BS ISO 18664-2015 Traditional Chinese Medicine Determination of heavy metals in herbal medicines used in Traditional Chinese Medicine《传统中药 传统中药中使用的中药材中重金属含量的测定》.pdf

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1、BSI Standards PublicationBS ISO 18664:2015Traditional Chinese Medicine Determination of heavy metalsin herbal medicines used inTraditional Chinese MedicineBS ISO 18664:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 18664:2015.The UK participation in its p

2、reparation was entrusted to TechnicalCommittee CH/100, Healthcare and medical equipment (Europeanand International).A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract.

3、 Users are responsible for its correctapplication. The British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 82697 9ICS 11.120.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority

4、of theStandards Policy and Strategy Committee on 31 July 2015.Amendments issued since publicationDate Text affectedBS ISO 18664:2015 ISO 2015Traditional Chinese Medicine Determination of heavy metals in herbal medicines used in Traditional Chinese MedicineMdecine traditionnelle chinoise Dosage des m

5、taux lourds dans les herbes mdicinales utilises dans la mdecine traditionnelle chinoiseINTERNATIONAL STANDARDISO18664First edition2015-08-01Reference numberISO 18664:2015(E)BS ISO 18664:2015ISO 18664:2015(E)ii ISO 2015 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2015, Published in Switzerlan

6、dAll 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 requeste

7、d from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 18664:2015ISO 18664:2015(E)Foreword ivIntroduction v

8、1 Scope . 12 Normative references 13 Terms and definitions . 24 Analytical methods. 24.1 Instrumental methods 24.1.1 Atomic Absorption Spectrometry (AAS) . 24.1.2 Inductively-Coupled Plasma-Atomic Emission Spectrometry (ICP-AES) 34.1.3 Inductively-Coupled Plasma Mass Spectrometry (ICP-MS) 34.2 Compa

9、rison of instrumental methods 3Annex 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. 5Bibliography 8 ISO 2015 All rights reserved iiiContents PageBS ISO 1866

10、4:2015ISO 18664:2015(E)ForewordISO (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

11、 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 Commissio

12、n (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 shoul

13、d 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 ide

14、ntifying 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 conve

15、nience 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 ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword

16、 - Supplementary informationThe committee responsible for this document is ISO/TC 249, Traditional Chinese medicine.iv ISO 2015 All rights reservedBS ISO 18664:2015ISO 18664:2015(E)IntroductionHeavy metals are natural constituents of the environment, and are commonly detected in air, water and soil.

17、 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 Medicin

18、e (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 Me

19、dicine 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 vBS ISO 18664:2015BS ISO 18664:2015Traditional Chinese Medicine Determination of heavy metals in herbal medic

20、ines used in Traditional Chinese Medicine1 ScopeThis 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

21、 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 maxi

22、mum limits (ML) for individual nations; rather, it is intended to give a reference for standardized testing method and risk assessment.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated

23、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 spectrometryISO

24、11212-1:1997, Starch and derived products Heavy metals content Part 1: Determination of arsenic content by atomic absorption spectrometryISO 11212-2:1997, Starch and derived products Heavy metals content Part 2: Determination of mercury content by atomic absorption spectrometryISO 11212-3:1997, Star

25、ch and derived products Heavy metals content Part 3: Determination of lead content by atomic absorption spectrometry with electrothermal atomizationISO 11212-4:1997, Starch and derived products Heavy metals content Part 4: Determination of cadmium content by atomic absorption spectrometry with elect

26、rothermal atomizationISO 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 spectr

27、ometryISO 17294-1:2004, Water quality Application of inductively coupled plasma mass spectrometry (ICP-MS) Part 1: General guidelinesISO 17294-2:2003, Water quality Application of inductively coupled plasma mass spectrometry (ICP-MS) Part 2: Determination of 62 elementsISO/TS 21033:2011, Animal and

28、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

29、cadmium by ICP-AESINTERNATIONAL STANDARD ISO 18664:2015(E) ISO 2015 All rights reserved 1BS ISO 18664:2015ISO 18664:2015(E)3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1arsenic contentquantity of arsenic determined in accordance with the condi

30、tions specified in this method and expressed as arsenic (As), in micrograms per kilogram of the product as receivedSOURCE: ISO 11212-1:1997, 2.13.2mercury contentquantity of mercury determined in accordance with the conditions specified in this method and expressed as mercury (Hg), in micrograms per

31、 kilogram of the product as receivedSOURCE: ISO 11212-2:1997, 2.13.3lead contentquantity 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 receivedSOURCE: ISO 11212-3:1997, 2.13.4cadmium contentquant

32、ity 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 receivedSOURCE: ISO 11212-4:1997, 2.14 Analytical methods4.1 Instrumental methods4.1.1 Atomic Absorption Spectrometry (AAS)AAS methods can

33、be used for the individual determination of lead, mercury, arsenic and cadmium in natural materials used in TCM. The detailed information is specified in the following documents.ISO 6561-2:2005, Fruits, vegetables and derived products Determination of cadmium content Part 2: Method using flame atomi

