ISO 22212

ISO/DISFDIS 22212
ISO/TC 249/SC 1
Secretariat: SAC
Date: 2025-08-2909-22
Traditional Chinese medicine — Gastrodia elata tuber
Médecine traditionnelle chinoise — Tubercule de Gastrodia elata
DISFDIS stage
Warning for WD’s and CD’s
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.

ISO/DISFDIS 22212:2025(en)
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ISO/DISFDIS 22212:2025(en)
Contents
Foreword . iv
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Requirements and recommendations . 3
5.1 General characteristics . 3
5.2 Morphological features . 3
5.3 Moisture . 3
5.4 Total ash . 3
5.5 Dilute ethanol-soluble extract . 3
5.6 Identification of marker compound(s) . 4
5.7 Marker compound(s) . 4
5.8 Heavy metals . 4
5.9 Pesticide residues . 4
5.10 Sulfur dioxide . 4
6 Sampling . 4
7 Test methods . 4
7.1 Macroscopic identification . 4
7.2 Determination of moisture . 4
7.3 Determination of total ash . 4
7.4 Determination of dilute ethanol-soluble extract . 4
7.5 Identification of marker compound(s) . 4
7.6 Determination of marker compound(s) . 4
7.7 Determination of heavy metals. 5
7.8 Determination of pesticide residues . 5
7.9 Determination of sulfur dioxide . 5
8 Test report . 5
9 Packaging, storage and transportation . 5
10 Marking and labelling . 5
Annex A (informative) Determination of moisture . 7
Annex B (informative) Determination of dilute ethanol-soluble extract . 8
Annex C (informative) Identification of gastrodin . 9
Annex D (informative) Identification of p-hydroxybenzyl alcohol . 11
Annex E (informative) Determination of gastrodin and p-hydroxybenzyl alcohol . 13
Annex F (informative) Reference values of national and regional limits in Gastrodia elata tuber15
Bibliography . 16

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ISO/DISFDIS 22212:2025(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
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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).
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)
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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.
This second edition cancels and replaces the first edition (ISO 22212:2019), which has been technically
revised.
The main changes are as follows:
— 5.3: change of "15,0 %" to "16,0 %";
— 5.4: change of "4,5 %" to "6,0 %";
— 5.5: change of "15,0 %" to "14,0 %";
— 5.6 correction of "brands" to "bands", replacement of "obtained from the test and reference solutions in
the same position with the same colour" with "specific to these compounds";
— 5.9: change of “shall” to “should”;
— 5.10: change of “shall” to “should”;
— 7.3: replacement of “ISO 1575” with “ISO 23723”;
— 7.8: replacement of "CAC/MRL01-2009 and CODEX STAN 229-1993, REV.1-2003" with "ISO 22258";
— 7.9: replacement of “ISO 5379” with “ISO 22590”;
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ISO/DISFDIS 22212:2025(en)
— Table F.1: update of Chinese Pharmacopoeia to 2020 edition, update of Korean Pharmacopoeia to the 12th
edition;
— Bibliography: update of Chinese Pharmacopoeia to 2020 edition, update of Korean Pharmacopoeia to the
12th edition.
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.
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ISO/DISFDIS 22212:2025(en)
Introduction
Gastrodia elata tuber, the dried tuber of Gastrodia elata Bl. (Orchidaceae) after it has been steamed thoroughly,
is a medicinal herb which has been used as an anticonvulsant, analgesic and sedative to treat general paralysis,
epilepsy, tetanus and vertigo in Asian countries for thousands of years.
There are at least 16 countries and regions using Gastrodia elata tuber and its products. Major users include
China, Japan, the republic of Korea, the United State, Australia, Austria and Singapore. Due to its great demand
and high price in the global market, trade in Gastrodia elata tuber has been complicated by adulteration,
substitution and species identification issues. The toxic roots of other species, such as the plants of the
Phytolaccaceae family, are sometimes misused as Gastrodia elata tuber, which can cause health risks. Factors
including contamination, packaging and storage conditions also affect the quality of Gastrodia elata tuber.
The establishment of an international standardInternational Standard for Gastrodia elata tuber is therefore
necessary to support its quality consistency, clinical effectiveness and safety in international trade.
As national implementation can differ, national standards bodies are invited to modify the values given in 5.3,
5.4, 5.5 and 5.7 in their national standards. Examples of national and regional values are given in Annex F.
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ISO/DISFDIS 22212:2025(en)
Traditional Chinese medicine — Gastrodia elata tuber
1 Scope
This document specifies minimum requirements and test methods for Gastrodia elata tuber that is derived
from cultivated and artificially propagated Gastrodia elata Bl.
It is applicable to Gastrodia elata tuber that is sold and used as Chinese materia medica, specifically excluding
the wild forms of the species.
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 22258, Traditional Chinese medicine — Determination of pesticide residues in natural products by gas
chromatography
ISO 22590, Traditional Chinese medicine — Determination of sulfur dioxide in natural products by titration
ISO 23723, Traditional Chinese medicine — General requirements for herbal raw material and materia medica
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 terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://www.electropedia.org/http://www.electropedia.org/
3.1
tuber
short fleshy usually underground stem bearing minute scale leaves each of which bears a bud in its axil and is
potentially able to produce a new plant
3.2
Gastrodia elata tuber
dried tuber (3.1) of Gastrodia elata Bl. (Orchidaceae) after it has been steamed or boiled thoroughly
3.3
bud
undeveloped or embryonic shoot in red-brown to dark brown, which is parrot-beak-shaped and grows on the
apex of the tuber (3.1)
Note 1 to entry: See Figure 1.
ISO/DISFDIS 22212:2025(en)
3.4
latent bud
bud (3.3) which remains undeveloped or dormant, arranged along the body of Gastrodia elata tuber (3.2)
Note 1 to entry: See Figure 1.
3.5
sample
portion taken from the sample batch (3.6) during one single sampling action
3.6
sample batch
sample (3.5) collected from the same particular place at the same time
Note 1 to entry: This is not more than 5 000 kg.
4 Descriptions
Gastrodia elata tuber is the dried tuber of Gastrodia elata Bl. (Orchidaceae) after it has been steamed or boiled
thoroughly, as shown in Figure 1.

A B C
Key
A front view
B lateral view
C cross-sectional view
1 bud or remain of stem
2 latent bud
3 longitudinal wrinkle
ISO/DISFDIS 22212:2025(en)
4 rounded scar
5 tuber width
6 tuber length
7 tuber thickness
8 epidermis
9 hypodermis
10 stele
11 vascular bundle
Figure 1 — Structure of Gastrodia elata tuber
5 Requirements and recommendations
5.1 General characteristics
The following requirements shall be met before sampling:
a) Gastrodia elata tuber shall be clean and free from foreign matter;.
...