SIST ISO 10315:2021

Cigarettes - Determination of nicotine in total particulate matter from the mainstream smoke - Gas-chromatographic method

This document specifies a method for the gas-chromatographic determination of nicotine in total particulate matter from the mainstream smoke. The smoking of cigarettes and the collection of mainstream smoke are carried out according to ISOÂ 4387.
NOTEÂ Â Â Â Â Â ISOÂ 20778 and ISOÂ 22253 provide the determination method of nicotine in smoke with an intense smoking regime.

Cigarettes - Dosage de la nicotine dans la matière particulaire totale du courant principal de fumée - Méthode par chromatographie en phase gazeuse

Le présent document spécifie une méthode de dosage de la nicotine par chromatographie en phase gazeuse dans la matière particulaire totale du courant principal de fumée. Le fumage de cigarettes et la collecte du courant principal de fumée sont effectués conformément à l’ISO 4387.
NOTE L’ISO 20778 et l’ISO 22253 fournissent la méthode de dosage de la nicotine dans la fumée avec un régime de fumage intense.

Cigarete - Določevanje nikotina v skupnih trdnih delcih iz običajnega dima - Plinsko-kromatografska metoda

General Information

• Status: Published
• Publication Date: 05-Sep-2021
• ICS: 65.160 - Tobacco, tobacco products and related equipment
• Technical Committee: TIT - Tobaco and tobaco products
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Sep-2021
• Due Date: 06-Nov-2021
• Completion Date: 06-Sep-2021
• Directive: TP046 - Pravilnik o pogojih, ki jih mora izpolnjevati laboratorij za izvajanje meritev
• Directive: TP184 - Zakon o omejevanju uporabe tobačnih in povezanih izdelkov (ZOUTPI)
• Ref Project: ISO 10315:2021 - Cigarettes — Determination of nicotine in total particulate matter from the mainstream smoke — Gas-chromatographic method

RELATIONS

• Replaces: SIST ISO 10315:2014 - Cigarettes - Determination of nicotine in smoke condensates - Gas-chromatographic method
• Effective Date: 01-Oct-2021

Standards Content (sample)

SLOVENSKI STANDARD
SIST ISO 10315:2021
01-oktober-2021
Nadomešča:
SIST ISO 10315:2014
Cigarete - Določevanje nikotina v skupnih trdnih delcih iz običajnega dima -
Plinsko-kromatografska metoda

Cigarettes - Determination of nicotine in total particulate matter from the mainstream

smoke - Gas-chromatographic method

Cigarettes - Dosage de la nicotine dans la matière particulaire totale du courant principal

de fumée - Méthode par chromatographie en phase gazeuse
Ta slovenski standard je istoveten z: ISO 10315:2021
ICS:
65.160 Tobak, tobačni izdelki in Tobacco, tobacco products
oprema and related equipment
SIST ISO 10315:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST ISO 10315:2021
---------------------- Page: 2 ----------------------
SIST ISO 10315:2021
INTERNATIONAL ISO
STANDARD 10315
Fourth edition
2021-06
Cigarettes — Determination of
nicotine in total particulate matter
from the mainstream smoke — Gas-
chromatographic method
Cigarettes — Dosage de la nicotine dans la matière particulaire totale
du courant principal de fumée — Méthode par chromatographie en
phase gazeuse
Reference number
ISO 10315:2021(E)
ISO 2021
---------------------- Page: 3 ----------------------
SIST ISO 10315:2021
ISO 10315:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
SIST ISO 10315:2021
ISO 10315:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Principle ........................................................................................................................................................................................................................ 1

5 Reagents ........................................................................................................................................................................................................................ 1

6 Apparatus ..................................................................................................................................................................................................................... 2

7 Procedure..................................................................................................................................................................................................................... 3

7.1 Test portion ................................................................................................................................................................................................ 3

7.2 Setting up the apparatus................................................................................................................................................................. 3

7.3 Calibration of the gas chromatograph ................................................................................................................................ 3

7.4 Determination ......................................................................................................................................................................................... 3

8 Expression of results ........................................................................................................................................................................................ 4

9 Repeatability and reproducibility ...................................................................................................................................................... 4

