PD CEN ISO/TS 16791:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Health informatics. Requirements for international machine-readable coding of medicinal product package identifiers
Hardcopy , PDF
21-10-2020
English
30-09-2015
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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
Gives guidance on identification and labelling of medicinal products from the point of manufacture of packaged medicinal product to the point of dispensing the product.
| Committee |
IST/35
|
| DevelopmentNote |
Renumbers and supersedes BS PD ISO/TS 16791. 2015 Version incorporate corrigendum to BS PD ISO/TS 16791. (10/2015)
|
| DocumentType |
Standard
|
| Pages |
32
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
This Technical Specification 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.
This Technical Specification 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).
| Standards | Relationship |
| CEN ISO/TS 16791:2015 | 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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