EN 17746:2023
(Main)Electronic cigarettes and e-liquids - Determination of nicotine delivery consistency over defined puff sequences within a single e-cigarette
Electronic cigarettes and e-liquids - Determination of nicotine delivery consistency over defined puff sequences within a single e-cigarette
This document specifies the method for the determination of nicotine delivery consistency of an electronic cigarette over the duration of use of e-liquid in the reservoir or a battery charge.
This document:
- defines the equipment to be used;
- specifies the preparation of the e-cigarette samples for testing;
- specifies the aerosol generation process;
- specifies the analytical method;
- specifies the determination of the test result.
This document does not seek to demonstrate whether there is consistency of nicotine delivery between e-cigarettes. The latter is the aim of a separate method under development, EN 17634 Electronic cigarettes and e-liquids - Determination of nicotine delivery consistency over defined puff sequences of a number of e-cigarettes of identical type [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].
Elektronische Zigaretten und E-Liquids - Bestimmung der gleichmäßigen Abgabe von Nikotin über definierte Zugsequenzen einer Anzahl von E-Zigaretten identischen Typs
Dieses Dokument legt ein Verfahren zur Bestimmung der gleichmäßigen Abgabe von Nikotin 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 einer einzelnen Produktionscharge zu erhalten und um eine chargenübergreifende Probenahme durchzuführen.
Ziel des Verfahrens nach diesem Dokument ist es nicht, nachzuweisen, ob eine Gleichmäßigkeit zwischen den zu Beginn und den gegen Ende einer Tankfüllung oder Batterieladung durchgeführten Zügen vorliegt. Letzteres ist das Ziel eines anderen Verfahrens, das mit EN 17746, Elektronische Zigaretten und Liquids für elektronische Zigaretten - Bestimmung der gleichmäßigen Abgabe von Nikotin über definierte Zugsequenzen innerhalb einer einzelnen E-Zigarette[1], entwickelt wird. Zwei unterschiedliche Verfahren wurden entwickelt, um die gleichmäßigen Abgabe von Nikotin zu bestimmen, bis Rechtsklarheit über die Festlegung der Richtlinie über Tabakerzeugnisse besteht, dass "Nikotindosen auf einem gleichmäßigen Niveau abgegeben werden"[2].
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
Le présent document spécifie la méthode de détermination de la constance de délivrance de la nicotine par une cigarette électronique pendant la durée d’utilisation du e liquide dans le réservoir ou pendant une charge de batterie.
Le présent document :
— définit l’équipement à utiliser ;
— spécifie la préparation des échantillons de e cigarettes pour les essais ;
— spécifie le processus de génération de l’aérosol ;
— spécifie la méthode d’analyse ;
— spécifie la détermination du résultat d’essai.
Ce document ne cherche pas à démontrer s’il y a une constance de délivrance de la nicotine entre les e cigarettes. Cette dernière fait l’objet d’une méthode séparée en cours d’élaboration, l’EN 17634 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 [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 eni e-cigareti
Ta dokument določa metodo za določanje konsistentnosti porazdelitve nikotina ene
elektronske cigarete [1].
Ta dokument:
opredeljuje opremo, ki jo je treba uporabljati;
določa pripravo vzorcev e-cigaret za preskušanje;
določa postopek zbiranja aerosolov;
določa analitično metodo;
opredeljuje določanje rezultata preskusa.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2023
Elektronske cigarete in e-tekočine - Ugotavljanje konsistentnosti porazdelitve
nikotina v določenem zaporedju vdihavanja pri eni e-cigareti
Electronic cigarettes and e-liquids - Determination of nicotine delivery consistency over
defined puff sequences within a single e-cigarette
Elektronische Zigaretten und Liquids für elektronische Zigaretten - Bestimmung der
Konsistenz der Nikotinabgabe über definierte Zugsequenzen innerhalb einer einzelnen
E-Zigarette
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
Ta slovenski standard je istoveten z: EN 17746:2023
ICS:
65.160 Tobak, tobačni izdelki in Tobacco, tobacco products
oprema and related equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 17746
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
within a single e-cigarette
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 une seule e- Zugsequenzen einer Anzahl von E-Zigaretten
cigarette 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 17746:2023 E
worldwide for CEN national Members.
