SIST EN 17634:2023
(Main)Electronic cigarettes and e-liquids - Determination of nicotine delivery consistency over defined puff sequences of a number of e-cigarettes of identical type
Electronic cigarettes and e-liquids - Determination of nicotine delivery consistency over defined puff sequences of a number of e-cigarettes of identical type
This document specifies the method for the determination of nicotine delivery consistency from several e-cigarette of identical type.
Suitable sampling procedures are described for obtaining results from within a single production batch, as well as for sampling across batches. Sampling within a single batch is likely to be required when obtaining data for regulatory submission. Sampling across commercially produced batches will improve the understanding about consistency.
This document:
defines the equipment to be used;
specifies the preparation of the e-cigarette samples for testing;
specifies the aerosol collection process;
specifies the analytical method..
Elektronische Zigaretten und Liquids für elektronische Zigaretten - Bestimmung der Konsistenz der Nikotinabgabe über definierte Zugsequenzen einer Anzahl von E-Zigarette identischen Typs
Dieses Dokument legt ein Verfahren zur Bestimmung der Konsistenz der Nikotinabgabe zwischen E Zigaretten (Geräte, Verbrauchsmaterialien und Kombinationen) fest.
Dieses Dokument:
- legt die anzuwendenden Geräte fest;
- legt die Vorbereitung der zu untersuchenden Proben fest;
- legt den Sammelvorgang von Aerosolen fest;
- legt das Analysenverfahren fest.
Es werden geeignete Probenahmeverfahren beschrieben, um Ergebnisse innerhalb eines einzelnen Fertigungsloses zu erhalten und um eine losübergreifende Probenahme durchzuführen.
Ziel des Verfahrens nach diesem Dokument ist es nicht, nachzuweisen, ob eine Konsistenz zwischen den zu Beginn und den gegen Ende einer Tankfüllung oder Batterieladung durchgeführten Zügen vorliegt. Letzteres ist das Ziel eines anderen Verfahrens, das sich derzeit in EN 17746, Elektronische Zigaretten und Liquids für elektronische Zigaretten - Bestimmung der Konsistenz der Nikotinabgabe über definierte Zugsequenzen innerhalb einer einzelnen E-Zigarette[1], in Vorbereitung befindet. Zwei unterschiedliche Verfahren wurden entwickelt, um die Konsistenz der Nikotinabgabe zu bestimmen, bis Rechtklarheit über die Festlegung der Richtlinie über Tabakerzeugnisse besteht, dass "Nikotindosen auf einem gleichmäßigen Niveau abgegeben werde"[2].
Cigarettes électroniques et e-liquides - Détermination de la constance de délivrance de la nicotine lors de séquences de bouffées définies avec plusieurs e-cigarettes identiques
Le présent document spécifie une méthode de détermination de la constance de délivrance de la nicotine entre des e cigarettes (dispositifs, consommables et combinaison des deux).
Le présent document :
- définit l’équipement à utiliser ;
- spécifie la préparation des échantillons pour les essais ;
- spécifie le processus de collecte de l’aérosol ;
- spécifie la méthode d’analyse.
Des modes opératoires d’échantillonnage appropriés sont décrits, afin d’obtenir des résultats à partir d’un seul lot de production, mais aussi à partir de plusieurs lots.
La méthode présentée dans ce document ne cherche pas à démontrer s’il y a une constance entre les bouffées produites au début ou vers la fin d’un contenant ou d’une charge de batterie. Cette dernière fait l’objet d’une méthode séparée en cours d’élaboration, l’EN 17746 Cigarettes électroniques et e liquides - Détermination de la constance de délivrance de la nicotine lors de séquences de bouffées définies avec une seule e cigarette [1]. Deux méthodes séparées ont été mises au point pour déterminer la constance de délivrance de la nicotine, en attendant la clarification réglementaire de l’exigence de la Directive sur les produits du tabac stipulant de « libérer les doses de nicotine de manière constante » [2].
Elektronske cigarete in e-tekočine - Ugotavljanje konsistentnosti porazdelitve nikotina v določenem zaporedju vdihavanja pri več e-cigaretah enakega tipa
Ta dokument določa metodo za ugotavljanje konsistentnosti porazdelitve nikotina v določenem zaporedju vdihavanja pri več e-cigaretah enakega tipa.