10 Alternative gas-chromatographic procedures and analysis precautions ..................................................5

10.1 General ........................................................................................................................................................................................................... 5

10.2 Alternative columns ............................................................................................................................................................................ 5

10.2.1 Packed columns ................................................................................................................................................................ 5

10.2.2 Capillary columns ........................................................................................................................................................... 5

10.3 Injection systems .................................................................................................................................................................................. 5

10.4 Alternative internal standards .................................................................................................................................................. 6

11 Test report ................................................................................................................................................................................................................... 6

Annex A (informative) Use of this method with the gas-chromatographic determination of water..7

Annex B (informative) Example of chromatogram ................................................................................................................................ 8

Bibliography ................................................................................................................................................................................................................................ 9

© ISO 2021 – All rights reserved iii
---------------------- Page: 5 ----------------------
SIST ISO 10315:2021
ISO 10315:2021(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 of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 126, Tobacco and tobacco products.

This fourth edition cancels and replaces the third edition (ISO 10315:2013), which has been technically

revised.
The main changes compared to the previous edition are as follows.

— The term "smoke condensate(s)" has been replaced with either “total particulate matter” or "total

particulate matter from the mainstream smoke" throughout the document.

— Extraction solution and calibration solutions stored at low temperature, are equilibrated to ambient

temperature before use (5.7).

— The linear regression equation for calibration is calculated by regression analysis with the area

ratios in accordance with the nicotine concentrations (7.3).
— Data in Clause 9 have been replaced with the results of ISO/TR 19478-1.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved
---------------------- Page: 6 ----------------------
SIST ISO 10315:2021
ISO 10315:2021(E)
Introduction

This document may be considered as part of a set produced by ISO/TC 126 which describes the

determination of total and nicotine-free dry particulate matter (NFDPM) in total particulate matter

from the mainstream smoke. The set comprises ISO 3308, ISO 3402, ISO 4387, ISO 8243, ISO 10315 (this

document) and ISO 10362-1.

A related International Standard, ISO 3400, determines total alkaloids, whereas this document

determines only nicotine by virtue of the gas-chromatographic separation. Occasionally, differences

can occur because of minor amounts of alkaloids other than nicotine in some types of tobacco.

Annex A provides information about the use of this method in conjunction with or simultaneously with

the gas-chromatographic method of water determination specified in ISO 10362-1.
No machine smoking regime can represent all human smoking behaviour.

— It is recommended that cigarettes also be tested under conditions of a different intensity of machine

smoking than those specified in this document.

— Machine smoking testing is useful to characterize cigarette emissions for design and regulatory

purposes, but communication of machine measurements to smokers can result in misunderstandings

about differences in exposure and risk across brands.

— Smoke emission data from machine measurements may be used as inputs for product hazard

assessment, but they are not intended to be nor are they valid as measures of human exposure or

risks. Communicating differences between products in machine measurements as differences in

exposure or risk is a misuse of testing using ISO standards.
© ISO 2021 – All rights reserved v
---------------------- Page: 7 ----------------------
SIST ISO 10315:2021
---------------------- Page: 8 ----------------------
SIST ISO 10315:2021
INTERNATIONAL STANDARD ISO 10315:2021(E)
Cigarettes — Determination of nicotine in total
particulate matter from the mainstream smoke — Gas-
chromatographic method

WARNING — The use of this document can involve hazardous materials, operations and

equipment. This document does not purport to address all the safety problems associated with

its use. It is the responsibility of the user of this document to establish appropriate safety and

health practices and determine the applicability of any other restrictions prior to use.

1 Scope

This document specifies a method for the gas-chromatographic determination of nicotine in total

particulate matter from the mainstream smoke. The smoking of cigarettes and the collection of

mainstream smoke are carried out according to ISO 4387.

NOTE ISO 20778 and ISO 22253 provide the determination method of nicotine in smoke with an intense

smoking regime.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 4387, Cigarettes — Determination of total and nicotine-free dry particulate matter using a routine

analytical smoking machine
3 Terms and definitions
No terms and definitions are listed in this document.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
4 Principle

The total particulate matter from the mainstream smoke, which shall be obtained in accordance with

ISO 4387, is dissolved in an extraction solution containing an internal standard. The nicotine content of

an aliquot of the smoke extract is determined by gas chromatography, and the nicotine content in the

total particulate matter from the mainstream smoke is calculated.

