Name: CEN ISO/TS 16791:2015
Brand: CEN

CEN ISO/TS 16791:2015

Withdrawn

Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers (ISO/TS 16791:2014)

Withdrawn date

10-03-2023

Published date

09-09-2015

Publisher

Comite Europeen de Normalisation

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Procedural background
5 Usage requirements
6 Economic aspects
Annex A (informative) - Relationship between PhPID and MPID
(Referencing ISO 11615 and ISO 11616)
Annex B (informative) - Packaging hierarchy
Annex C (informative) - Relationship between MPID, PCID
and GTIN
Annex D (informative) - Examples for Package Identifier
Bibliography

ISO/TS 16791:2014 provides guidance on identification and labelling of medicinal products from the point of manufacture of packaged medicinal product to the point of dispensing the product.ISO/TS 16791:2014 outlines best practice for AIDC barcoding solutions for applications. Users can, however, consider the coding interoperability requirements for other AIDC technologies e.g. Radio Frequency Identification (RFID).

Committee	CEN/TC 251
DocumentType	Technical Specification
PublisherName	Comite Europeen de Normalisation
Status	Withdrawn
SupersededBy	CEN ISO/TS 16791:2020

Standards	Relationship
ONORM ONR CEN ISO/TS 16791 : 2015	Identical
NEN NVN CEN ISO/TS 16791 : 2015	Identical
S.R. CEN ISO/TS 16791:2015	Identical
PD CEN ISO/TS 16791:2015	Identical
DIN CEN ISO/TS 16791;DIN SPEC 13224:2015-12	Identical
UNI CEN ISO/TS 16791 : 2015	Identical
DIN CEN ISO/TS 16791;DIN SPEC 13224:2015-12	Identical

ISO/IEC 16022:2006	Information technology Automatic identification and data capture techniques Data Matrix bar code symbology specification
ISO/IEC 8859-1:1998	Information technology 8-bit single-byte coded graphic character sets Part 1: Latin alphabet No. 1
ISO/IEC 10646:2014	Information technology Universal Coded Character Set (UCS)
ISO/IEC 15459-4:2014	Information technology Automatic identification and data capture techniques Unique identification Part 4: Individual products and product packages
ISO 11615:2017	Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information
ISO/IEC 15416:2016	Automatic identification and data capture techniques — Bar code print quality test specification — Linear symbols
ISO/IEC TR 24720:2008	Information technology Automatic identification and data capture techniques Guidelines for direct part marking (DPM)
ISO/IEC 15459-2:2015	Information technology Automatic identification and data capture techniques Unique identification Part 2: Registration procedures
ISO/HL7 27953-2:2011	Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 2: Human pharmaceutical reporting requirements for ICSR
ISO/IEC 15459-3:2014	Information technology Automatic identification and data capture techniques Unique identification Part 3: Common rules
ISO/IEC 15459-6:2014	Information technology Automatic identification and data capture techniques Unique identification Part 6: Groupings
ISO 11240:2012	Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of units of measurement
ISO/IEC 15424:2008	Information technology Automatic identification and data capture techniques Data Carrier Identifiers (including Symbology Identifiers)
ISO 11238:2012	Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on substances
ISO/IEC 15417:2007	Information technology Automatic identification and data capture techniques Code 128 bar code symbology specification
ISO/IEC 19762-1:2008	Information technology Automatic identification and data capture (AIDC) techniques Harmonized vocabulary Part 1: General terms relating to AIDC
ISO/TR 25257:2009	Health informatics Business requirements for an international coding system for medicinal products
ISO 28219:2017	Packaging — Labelling and direct product marking with linear bar code and two-dimensional symbols
ISO/IEC TR 29158:2011	Information technology Automatic identification and data capture techniques Direct Part Mark (DPM) Quality Guideline
ISO/IEC 15459-1:2014	Information technology Automatic identification and data capture techniques Unique identification Part 1: Individual transport units
ISO/HL7 27953-1:2011	Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 1: Framework for adverse event reporting
ISO/IEC 15415:2011	Information technology Automatic identification and data capture techniques Bar code symbol print quality test specification Two-dimensional symbols
ISO/IEC 15418:2016	Information technology Automatic identification and data capture techniques GS1 Application Identifiers and ASC MH10 Data Identifiers and maintenance
ISO/IEC 15423:2009	Information technology Automatic identification and data capture techniques Bar code scanner and decoder performance testing
ISO 22742:2010	Packaging — Linear bar code and two-dimensional symbols for product packaging
ISO 11239:2012	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