ISO/DTS 25006
(Main)Traditional Chinese medicine — Sporoderm-broken Ganoderma lucidum spore powder
Traditional Chinese medicine — Sporoderm-broken Ganoderma lucidum spore powder
This document specifies minimum requirements and test methods for sporoderm-broken Ganoderma lucidum spore powder. It is applicable to sporoderm-broken Ganoderma lucidum spore powder that is sold and used as supplements and dietary ingredients.
Médecine traditionnelle chinoise — Poudre de spores de Ganoderma lucidum à sporoderme cassé
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FINAL DRAFT
Technical
Specification
ISO/TC 249/SC 1
Traditional Chinese medicine —
Secretariat: SAC
Sporoderm-broken Ganoderma
Voting begins on:
lucidum spore powder
2025-04-22
Voting terminates on:
2025-06-17
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
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LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
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TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
Technical
Specification
ISO/TC 249/SC 1
Traditional Chinese medicine —
Secretariat: SAC
Sporoderm-broken Ganoderma
Voting begins on:
lucidum spore powder
Voting terminates on:
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.
© ISO 2025
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 General characteristics .2
4.2 Microscopic features .2
4.3 High performance liquid chromatography (HPLC) identification.2
4.4 Moisture .2
4.5 Total ash .3
4.6 Peroxide value .3
4.7 Sporoderm-broken rate .3
4.8 Aflatoxins B .3
4.9 Marker compounds .3
4.10 Microorganisms .3
4.11 Heavy metals .3
4.12 Pesticide residues .3
5 Test methods . 3
5.1 General characteristics .3
5.2 Microscopic identification .3
5.3 High performance liquid chromatography (HPLC) identification.3
5.4 Determination of moisture content .3
5.5 Determination of total ash .3
5.6 Determination of peroxide value .4
5.7 Determination of sporoderm-broken rate .4
5.8 Determination of aflatoxins B .4
5.9 Determination of marker compounds .4
5.10 Determination of microorganisms .4
5.11 Determination of heavy metals .4
5.12 Determination of pesticide residues .4
6 Test report . 4
7 Packaging, storage and transportation . 4
8 Marking and labelling . 5
Annex A (informative) High performance liquid chromatography (HPLC) identification . 6
Annex B (informative) Determination of peroxide value . 8
Annex C (informative) Determination of sporoderm-broken rate . 9
Annex D (informative) Determination of polysaccharides content .10
Annex E (informative) Determination of the triterpenoids content by high performance liquid
chromatography - ultraviolet (HPLC-UV) .12
Annex F (informative) Reference information of national and regional requirements .15
Bibliography . 17
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 medicine, Subcommittee SC 1,
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
Ganoderma lucidum spore is the reproduction unit of Ganoderma lucidum, which is also known as Lingzhi or
Reishi. The spore has a double-layered spore wall (sporoderm) mainly composed of chitin. The sporoderm
cannot be digested and degraded in the body, thus hindering the release and absorption of active components
such as polysaccharides and triterpenoids. Therefore, the sporoderm-breaking process is critical to
improving the effect and bioavailability of Ganoderma lucidum. Currently, the mainstream sporoderm-
breaking methods include extrusion, grinding, shearing, jet pulverization, etc., and mainly use equipment
such as vibration mills, homogenizers, and supersonic jet pulverizers.
Sporoderm-broken Ganoderma lucidum spore powder is gaining increasing acceptance and popularity as an
herbal medicine and a dietary ingredient, and possesses various bioactivities, including immunomodulation,
liver protection, and antitumor effects. The industry has developed rapidly and its market share has
gradually expanded. The yield of Ganoderma lucidum spore powder in China was about 10 000 t in 2020,
with a growth rate of 12,72 %, and the output value was 3,814 billion CNY, accounting for 47 % of the total
Ganoderma lucidum industry. In the international market, Japan, the Republic of Korea, USA, Malaysia and
other countries and regions have large-scale enterprises that produce and sell Ganoderma lucidum spore
powder products. According to incomplete statistics, the annual sales of Ganoderma lucidum and Ganoderma
lucidum spore powder related products exceed one billion USD.
However, quality stan
...
ISO #####-#:####(X)/DTS 25006
ISO/TC 249/WG 2SC 1
Secretariat: SAC
Date: YYYY-MM-DD2025-04-08
Traditional Chinese medicine — — Sporoderm-broken
Ganoderma lucidum spore powder
WD/CD/DIS/FDIS stage
Warning for WDs and CDs
This document is not an ISO International Standard. It is distributed for review and comment. It is subject to
change without notice and may not be referred to as an International Standard.
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 supporting documentation.
