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S.R. CEN ISO/TS 16791:2015

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by
withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

HEALTH INFORMATICS - REQUIREMENTS FOR INTERNATIONAL MACHINE-READABLE CODING OF MEDICINAL PRODUCT PACKAGE IDENTIFIERS (ISO/TS 16791:2014)
Available format(s)

Hardcopy , PDF

Withdrawn date

13-05-2021

Language(s)

English

Published date

01-01-2015

Preview

National Foreword
European foreword
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.

DocumentType
Standard
Pages
40
PublisherName
National Standards Authority of Ireland
Status
Withdrawn
SupersededBy

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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