ISO 13615-2024 PDF

Full title and description

St ISO 13615-2024 — Traditional Chinese medicine — Atractylodes macrocephala rhizome. This International Standard specifies descriptions, quality and safety requirements, sampling and test methods for Atractylodes macrocephala rhizome (whole medicinal material and decoction pieces) derived from Atractylodes macrocephala Koidz, intended for use and trade as a natural medicine.

Abstract

This standard sets out identification and quality criteria and associated test methods (including chromatographic identification, moisture, ash, residues and limits for contaminants) for Atractylodes macrocephala rhizome used in traditional Chinese medicine and international trade. It aims to harmonize existing national/regional specifications and support safety and market consistency for producers, suppliers and regulators.

General information

• Status: Published.
• Publication date: July 2024 (published 26 July 2024).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.120.10 (Medicaments / traditional Chinese medicine).
• Edition / version: Edition 1, 2024.
• Number of pages: 12.

Scope

Specifies requirements and test methods for Atractylodes macrocephala rhizome derived from Atractylodes macrocephala Koidz and applies to material sold and used as a natural medicine in international trade, including whole Chinese materia medica and decoction pieces. The standard addresses morphological description, identification, quality/safety limits and sampling/testing procedures to support international harmonization.

Key topics and requirements

• Descriptive requirements and morphological features for whole rhizome and decoction pieces.
• Identification methods: thin-layer chromatography (TLC) and high-performance liquid chromatography (HPLC) specifications.
• Physicochemical tests: moisture content, total ash, ethanol-soluble extractives, essential oil content.
• Residues and contaminants: sulfur dioxide residues, heavy metals and pesticide residues with specified limits.
• Sampling procedures and detailed test-method references for laboratory verification.
• Guidance for national adaptation of some limit values to reflect regional pharmacopoeial practice.

These topics and the detailed test-methods are defined in the standard to enable consistent quality control and regulatory compliance.

Typical use and users

Used by pharmacopeial bodies, national standards organizations, herbal raw‑material suppliers and traders, manufacturers of decoction pieces and finished herbal products, quality-control and testing laboratories, importers/exporters, and regulators responsible for herbal medicine safety and trade compliance.

Related standards

Related ISO and international documents include other ISO standards on traditional Chinese medicine (for example ISO 13619 on Gardenia jasminoides fruit), ISO standards for testing contaminants and coding in TCM (ISO 18664, ISO 18668 series), and relevant national pharmacopoeial monographs and testing standards. These documents together support a harmonized framework for quality, safety and coding of Chinese medicinal materials.

Keywords

Atractylodes macrocephala; Bái Zhú; traditional Chinese medicine; rhizome; decoction pieces; identification; TLC; HPLC; moisture; total ash; heavy metals; pesticide residues; quality control; ISO 13615:2024.

FAQ

Q: What is this standard?

A: ISO 13615:2024 is an international standard that specifies descriptions, quality and safety requirements, sampling and test methods for Atractylodes macrocephala rhizome used in traditional Chinese medicine and trade.

Q: What does it cover?

A: It covers morphological descriptions, identification (TLC, HPLC), physicochemical tests (moisture, ash, extractives, essential oil), residues and contaminant limits (sulfur dioxide, heavy metals, pesticides), sampling and laboratory test methods to ensure consistent quality and safety.

Q: Who typically uses it?

A: Manufacturers, suppliers, quality-control laboratories, importers/exporters, regulators, pharmacopeial authorities and standards bodies involved in cultivation, production, testing and trade of Atractylodes macrocephala rhizome.

Q: Is it current or superseded?

A: Current — ISO 13615:2024 was published in July 2024 (first edition) and is the active international standard for this materia medica.

Q: Is it part of a series?

A: It is part of ISO’s body of standards for traditional Chinese medicine developed by ISO/TC 249/SC 1; related standards address other individual herbal materials and test methods (for example ISO 13619 and other TCM-related ISO documents).

Q: What are the key keywords?

A: Atractylodes macrocephala, Bái Zhú, rhizome, decoction pieces, TLC, HPLC, moisture, total ash, heavy metals, pesticide residues, traditional Chinese medicine, ISO 13615:2024.