ISO 21300:2019

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 2019
© ISO 2019
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ii © ISO 2019 – All rights reserved

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
Foreword
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This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
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iv © ISO 2019 – All rights reserved

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.
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
...