oSIST prEN 17634:2021
(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 Puffsequenzen einer Anzahl von E-Zigarette identischen Typs
Dieses Dokument legt das Verfahren zur Bestimmung der Konsistenz der Nikotinabgabe von verschiedenen E-Zigaretten identischen Typs fest.
Dieses Dokument:
- legt die anzuwendenden Geräte fest;
- legt die Vorbereitung der zu untersuchenden E-Zigaretten fest;
- legt den Sammelvorgang von Aerosolen fest;
- legt das Analyseverfahren fest.
Es werden geeignete Probenahmeverfahren beschrieben, um Ergebnisse innerhalb eines einzelnen Fertigungsloses zu erhalten und um eine losübergreifende Probenahme durchzuführen.
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 la méthode de détermination de la constance de délivrance de la nicotine par plusieurs e cigarettes identiques.
Le présent document :
- définit l’équipement à utiliser ;
- spécifie la préparation des e cigarettes 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.
Elektronske cigarete in e-tekočine - Ugotavljanje doslednosti pri dovajanju nikotina v določenem zaporedju vdihavanja pri več e-cigaretah enakega tipa
General Information
Standards Content (sample)
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 typeElektronische 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
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
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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
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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.
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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-liquidsISO 20768, Vapour products — Routine analytical vaping machine — Definitions and standard conditions
3 Terms and definitionsFor 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.
3.2clearomizer
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.
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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 userNote 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.
3.5e‐liquid
base liquid, which may or may not contain nicotine and/or additives, intended for transformation into an
aerosol by an electronic cigarette3.6
e‐liquid cartridge
e-liquid container that can be loaded directly into an e-cigarette, which can be disposable
3.7e‐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
name3.9
nicotine
(S)-3-(1-methyl-2-pyrrolidinyl) pyridine, conforming to the Chemical Abstracts Service nomenclature
under No CAS: 54-11-53.10
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
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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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