A model document of an International Standard (the Model International Standard) is available at:
© ISO #### – All rights reserved
ISO #####-#:####(X)
2 © ISO #### – All rights reserved
ISO #####-#:####(X/DTS 25006:(en)
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
EmailE-mail: copyright@iso.org
Website: www.iso.orgwww.iso.org
Published in Switzerland
© ISO #### 2025 – All rights reserved
iii
ISO #####-#:####(X/DTS 25006:(en)
Contents
Foreword . v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 General characteristics . 2
4.2 Microscopic features . 2
4.3 High performance liquid chromatography (HPLC) identification . 1
4.4 Moisture . 1
4.5 Total ash . 1
4.6 Peroxide value . 1
4.7 Sporoderm-broken rate . 1
4.8 Aflatoxins B1 . 1
4.9 Marker compounds . 1
4.10 Microorganisms . 1
4.11 Heavy metals . 1
4.12 Pesticide residues . 2
5 Test methods . 2
5.1 General characteristics . 2
5.2 Microscopic identification . 2
5.3 High performance liquid chromatography (HPLC) identification . 2
5.4 Determination of moisture content . 2
5.5 Determination of total ash . 2
5.6 Determination of peroxide value . 2
5.7 Determination of sporoderm-broken rate . 2
5.8 Determination of aflatoxins B1 . 2
5.9 Determination of marker compounds . 2
5.10 Determination of microorganisms . 2
5.11 Determination of heavy metals . 2
5.12 Determination of pesticide residues . 2
6 Test report . 3
7 Packaging, storage and transportation . 3
8 Marking and labelling . 3
Annex A (informative) High performance liquid chromatography (HPLC) identification . 4
Annex B (informative) Determination of peroxide value . 7
Annex C (informative) Determination of sporoderm-broken rate . 9
Annex D (informative) Determination of polysaccharides content . 10
Annex E (informative) Determination of the triterpenoids content by high performance liquid
chromatography - ultraviolet (HPLC-UV) . 12
Annex F (informative) Reference information of national and regional requirements . 16
Bibliography . 18
© ISO #### 2025 – All rights reserved
iv
ISO #####-#:####(X/DTS 25006:(en)
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).
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 medicine, Subcommittee SC 1,
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.
© ISO #### 2025 – All rights reserved
v
ISO #####-#:####(X/DTS 25006:(en)
Introduction
Ganoderma lucidum spore is the reproduction unit of Ganoderma lucidum, which is also known as Lingzhi or
Reishi. The spore has a double-layered spore wall (sporoderm) mainly composed of chitin. The sporoderm
cannot be digested and degraded in the body, thus hindering the release and absorption of active components
such as polysaccharides and triterpenoids. Therefore, the sporoderm-breaking process is critical to
improveimproving the effect and bioavailability. The current of Ganoderma lucidum. Currently, the
mainstream sporoderm-breaking methods include extrusion, grinding, shearing, jet pulverization, etc., and
mainly use equipment such as vibration mills, homogenizers, and supersonic jet pulverizers. Therefore, it is
necessary to develop scientific and reasonable standards to ensure the safety and effectiveness of sporoderm-
broken Ganoderma lucidum spore powder. For consumers, the development of the standards will help
improve the quality of sporoderm-broken Ganoderma lucidum spore powder and related products, and ensure
the safety and effectiveness.
Sporoderm-broken Ganoderma lucidum spore powder is gaining increasing acceptance and popularity as an
herbal medicine and a dietary ingredient, and possesses various bioactivities, including immunomodulation,
liver protection, and antitumor effects. The industry has developed rapidly and its market share has gradually
expanded. The yield of Ganoderma lucidum spore powder in China iswas about 10 000 t in 2020, with a growth
rate of 12,72 %, and the output value iswas 3,814 billion RMBCNY, accounting for 47 % of the total Ganoderma
lucidum industry. In the international market, Japan, Souththe Republic of Korea, USA, Malaysia and other
countries and regions have large-scale enterprises that produce and sell Ganoderma lucidum spore powder
products. According to incomplete statistics, the annual sales of Ganoderma lucidum and Ganoderma lucidum
spore powder related products exceed one billion $.USD.
However, quality standards of sporoderm-broken Ganoderma lucidum spore powder are lacking. At present,
there is no pharmacopoeia standard for the quality of sporoderm-broken Ganoderma lucidum spore powder.
Therefore, it is necessary to clarifydevelop an International Standard to ensure the safety, effectiveness and
quality of sporoderm-broken Ganoderma lucidum spore powder and related products. This document
promotes sporoderm-broken Ganoderma lucidum spore powder and related products in the market by
clarifying the chemical composition and active components of Ganoderma lucidum spore powder through
systematic basic research, and transform it into a scientific, reasonable, and market-relevant international
standard. This is important for ensuring the quality and promoting the market of this productresearch.
As national implementation can differ, national standards bodies are invited to modify the values given in
4.44.4, 4.5, 4.5 and 4.74.7 in their national standards. Examples of national and regional values are given in
Annex FAnnex F.
© ISO #### 2025 – All rights reserved
vi
ISO #####-#:####(X/DTS 25006:(en)
Traditional Chinese medicine — Sporoderm-broken Ganoderma
lucidum spore powder
1 Scope
This document specifies requirements and test methods for sporoderm-broken Ganoderma lucidum spore
powder that is derived from Ganoderma lucidum (Leyss. ex Fr.) Karst.
It is applicable to sporoderm-broken Ganoderma lucidum spore powder that is sold and used as natural
medicine and raw material for health products in international trade.
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 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in
Traditional Chinese Medicine
ISO/TS 21310, Traditional Chinese medicine — Microscopic examination of medicinal herbs
ISO 21371, Traditional Chinese medicine — Lab
...
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