NOTE In countries not in a position to use the gas-chromatographic method, reference is made to ISO 3400

for the determination of total nicotine alkaloids. In such cases, values obtained using the method described in

ISO 3400 can be used with the addition of a note in the expression of results.
5 Reagents
Use only reagents of recognized analytical reagent grade.
© ISO 2021 – All rights reserved 1
---------------------- Page: 9 ----------------------
SIST ISO 10315:2021
ISO 10315:2021(E)

5.1 Carrier gas, helium (CAS: 7440-59-7), nitrogen (CAS: 7727-37-9) or hydrogen (CAS:

...

INTERNATIONAL ISO
STANDARD 10315
Fourth edition
2021-06
Cigarettes — Determination of
nicotine in total particulate matter
from the mainstream smoke — Gas-
chromatographic method
Cigarettes — Dosage de la nicotine dans la matière particulaire totale
du courant principal de fumée — Méthode par chromatographie en
phase gazeuse
Reference number
ISO 10315:2021(E)
ISO 2021
---------------------- Page: 1 ----------------------
ISO 10315:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 10315:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Principle ........................................................................................................................................................................................................................ 1

5 Reagents ........................................................................................................................................................................................................................ 1

6 Apparatus ..................................................................................................................................................................................................................... 2

7 Procedure..................................................................................................................................................................................................................... 3

7.1 Test portion ................................................................................................................................................................................................ 3

7.2 Setting up the apparatus................................................................................................................................................................. 3

7.3 Calibration of the gas chromatograph ................................................................................................................................ 3

7.4 Determination ......................................................................................................................................................................................... 3

8 Expression of results ........................................................................................................................................................................................ 4

9 Repeatability and reproducibility ...................................................................................................................................................... 4

10 Alternative gas-chromatographic procedures and analysis precautions ..................................................5

10.1 General ........................................................................................................................................................................................................... 5

10.2 Alternative columns ............................................................................................................................................................................ 5

10.2.1 Packed columns ................................................................................................................................................................ 5

10.2.2 Capillary columns ........................................................................................................................................................... 5

10.3 Injection systems .................................................................................................................................................................................. 5

10.4 Alternative internal standards .................................................................................................................................................. 6

11 Test report ................................................................................................................................................................................................................... 6

Annex A (informative) Use of this method with the gas-chromatographic determination of water..7

Annex B (informative) Example of chromatogram ................................................................................................................................ 8

Bibliography ................................................................................................................................................................................................................................ 9

© ISO 2021 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 10315:2021(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 of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 126, Tobacco and tobacco products.

This fourth edition cancels and replaces the third edition (ISO 10315:2013), which has been technically

revised.
The main changes compared to the previous edition are as follows.

— The term "smoke condensate(s)" has been replaced with either “total particulate matter” or "total

particulate matter from the mainstream smoke" throughout the document.

— Extraction solution and calibration solutions stored at low temperature, are equilibrated to ambient

temperature before use (5.7).

— The linear regression equation for calibration is calculated by regression analysis with the area

ratios in accordance with the nicotine concentrations (7.3).
— Data in Clause 9 have been replaced with the results of ISO/TR 19478-1.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 10315:2021(E)
Introduction

This document may be considered as part of a set produced by ISO/TC 126 which describes the

determination of total and nicotine-free dry particulate matter (NFDPM) in total particulate matter

from the mainstream smoke. The set comprises ISO 3308, ISO 3402, ISO 4387, ISO 8243, ISO 10315 (this

document) and ISO 10362-1.

A related International Standard, ISO 3400, determines total alkaloids, whereas this document

determines only nicotine by virtue of the gas-chromatographic separation. Occasionally, differences

can occur because of minor amounts of alkaloids other than nicotine in some types of tobacco.

Annex A provides information about the use of this method in conjunction with or simultaneously with

the gas-chromatographic method of water determination specified in ISO 10362-1.
No machine smoking regime can represent all human smoking behaviour.