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 . 6
7 Generation of aerosol collected mass for determination of consistency of nicotine
delivery . 6
7.1 Sample 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 collected mass . 7
7.3.1 Vaping plan . 7
7.3.2 Collection of the aerosol . 7
7.3.3 Setting up the vaping machine . 7
7.3.4 Procedure for vaping run . 7
7.4 Determination of nicotine . 8
7.5 Determination of nicotine delivery consistency . 9
8 Test report . 9
Bibliography . 11
European foreword
This document (EN 17746:2023) 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.
1 Scope
This document specifies the method for the determination of nicotine delivery consistency of an
electronic cigarette over the duration of use of e-liquid in the reservoir or a battery charge.
This document:
— defines the equipment to be used;
— specifies the preparation of the e-cigarette samples for testing;
— specifies the aerosol generation process;
— specifies the analytical method;
— specifies the determination of the test result.
This document does not seek to demonstrate whether there is consistency of nicotine delivery between
e-cigarettes. The latter is the aim of a separate method under development, EN 17634 Electronic
cigarettes and e-liquids — Determination of nicotine delivery consistency over defined puff sequences of a
number of e-cigarettes of identical type [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 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
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 vapouriser or
ENDS/ENNDS.
Note 2 to entry: Electronic cigarette differs from tobacco products in that they do not contain tobacco.
3.2
e-liquid
base liquid, which may or may not contain nicotine and/or additives, intended for transformation into an
aerosol by an electronic cigarette
3.3
vaped until exhaustion
aerosol generation via vaping machine until a pre-determined endpoint
3.4
open system
electronic cigarette where the user fills a reservoir with e-liquid
3.5
aerosol collected mass
ACM
mass of aerosol collected on an aerosol trapping system from the operation of a vapour product by a
routine analytical vaping machine after a defined number of puffs
Note 1 to entry: Routine analytical vaping machine is described in ISO 20768.
3.6
vaping
action of generating an aerosol with an airflow from an electronic cigarette
3.7
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.
3.8
nicotine
(S)-3-(1-methyl-2-pyrrolidinyl) pyridine, conforming to the Chemical Abstracts Service nomenclature
under No CAS: 54-11-5
3.9
clearomizer
e-liquid reservoir with in-built atomizer
3.10
e-liquid cartridge
e-liquid container that can be loaded directly into an e-cigarette, which can be disposable
3.11
coil
resistive component of the atomiser
Note 1 to entry: Coils are made of metal, ceramic, or other resistive materials.
3.12
sequence
defined number of puffs for aerosol generation
4 Principle
The test specimens are vaped until exhaustion (of battery or e-liquid) on a routine analytical vaping
machine with simultaneous collection of sequences of aerosol collected mass. 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 aerosol collected mass is used for the subsequent determination of nicotine. The
determined amount of nicotine per sequence can be used for the statistical determination of nicotine
delivery consistency.
5 Apparatus
Use the apparatus as defined by EN ISO 24199.
6 Sampling
The sample should contain e-cigarettes taken from different parts of the population the study aims to
test. Make up the test sample required for the test by randomly selecting e-cigarettes from the different
parts of the population represented in the laboratory sample.
7 Generation of aerosol collected mass for determination of consistency of
nicotine delivery
7.1 Sample preparation for analytical vaping
7.1.1 General
For the overall protocol, at least 5 test e-cigarettes are needed: 2 for the determination of the required
number of puffs per sequence and 3 for the determination of the nicotine delivery consistency.
It is recommended to prepare at least two more e-cigarettes in the same way for redundancy in case any
problems occur during testing.
7.1.2 Disposable e-cigarettes
For testing disposable e-cigarettes, a fresh e-cigarette shall be taken from an unopened pack.
7.1.3 Rechargeable E-cigarettes
For any e-cigarettes equipped with rechargeable batteries ensure that the battery is fully charged
following the instructions for use.
7.1.4 Refillable E-cigarettes
For any e-cigarettes with the e-liquid supplied in pre-filled e-liquid cartridges a new e-liquid cartridge
shall be taken from an un-opened pack and inserted into the e-cigarette following the instructions for
use.
Any e-cigarettes designed for individual filling (open systems) shall be filled with the type of e-liquid
specified in the e-cigarette’s instructions for use. If no specific e-liquids or e-liquid characteristics are
specified, one of the standard liquids as specified in EN 17375 shall be used.
...
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