ISO 20255:2026
(Main)Traditional Chinese medicine — Epimedium brevicorum, Epimedium sagittatum, Epimedium pubescens, and Epimedium koreanum herb
- Abstract
This document specifies the minimum requirements and test methods for wild and cultivated Epimedium herb. This document applies to Epimedium herb that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
- Status
- Published
- Publication Date
- 27-Sep-2026
- Technical Committee
- ISO/TC 249 - Traditional Chinese medicine
- Drafting Committee
- ISO/TC 249 - Traditional Chinese medicine
- Current Stage
- 6060 - International Standard published
- Start Date
- 28-Sep-2026
- Due Date
- 01-Mar-2027
- Completion Date
- 28-Sep-2026
ISO 20255:2026 is an International Standard published by ISO for Traditional Chinese medicine - Epimedium brevicornu, Epimedium sagittatum, Epimedium pubescens, and Epimedium koreanum herb. This first edition specifies minimum requirements and test methods for wild and cultivated Epimedium herb used as natural medicines in international trade, including Chinese materia medica and decoction pieces. It gives buyers, manufacturers, and laboratories a common basis for identifying the herb and checking quality, contamination, and labelling.
What does ISO 20255:2026 specify?
ISO 20255:2026 specifies the scope, identity checks, quality limits, sampling, test methods, reporting, packaging, and labelling for Epimedium herb. It is organized into Clauses 1 to 10, plus three informative annexes that support identification and quantitative analysis.
The document covers:
- the four source species named in the title
- wild and cultivated material
- products sold and used in international trade as natural medicines
- Chinese materia medica and decoction pieces derived from the plant
The main structure is:
- Clause 1 - Scope
- Clause 2 - Normative references
- Clause 3 - Terms and definitions
- Clause 4 - Descriptions
- Clause 5 - Requirements and recommendations
- Clause 6 - Sampling
- Clause 7 - Test methods
- Clause 8 - Test report
- Clause 9 - Packaging, storage and transportation
- Clause 10 - Marking and labelling
| Annex | What it covers |
|---|---|
| Annex A | Thin-layer chromatogram (TLC) identification |
| Annex B | Determination of marker compounds |
| Annex C | Reference information on national and regional requirements |
What are the key requirements of ISO 20255:2026?
ISO 20255:2026 combines visual identity checks, microscopic features, analytical limits, and handling requirements. In practice, this means a batch has to look right, test right, and be packaged and labelled in a way that supports traceability.
Identity and authenticity
Clause 5.1 requires Epimedium herb to be clean and free from stem and foreign matter. It also excludes moldy leaves, external contaminants, and visible living insects. For a buyer or inspector, this is the first screen for unacceptable raw material before any laboratory test.
Clause 5.2 uses species-specific microscopic characteristics for Epimedium brevicornu Maxim., Epimedium sagittatum (Sieb.et Zucc.) Maxim., Epimedium pubescens Maxim., and Epimedium koreanum Nakai. These features help confirm botanical identity and spot substitution or adulteration when the material is cut, dried, or powdered.
Clause 7.1 supports macroscopic identification by taking random samples of not less than 250 g from each batch and examining them by naked eye in sunlight. That gives a practical field check before laboratory work begins.
Quality limits
Clause 5.3 sets a moisture limit of not more than 12.5 %. Clause 5.4 sets total ash at not more than 8.5 %, and Clause 5.5 sets ethanol-soluble extractives at not less than 15.0 %. These are basic quality indicators: moisture affects storage stability, ash indicates inorganic residue, and extractives give an indication of the soluble material expected from the herb.
The introduction notes that national standards bodies may adjust the values in Clauses 5.3 to 5.5, and Annex C gives examples of national and regional requirements. That matters if a user needs to compare ISO 20255:2026 with local pharmacopoeial limits.
