ISO 21370:2026

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
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/WG 1 - Quality and safety of raw materials and traditional processing
• Current Stage: 6060 - International Standard published
• Start Date: 06-Feb-2026
• Due Date: 05-Aug-2026
• Completion Date: 06-Feb-2026

Relations

• Revises: ISO 21370:2019 - Traditional Chinese medicine — Dendrobium officinale stem
• Effective Date: 08-Feb-2025

Overview

ISO 21370:2026 - Traditional Chinese medicine - Dendrobium officinale stem sets out minimum requirements and test methods for Dendrobium officinale stem. This international standard applies to stems of Dendrobium officinale Kimura et Migo that are cultivated, sold, and used as Chinese materia medica (whole medicinal materials) and decoction pieces. By providing comprehensive requirements for quality, safety, identification, and labelling, ISO 21370:2026 supports the harmonization of global trade and the safe, effective use of this highly valued herb in Traditional Chinese Medicine (TCM).

The Dendrobium officinale stem, also known as Tiepishihu, is a widely recognized TCM herb with a growing international market. The standard addresses persistent industry challenges, such as adulteration and variable quality norms across countries, by establishing clear and internationally accepted criteria.

Key Topics

• Product Scope: Covers stems from cultivated Dendrobium officinale used as crude medicinal materials and processed pieces, including forms such as fresh, dried, and spiral-shaped processed stems.
• Quality and Safety Requirements:
  • Cleanliness and absence of foreign matter, insects, or moulds
  • Morphological descriptions for identification of fresh, dried, and processed forms
  • Chemical quality criteria including maximum permissible moisture (≤14.0%), total ash (≤7.0%), and minimum ethanol-soluble extractives (≥5.0%) for dried and processed stems
  • Determination of marker compounds such as polysaccharides, mannose, and the ratio of mannose to glucose
  • Limits and testing for heavy metals (e.g., arsenic, lead, mercury, cadmium) and pesticide residues
• Identification and Testing Methods:
  • Thin-layer chromatography (TLC) for authenticity
  • Standardized methods for determining key quality indicators and contaminants
  • Clear requirements for reporting, packaging, labelling, and storage
• Labelling and Documentation:
  • Accurate identification, traceability, and complete labelling per ISO standards

Applications

Industry and Trade

• Herbal Medicines Manufacturing: Helps ensure that manufacturers use authentic, high-quality Dendrobium officinale stems in traditional herbal preparations and health products.
• Global Trade: Provides internationally recognized specifications for exporters and importers, reducing disputes and assuring buyers of consistent product quality.
• Regulatory Compliance: Assists in meeting safety and quality requirements for domestic and international markets, as stipulated by regulatory authorities and pharmacopeias.

Healthcare

• Clinical and Pharmacy Use: Ensures that practitioners and pharmacists have reliable benchmarks for sourcing and prescribing Dendrobium officinale stem in TCM therapies.
• Consumer Safety: Protects end-users by minimizing risks from adulterated or contaminated herbal products.

Research and Quality Control

• Analytical Laboratories: Supports standardized testing for authenticity, purity, and potency in research, quality control, and reference studies of herbal materials.

Related Standards

Adherence to ISO 21370:2026 is supported by several other international standards relevant to TCM and herbal product quality:

• ISO 18664: Determination of heavy metals in herbal medicines used in Traditional Chinese Medicine
• ISO 19609-2: Identity testing of herbal constituents
• ISO 21371: Labelling requirements for oral and topical products
• ISO 22217: Storage requirements for raw materials and decoction pieces
• ISO 22258: Determination of pesticide residues in natural products
• ISO 23723: General requirements for herbal raw materials and materia medica

These related standards provide a framework for ensuring safety, quality, and traceability of herbal medicines across different regions and regulatory environments.

In summary, ISO 21370:2026 is essential for anyone involved in the production, trade, regulation, or use of Dendrobium officinale stem, by providing internationally harmonized requirements and test methods that uphold the safety, efficacy, and quality of this important Traditional Chinese Medicine material.

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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
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
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
...