ISO 19661:2026 PDF

Overview

ISO 19661:2026 - Traditional Chinese medicine - Anemarrhena asphodeloides rhizome sets international quality and safety requirements for the rhizome of Anemarrhena asphodeloides (commonly "Zhimu"), a key herbal ingredient in Traditional Chinese Medicine (TCM). This ISO standard applies to both whole medicinal materials and decoction pieces derived from Anemarrhena asphodeloides and is designed to ensure consistency, safety, and traceability in global trade. It is widely utilized in the export, processing, and regulatory oversight of natural medicines, supporting the harmonization of standards across regions.

Key Topics

• Quality and Safety Specifications: The standard defines strict requirements for the physical, chemical, and safety attributes of Anemarrhena asphodeloides rhizome. These include:

  • Cleanliness and removal of foreign matter and fibrous roots
  • Absence of visible contaminants, insects, or mold
  • Morphological and microscopic identification
  • Moisture, total ash, and acid-insoluble ash content limits
  • Testing for heavy metals (arsenic, mercury, lead, cadmium)
  • Limits on pesticide residues
  • Marker compound quantification (such as mangiferin)

• Standardized Sampling and Testing: Methods for sampling, macroscopic/microscopic examination, thin-layer chromatography (TLC), and quantitative testing are standardized to ensure reliable results.

• Packaging, Transportation, and Labelling: Requirements ensure the rhizome is packaged for protection against light, moisture, contamination, and damage during transit. Labelling must include origin, mass, production/expiry dates, storage methods, and quality details, following global TCM product standards.

• Test Reporting: Specific elements for complete and clear test reporting are outlined, supporting full traceability and regulatory compliance.

Applications

• International Trade: ISO 19661:2026 is essential for exporters and importers of Anemarrhena asphodeloides rhizome, enabling compliance with diverse regulatory frameworks and facilitating entry into markets such as Japan, Korea, the EU, and the US.

• Pharmaceutical Manufacturing: Used by TCM manufacturers to validate the safety and efficacy of raw materials in patented medicines, Kampo formulas, and herbal decoctions.

• Inspection and Regulatory Bodies: Government and quality control labs reference this standard when inspecting batches, setting national norms, or evaluating imports.

• Product Labelling and Consumer Assurance: Ensures end-users and healthcare professionals receive clear and traceable information about origin, composition, and safety.

Related Standards

• ISO 18664: Traditional Chinese Medicine - Determination of heavy metals in herbal medicines
• ISO 23723: Traditional Chinese medicine - General requirements for herbal raw material and materia medica
• ISO/TS 21310: Microscopic examination of medicinal herbs
• ISO 21371: Labelling requirements of products intended for oral or topical use
• ISO 22217: Storage requirements for raw materials and decoction pieces
• ISO 22258: Determination of pesticide residues in natural products by gas chromatography

Practical Value

Adopting ISO 19661:2026 helps stakeholders in the TCM supply chain:

• Enhance product quality, safety, and international acceptance
• Reduce risk of contamination and regulatory non-compliance
• Improve efficiency in processing and logistics through unified protocols
• Support market expansion for manufacturers and exporters

ISO 19661:2026 is a cornerstone document for the standardization and globalization of herbal medicines, enabling safe, consistent, and high-quality products that benefit producers, practitioners, and consumers worldwide.