Chemical identification and analytical checks
Clause 5.6 requires TLC identification to show spots from the test and reference solutions in the same position and with the same colour. Annex A gives the TLC procedure, including the icariin reference, the solvent system, and the ultraviolet examination condition. This provides a fast identity test that laboratories can use to compare a batch against a known marker profile.
Clause 5.7 requires determination of marker compounds such as icariin. Annex B gives an HPLC-based method for this purpose. In practice, this gives a quantitative marker for batch comparison and quality control.
Clause 5.8 requires determination of heavy metals such as arsenic, mercury, lead, and cadmium, and Clause 7.8 points to ISO 18664 for the test method. Clause 5.9 requires determination of pesticide residues, with Clause 7.9 pointing to ISO 22258. These checks address safety and regulatory concerns in trade and manufacturing.
Clause 5.10 requires foreign matter to be determined. That helps users set acceptance criteria for visible contamination and non-plant material.
Sampling, reporting, packaging, and labelling
Clause 6 says the sampling method in ISO 23723 applies. Clause 7 also uses ISO 21310 for microscopic examination, ISO 23723 for moisture, total ash, and ethanol-soluble extractives, ISO 18664 for heavy metals, and ISO 22258 for pesticide residues. This keeps the document aligned with shared laboratory methods.
Clause 8 requires the test report to identify the sample, state the sampling and test methods used, give the results, record any relevant operating details or incidents, and show the test date. That supports traceability in audits, disputes, and quality release.
Clause 9 requires packaging that does not transmit odour or flavour and does not contain harmful substances. It also requires storage according to ISO 22217 and protection during long-distance delivery from light, moisture, pollution, and foreign substances. Clause 10 requires labelling in line with ISO 21371, including product grade, quality features determined under Clause 5, maximum batch and sample mass, origin, expiry date, and storage method.
What terms does ISO 20255:2026 define?
- Epimedium herb - The terrestrial part or leaves of Epimedium brevicornu Maxim., Epimedium sagittatum (Sieb.et Zucc.) Maxim., Epimedium pubescens Maxim., and Epimedium koreanum Nakai.
- Chinese materia medica - In this document, a traded medicinal material form of Epimedium herb, meaning the whole medicinal material rather than a finished medicine.
- Decoction pieces - Processed products derived from the plant that are used as natural medicines.
- TLC - Thin-layer chromatogram identification, a comparison test that checks whether test and reference spots match in position and colour.
- Marker compounds - Chemical constituents such as icariin used to characterize and compare the herb.
- Heavy metals - The contaminant group named in the document, including arsenic, mercury, lead, and cadmium.
- Foreign matter - Unwanted material that should be measured and controlled in the herb batch.
Who uses ISO 20255:2026?
ISO 20255:2026 is used by laboratories, manufacturers, traders, importers, and inspectors working with Traditional Chinese medicine raw materials. Quality control teams use it to confirm botanical identity, check marker compounds, and verify moisture, ash, extractives, heavy metals, and pesticide residues.
Procurement teams and buyers use it to write product specifications and acceptance criteria. Regulatory and inspection personnel use it to review test reports, packaging, and labelling. It is also relevant to packers and warehouses because it sets expectations for storage, transport, and package marking.
Which standards are used with ISO 20255:2026?
- ISO 18664 - Provides the method for determining heavy metals in herbal medicines used in Traditional Chinese Medicine.
- ISO 21310 - Provides the microscopic examination method for medicinal herbs.
- ISO 21371 - Provides labelling requirements for products intended for oral or topical use.
- ISO 22217 - Provides storage requirements for raw materials and decoction pieces.
- ISO 22258 - Provides the gas chromatography method for determining pesticide residues in natural products.
- ISO 23723 - Provides the general requirements for herbal raw material and materia medica, and is also used here for sampling and several basic determinations.
What does the ISO 20255:2026 document contain?
ISO 20255:2026 contains descriptive botanical sections for the four Epimedium species, including leaf morphology and microscopic features, supported by figures in Clause 4. It then sets out the practical quality checks in Clause 5, along with the sampling and test methods in Clauses 6 and 7.