— It is recommended that cigarettes also be tested under conditions of a different intensity of machine

smoking than those specified in this document.

— Machine smoking testing is useful to characterize cigarette emissions for design and regulatory

purposes, but communication of machine measurements to smokers can result in misunderstandings

about differences in exposure and risk across brands.

— Smoke emission data from machine measurements may be used as inputs for product hazard

assessment, but they are not intended to be nor are they valid as measures of human exposure or

risks. Communicating differences between products in machine measurements as differences in

exposure or risk is a misuse of testing using ISO standards.
© ISO 2021 – All rights reserved v
---------------------- Page: 5 ----------------------
INTERNATIONAL STANDARD ISO 10315:2021(E)
Cigarettes — Determination of nicotine in total
particulate matter from the mainstream smoke — Gas-
chromatographic method

WARNING — The use of this document can involve hazardous materials, operations and

equipment. This document does not purport to address all the safety problems associated with

its use. It is the responsibility of the user of this document to establish appropriate safety and

health practices and determine the applicability of any other restrictions prior to use.

1 Scope

This document specifies a method for the gas-chromatographic determination of nicotine in total

particulate matter from the mainstream smoke. The smoking of cigarettes and the collection of

mainstream smoke are carried out according to ISO 4387.

NOTE ISO 20778 and ISO 22253 provide the determination method of nicotine in smoke with an intense

smoking regime.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 4387, Cigarettes — Determination of total and nicotine-free dry particulate matter using a routine

analytical smoking machine
3 Terms and definitions
No terms and definitions are listed in this document.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
4 Principle

The total particulate matter from the mainstream smoke, which shall be obtained in accordance with

ISO 4387, is dissolved in an extraction solution containing an internal standard. The nicotine content of

an aliquot of the smoke extract is determined by gas chromatography, and the nicotine content in the

total particulate matter from the mainstream smoke is calculated.

NOTE In countries not in a position to use the gas-chromatographic method, reference is made to ISO 3400

for the determination of total nicotine alkaloids. In such cases, values obtained using the method described in

ISO 3400 can be used with the addition of a note in the expression of results.
5 Reagents
Use only reagents of recognized analytical reagent grade.
© ISO 2021 – All rights reserved 1
---------------------- Page: 6 ----------------------
ISO 10315:2021(E)

5.1 Carrier gas, helium (CAS: 7440-59-7), nitrogen (CAS: 7727-37-9) or hydrogen (CAS: 1333-74-0)

of high purity.

5.2 Auxiliary gases, hydrogen (CAS: 1333-74-0) of high purity and air for the flame ionization detector.

5.3 Propan-2-ol (CAS: 67-63-0), with maximum water content of 1,0 mg/ml.

5.4 Internal standard, n-heptadecane (CAS: 629-78-7) or quinaldine (CAS: 91-63-4) of purity not less

than 99 %.

Carvone (CAS: 99-49-0), n-octadecane (CAS: 593-45-3), or other appropriate internal standards may be

used after assessment of their purity and determination that the internal standard does not co-elute

with other components in the s
...

NORME ISO
INTERNATIONALE 10315
Quatrième édition
2021-06
Cigarettes — Dosage de la nicotine
dans la matière particulaire totale
du courant principal de fumée —
Méthode par chromatographie en
phase gazeuse
Cigarettes — Determination of nicotine in total particulate matter
from the mainstream smoke — Gas-chromatographic method
Numéro de référence
ISO 10315:2021(F)
© ISO 2021
---------------------- Page: 1 ----------------------
ISO 10315:2021(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2021

Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette

publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,

y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut

être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.

ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: [phone]
E-mail: [e-mail]
Web: www.iso.org
Publié en Suisse
© ISO 2021 – Tous droits réservés
---------------------- Page: 2 ----------------------
ISO 10315:2021(F)
Sommaire Page

Avant-propos .............................................................................................................................................................................................................................iv

Introduction .................................................................................................................................................................................................................................v

1 Domaine d’application ................................................................................................................................................................................... 1

2 Références normatives ..................................................................................................................................................................................1

3 Termes et définitions ...................................................................................................................................................................................... 1

4 Principe.......................................................................................................................................................................................................................... 1

5 Réactifs ........................................................................................................................................................................................................................... 2

6 Appareillage .............................................................................................................................................................................................................. 2

7 Mode opératoire ................................................................................................................................................................................................... 3

7.1 Prise d’essai ............................................................................................................................................................................................... 3

7.2 Mise en marche de l’appareillage ........................................................................................................................................... 3

7.3 Étalonnage du chromatographe en phase gazeuse ................................................................................................ 3

7.4 Détermination ......................................................................................................................................................................................... 4

8 Expression des résultats ............................................................................................................................................................................. 4

9 Répétabilité et reproductibilité ........................................................................................................................................................... 4

10 Autres méthodes de chromatographie en phase gazeuse et précautions à prendre

pour l’analyse .......................................................................................................................................................................................................... 5

10.1 Généralités ................................................................................................................................................................................................. 5

10.2 Autres colonnes ..................................................................................................................................................................................... 5

10.2.1 Colonnes remplies ............................................................................................................................................................. 5

10.2.2 Colonnes capillaires ......................................................................................................................................................... 5

10.3 Systèmes d’injection .......................................................................................................................................................................... 6

10.4 Autres étalons internes................................................................................................................................................................... 6

11 Rapport d’essai ......................................................................................................................................................................................................6

Annexe A (informative) Utilisation de la présente méthode en association avec le dosage de

l’eau par chromatographie en phase gazeuse ....................................................................................................................... 7

Annexe B (informative) Exemple de chromatogramme .................................................................................................................. 8

Bibliographie .............................................................................................................................................................................................................................. 9

iii
© ISO 2021 – Tous droits réservés
---------------------- Page: 3 ----------------------
ISO 10315:2021(F)
Avant-propos

L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes

nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est

en général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude

a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,

gouvernementales et non gouvernementales, en liaison avec l’ISO participent également aux travaux.

L’ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui

concerne la normalisation électrotechnique.

Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont

décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents

critères d'approbation requis pour les différents types de documents ISO. Le présent document a

été rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir

www.iso.org/directives).

L'attention est attirée sur le fait que certains des éléments du présent document peuvent faire l'objet de

droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable

de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant

les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de

l'élaboration du document sont indiqués dans l'Introduction et/ou dans la liste des déclarations de

brevets reçues par l'ISO (voir www.iso.org/brevets).

Les appellations commerciales éventuellement mentionnées dans le présent document sont données

pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un

engagement.

Pour une explication de la nature volontaire des normes, la signification des termes et expressions

spécifiques de l’ISO liés à l’évaluation de la conformité, ou pour toute information au sujet de l’adhésion

de l’ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles

techniques au commerce (OTC), voir www.iso.org/avant-propos.

Le présent document a été élaboré par le comité technique ISO/TC 126, Tabac et produits du tabac.

Cette quatrième édition annule et remplace la troisième édition (ISO 10315:2013), qui a fait l’objet d’une

révision technique.

Les principales modifications par rapport à l’édition précédente sont les suivantes:

— Le terme «condensat(s) de fumée» a été remplacé par «matière particulaire totale» ou par «matière

particulaire totale du courant principal de fumée» dans tout le présent document.

— Les solutions d’extraction et d’étalonnage conservées à basse température s’équilibrent à la

température ambiante avant utilisation (5.7).

— L’équation de régression linéaire pour l’étalonnage est calculée par une analyse de régression avec

les rapports des aires en fonction des concentrations en nicotine (7.3).

— Les données à l’Article 9 ont été remplacées par les résultats de l’ISO/TR 19478-1.

Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent

document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes

se trouve à l’adresse www.iso.org/fr/members.html.
© ISO 2021 – Tous droits réservés
---------------------- Page: 4 ----------------------
ISO 10315:2021(F)
Introduction

Le présent document peut être considéré comme appartenant à une série élaborée par l’ISO/TC 126

et décrivant la détermination de la matière particulaire totale et de la matière particulaire anhydre et

exempte de nicotine (MPAEN) dans la matière particulaire totale du courant principal de fumée. Cette

série comprend les normes ISO 3308, ISO 3402, ISO 4387, ISO 8243, ISO 10315 (le présent document) et

ISO 10362-1.

