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CEN ISO/TS 16791:2020

(Main)

Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers (ISO/TS 16791:2020)

Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers (ISO/TS 16791:2020)

This document provides guidelines on identification and labelling of medicinal products from the point of manufacture of packaged medicinal product to the point of dispensing the product.
This document 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 16791:2020)

Dieses Dokument bietet Leitlinien zur Identifizierung und Etikettierung von Arzneimitteln von der Herstellung des verpackten Arzneimittels bis zur Verabreichung des Produkts.
Es beschreibt bewährte Methoden für AIDC-Strichcodierungslösungen für Anwendungen. Anwender können die Interoperabilitätsanforderungen an die Kodierung jedoch auch auf andere AIDC-Technologien, wie die Identifikation mittels Hochfrequenz (en: Radio Frequency Identification, RFID), übertragen.

Informatique de santé - Exigences pour une identification internationale, lisible par capture automatique, des produits médicinaux (ISO/TS 16791:2020)

Zdravstvena informatika - Zahteve za mednarodne strojno berljive kode za pakiranje zdravil (ISO/TS 16791:2020)

General Information

Status
Published
Publication Date
13-Oct-2020
ICS
35.240.80 - IT applications in health care technology
Technical Committee
CEN/TC 251 - Medical informatics
Drafting Committee
CEN/TC 251/WG 1 - Information models
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
14-Oct-2020
Completion Date
14-Oct-2020
Ref Project
SIST-TS CEN ISO/TS 16791:2021 - Health informatics -- Requirements for international machine-readable coding of medicinal product package identifiers (ISO/TS 16791:2020)

Relations

Replaces
CEN ISO/TS 16791:2015 - Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers (ISO/TS 16791:2014)
Effective Date
21-Oct-2020

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SLOVENSKI STANDARD
01-januar-2021
Nadomešča:
SIST-TS CEN ISO/TS 16791:2015
Zdravstvena informatika - Zahteve za mednarodne strojno berljive kode za
pakiranje zdravil (ISO/TS 16791:2020)
Health informatics -- Requirements for international machine-readable coding of
medicinal product package identifiers (ISO/TS 16791:2020)
Medizinische Informatik - Anforderungen für internationale maschinenlesbare
Kodierungen von Identifikatoren für Arzneimittelpackungen (ISO/TS 16791:2020)
Informatique de santé -- Exigences pour une identification internationale, lisible par
capture automatique, des produits médicinaux (ISO/TS 16791:2020)
Ta slovenski standard je istoveten z: CEN ISO/TS 16791:2020
ICS:
35.040.50 Tehnike za samodejno Automatic identification and
razpoznavanje in zajem data capture techniques
podatkov
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
October 2020
TECHNISCHE SPEZIFIKATION
ICS 35.240.80 Supersedes CEN ISO/TS 16791:2015
English Version
Health informatics - Requirements for international
machine-readable coding of medicinal product package
identifiers (ISO/TS 16791:2020)
Informatique de santé - Exigences pour une Medizinische Informatik - Anforderungen für
identification internationale, lisible par capture internationale maschinenlesbare Kodierungen von
automatique, des produits médicinaux (ISO/TS Identifikatoren für Arzneimittelpackungen (ISO/TS
16791:2020) 16791:2020)
This Technical Specification (CEN/TS) was approved by CEN on 7 September 2020 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 16791:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (CEN ISO/TS 16791:2020) 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 shall not be held responsible for identifying any or all such patent rights.
This document supersedes CEN ISO/TS 16791:2015.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO/TS 16791:2020 has been approved by CEN as CEN ISO/TS 16791:2020 without any
modification.
TECHNICAL ISO/TS
SPECIFICATION 16791
Second edition
2020-09
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 16791:2020(E)
©
ISO 2020
ISO/TS 16791:2020(E)
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

ISO/TS 16791:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviated terms . 1
3.1 Terms and definitions . 1
3.2 Abbreviated terms . 6
4 Procedural background. 6
4.1 General . 6
4.2 Identification . 6
4.3 International machine-readable coding . 7
4.4 Medicinal product . 7
4.5 Labelling . 8
4.6 Package identifier . 8
4.7 Serialization . 9
5 Usage requirements . 9
5.1 General . 9
5.2 Traceability .10
5.2.1 Principles .10
5.2.2 Guidelines .11
5.3 Measures to combat falsification of medicines .12
5.3.1 Principles .12
5.3.2 Guidelines for both approaches .13
5.3.3 Product authentication . .13
5.3.4 Supply chain integrity .14
5.4 Improving patient safety at point of care .14
5.4.1 Principles .14
5.4.2 Guidelines .14
5.5 Support of healthcare systems .15
5.5.1 Principles .15
5.5.2 Guidelines .16
5.6 Procurement and stock management .16
5.6.1 Principles .16
5.6.2 Guidelines .17
5.7 Overview of guidelines .17
6 Economic aspects .17
6.1 General .17
6.2 Manufacturer perspective .18
6.3 Healthcare provider perspective .18
Annex A (informative) Relationship between PhPID and MPID .19
Annex B (informative) Packaging hierarchy, relationship between MPID, PCID and GTIN® .21
Annex C (informative) Identification of trade items and logistic units .23
Annex D (informative) Examples for Package Identifier .24
Annex E (informative) Personalized Medicine .33
Bibliography .
...

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