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
Current Stage
9093 - International Standard confirmed
Start Date
13-May-2021
Completion Date
13-May-2021
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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

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior

written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of

the requester.
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copyright@iso.org
www.iso.org
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.
© ISO 2015 – All rights reserved v
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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

© ISO 2015 – All rights reserved 1
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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
...

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