Annex A gives a TLC method with sample and reference solution preparation, a mobile phase, and example chromatograms. Annex B gives an HPLC method for icariin, including chromatographic conditions, system suitability checks, and a calculation formula. Annex C summarizes national and regional quality requirements for Epimedium herb, which helps users compare ISO 20255:2026 with other market requirements.
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Frequently Asked Questions
ISO 20255:2026 is a standard published by the International Organization for Standardization (ISO). Its full title is "Traditional Chinese medicine — Epimedium brevicorum, Epimedium sagittatum, Epimedium pubescens, and Epimedium koreanum herb". This standard covers: This document specifies the minimum requirements and test methods for wild and cultivated Epimedium herb. This document applies to Epimedium herb that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
This document specifies the minimum requirements and test methods for wild and cultivated Epimedium herb. This document applies to Epimedium herb that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
ISO 20255:2026 is classified under the following ICS (International Classification for Standards) categories: 11.120.10 - Medicaments. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 20255:2026 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
International
Standard
ISO 20255
First edition
Traditional Chinese medicine —
2026-09
Epimedium brevicorum, Epimedium
sagittatum, Epimedium pubescens,
and Epimedium koreanum herb
Médecine traditionnelle chinoise — Plantes Epimedium
brevicorum, Epimedium sagittatum, Epimedium pubescens et
Epimedium koreanum
Reference number
© ISO 2026
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
4.1 Epimedium brevicornu Maxim. .2
4.2 Epimedium sagittatum (Sieb.et Zucc.) Maxim. .2
4.3 Epimedium pubescens Maxim. .2
4.4 Epimedium koreanum Nakai .2
5 Requirements and recommendations . 7
5.1 General characteristics .7
5.2 Microscopic characteristics .7
5.3 Moisture .9
5.4 Total ash .9
5.5 Ethanol-soluble extractives .9
5.6 Thin-layer chromatogram (TLC) identification .9
5.7 Marker compounds .9
5.8 Heavy metals .9
5.9 Pesticide residues .9
5.10 Foreign matter .9
6 Sampling . 9
7 Test methods . 10
7.1 Macroscopic identification .10
7.2 Microscopic identification .10
7.3 Determination of moisture .10
7.4 Determination of total ash .10
7.5 Determination of ethanol-soluble extractives .10
7.6 Thin-layer chromatogram identification .10
7.7 Determination of marker compounds .10
7.8 Determination of heavy metals .10
7.9 Determination of pesticide residues .10
8 Test report .10
9 Packaging, storage and transportation .11
10 Marking and labelling .11
Annex A (informative) Thin-layer chromatogram (TLC) identification .12
Annex B (informative) Determination of marker compounds .15
Annex C (informative) Reference information of national and regional requirements on
Epimedium herb . 17
Bibliography . 19
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 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)
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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/SC 1, 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
The genus Epimedium belongs to the family Berberidaceae. It has more than 50 species, distributed in North
Africa, northern Italy to the Black Sea, Western Himalayas, Northeast Asia including Korea, Japan, and
part of China. Epimedium is a typical forest plant. In nature, plants of this genus form dense thickets and
bloom on humus-rich, slightly moist soil under the canopy of foothill forests, where the young foliage fully
obscure the sun. They are not tolerant direct sunlight, especially in hot summer. Even in the spring, except
in the morning and evening, their leaves can get burned when exposed to direct sunlight. Therefore, when
planting Epimedium, it is desirable to create the conditions similar to their natural habitat and to place them
in the shade or partial shade from tall trees and shrubs. China is the geographical distribution centre of
Epimedium, where nearly 40 species are found, comprising over 80 % of the genus.
In China, Epimedium herb (known as “Yin Yang Huo”) mainly includes four species, Epimedium brevicornu
Maxim., Epimedium sagittatum (Sieb.et Zucc.) Maxim., Epimedium pubescens Maxim. and Epimedium koreanum
Nakai. Epimedium koreanum Nakai is also distributed in North Korea, Japan, Russia, and Italy.
