Overview
ISO 8071:2024 - Traditional Chinese medicine - Ligusticum chuanxiong rhizome is the first international standard that defines quality requirements for the dried rhizome of Ligusticum chuanxiong Hort. (chuanxiong rhizome). Published by ISO (Technical Committee ISO/TC 249) in March 2024, the standard applies to whole materia medica and decoction pieces sold or used as natural medicine in international trade. It establishes descriptive, safety and analytical expectations to support consistent quality, testing and labelling across markets.
Key Topics and Technical Requirements
ISO 8071:2024 covers both macroscopic and microscopic description and specific quality controls, including:
- Morphological features: shape, surface texture, colour, typical section appearance and sensory attributes (e.g., intense characteristic aroma; slightly numbing, slightly sweet aftertaste). The rhizome is typically 2–7 cm in diameter.
- Microscopic features and powder characteristics: cork, cortex, phloem, cambium structure; oil cavities; abundant starch grains (simple grains 3 µm–19 µm, up to 22 µm long), and typical vessel/fibre descriptions.
- Chemical and safety parameters: identification and quantification of a marker compound (Annex A describes determination of ferulic acid), extractives, essential oil content, moisture, total and acid‑insoluble ash.
- Contaminant limits and tests: foreign matter, heavy metals, pesticide residues, sulfur dioxide, aflatoxins.
- Sampling, test methods and reporting: standardized procedures for sampling, macroscopic/microscopic identification, chemical assays and how to document results.
- Product handling and market information: marking and labelling requirements, packaging, storage and transportation, plus guidance on traditional grade information (Annex C).
Note: national bodies may adapt numeric limits in clauses 5.4–5.10 to reflect regional regulations (see Annex B).
Practical Applications - Who Uses This Standard
ISO 8071:2024 is useful for:
- Manufacturers and processors of traditional Chinese medicinal materials and decoction pieces - to set internal quality specs and production controls.
- Quality control and analytical laboratories - to adopt standardized sampling and test methods (chemical, microscopic and contaminant testing).
- Exporters / importers and traders - to ensure consignments meet internationally recognized criteria for trade.
- Regulators and certification bodies - to harmonize inspection, registration and market surveillance.
- Traditional Chinese medicine practitioners and formulators - to verify raw material authenticity and safety for clinical use.
Related Standards
ISO 8071:2024 references and aligns with other TCM standards, including:
Adoption of ISO 8071:2024 helps harmonize quality control for Ligusticum chuanxiong rhizome in global TCM supply chains, improving safety, traceability and market access.