Opisani so ustrezni postopki vzorčenja za pridobivanje rezultatov znotraj ene proizvodne serije in tudi za vzorčenje v več serijah. Vzorčenje znotraj ene serije je običajno potrebno, kadar je treba pridobiti podatke za predložitev regulativnemu organu. Z vzorčenjem v več komercialno proizvedenih serijah se poveča razumevanje konsistentnosti.
Ta dokument:
opredeljuje opremo, ki jo je treba uporabljati;
določa pripravo vzorcev e-cigaret za preskušanje;
določa postopek zbiranja aerosolov;
določa analitično metodo.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 17634:2023
01-julij-2023
Elektronske cigarete in e-tekočine - Ugotavljanje konsistentnosti porazdelitve
nikotina v določenem zaporedju vdihavanja pri več e-cigaretah enakega tipa
Electronic cigarettes and e-liquids - Determination of nicotine delivery consistency over
defined puff sequences of a number of e-cigarettes of identical type
Elektronische Zigaretten und Liquids für elektronische Zigaretten - Bestimmung der
Konsistenz der Nikotinabgabe über definierte Zugsequenzen einer Anzahl von E-
Zigarette identischen Typs
Cigarettes électroniques et e-liquides - Détermination de la constance de délivrance de
la nicotine lors de séquences de bouffées définies avec plusieurs e-cigarettes identiques
Ta slovenski standard je istoveten z: EN 17634:2023
ICS:
65.160 Tobak, tobačni izdelki in Tobacco, tobacco products
oprema and related equipment
SIST EN 17634:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 17634:2023
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SIST EN 17634:2023
EN 17634
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2023
EUROPÄISCHE NORM
ICS 65.160
English Version
Electronic cigarettes and e-liquids - Determination of
nicotine delivery consistency over defined puff sequences
of a number of e-cigarettes of identical type
Cigarettes électroniques et e-liquides - Détermination Elektronische Zigaretten und E-Liquids - Bestimmung
de la constance de délivrance de la nicotine lors de der gleichmäßigen Abgabe von Nikotin über definierte
séquences de bouffées définies avec plusieurs e- Zugsequenzen einer Anzahl von E-Zigaretten
cigarettes identiques identischen Typs
This European Standard was approved by CEN on 10 March 2023.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 17634:2023 E
worldwide for CEN national Members.
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SIST EN 17634:2023
EN 17634:2023 (E)
Contents Page
European foreword . 3
1 Scope . 4
2 Normative references . 4
3 Terms and definitions . 4
4 Principle . 6
5 Apparatus . 6
6 Sampling of test e-cigarettes . 6
7 Generation and collection of total aerosol matter . 6
7.1 E-cigarette preparation for analytical vaping . 6
7.1.1 General . 6
7.1.2 Disposable e-cigarettes . 6
7.1.3 Rechargeable e-cigarettes . 6
7.1.4 Refillable e-cigarettes . 6
7.2 Preliminary tests before vaping . 7
7.3 Vaping and collection of aerosol matter . 7
7.3.1 Vaping plan . 7
7.3.2 Preparation for vaping run . 7
7.3.3 Procedure for vaping run . 7
7.3.4 Determination of nicotine . 8
7.4 Determination of nicotine consistency . 8
8 Test report . 9
Bibliography . 11
2
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SIST EN 17634:2023
EN 17634:2023 (E)
European foreword
This document (EN 17634:2023) has been prepared by Technical Committee CEN/TC 437 “Electronic
cigarettes and e‐liquids”, the secretariat of which is held by AFNOR.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by November 2023, and conflicting national standards shall
be withdrawn at the latest by November 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN‐CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,
Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North
Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the United
Kingdom.
3
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SIST EN 17634:2023
EN 17634:2023 (E)
1 Scope
This document specifies a method for the determination of nicotine delivery consistency between e‐
cigarettes (devices, consumables and combinations).
This document:
— defines the equipment to be used;
— specifies the preparation of the samples for testing;
— specifies the aerosol collection process;
— specifies the analytical method.
Suitable sampling procedures are described for obtaining results from within a single production batch,
as well as for sampling across batches.