Une Norme Internationale apparentée, l’ISO 3400, détermine la concentration en alcaloïdes totaux,

alors que le présent document ne détermine que la concentration en nicotine au moyen de la séparation

par chromatographie en phase gazeuse. Parfois, des différences peuvent apparaître en raison de faibles

quantités d’alcaloïdes autres que la nicotine dans certains types de tabac.

L’Annexe A fournit des informations sur l’utilisation de la présente méthode en association, ou

simultanément, avec la méthode de dosage de l’eau par chromatographie en phase gazeuse spécifiée

dans l’ISO 10362-1.

Aucun régime de fumage mécanique ne peut reproduire parfaitement le comportement des fumeurs:

— Il est recommandé que les cigarettes soient aussi soumises à essai dans des conditions d’intensité de

fumage mécanique différentes de celles spécifiées dans le présent document.

— L’essai de fumage mécanique permet de caractériser les émissions des cigarettes pour des besoins

de conception et de réglementation, mais communiquer aux fumeurs les résultats de mesures sur

machine peut susciter des malentendus sur les niveaux d’exposition et de risque selon les marques.

— Les données concernant l’émission de fumées obtenues par des mesures mécaniques peuvent

être utilisées comme des données de base pour l’évaluation des dangers du produit, mais elles ne

constituent pas des mesures valables de l’exposition des individus ou des risques et ce n’est pas

leur but. C’est faire un usage impropre des essais réalisés conformément aux normes ISO que de

communiquer que les différences de mesures mécaniques entre différents produits correspondent

à des différences de niveaux d’exposition ou de risque.
© ISO 2021 – Tous droits réservés
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NORME INTERNATIONALE ISO 10315:2021(F)
Cigarettes — Dosage de la nicotine dans la matière
particulaire totale du courant principal de fumée —
Méthode par chromatographie en phase gazeuse

AVERTISSEMENT — L’utilisation du présent document peut impliquer des réactifs, manipulations

ou matériels dangereux. Le présent document n’a pas pour but de traiter tous les problèmes de

sécurité qui sont liés à son utilisation. Il incombe à l’utilisateur du présent document d’établir

des pratiques d’hygiène et de sécurité appropriées et de déterminer l’applicabilité de toutes

autres restrictions avant son utilisation.
1 Domaine d’application

Le présent document spécifie une méthode de dosage de la nicotine par chromatographie en phase

gazeuse dans la matière particulaire totale du courant principal de fumée. Le fumage de cigarettes et la

collecte du courant principal de fumée sont effectués conformément à l’ISO 4387.

NOTE L’ISO 20778 et l’ISO 22253 fournissent la méthode de dosage de la nicotine dans la fumée avec un

régime de fumage intense.
2 Références normatives

Les documents suivants sont cités dans le texte de sorte qu’ils constituent, pour tout ou partie de leur

contenu, des exigences du présent document. Pour les références datées, seule l’édition citée s’applique.

Pour les références non datées, la dernière édition du document de référence s’applique (y compris les

éventuels amendements).

ISO 4387, Cigarettes — Détermination de la teneur en matière particulaire totale et en matière particulaire

anhydre et exempte de nicotine au moyen d'une machine à fumer analytique de routine

3 Termes et définitions
Aucun terme n’est défini dans le présent document.

L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en

normalisation, consultables aux adresses suivantes:

— ISO Online browsing platform: disponible à l'adresse https:// www .iso .org/ obp

— IEC Electropedia: disponible à l'adresse https:// www .electropedia .org/
4 Principe

Dissolution de la matière particulaire totale du courant principal de fumée, qui doit être obtenue

conformément à l’ISO 4387, dans une solution d’extraction contenant un étalon interne. Détermination

de la teneur en nicotine d’une partie aliquote de l’extrait de fumée par chromatographie en phase

gazeuse et calcul de la teneur en nicotine dans la matière particulaire totale du courant principal de

fumée.

