ISO 9319:2024

Overview - ISO 9319:2024 (Poria cocos sclerotium)

ISO 9319:2024 is an international standard for Traditional Chinese Medicine - Poria cocos sclerotium. It specifies quality and safety requirements, sampling and test methods for the dried sclerotium of the fungus Poria cocos (Schw.) Wolf used as natural medicines, including Chinese materia medica (whole medicinal materials) and decoction pieces. The standard supports consistent product quality in international trade and helps address issues such as adulteration and variable processing or storage.

Key topics and technical requirements

The standard covers identification, quality limits and laboratory methods, including:

• Descriptions and trade forms: whole poria, cubic poria, sliced poria and powdered poria with macroscopic and morphological characteristics.
• Identification methods: macroscopic and microscopic examination (powder morphology, hyphae characteristics) and thin‑layer chromatography (TLC) matching with reference solutions.
• Chemical reactions: specified chemical colour reaction (e.g., iodinated potassium iodide produces a deep red colour on sample).
• Quantitative quality limits:
  • Moisture: not more than 15.0% mass fraction.
  • Total ash: not more than 2.0% mass fraction.
• Extractives: determination of ethanol‑soluble and water‑soluble extractives to assess extractable constituents.
• Marker compound: determination of marker compound(s) such as pachymic acid (method included).
• Safety testing: limits and test methods for heavy metals, pesticide residues and sulfur dioxide.
• Sampling, test reporting, packaging, storage and labelling: requirements to ensure integrity during trade and use.
• Informative annexes include TLC identification, pachymic acid determination and examples of national/regional values.

Applications - who uses ISO 9319 and why

ISO 9319 is practical for stakeholders across the supply chain:

• Manufacturers and processors of Poria cocos sclerotium - to standardize production, processing and product specifications.
• Quality control and analytical laboratories - to adopt validated test methods (microscopy, TLC, moisture, ash, pachymic acid, heavy metals, pesticide and SO2 testing).
• Exporters/importers and traders - to demonstrate compliance with an internationally recognized specification for raw material and decoction pieces.
• Regulators and pharmacopoeia authors - to harmonize national requirements and reduce trade barriers.
• Practitioners of Traditional Chinese Medicine - to ensure clinical safety and consistent therapeutic quality of materia medica.

Related standards

ISO 9319 references and aligns with other ISO TCM standards, including:

• ISO 18664 (heavy metals determination)
• ISO/TS 21310 (microscopic examination)
• ISO 21371 (labelling requirements)
• ISO 22217 (storage requirements)
• ISO 22258 (pesticide residues by GC)
• ISO 22590 (sulfur dioxide determination)
• ISO 23723 (general requirements for herbal raw materials)

Adoption of ISO 9319 improves supply-chain transparency, lab comparability and regulatory acceptance for Poria cocos sclerotium in global markets.