The method in this document does not seek to demonstrate whether there is consistency between puffs
generated at the start or nearer the end of a tank fill or battery charge. The latter is the aim of a separate
method under development, EN 17746 Electronic cigarettes and e-liquids — Determination of nicotine
delivery consistency over defined puff sequences within a single e-cigarette [1]. Two separate methods have
been developed to determine consistency of nicotine delivery, pending regulatory clarity on the Tobacco
Products Directive's requirement to “deliver nicotine doses at consistent levels” [2].
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.
EN 17375, Electronic cigarettes and e-liquids — Reference e-liquids
EN ISO 24197, Vapour products — Determination of e-liquid vaporized mass and aerosol collected mass
(ISO 24197)
EN ISO 24199, Vapour products — Determination of nicotine in vapour product emissions — Gas
chromatographic method (ISO 24199)
ISO 20768, Vapour products — Routine analytical vaping machine — Definitions and standard conditions
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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/ui
— IEC Electropedia: available at https://www.electropedia.org/
3.1
aerosol
system of colloidal particles suspended in gas by the use of an e‐cigarette
Note 1 to entry: Vapour is a generally accepted, but scientifically incorrect, term for aerosol.
4
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SIST EN 17634:2023
EN 17634:2023 (E)
3.2
clearomizer
e‐liquid reservoir with in‐built atomizer
3.3
coil
resistive component of the atomiser
Note 1 to entry: Coils are made of metal, ceramic, or other resistive materials.
3.4
electronic cigarette
e-cigarette
product, that vaporises e‐liquid to generate an inhalable aerosol carried by air drawn through the device
by the user
Note 1 to entry: Electronic cigarette is also referred to as e‐cig, vapour product, personal vaporizer or
ENDS/ENNDS.
Note 2 to entry: Electronic cigarette differs from tobacco products in that they do not contain tobacco.
3.5
e-liquid
base liquid, which may or may not contain nicotine and/or additives, intended for transformation into an
aerosol by an electronic cigarette
3.6
e-liquid cartridge
e‐liquid container that can be loaded directly into an e‐cigarette, which can be disposable
3.7
e-liquid vaporized mass
EVM
mass of e‐liquid transferred from the vapour product to the aerosol
3.8
identical e-cigarettes
e‐cigarettes made according to the same technical specifications and with the same brand and model
name
3.9
nicotine
(S)‐3‐(1‐methyl‐2‐pyrrolidinyl) pyridine, conforming to the Chemical Abstracts Service nomenclature
under No CAS: 54‐11‐5
3.10
open system
electronic cigarette where the user fills a reservoir with e‐liquid
3.11
sequence
defined number of
...
SLOVENSKI STANDARD
oSIST prEN 17634:2021
01-november-2021
Elektronske cigarete in e-tekočine - Ugotavljanje doslednosti pri dovajanju
nikotina v določenem zaporedju vdihavanja pri več e-cigaretah enakega tipa
Electronic cigarettes and e‐liquids - Determination of nicotine delivery consistency over
defined puff sequences of a number of e-cigarettes of identical type
Elektronische Zigaretten und Liquids für elektronische Zigaretten - Bestimmung der
Konsistenz der Nikotinabgabe über definierte Puffsequenzen einer Anzahl von E-
Zigarette identischen Typs
Ta slovenski standard je istoveten z: prEN 17634
ICS:
65.160 Tobak, tobačni izdelki in Tobacco, tobacco products
oprema and related equipment
oSIST prEN 17634:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN 17634:2021
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oSIST prEN 17634:2021
DRAFT
EUROPEAN STANDARD
prEN 17634
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2021
ICS 65.160
English Version
Electronic cigarettes and e-liquids - Determination of
nicotine delivery consistency over defined puff sequences
of a number of e-cigarettes of identical type
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 437.
If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations
which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 17634:2021 E
worldwide for CEN national Members.
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oSIST prEN 17634:2021
prEN 17634:2021 (E)
Contents Page
European foreword . 3
1 Scope . 4
2 Normative references . 4
3 Terms and definitions . 4
4 Principle . 5
5 Apparatus . 6
6 Sampling of test e‐cigarettes . 6
7 Generation and collection of total aerosol matter . 6
7.1 E‐cigarette preparation for analytical vaping . 6
7.1.1 General . 6
7.1.2 Disposable e‐cigarettes . 6
7.1.3 Rechargeable e‐cigarettes . 6
7.1.4 Refillable e‐cigarettes . 6
7.2 Preliminary tests before vaping . 6
7.3 Vaping and collection of aerosol matter . 7
7.3.1 Vaping plan . 7
7.3.2 Preparation of aerosol traps . 7
7.3.3 Setting up the vaping machine . 7
7.3.4 Procedure for vaping run . 7
7.3.5 Determination of nicotine . 8
7.4 Determination of nicotine consistency . 8
8 Test report . 9
Annex A (informative) Laboratory equipment . 11
Bibliography . 12
2
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oSIST prEN 17634:2021
prEN 17634:2021 (E)
European foreword
This document (prEN 17634:2021) has been prepared by Technical Committee CEN/TC 437 “Electronic
cigarettes and e-liquids”, the secretariat of which is held by AFNOR.
