ISO 4904:2023

Traditional Chinese medicine — Inner pack of decoction pieces

This document specifies requirements for the inner pack of decoction pieces of Chinese medicines, including packaging materials, physical properties, specifications and labels. This document is applicable to the manufacturing, inspection, operation, circulation, use, supervision and management of inner pack of decoction pieces.

Médecine traditionnelle chinoise — Sachet interne des décoctions

General Information

• Status: Published
• Publication Date: 24-Oct-2023
• ICS: 11.020.99 - Other standards related to health care in general
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/WG 2 - Quality and safety of manufactured TCM products
• Current Stage: 6060 - International Standard published
• Start Date: 25-Oct-2023
• Due Date: 29-May-2023
• Completion Date: 25-Oct-2023

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 4904
First edition
2023-10
Traditional Chinese medicine — Inner
pack of decoction pieces
Médecine traditionnelle chinoise — Sachet interne des décoctions
Reference number
© ISO 2023
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
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Physical property requirements for inner pack of decoction pieces.2
5 Requirements for inner pack materials of decoction pieces . 3
6 Setting of packing dose specifications. 3
6.1 Setting principles . 3
6.2 Specification requirements . 4
6.3 Other requirements . 4
7 Requirements for labels . 4
8 Requirements for quick response (QR) codes . 5
8.1 QR code area . 5
8.2 QR code scanning results . 5
9 Requirements for colour codes .6
Annex A (informative) Specifications and corresponding colour codes for inner pack
of decoction pieces . 7
Bibliography . 8
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use
of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all
such patent rights.
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.
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
Packing material used for the inner pack of decoction pieces should meet basic quality criteria, because
the inner packaging comes into direct contact with the decoction pieces. At present, there are no
internationally recognized standards that define the specifications for inner packaging. Therefore, the
inner packaging is often not standardized, not in compliance with hygienic requirements, not suitable
for the packaging of medicines and not applicable to the nature of decoction pieces. Hence, the inner
pack should be standardized to ensure the quality, safety and efficacy of decoction pieces.
In view of the current situation where there is often no inner pack of decoction pieces or the inner
pack is not in compliance with relevant requirements, this document promotes the harmonisation
of packaging for decoction pieces, leading to reduced trade barriers. This document, along with
ISO 18668-1, ISO 18668-2 and ISO 20333, can promote the process of standardization, informatization
and modernization of Chinese medicines.
v
INTERNATIONAL STANDARD ISO 4904:2023(E)
Traditional Chinese medicine — Inner pack of decoction
pieces
1 Scope
This document specifies requirements for the inner pack of decoction pieces of Chinese medicines,
including packaging materials, physical properties, specifications and labels.
This document is applicable to the manufacturing, inspection, operation, circulation, use, supervision
and management of inner pack of 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 11615, Health informatics — Identification of medicinal products — Data elements and structures for
the unique identification and exchange of regulated medicinal product information
ISO 15378, Primary packaging materials for medicinal products — Particular requirements for the
application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
ISO 18668-1:2016, Traditional Chinese medicine — Coding system for Chinese medicines — Part 1: Coding
rules for Chinese medicines
ISO 18668-2, Traditional Chinese medicine — Coding system for Chinese medicines — Part 2: Codes for
decoction pieces
ISO 20333, Traditional Chinese medicine — Coding rules for Chinese medicines in supply chain management
ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical
use
ISO 22217, Traditional Chinese medicine —Storage requirements for raw materials and decoction pieces
ISO 23963-1, Traditional Chinese medicine — Requirements for process traceability systems in Chinese
materia medica and decoction pieces — Part 1: Components
ISO 23963-2, Traditional Chinese medicine — Requirements for process traceability system of Chinese
materia medica and decoction pieces — Part 2: Electronic labelling
ASTM D3981, Standard specification for polyethylene films made from medium-density polyethylene for
general use and packaging applications
ASTM D4635, Standard specification for plastic films made from low-density polyethylene and linear low-
density polyethylene for general use and packaging applications
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 addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
inner pack
package in direct contact with decoction pieces (3.2)
3.2
decoction piece
prescription medicinal processed from Chinese Materia Medica in accordance with traditional Chinese
medicine and processing methods for Chinese medicines, which can be directly used in clinical practice
or the production of prepared medicines
[SOURCE: ISO 18668-1:2016, 3.3, modified — "under guidance" replaced by "in accordance with". Note
1 to entry has been merged into the definition.]
3.3
colour code
different colours used on the package or label of decoction pieces (3.2) for indicating different
specifications, including colour card (3.4) number, RGB and HEX/HTML
3.4
colour card
specific colour definitions are provided by different companies and are used for colour communication
systems in various areas, including printing, textile, plastics, drawing and digital technology
3.5
inner pack materials
materials which are us
...