ISO 19609-3-2022 PDF

Full title and description

St ISO 19609-3:2022 — Traditional Chinese medicine — Quality and safety of raw materials and finished products made with raw materials — Part 3: Testing for contaminants. This part specifies sample preparation methods and testing-related requirements used to determine contamination of raw materials and finished products for traditional Chinese medicine (heavy metals, pesticides, aflatoxins and microbiological contaminants).

Abstract

This document defines sample preparation procedures and testing considerations for detecting and assessing contaminants (including heavy metals, pesticide residues, aflatoxins and microorganisms) in starting materials and finished products used in traditional Chinese medicine. It is intended to support consistent laboratory practice for contaminant testing within quality and safety frameworks for TCM materials.

General information

• Status: Published.
• Publication date: 2022-11 (Edition 1, 2022).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.120.10 (Pharmaceuticals; Traditional Chinese medicine).
• Edition / version: Edition 1 (2022).
• Number of pages: 11 pages.

Scope

Specifies sample preparation methods and related guidance for the determination of contamination by heavy metals, pesticides, aflatoxins and microorganisms in raw materials and finished products used in traditional Chinese medicine. The document applies to quality-control testing and laboratory procedures for TCM starting materials and finished products and complements other parts of the ISO 19609 series that address identity testing, general requirements and other analytical aspects.

Key topics and requirements

• Definitions and intended application to raw materials and finished TCM products.
• Sample preparation techniques suitable for contaminant analysis (for heavy metals, pesticides, aflatoxins and microbiological agents).
• Guidance on representative sampling and handling prior to analysis to minimise cross‑contamination and degradation of analytes.
• Specification of contaminants covered (heavy metals, selected pesticide residues, aflatoxins, and microbiological contaminants) and the scope of testing methods to be applied.
• Requirements for documenting test methods, traceability of results and reporting to support quality and regulatory use.
• Relationship to other parts of the ISO 19609 series for complementary requirements (identity testing, general requirements, testing for preservatives/unwanted compounds).

Typical use and users

Used by quality and analytical laboratories, manufacturers and suppliers of traditional Chinese medicine ingredients and finished products, regulatory authorities and conformity assessment bodies. It is intended for laboratory personnel responsible for contaminant testing, QC managers in TCM production, and standards/technical committees developing TCM testing protocols.

Related standards

ISO 19609 is a multipart series addressing quality and safety of raw materials and finished products for traditional Chinese medicine. Relevant parts include ISO 19609-1 (general requirements), ISO 19609-2 (identity testing of constituents of herbal origin), ISO 19609-3 (this document: testing for contaminants) and ISO 19609-4 (testing for preservatives and unwanted compounds).

Keywords

Traditional Chinese medicine, TCM, contaminants, heavy metals, pesticides, aflatoxins, microbiological testing, sample preparation, quality control, ISO 19609-3:2022.

FAQ

Q: What is this standard?

A: ISO 19609-3:2022 is an international standard that specifies sample preparation and testing considerations for detecting contaminants in raw materials and finished products used in traditional Chinese medicine.

Q: What does it cover?

A: It covers sample preparation methods and testing-related requirements for contaminants including heavy metals, pesticide residues, aflatoxins and microorganisms, and provides guidance for laboratory handling, documentation and reporting of results for TCM materials.

Q: Who typically uses it?

A: Analytical and quality-control laboratories, TCM raw material and finished-product manufacturers, suppliers, regulatory authorities and conformity assessment bodies involved in TCM product safety and quality assurance.

Q: Is it current or superseded?

A: As published, ISO 19609-3:2022 is a current published international standard (Edition 1, 2022). Users should check national or ISO catalogue updates for any subsequent revisions or amendments.

Q: Is it part of a series?

A: Yes — ISO 19609 is a multipart series addressing quality and safety of raw materials and finished products made with raw materials for traditional Chinese medicine; related parts include ISO 19609-1, -2, -3 and -4.

Q: What are the key keywords?

A: Traditional Chinese medicine; contaminants; heavy metals; pesticides; aflatoxins; microbiological testing; sample preparation; quality control; ISO 19609-3:2022.