This document is currently submitted to the CEN Enquiry.
3
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oSIST prEN 17634:2021
prEN 17634:2021 (E)
1 Scope
This document specifies the method for the determination of nicotine delivery consistency from several
e- cigarettes of identical type.
This document:
— defines the equipment to be used;
— specifies the preparation of the e-cigarettes for testing;
— specifies the aerosol collection process;
— specifies the analytical method.
Suitable sampling procedures are described for obtaining results from within a single production batch,
as well as for sampling across batches.
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.
EN 17375, Electronic cigarettes and e-liquids - Reference e-liquids
ISO 20768, Vapour products — Routine analytical vaping machine — Definitions and standard conditions
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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/
3.1
aerosol
system of colloidal particles suspended in gas by the use of an e-cigarette
Note 1 to entry: Vapour is a generally accepted (but scientifically incorrect) term for aerosol.
3.2
clearomizer
e-liquid reservoir with in-built atomizer
3.3
coil
resistive component of the atomiser
Note 1 to entry: Made of metal, ceramic, or other resistive materials.
4
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oSIST prEN 17634:2021
prEN 17634:2021 (E)
3.4
electronic cigarette
e-cigarette
product, that vaporises e-liquid to generate an inhalable aerosol carried by air drawn through the device
by the user
Note 1 to entry: Electronic cigarette is also referred to as e-cig, vapour product, personal vaporizer or
ENDS/ENNDS.
Note 2 to entry: Electronic cigarette differs from tobacco products in that they do not contain tobacco.
3.5
e‐liquid
base liquid, which may or may not contain nicotine and/or additives, intended for transformation into an
aerosol by an electronic cigarette
3.6
e‐liquid cartridge
e-liquid container that can be loaded directly into an e-cigarette, which can be disposable
3.7
e‐liquid vaporized mass
EVM
mass of e-liquid transferred from the vapour product to the aerosol
3.8
identical e‐cigarettes
e-cigarettes made according to the same technical specifications and with the same brand and model
name
3.9
nicotine
(S)-3-(1-methyl-2-pyrrolidinyl) pyridine, conforming to the Chemical Abstracts Service nomenclature
under No CAS: 54-11-5
3.10
open system
electronic cigarette where the user fills a reservoir with e-liquid
3.11
sequence
defined number of puffs for aerosol generation
3.12
vaping
action of generating an aerosol with an airflow from an electronic cigarette
4 Principle
The test e-cigarettes are vaped on a routine analytical vaping machine that meets the requirements of
ISO 20768, with collection of sequences of aerosol matter. If used, the consistency of the laboratory
vaping process and subsequent analytical procedures are controlled by using a standardized clearomizer
or a reference clearomizer together with a standardized e-liquid as specified in EN 17375. The collected
aerosol matter is used for the subsequent determination of nicotine. The determined amount of nicotine
5
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oSIST prEN 17634:2021
prEN 17634:2021 (E)
per sequence is used for the statistical determination of nicotine delivery consistency. Relevant ISO
methods are currently under development. Once available, these shall be used.
5 Apparatus
Use the apparatus as defined by the ISO method for nicotine determination in aerosol. As long as this
standard is not published use the Normal laboratory apparatus and, in particular, the following items
listed in Annex A.
6 Sampling of test e‐cigarettes
Measurements shall be performed across at least 2 e-cigarettes per batch and at least 10 e-cigarettes in
total. If the purpose of the testing is to obtain data on the consistency of nicotine delivery within a
production batch, or across several production batches, the e-cigarettes shall be randomly taken from the
production batch(es).
7 Generation and collection of total aerosol matter
7.1 E‐cigarette preparation for analytical vaping
7.1.1 General
For the over
...
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