CEN ISO/TS 16791:2015
Withdrawn
Withdrawn
View Superseded by
Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers (ISO/TS 16791:2014)
Published date
09-09-2015
Publisher
Withdrawn date
03-10-2023
Superseded by
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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Withdrawn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 |
| 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 |
| 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 |
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