ISO 18664:2015

Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in Traditional Chinese Medicine

ISO 18664:2015 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. ISO 18664:2015 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.

Médecine traditionnelle chinoise — Dosage des métaux lourds dans les herbes médicinales utilisées dans la médecine traditionnelle chinoise

General Information

• Status: Published
• Publication Date: 20-Jul-2015
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/WG 1 - Quality and safety of raw materials and traditional processing
• Current Stage: 9093 - International Standard confirmed
• Completion Date: 13-May-2021

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 18664
First edition
2015-08-01
Traditional Chinese Medicine —
Determination of heavy metals in
herbal medicines used in Traditional
Chinese Medicine
Médecine traditionnelle chinoise — Dosage des métaux lourds dans les
herbes médicinales utilisées dans la médecine traditionnelle chinoise
Reference number
ISO 18664:2015(E)
©
ISO 2015

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ISO 18664:2015(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
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ii © ISO 2015 – All rights reserved

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ISO 18664:2015(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Analytical methods. 2
4.1 Instrumental methods . 2
4.1.1 Atomic Absorption Spectrometry (AAS) . 2
4.1.2 Inductively-Coupled Plasma-Atomic Emission Spectrometry (ICP-AES) . 3
4.1.3 Inductively-Coupled Plasma Mass Spectrometry (ICP-MS) . 3
4.2 Comparison of instrumental methods . 3
Annex A (informative) Reference of national, regional and organizational limits of heavy
metals in natural TCM materials and calculated limits using Target Hazard
Quotients based on USEPA and WHO. 5
Bibliography . 8
© ISO 2015 – All rights reserved iii

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ISO 18664:2015(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 249, Traditional Chinese medicine.
iv © ISO 2015 – All rights reserved

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ISO 18664:2015(E)

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.
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INTERNATIONAL STANDARD ISO 18664:2015(E)
Traditional Chinese Medicine — Determination of heavy
metals in herbal medicines used in Traditional Chinese
Medicine
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.
ISO 6561-2:2005, Fruits, vegetables and derived products — Determination of cadmium content —
Part 2: Method using flame atomic absorption spectrometry
ISO 11212-1:1997, Starch and derived products — Heavy metals content — Part 1: Determination of arsenic
content by atomic absorption spectrometry
ISO 11212-2:1997, Starch and derived products — Heavy metals content — Part 2: Determination of
mercury content by atomic absorption spectrometry
ISO 11212-3:1997, Starch and derived products — Heavy metals content — Part 3: Determination of lead
content by atomic absorption spectrometry with electrothermal atomization
ISO 11212-4:1997, Starch and derived products — Heavy metals content — Part 4: Determination of
cadmium content by atomic absorption spectrometry with electrothermal atomization
ISO 11885:2007, Water quality — Determination of selected elements by inductively coupled plasma optical
emission spectrometry (ICP-OES)
ISO 17239:2004, Fruits, vegetables and derived products — Determination of arsenic content — Method
using hydride generation atomic absorption spectrometry
ISO 17294-1:2004, Water quality — Application of inductively coupled plasma mass spectrometry (ICP-
MS) — Part 1: General guidelines
ISO 17294-2:2003, Water quality — Application of inductively coupled plasma mass spectrometry (ICP-
MS) — Part 2: Determination of 62 elements
ISO/TS 21033:2011, Animal and vegetable fats and oils — Determination of trace elements by inductively
coupled plasma optical emission spectroscopy (ICP-OES)
ISO 27085:2009, Animal feeding stuffs — Determination of calcium, sodium, phosphorus, magnesium,
potassium, iron, zinc, copper, manganese, cobalt, molybdenum, arsenic, lead and cadmium by ICP-AES
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ISO 18664:2015(E)

3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
arsenic content
quantity of arsenic determined in accordance with the conditions specified in this method and
expressed as arsenic (As), in micrograms per kilogram of the product as received
[SOURCE: ISO 11212-1:1997, 2.1]
3.2
mercury content
quantity of mercury determined in accordance with the conditions specified in this method and
expressed as mercury (Hg), in micrograms per kilogram of the product as received
[SOURCE: ISO 11212-2:1997, 2.1]
3.3
lead content
quantity of lead determined in accordance with the conditions specified in this method and expressed
as lead (Pb), in micrograms per kilogram of the product as received
[SOURCE: ISO 11212-3:1997, 2.1]
3.4
cadmium content
quantity of cadmium determined in accordance with the conditions specified in this method and
expressed as cadmium (Cd), in micrograms per kilogram of the product as recei
...