ISO 23963-2:2022

Traditional Chinese medicine — Requirements for process traceability system of Chinese materia medica and decoction pieces — Part 2: Electronic labelling

This document specifies the content of electronic labelling in the form of QR codes on the outer packing of Chinese materia medica and decoction pieces. This document is applicable to the cultivation, production, sales, use units and consumers of Chinese materia medica and decoction pieces.

Médecine traditionnelle chinoise — Exigences relatives au système de traçabilité du processus pour la Materia Medica chinoise et les décoctions — Partie 2: Étiquetage électronique

General Information

• Status: Published
• Publication Date: 31-Jul-2022
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/JWG 1 - Joint ISO/TC 249 - ISO/TC 215 WG: Informatics
• Parallel Committee: ISO/TC 215 - Health informatics
• Current Stage: 6060 - International Standard published
• Start Date: 01-Aug-2022
• Due Date: 18-Mar-2022
• Completion Date: 01-Aug-2022

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 23963-2
First edition
2022-08
Traditional Chinese medicine —
Requirements for process traceability
system of Chinese materia medica and
decoction pieces —
Part 2:
Electronic labelling
Médecine traditionnelle chinoise — Exigences relatives au système
de traçabilité du processus pour la Materia Medica chinoise et les
décoctions —
Partie 2: Étiquetage électronique
Reference number
ISO 23963-2:2022(E)
© ISO 2022

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ISO 23963-2:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
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
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Published in Switzerland
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ISO 23963-2:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements of electronic labelling .2
5 Content of electronic labelling . 2
5.1 Basic information . 2
5.1.1 Product name . 2
5.1.2 Barcode . 2
5.1.3 Code. 2
5.1.4 Brand . 3
5.1.5 Place of origin . 3
5.1.6 Harvest time . 3
5.1.7 Processing method . 3
5.1.8 Specification . 3
5.1.9 Efficacy . 3
5.1.10 Adverse reaction. 3
5.1.11 Contraindication . 3
5.2 Manufacturer information . 3
5.2.1 Manufacturer . 3
5.2.2 Address . 3
5.2.3 Telephone number . 3
5.2.4 Website . 3
5.2.5 Product time . 4
5.3 Distributor information . 4
5.3.1 Distributor . 4
5.3.2 Address . 4
5.3.3 Telephone number . 4
5.3.4 Website . 4
5.3.5 Packing time . 4
5.4 Additional information. 4
5.4.1 Storage method . 4
5.4.2 Applied standards . 4
5.4.3 Picture . 4
5.4.4 Decocting method . 4
5.4.5 Administration method. 5
5.4.6 Other information . 5
Bibliography . 6
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ISO 23963-2:2022(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 of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/
iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
A list of all parts in the ISO 23963 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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ISO 23963-2:2022(E)
Introduction
Chinese medicine (medicinal plants, animals and minerals) originates from a wide variety of different
sources of supply. The
...