ISO 21370:2026
(Main)Traditional Chinese medicine — Dendrobium officinale stem
Traditional Chinese medicine — Dendrobium officinale stem
This document specifies minimum requirements and test methods for Dendrobium officinale stem that is derived from cultivated Dendrobium officinale Kimura et Migo. It is applicable to Dendrobium officinale stem that is sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
Médecine traditionnelle chinoise — Tige de Dendrobium officinale
General Information
- Status
- Published
- Publication Date
- 05-Feb-2026
- Technical Committee
- ISO/TC 249 - Traditional Chinese medicine
- Current Stage
- 6060 - International Standard published
- Start Date
- 06-Feb-2026
- Due Date
- 05-Aug-2026
- Completion Date
- 06-Feb-2026
Relations
- Effective Date
- 08-Feb-2025
Overview
ISO 21370 specifies minimum requirements and test methods for the stem of Dendrobium officinale Kimura et Migo, a traditional Chinese medicine widely used in Asia. The standard covers fresh, dried, and processed forms of the Dendrobium officinale stem, which is used as Chinese materia medica. It ensures the quality, safety, and authenticity of this valuable herbal medicine by providing harmonized international guidelines for cultivation, packaging, testing, and labeling.
This international standard addresses current challenges in the market such as adulteration and inconsistent quality by standardizing morphological features, chemical properties, and safety criteria. It fosters quality assurance for manufacturers, distributors, researchers, and users of Dendrobium officinale stem products.
Key Topics
Scope and Applicability
ISO 21370 applies to Dendrobium officinale stems derived from cultivated plants, including whole medicinal materials and decoction pieces.Morphological Identification
The standard describes the physical characteristics of fresh, dried, and processed stems. For example, the processed stem (Tiepi Fengdou) is spiral-shaped with 2 to 6 spires and has distinctive colors like yellowish-green or golden yellow.Quality and Safety Requirements
- Cleanliness and freedom from contaminants such as insects, molds, and foreign matter.
- Limits on moisture content (max 14%), total ash (max 7%), and minimum ethanol-soluble extractives (min 5%).
- Marker compounds testing including polysaccharides, mannose content, and ratios of mannose to glucose.
- Heavy metal contaminants such as arsenic, mercury, lead, and cadmium are regulated within safe limits.
- Pesticide residue determination ensures compliance with safety regulations.
Test Methods
- Macroscopic identification based on physical traits.
- Thin-layer chromatography (TLC) to confirm chemical fingerprints matching reference solutions.
- Standardized quantitative methods for moisture, ash content, extractives, marker compounds, heavy metals, and pesticide residues.
Sampling and Testing Protocols
Sampling procedures follow ISO 23723 to ensure representative and consistent test results.Packaging, Storage, and Transportation
Packaging materials must not transfer odors or contaminants to the product. Storage conditions include protection from light, moisture, and pollution, consistent with ISO 22217.Marking and Labelling
Product packages must carry plant names, quality features, product masses, and country of origin following ISO 21371 labeling standards.
Applications
Traditional Chinese Medicine Manufacturing
Enables manufacturers to produce standardized Dendrobium officinale stem products that meet international quality benchmarks, ensuring efficacy and consumer safety.Quality Control and Testing Laboratories
Provides authoritative test methods and pass/fail criteria facilitating accurate quality assessment and regulatory compliance.Trade and Export Compliance
Harmonized international requirements facilitate smoother cross-border trade by aligning national standards with global norms.Research and Development
Supports pharmacological studies by defining precise chemical and physical properties, aiding in reproducibility and validation of medicinal effects.Regulatory Authorities
Helps regulators define safety limits and enforce compliance in herbal medicine markets, reducing risks related to adulteration, contaminants, and ineffective products.
Related Standards
- ISO 18664 – Traditional Chinese Medicine: Determination of heavy metals in herbal medicines
- ISO 19609-2 – Quality and safety assessment for raw materials: Identity testing of herbal constituents
- ISO 21371 – Labeling requirements for traditional Chinese medicinal products
- ISO 22217 – Storage requirements for raw medicinal materials and decoction pieces
- ISO 22258 – Determination of pesticide residues in natural products by gas chromatography
- ISO 23723 – General requirements and sampling methods for herbal raw materials and materia medica
These complementary standards provide comprehensive guidance on quality control, safety evaluation, labeling, and packaging for traditional Chinese medicinal materials, supporting the implementation of ISO 21370.
ISO 21370 is a crucial standard for ensuring the integrity, safety, and effectiveness of Dendrobium officinale stem products in traditional medicine. Adopting and adhering to its requirements promotes quality assurance, facilitates international trade, and protects consumer health in the growing herbal medicine market.
