ISO/TS 16791:2020

Health informatics — Requirements for international machine-readable coding of medicinal product package identifiers

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).

Informatique de santé — Exigences pour une identification internationale, lisible par capture automatique, des produits médicinaux

General Information

• Status: Published
• Publication Date: 28-Sep-2020
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215/WG 6 - Pharmacy and medicines business
• Current Stage: 9092 - International Standard to be revised
• Completion Date: 20-Jun-2024

Relations

• Consolidates: ISO 8124-1:2014 - Safety of toys — Part 1: Safety aspects related to mechanical and physical properties
• Effective Date: 06-Jun-2022
• Revises: ISO/TS 16791:2014 - Health informatics — Requirements for international machine-readable coding of medicinal product package identifiers
• Effective Date: 27-Jan-2018

Standards Content (Sample)

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

---------------------- Page: 1 ----------------------
ISO/TS 16791:2020(E)

COPYRIGHT PROTECTED DOCUMENT
© 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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

---------------------- Page: 2 ----------------------
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
...

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

---------------------- Page: 1 ----------------------
ISO/TS 16791:2020(E)

COPYRIGHT PROTECTED DOCUMENT
© 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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

---------------------- Page: 2 ----------------------
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
...