Overview
ISO 21314:2026 sets out the essential requirements and test methods for Salvia miltiorrhiza root and rhizome-commonly known as Danshen-in the context of traditional Chinese medicine (TCM). The standard covers both unprocessed and traditionally processed forms of this botanical, focusing on its use as a natural medicinal product in international trade. The guidance ensures quality, safety, and consistency for Salvia miltiorrhiza root and rhizome as global demand for traditional herbal remedies grows.
The publication includes standardized terminology, detailed criteria for botanical identity and purity, and requirements for chemical markers, heavy metals, and pesticide residues. The standard aims to harmonize diverse national approaches, facilitating fair trade and protecting end-user safety in herbal medicine.
Key Topics
Applications
ISO 21314:2026 is vital for:
Related Standards
Applying ISO 21314:2026 often requires referencing additional standards, including:
- ISO 18664: Traditional Chinese Medicine - Determination of heavy metals in herbal medicines.
- ISO 22258: Traditional Chinese Medicine - Determination of pesticide residues.
- ISO 23723: General requirements for herbal raw material and materia medica.
Other influential documents include national pharmacopeias (Chinese, British, US, European, Hong Kong, and Korean), each with specific limits and testing methods for herbal substances.
Practical Value
By implementing ISO 21314:2026, stakeholders ensure Salvia miltiorrhiza root and rhizome meet internationally recognized benchmarks for quality and safety. The standard supports the expansion of TCM products into new markets, fosters consumer confidence, and underpins the development of robust, science-based herbal medicine supply chains. For both regulatory authorities and commercial operators, this ISO standard is a key resource for global best practices in the trade and use of traditional herbal medicines.
