ISO 23963-2:2022

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 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
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
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
iii
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.
iv
Introduction
Chinese medicine (medicinal plants, animals and minerals) originates from a wide variety of different
sources of supply. The production documentation is handled differently by each company and important
manufacturing steps are usually not fully documented. Several companies are usually involved in the
manufacturing process of Chinese medicine and relevant information is often not passed on fully from
one company to the other. This makes it very difficult for manufacturers and consumers to retrace the
entire production process (e.g. cultivation, harvesting, processing, storage and logistics) and to assess
the quality and safety of the Chinese medicine. The lack of transparency in the manufacturing process
slows down to a certain extent the further development and internationalization of traditional Chinese
medicine. Therefore, a supply chain traceability system is needed which ensures that the documentation
of all product-relevant information is standardized and available at all times. Such a system will enable
companies to better evaluate their suppliers and to convince end users of the quality and safety of their
products.
This document is consistent with ISO 18668-1, ISO 18668-2, ISO 18668-3 and ISO 20333. It includes the
application of these documents and provides a solution to improve the management of all processes
relating to Chinese medicine, contributes to the establishment of the traditional Chinese medicine
supply chain traceability system and quality-investigating mechanism, enhances product quality and
competitiveness, protects consumers' rights and ensures safe and effective application in clinical use.
This document can promote the process of standardization, informatization and modernization for
traditional Chinese medicine.
v
INTERNATIONAL STANDARD ISO 23963-2:2022(E)
Traditional Chinese medicine — Requirements for process
traceability system of Chinese materia medica and
decoction pieces —
Part 2:
Electronic labelling
1 Scope
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 18668-2, Traditional Chinese medicine — Coding system for Chinese medicines — Part 2: Codes for
decoction pieces
ISO 18668-3, Traditional Chinese medicine — Coding system for Chinese medicines — Part 3: Codes for
Chinese Materia Medica
ISO 20333, Traditional Chinese medicine — Coding rules for Chinese medicines in supply chain management
ISO 22217, Traditional Chinese medicine —Storage requirements for raw materials and decoction pieces
ISO 23963-1, Traditional Chinese medicine — Requirements for process traceability system of Chinese
materia medica and decoction pieces — Part 1: Components
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following address
...