ISO 21300:2019
(Main)Traditional Chinese medicine — Guidelines and specification for Chinese materia medica
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
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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 2019
© 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
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
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
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 materia medica. In the Latin name, the genus name or
genus name plus species name is followed by the applicable medicinal parts. Items are listed in alphabetical
order of the Latin name for easy and convenient searching.
— Chinese name: Han (Chinese) character name of the Chinese materia medica. Han characters include both the
simplified character and the traditional character, which is given in parentheses.
— Pinyin name: Pinyin name (Chinese phonetic) of the Chinese materia medica. The “four tones” have been
added in Pinyin to facilitate practice by users. Pinyin syllabication (in parentheses) is provided to facilitate
correct pronunciation.
— Scientific name: Latin scientific name of the source of the Chinese materia medica.
— English name: Commonly used English name of the Chinese materia medica.
[SOURCE: ISO 18662-1:2017, 3.1]
3.2
specification
explicit set of requirements to be satisfied for Chinese materia medica
3.3
category
collection of Chinese materia medica of the same species which has common features
3.4
primary processing
stage of the pre-treatment of natural materials during the collecting and harvesting process by which
the raw materials are transformed into medicinal materials
3.5
extraneous matter rate
rate of the matter of a given plant which is not retained for use as Chinese materia medica
3.6
origin
biological species of Chinese materia medica
4 Requirements
4.1 Total ash
The mass fraction of total ash of the Chinese materia medica shall be determined.
4.2 Sulfated ash
The mass fraction of sulfated ash of the Chinese materia medica shall be determined depending on the
characteristics of the Chinese materia medica.
4.3 Ash insoluble in hydrochloric acid
The mass fraction of ash insoluble in hydrochloric acid of the Chinese materia medica shall be
determined depending on the characteristics of the Chinese materia medica.
4.4 Heavy metals
The contents of heavy metals shall be determined depending on the characteristics of the Chinese
materia medica.
4.5 Foreign matter
The contents of foreign matter shall be determined.
4.6 Identification
The contents of the marker compounds shall be identified.
4.7 Pesticide residues
The contents of pesticide residues shall be determined depending on the characteristics of the Chinese
materia medica.
4.8 Sulfur dioxide
The contents of sulfur dioxide shall be determined depending on the characteristics of th
...
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
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
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
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
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 materia medica. In the Latin name, the genus name or
genus name plus species name is followed by the applicable medicinal parts. Items are listed in alphabetical
order of the Latin name for easy and convenient searching.
— Chinese name: Han (Chinese) character name of the Chinese materia medica. Han characters include both the
simplified character and the traditional character, which is given in parentheses.
— Pinyin name: Pinyin name (Chinese phonetic) of the Chinese materia medica. The “four tones” have been
added in Pinyin to facilitate practice by users. Pinyin syllabication (in parentheses) is provided to facilitate
correct pronunciation.
— Scientific name: Latin scientific name of the source of the Chinese materia medica.
— English name: Commonly used English name of the Chinese materia medica.
[SOURCE: ISO 18662-1:2017, 3.1]
3.2
specification
explicit set of requirements to be satisfied for Chinese materia medica
3.3
category
collection of Chinese materia medica of the same species which has common features
3.4
primary processing
stage of the pre-treatment of natural materials during the collecting and harvesting process by which
the raw materials are transformed into medicinal materials
3.5
extraneous matter rate
rate of the matter of a given plant which is not retained for use as Chinese materia medica
3.6
origin
biological species of Chinese materia medica
4 Requirements
4.1 Total ash
The mass fraction of total ash of the Chinese materia medica shall be determined.
4.2 Sulfated ash
The mass fraction of sulfated ash of the Chinese materia medica shall be determined depending on the
characteristics of the Chinese materia medica.
4.3 Ash insoluble in hydrochloric acid
The mass fraction of ash insoluble in hydrochloric acid of the Chinese materia medica shall be
determined depending on the characteristics of the Chinese materia medica.
4.4 Heavy metals
The contents of heavy metals shall be determined depending on the characteristics of the Chinese
materia medica.
4.5 Foreign matter
The contents of foreign matter shall be determined.
4.6 Identification
The contents of the marker compounds shall be identified.
4.7 Pesticide residues
The contents of pesticide residues shall be determined depending on the characteristics of the Chinese
materia medica.
4.8 Sulfur dioxide
The contents of sulfur dioxide shall be determined depending on the characteristics of th
...
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