CEN ISO/TS 16791:2015
(Main)Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers (ISO/TS 16791:2014)
Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers (ISO/TS 16791:2014)
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).
Medizinische Informatik - Anforderungen für internationale maschinenlesbare Kodierungen von Identifikatoren für Arzneimittelpackungen (ISO/TS 16791:2014)
Informatique de santé - Exigences pour une identification internationale, lisible par capture automatique, des produits médicinaux (ISO/TS 16791:2014)
Zdravstvena informatika - Zahteve za mednarodne strojno berljive kode za pakiranje zdravil (ISO/TS 16791:2014)
Ta tehnična specifikacija določa smernice za identifikacijo in označevanje zdravil od proizvodnje pakiranega zdravila do razdeljevanja izdelka. Ta tehnična specifikacija opisuje najboljše prakse za rešitve kod AIDC za aplikacije. Uporabniki lahko upoštevajo zahteve za interoperabilnost kod za druge tehnologije AIDC, na primer radiofrekvenčno identifikacijo (RFID).
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2015
Zdravstvena informatika - Zahteve za mednarodne strojno berljive kode za
pakiranje zdravil (ISO/TS 16791:2014)
Health informatics - Requirements for international machine-readable coding of medicinal
product package identifiers (ISO/TS 16791:2014)
Medizinische Informatik - Anforderungen für maschinenlesbare internationale
Kodierungen für Verpackungen von Arzneimitteln (ISO/TS 16791:2014)
Informatique de santé - Exigences pour une identification internationale, lisible par
capture automatique, des produits médicinaux (ISO/TS 16791:2014)
Ta slovenski standard je istoveten z: CEN ISO/TS 16791:2015
ICS:
35.040 Nabori znakov in kodiranje Character sets and
informacij information coding
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
CEN ISO/TS 16791
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
September 2015
TECHNISCHE SPEZIFIKATION
ICS 35.240.80
English Version
Health informatics - Requirements for international
machine-readable coding of medicinal product package
identifiers (ISO/TS 16791:2014)
Informatique de santé - Exigences pour une Medizinische Informatik - Anforderungen für
identification internationale, lisible par capture maschinenlesbare internationale Kodierungen für
automatique, des produits médicinaux (ISO/TS Verpackungen von Arzneimitteln (ISO/TS 16791:2014)
16791:2014)
This Technical Specification (CEN/TS) was approved by CEN on 31 August 2015 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 16791:2015 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (CEN ISO/TS 16791:2015) has been prepared by Technical Committee ISO/TC 215
“Health informatics” in collaboration with Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO/TS 16791:2014 has been approved by CEN as CEN ISO/TS 16791:2015 without any
modification.
TECHNICAL ISO/TS
SPECIFICATION 16791
First edition
2014-04-01
Health informatics — Requirements
for international machine-readable
coding of medicinal product package
identifiers
Informatique de santé — Exigences pour une identification
internationale, lisible par capture automatique, des produits
médicinaux
Reference number
ISO/TS 16791:2014(E)
©
ISO 2014
ISO/TS 16791:2014(E)
© ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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Published in Switzerland
ii © ISO 2014 – All rights reserved
ISO/TS 16791:2014(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 Terms . 1
3.2 Abbreviations . 5
4 Procedural background. 6
4.1 General . 6
4.2 Identification . 6
4.3 International machine readable coding . 6
4.4 Medicinal product . 7
4.5 Labelling . 7
4.6 Package identifier . 8
4.7 Serialization . 8
5 Usage requirements . 9
5.1 General . 9
5.2 Traceability . 9
5.3 Measures to combat falsification of medicines .10
5.4 Improving patient safety at point of care .12
5.5 Support of healthcare systems .12
5.6 Procurement and stock management .14
5.7 Overview of the normative options . .15
6 Economic aspects .15
6.1 General .15
6.2 Manufacturer perspective .16
6.3 Healthcare provider perspective .16
Annex A (informative) Relationship between PhPID and MPID (Referencing ISO 11615 and
ISO 11616) .17
Annex B (informative) Packaging hierarchy .18
Annex C (informative) Relationship between MPID, PCID and GTIN .19
Annex D (informative) Examples for Package Identifier .20
Bibliography .22
ISO/TS 16791:2014(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 215, Health informatics.
iv © ISO 2014 – All rights reserved
ISO/TS 16791:2014(E)
Introduction
Globally, healthcare regulators, medicinal pr
...
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