34、c absorption spectrometryISO 11212-1:1997, Starch and derived products Heavy metals content Part 1: Determination of arsenic content by atomic absorption spectrometryISO 11212-2:1997, Starch and derived products Heavy metals content Part 2: Determination of mercury content by atomic absorption spect

35、rometryISO 11212-3:1997, Starch and derived products Heavy metals content Part 3: Determination of lead content by atomic absorption spectrometry with electrothermal atomizationISO 11212-4:1997, Starch and derived products Heavy metals content Part 4: Determination of cadmium content by atomic absor

36、ption spectrometry with electrothermal atomizationISO 17239:2004, Fruits, vegetables and derived products Determination of arsenic content Method using hydride generation atomic absorption spectrometry2 ISO 2015 All rights reservedBS ISO 18664:2015ISO 18664:2015(E)4.1.2 Inductively-Coupled Plasma-At

37、omic Emission Spectrometry (ICP-AES)ICP-AES methods can be used for the simultaneous determination of lead, mercury, arsenic and cadmium in natural materials used in TCM. The detailed information is specified in the following documents.ISO 11885:2007, Water quality Determination of selected elements

38、 by inductively coupled plasma optical emission spectrometry (ICP-OES)ISO/TS 21033:2011, Animal and vegetable fats and oils Determination of trace elements by inductively coupled plasma optical emission spectroscopy (ICP-OES) First EditionISO 27085:2009, Animal feeding stuffs-Determination of calciu

39、m, sodium, phosphorus, magnesium, potassium, iron, zinc, copper, manganese, cobalt, molybdenum, arsenic, lead and cadmium by ICP-AES First Edition4.1.3 Inductively-Coupled Plasma Mass Spectrometry (ICP-MS)ICP-MS methods can be used for the simultaneous determination of lead, mercury, arsenic and cad

40、mium in natural materials used in TCM. The detailed information is specified in the following documents.ISO 17294-1:2004, Water quality Application of inductively coupled plasma mass spectrometry (ICP-MS) Part 1: General guidelinesISO 17294-2:2003, Water quality Application of inductively coupled pl

41、asma mass spectrometry (ICP-MS) Part 2: Determination of 62 elements4.2 Comparison of instrumental methodsAll of these instrumental methods have advantages and disadvantages. Table 1 below provides a tabular overview, including detection limits, sample throughout, linear dynamic range, interferences

42、, precision, and ease of use, applicability, unattended use, method development, initial costs, operating costs, and cost per sample. Table 1 Comparison of various instrumental techniquesFAAS GFAAS ICP-AES ICP-MSDetection limit (g/L)Very good for some elements Arsenic 150Cadmium 0,8Lead 15Mercury 30

43、0Excellent for most elementsArsenic 1Cadmium 0,002Lead 0,5Mercury 0,6Very good for some elementsArsenic 20Cadmium 0,1Lead 1Mercury 1Excellent for most elementsArsenic 0,05Cadmium 0,05Lead 0,05Mercury 0,05Analytical capabilitySingle element Single element Multi-element Multi-elementLinear dynamic ran

44、ge103102105105Precision 0,1 % to 1 % 1 % to 5 % 0,3 % to 2 % 1 % to 3 %Interferences spectralFew Very few Common FewInterferences chemicalMany Many Very few SomeNOTE Comparison of various instrumental techniques is selected from The American Herbal Products Association (AHPA), Heavy Metals: Analysis

45、 and Limits in Herbal Dietary Supplements. AHPA, US, 2009. ISO 2015 All rights reserved 3BS ISO 18664:2015ISO 18664:2015(E)FAAS GFAAS ICP-AES ICP-MSInterference physicalSome Very few Some SomeMethod developmentEasy Fairly easy Fairly easy More difficultEase of use Easy Easy Easy EasyInitial cost Low

46、 Medium High Very highOperating cost Low High Medium HighCost per sample Low Medium Low MediumNOTE Comparison of various instrumental techniques is selected from The American Herbal Products Association (AHPA), Heavy Metals: Analysis and Limits in Herbal Dietary Supplements. AHPA, US, 2009.Table 1 (

47、continued)4 ISO 2015 All rights reservedBS ISO 18664:2015ISO 18664:2015(E)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 WHODifferent countries, regions an

48、d organizations give their own limits of heavy metals in natural materials of TCM. Table A.1 shows these limits in various types of herbal products. Also, some health authorities provide risk assessment methods (USEPA) and recommend heavy metals intake per week (WHO). According to these information

49、and TCMs characteristics, the calculated limits using Target Hazard Quotients are also listed with the summarized maximum and minimum limits from previous references in Table A.1.Table A.1 The national, regional and organizational limits of heavy metals in natural TCM materials and calculated limits using Target Hazard Quotients based on USEPA and WHO (mg/kg)PbaAsaCdaHgaObjectAnalytical methodsAuthority organization or regulationAustralia 5,0 1 0,1Unpr