaden für Datenelemente und Strukturen zur eindeutigen Identifikation und zum Austausch von vorgeschriebenen Informationen von Stoffen (ISO/TS 19844:2016); Englische Fassung CEN ISO/TS 19844:2017, nur auf CD-ROM
Procedure
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Overview
This document provides comprehensive implementation guidelines for DIN EN ISO 11238. It describes an information model for defining and identifying substances contained in medicinal products or used for medical purposes, including food supplements, food and feed additives, and cosmetics. Since this document is based on DIN EN ISO 11238 and the latter - at least in the original ISO version - is referenced in the pharmacovigilance legislation, this document is also of great importance. Compared to DIN CEN ISO/TS 19844:2016-08, in addition to editorial changes, four further normative annexes have been added to describe further substance groups. This document (CEN ISO/TS 19844:2017) has been prepared by Technical Committee ISO/TC 215 "Health Informatics" (secretariat: ANSI, United States) with the participation of German experts and adopted by Technical Committee CEN/TC 251 "Medical Informatics" (secretariat: NEN, the Netherlands). The responsible German standardization committee is Working Committee NA 063-07-03 AA "Terminologie" ("Terminology") at DIN Standards Committee Medicine (NAMed).
Document: references other documents
Responsible national committee
Responsible european committee
CEN/TC 251/WG 1 - Enterprise and Information
