ISO 18664:2015 漢方薬—漢方薬で使用される漢方薬中の重金属の測定 | ページ 2

Foreword

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The committee responsible for this document is ISO/TC 249, Traditional Chinese medicine.

Introduction

Heavy metals are natural constituents of the environment, and are commonly detected in air, water and soil. However, technical and industrial processes may release heavy metals into the environment, and they have gained attention as contaminants. At present, there is no uniformly accepted International Standard which defines maximum limits for heavy metals in materials used in Traditional Chinese Medicine (TCM), resulting in disputes about what levels should be considered acceptable in TCM materials.

ISO 18664 was developed in response to worldwide demand for harmonization of the determination of heavy metals in herbal medicines used in TCM. The International Standard is applicable to Traditional Medicine systems derived from ancient Chinese medicine.

For reference, the maximum limits of heavy metals in natural materials of TCM have been provided in Annex A.

1 Scope

This International Standard specifies determination methods of lead (Pb), arsenic (As), cadmium (Cd) and mercury (Hg) in herbal medicines used in Traditional Chinese Medicine (TCM). It is applicable to natural materials of TCM that are sold and used as food supplements, functional foods or natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from plants or animals. It is not applicable to mineral drugs used in TCM.

This International Standard is not intended to set maximum limits (ML) for individual nations; rather, it is intended to give a reference for standardized testing method and risk assessment.

2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

Bibliography