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 4904:2023(E)
© ISO 2023

---------------------- Page: 1 ----------------------
ISO 4904:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
  © ISO 2023 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 4904:2023(E)
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
© ISO 2023 – All rights reserved

---------------------- Page: 3 ----------------------
ISO 4904:2023(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO m
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 4904
ISO/TC 249
Traditional Chinese medicine — Inner
Secretariat: SAC
pack of decoction pieces
Voting begins on:
2023-07-07
Voting terminates on:
2023-09-01
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 4904:2023(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2023

---------------------- Page: 1 ----------------------
ISO/FDIS 4904:2023(E)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 4904
ISO/TC 249
Traditional Chinese medicine — Inner
Secretariat: SAC
pack of decoction pieces
Voting begins on:
Voting terminates on:
COPYRIGHT PROTECTED DOCUMENT
© 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.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: [phone]
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: [e-mail]
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 4904:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
  © ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023

---------------------- Page: 2 ----------------------
ISO/FDIS 4904:2023(E)
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 .
...

2023-04-1806
ISO/DIS FDIS 4904:2023(E)
ISO/TC 249/SC 0/WG 2
Secretariat: SAC
Traditional Chinese Medicinemedicine — Inner pack of decoction pieces

---------------------- Page: 1 ----------------------
ISO/DIS FDIS 4904:20222023(E)
Copyright notice
This ISO document is a working draft or committee draft and is copyright-protected by ISO. While
the reproduction of working drafts or committee drafts in any form for use by participants in the
ISO standards development process is permitted without prior permission from ISO, neither this
document nor any extract from it may be reproduced, stored or transmitted in any form for any
other purpose without prior written permission from ISO.
Requests for permission to reproduce this document for the purpose of selling it should be
addressed as shown below or to ISO’s member body in the country of the requester:
[Indicate :
the full address
telephone number
fax number
telex number
and electronic mail address
as appropriate, of the Copyright Manager of the ISO member body responsible for the secretariat of
the TC or SC within the framework of which the draft has been prepared]
Reproduction for sales purposes may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2022 2023 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/DIS FDIS 4904:20222023(E)
Contents Page
Contents . iii
Foreword . iv
Introduction . v
1 Scope . 6
2 Normative references . 6
3 Terms and definitions. 6
4 Physical properties requirements for inner pack of decoction pieces . 8
5 Requirements for inner pack materials of decoction pieces . 8
6 Setting of packing dose specifications . 9
7 Requirements for labels. 10
8 Requirements for Quick Response (QR) codes . 11
9 Requirements for Colour codes . 11
Annex A (informative) Specifications and Corresponding Colour Codes for inner pack of
Decoction pieces . 13
Bibliography . 14
© ISO 2022 2023 – All rights reserved iii

---------------------- Page: 3 ----------------------
ISO/DIS FDIS 4904:20222023(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 documentsdocument 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 drawnISO draws
...