Traditional Chinese medicine -- Guidelines and specification for Chinese materia medica

This document specifies the general requirements for Chinese materia medica specification. This specification is relevant for dividing Chinese materia medica into categories. It provides guidelines for writing the specifications of individual Chinese materia medica.

Médecine traditionnelle chinoise -- Lignes directrices et spécification relatives aux matières médicales chinoises

General Information

Status
Published
Publication Date
03-Mar-2019
Current Stage
6060 - International Standard published
Start Date
30-Jan-2019
Completion Date
04-Mar-2019
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ISO 21300:2019 - Traditional Chinese medicine -- Guidelines and specification for Chinese materia medica
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INTERNATIONAL ISO
STANDARD 21300
First edition
2019-03
Traditional Chinese medicine —
Guidelines and specification for
Chinese materia medica
Médecine traditionnelle chinoise — Lignes directrices et spécification
relatives aux matières médicales chinoises
Reference number
ISO 21300:2019(E)
ISO 2019
---------------------- Page: 1 ----------------------
ISO 21300:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

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
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Phone: +41 22 749 01 11
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Email: copyright@iso.org
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Published in Switzerland
ii © ISO 2019 – All rights reserved
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ISO 21300:2019(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Requirements .......................................................................................................................................................................................................... 2

4.1 Total ash ........................................................................................................................................................................................................ 2

4.2 Sulfated ash ................................................................................................................................................................................................ 2

4.3 Ash insoluble in hydrochloric acid ......................................................................................................................................... 2

4.4 Heavy metals ............................................................................................................................................................................................. 2

4.5 Foreign matter ......................................................................................................................................................................................... 2

4.6 Identification ............................................................................................................................................................................................ 2

4.7 Pesticide residues ................................................................................................................................................................................. 2

4.8 Sulfur dioxide ........................................................................................................................................................................................... 2

4.9 Aflatoxin ........................................................................................................................................................................................................ 3

5 Indicators of the specification ................................................................................................................................................................ 3

5.1 Origin ............................................................................................................................................................................................................... 3

5.2 Growing method .................................................................................................................................................................................... 3

5.3 Medicinal parts ....................................................................................................................................................................................... 4

5.4 Harvest time .............................................................................................................................................................................................. 4

5.5 Primary processing ............................................................................................................................................................................. 4

5.6 Extraneous matter rate .................................................................................................................................................................... 5

5.7 Morphology ................................................................................................................................................................................................ 5

5.7.1 Individual number per 500 g ................................................................................................................................ 5

5.7.2 Length per piece ............................................................................................................................................................... 6

5.7.3 Thickness per piece ....................................................................................................................................................... 6

5.7.4 Diameter per piece ......................................................................................................................................................... 7

5.7.5 Colour ........................................................................................................................................................................................ 7

6 Marking, labelling, packaging, transport and storage .................................................................................................. 8

6.1 Marking and labelling ....................................................................................................................................................................... 8

6.2 Packaging ..................................................................................................................................................................................................... 8

6.3 Transport and storage ...................................................................................................................................................................... 8

Bibliography ................................................................................................................................................................................................................................ 9

© ISO 2019 – All rights reserved iii
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ISO 21300:2019(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.

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 © ISO 2019 – All rights reserved
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ISO 21300:2019(E)
Introduction

Chinese materia medica is a special commodity used for preventing and treating diseases. Chinese

materia medica is imported and exported by many countries, with important differences in quality.

This document is intended to provide a basis for fixing the price of different Chinese materia medica.

It is intended to help regulate manufacturing and distribution, maintain quality, safety and market

orders, and promote the development of trade and exchange in Chinese materia medica.

© ISO 2019 – All rights reserved v
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INTERNATIONAL STANDARD ISO 21300:2019(E)
Traditional Chinese medicine — Guidelines and
specification for Chinese materia medica
1 Scope

This document specifies the general requirements for Chinese materia medica specification. This

specification is relevant for dividing Chinese materia medica into categories. It provides guidelines for

writing the specifications of individual Chinese materia medica.
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 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical use

3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
Chinese materia medica
CMM

medicinal parts of medicinal plants, animals and minerals after preliminary processing, which are used

as raw materials to make decoction pieces in Chinese medicines

Note 1 to entry: The different nomenclatures of the Chinese materia medica in use are described as follows:

— Latin name: Latin pharmaceutical name of the Chinese mater
...

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