Modern pharmacological studies show that Epimedium herb has various bioactivities, including anti-
aging, antitumor, anti-depression and anti-osteoporosis effects. It can also enhance immunity, promote
hematopoiesis, increase cardiovascular flow, and regulate bone metabolism.
As national implementation can differ, national standards bodies are invited to modify the values given in
5.3, 5.4 and 5.5 in their national standards. Examples of national and regional values are given in Annex C.
v
International Standard ISO 20255:2026(en)
Traditional Chinese medicine — Epimedium brevicorum,
Epimedium sagittatum, Epimedium pubescens, and Epimedium
koreanum herb
1 Scope
This document specifies the minimum requirements and test methods for wild and cultivated Epimedium
herb.
This document applies to Epimedium herb that is sold and used as natural medicines in international trade,
including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
2 Normative references
The following documents are referred to in the text in such a way that some or all 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 21310, Traditional Chinese medicine — Microscopic examination of medicinal herbs
ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical use
ISO 22217, Traditional Chinese medicine —Storage requirements for raw materials and decoction pieces
ISO 22258, Traditional Chinese medicine — Determination of pesticide residues in natural products by gas
chromatography
ISO 23723, Traditional Chinese medicine — General requirements for herbal raw material and materia medica
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/
3.1
Epimedium herb
terrestrial part or leaves of Epimedium brevicornu Maxim., Epimedium sagittatum (Sieb.et Zucc.) Maxim.,
Epimedium pubescens Maxim., and Epimedium koreanum Nakai (Fam. Berberidaceae)
4 Descriptions
4.1 Epimedium brevicornu Maxim.
Leaf of Epimedium brevicornu is ternately compound. Leaflets are oval in shape, 3 cm to 8 cm in length and
2 cm to 6 cm in width. The apex of leaflet is acuminate. The terminal leaflet is cordate at the base. Bilateral
leaflets are small and oblique cordate. The outer side of the leaf is large and auriculate. The margin of the
leaf is yellow and thorny serrulation. (see Figure 1 A).
The upper surface of the leaflet is yellowish-green, and the lower surface is greyish-green. There are 7 to 9
main veins, with sparsely covering slender hairs at the base. Both surfaces have prominent secondary thin
veins and distinct, reticulated veins. The petiolule is 1 cm to 5 cm in length. The texture is close to leathery.
It has a slight characteristic odour and a slightly bitter taste.
4.2 Epimedium sagittatum (Sieb.et Zucc.) Maxim.
Leaf of Epimedium sagittatum is ternately compound. Leaflets are ternately compound, long-ovoid to ovoid-
lanceolate, 4 cm to 12 cm in length, 2,5 cm to 5 cm in width, with acuminate apices. Bilateral leaflets are
distinctly oblique at the base and their outer sides are mostly arrow-shaped. The lower surface of the leaf
lamina is sparsely covered with thick, short pronated hairs or nearly glabrous. The lamina is leathery (see
Figure 2A).
4.3 Epimedium pubescens Maxim.
Leaf of Epimedium pubescens is ternately compound. The leaflets are 3 to 20 cm in length and 2 cm to 8 cm
in width. The upper surface of the leaflet is dark green to brownish-green and glabrous, with a papery and
coriaceous texture. The lower surface of the leaflet is pale green to greenish-grey. The petioles are densely
covered with flossy pubescence. The lamina of the leaflet is ovate or narrowly ovate to lanceolate with a
serrulate, spiny margin. The apex of the leaflet is acuminate or shortly acuminate. (see Figure 3 A).
4.4 Epimedium koreanum Nakai
Leaf of Epimedium koreanum is ternately compound. Leaflets are relatively large, 4 cm to 10 cm in length,
3,5 cm to 7 cm in width. The upper surface of the leaflet is dark green with
...



