ISO 21370:2026

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.