NOTE Dans les pays qui ne sont pas en mesure d’utiliser la méthode par chromatographie en phase gazeuse,

se référer à l’ISO 3400 pour le dosage des alcaloïdes nicotiniques totaux. En pareil cas, les valeurs obtenues par

la méthode décrite dans l’ISO 3400 peuvent être utilisées, moyennant l’ajout d’une note lors de l’expression des

résultats.
© ISO 2021 – Tous droits réservés
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ISO 10315:2021(F)
5 Réactifs
Utiliser uniquement des réactifs de qualité analytique reconnue.

5.1 Gaz vecteur, hélium (n° CAS: 7440-59-7), azote (n° CAS: 7727-37-9) ou hydrogène (n° CAS: 1333-

74-0) de grande pureté.

5.2 Gaz auxiliaires, hydrogène (n° CAS: 1333-74-0) de grande pureté et air pour le détecteur à

ionisation de flamme.
5.3 Propan-2-ol (n° CAS: 67-63-0), avec une teneur maximale en eau de 1,0 mg/ml.

5.4 Étalon interne, n-heptadécane (n° CAS: 629-78-7) ou 2-méthylquinoline (n° CAS: 91-63-4) d’une

pureté d’au moins 99 %.

La carvone (n° CAS: 99-49-0), le n-octadécane (n° CAS: 593-45-3) ou d’autres étalons internes appropriés

peuvent être utilisés après évaluation de leur pureté et détermination de l’absence de coélution de

l’étalon interne avec d’autres composants dans l’extrait de fumée. Il convient de veiller à ce que l’aire

du pic de l’étalon interne reste cohérente sur l’ensemble des extraits de fumée. Si l’on constate des

incohérences, il est recommandé de procéder à une analyse d’un extrait d’échantillon de fumée sans

étalon interne dans la solution d’extracti
...

INTERNATIONAL ISO
STANDARD 10315
Fourth edition
Cigarettes — Determination of
nicotine in total particulate matter
from the mainstream smoke — Gas-
chromatographic method
Cigarettes — Dosage de la nicotine dans la matière particulaire totale
du courant principal de fumée — Méthode par chromatographie en
phase gazeuse
PROOF/ÉPREUVE
Reference number
ISO 10315:2021(E)
ISO 2021
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ISO 10315:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii PROOF/ÉPREUVE © ISO 2021 – All rights reserved
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ISO 10315:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Principle ........................................................................................................................................................................................................................ 1

5 Reagents ........................................................................................................................................................................................................................ 1

6 Apparatus ..................................................................................................................................................................................................................... 2

7 Procedure..................................................................................................................................................................................................................... 3

7.1 Test portion ................................................................................................................................................................................................ 3

7.2 Setting up the apparatus................................................................................................................................................................. 3

7.3 Calibration of the gas chromatograph ................................................................................................................................ 3

7.4 Determination ......................................................................................................................................................................................... 3

8 Expression of results ........................................................................................................................................................................................ 4

9 Repeatability and reproducibility ...................................................................................................................................................... 4

10 Alternative gas-chromatographic procedures and analysis precautions ..................................................5

10.1 General ........................................................................................................................................................................................................... 5

10.2 Alternative columns ............................................................................................................................................................................ 5

10.2.1 Packed columns ................................................................................................................................................................ 5

10.2.2 Capillary columns ........................................................................................................................................................... 5

10.3 Injection systems .................................................................................................................................................................................. 5

10.4 Alternative internal standards .................................................................................................................................................. 5

11 Test report ................................................................................................................................................................................................................... 6

Annex A (informative) Use of this method with the gas-chromatographic determination of water..7

Annex B (informative) Example of chromatogram ................................................................................................................................ 8

Bibliography ................................................................................................................................................................................................................................ 9

© ISO 2021 – All rights reserved PROOF/ÉPREUVE iii
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ISO 10315:2021(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 of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 126, Tobacco and tobacco products.

This fourth edition cancels and replaces the third edition (ISO 10315:2013), which has been technically

revised.
The main changes compared to the previous edition are as follows.

— The term "smoke condensate(s)" has been replaced with either “total particulate matter” or "total

particulate matter from the mainstream smoke" throughout the document.