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Frequently Asked Questions
ISO 21370:2026 is a standard published by the International Organization for Standardization (ISO). Its full title is "Traditional Chinese medicine — Dendrobium officinale stem". This standard covers: This document specifies minimum requirements and test methods for Dendrobium officinale stem that is derived from cultivated Dendrobium officinale Kimura et Migo. It is applicable to Dendrobium officinale stem that is sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
This document specifies minimum requirements and test methods for Dendrobium officinale stem that is derived from cultivated Dendrobium officinale Kimura et Migo. It is applicable to Dendrobium officinale stem that is sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
ISO 21370:2026 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 21370:2026 has the following relationships with other standards: It is inter standard links to ISO 21370:2019. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 21370:2026 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 21370
Second edition
Traditional Chinese medicine —
2026-02
Dendrobium officinale stem
Médecine traditionnelle chinoise — Tige de Dendrobium
officinale
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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Email: copyright@iso.org
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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
5 Quality and safety requirements and recommendations . 3
5.1 General characteristics .3
5.2 Morphological features .3
5.2.1 Fresh stem .3
5.2.2 Dried stem .3
5.2.3 Processed stem .3
5.3 Thin-layer chromatography (TLC) identification .3
5.4 Moisture .3
5.5 Total ash .3
5.6 Ethanol-soluble extractives .3
5.7 Marker compounds .4
5.8 Heavy metals .4
5.9 Pesticide residues .4
6 Sampling . 4
7 Test methods . 4
7.1 Macroscopic identification .4
7.2 TLC identification .4
7.3 Determination of moisture content .4
7.4 Determination of total ash .4
7.5 Determination of ethanol-soluble extractives .4
7.6 Determination of marker compounds .4
7.7 Determination of heavy metals .4
7.8 Determination of pesticide residues .4
8 Test report . 5
9 Packaging, storage and transportation . 5
10 Marking and labelling . 5
Annex A (informative) TLC identification . 6
Annex B (informative) Determination of polysaccharides . 7
Annex C (informative) Determination of mannose and peak area ratio of mannose to glucose . 9
Annex D (informative) Reference information of national and regional requirements .12
Bibliography .13
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)
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
http://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.
This second edition cancels and replaces the first edition (ISO 21370:2019), which has been technically
revised.
The main changes are as follows:
— addition of the definition of "stem" in 3.1;
— addition of the definition of "Dendrobium officinale stem" in 3.2;
— update of Normative references and Bibliography;
— Clause 4: insertion of Figure 1 a) "plant of Dendrobium officinale stem';
— Annex D: update of the edition date of the Chinese Pharmacopoeia; addition of the data from the Korean
Herbal Pharmacopoeia; removal of all data from Taiwan Herbal Pharmacopoeia.
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
Dendrobium officinale stem is a widely used herb medicine in China and many other Asian countries, also
known as Tiepishihu in Chinese. In traditional Chinese medicine, this herb is used to treat fever, retching and
excessive thirst. Modern pharmacological studies also demonstrate its great potential in diabetes treatment
and immuno-enhancement. Therefore, the market for Dendrobium officinale has developed very rapidly, as
indicated by the increase in yield, production output and trade volume.
However, there remain many challenges, such as adulteration of similar species and lack of suitable testing
methods for quality assessment. In addition, though Dendrobium officinale has been recorded in several
[1] [2]
pharmacopoeias and standards, such as Chinese Pharmacopoeia , the Korean Herbal Pharmacopoeia and
[3]
Hong Kong Chinese Materia Medica Standards , specifications and quality requirements of these standards
vary, thus there is a clear and urgent need to develop an International Standard for harmonizing the existing
standards, as well as ensuring the safety and effectiveness of Dendrobium officinale.
As national implementation can differ, national standards bodies are invited to modify the values given in
5.4, 5.5 and 5.6 in their national standards. Examples of national and regional values are given in Annex D.
v
International Standard ISO 21370:2026(en)
Traditional Chinese medicine — Dendrobium officinale stem
1 Scope
This document specifies minimum requirements and test methods for Dendrobium officinale stem that is
derived from cultivated Dendrobium officinale Kimura et Migo.
It is applicable to Dendrobium officinale stem that is sold and used as 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 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 19609-2, Traditional Chinese medicine — Quality and safety of raw materials and finished products made
with raw materials — Part 2: Identity testing of constituents of herbal origin
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
Dendrobium officinale stem
stem of Dendrobium officinale Kimura et Migo, including fresh stem (3.2), dried stem (3.3) and processed stem
(3.4)
3.2
fresh stem
stem that is newly harvested and has not undergone any processing
3.3
dried stem
stem prepared by cleaning, cutting and then heating or sun-drying
3.4
processed stem
stem processed by trimming off the fibrous root and leaves, stir-baking while twisting to a spiral or spring
form and drying
Note 1 to entry: This is the common trade form of dried stem of Dendrobium officinale. It is usually called Tiepi Fengdou
in Chinese.
4 Descriptions
Dendrobium officinale stem generally has three trade forms, including fresh stem, dried stem and processed
stem (Tiepi Fengdou), as shown in Figure 1.
a) Plant of Dendrobium officinale stem b) Fresh stem c) Dried stem d) Processed stem
(Tiepi Fengdou)
Key
1 leaf
2 leaf sheath
3 root
4 node
Figure 1 — Structure of Dendrobium officinale
5 Quality and safety requirements and recommendations
5.1 General characteristics
The following requirements shall be met before sampling:
a) Dendrobium officinale stem shall be clean and free from foreign matt
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