— Extraction solution and calibration solutions stored at low temperature, are equilibrated to ambient

temperature before use (5.7).

— The linear regression equation for calibration is calculated by regression analysis with the area

ratios in accordance with the nicotine concentrations (7.3).
— Data in Clause 9 have been replaced with the results of ISO/TR 19478-1.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
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ISO 10315:2021(E)
Introduction

This document may be considered as part of a set produced by ISO/TC 126 which describes the

determination of total and nicotine-free dry particulate matter (NFDPM) in total particulate matter

from the mainstream smoke. The set comprises ISO 3308, ISO 3402, ISO 4387, ISO 8243, ISO 10315 (this

document) and ISO 10362-1.

A related International Standard, ISO 3400, determines total alkaloids, whereas this document

determines only nicotine by virtue of the gas-chromatographic separation. Occasionally, differences

can occur because of minor amounts of alkaloids other than nicotine in some types of tobacco.

Annex A provides information about the use of this method in conjunction with or simultaneously with

the gas-chromatographic method of water determination specified in ISO 10362-1.
No machine smoking regime can represent all human smoking behaviour.

— It is recommended that cigarettes also be tested under conditions of a different intensity of machine

smoking than those specified in this document.

— Machine smoking testing is useful to characterize cigarette emissions for design and regulatory

purposes, but communication of machine measurements to smokers can result in misunderstandings

about differences in exposure and risk across brands.

— Smoke emission data from machine measurements may be used as inputs for product hazard

assessment, but they are not intended to be nor are they valid as measures of human exposure or

risks. Communicating differences between products in machine measurements as differences in

exposure or risk is a misuse of testing using ISO standards.
© ISO 2021 – All rights reserved PROOF/ÉPREUVE v
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INTERNATIONAL STANDARD ISO 10315:2021(E)
Cigarettes — Determination of nicotine in total
particulate matter from the mainstream smoke — Gas-
chromatographic method

WARNING — The use of this document can involve hazardous materials, operations and

equipment. This document does not purport to address all the safety problems associated with

its use. It is the responsibility of the user of this document to establish appropriate safety and

health practices and determine the applicability of any other restrictions prior to use.

1 Scope

This document specifies a method for the gas-chromatographic determination of nicotine in total

particulate matter from the mainstream smoke. The smoking of cigarettes and the collection of

mainstream smoke are carried out according to ISO 4387.

NOTE ISO 20778 and ISO 22253 provide the determination method of nicotine in smoke with an intense

smoking regime.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 4387, Cigarettes — Determination of total and nicotine-free dry particulate matter using a routine

analytical smoking machine
3 Terms and definitions
No terms and definitions are listed in this document.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
4 Principle

The total particulate matter from the mainstream smoke, which shall be obtained in accordance with

ISO 4387, is dissolved in an extraction solution containing an internal standard. The nicotine content of

an aliquot of the smoke extract is determined by gas chromatography, and the nicotine content in the

total particulate matter from the mainstream smoke is calculated.

NOTE In countries not in a position to use the gas-chromatographic method, reference is made to ISO 3400

for the determination of total nicotine alkaloids. In such cases, values obtained using the method described in

ISO 3400 can be used with the addition of a note in the expression of results.
5 Reagents
Use only reagents of recognized analytical reagent grade.
© ISO 2021 – All rights reserved PROOF/ÉPREUVE 1
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ISO 10315:2021(E)

5.1 Carrier gas, helium (CAS: 7440-59-7), nitrogen (CAS: 7727-37-9) or hydrogen (CAS: 1333-74-0)

of high purity.

5.2 Auxiliary gases, hydrogen (CAS: 1333-74-0) of high purity and air for the flame ionization detector.

5.3 Propan-2-ol (CAS: 67-63-0), with maximum water content of 1,0 mg/ml.

5.4 Internal standard, n-heptadecane (CAS: 629-78-7) or quinaldine (CAS: 91-63-4) of purity not less

than 99 %.

Carvone (CAS: 99-49-0), n-octadecane (CAS: 593-45-3), or other appropriate internal standards may be

used after assessment of their purity and determination that the internal standard does not co-elute

with other components in the smoke extract. The peak a
...