BS PD ISO TR 19478-2-2015 ISO and Health Canada intense smoking parameters Examination of factors contributing to variability in the routine measurement of TPM water and NFDPM smok.pdf

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1、BSI Standards Publication PD ISO/TR 19478-2:2015 ISO and Health Canada intense smoking parameters Part 2: Examination of factors contributing to variability in the routine measurement of TPM, water and NFDPM smoke yields of cigarettesPD ISO/TR 19478-2:2015 PUBLISHED DOCUMENT National foreword This P

2、ublished Document is the UK implementation of ISO/TR 19478-2:2015. The UK participation in its preparation was entrusted to Technical Committee AW/40, Tobacco and tobacco products. A list of organizations represented on this committee can be obtained on request to its secretary. This publication doe

3、s not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2015. Published by BSI Standards Limited 2015 ISBN 978 0 580 88137 4 ICS 65.160 Compliance with a British Standard cannot confer immunity from leg

4、al obligations. This Published Document was published under the authority of the Standards Policy and Strategy Committee on 31 August 2015. Amendments issued since publication Date Text affectedPD ISO/TR 19478-2:2015 ISO 2015 ISO and Health Canada intense smoking parameters Part 2: Examination of fa

5、ctors contributing to variability in the routine measurement of TPM, water and NFDPM smoke yields of cigarettes Paramtres de fumage ISO et Sant Canada Intense Partie 2: Examen des facteurs contribuant la variabilit des mesures de routine de MPT , deau et de MPAEN dans la fume de cigarette TECHNICAL

6、REPORT ISO/TR 19478-2 Reference number ISO/TR 19478-2:2015(E) First edition 2015-08-01PD ISO/TR 19478-2:2015ISO/TR 19478-2:2015(E)ii ISO 2015 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2015, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publicati

7、on 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 ISOs member body in the country o

8、f the requester. ISO copyright office Ch. de Blandonnet 8 CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightiso.org www.iso.orgPD ISO/TR 19478-2:2015ISO/TR 19478-2:2015(E)Foreword iv Introduction v 1 Scope . 1 2 T erms and definitions . 1 3 Abbreviated t

9、erms 2 4 Principle 2 5 The influenc e of smoking int ensity on the yield and c omposition of cig ar ett e smok e .3 5.1 General . 3 5.2 A review of information relevant to conclusion i) of ISO/TR 19478-1:2014 . 3 5.3 Puff by puff smoke temperature measurements . 4 5.4 Puff by puff smoke yields . 6 5

10、.5 Smoking intensity and cigarette smoke yields .13 5.6 Factors relevant to understanding how cigarettes burn and their use for predicting smoke yield .22 5.6.1 A review of additional studies .22 5.6.2 A review of WG 10 study data .34 6 Comparison of the design and performance of rotary and linear s

11、moking machines .37 6.1 A review of information relevant to conclusion j) of ISO/TR 19478-1:2014 37 6.2 Zone 1: The cigarette zone .39 6.2.1 Airflow/cigarette movement 39 6.2.2 Puffing 43 6.2.3 Termination of smoking .44 6.3 Zone 2: The smoke collection zone 49 6.3.1 General.49 6.3.2 Connection of t

12、he cigarette holder to the CFH 49 6.3.3 Collection of TPM and measurement of water and NFDPM 52 6.4 Zone 3: The puff generator 56 7 Overall summary .61 8 Conclusions .62 9 Conclusions from ISO/TR 19478-1 .63 Annex A (informative) Summaries of presentations to WG 10 and the Ad Hoc Group 64 Annex B (i

13、nformative) List of meetings of ISO/TC 126/WG 10 and the Ad Hoc Group72 Annex C (informative) Equipment and procedures for smoking cigarettes .73 Bibliography .75 ISO 2015 All rights reserved iii Contents PagePD ISO/TR 19478-2:2015ISO/TR 19478-2:2015(E) Foreword ISO (the International Organization f

14、or 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 th

15、e 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 proc

16、edures 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 editori

17、al 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

18、 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 expla

19、nation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information The committee responsible for this docu

20、ment is ISO/TC 126, Tobacco and tobacco products. ISO/TR 19478 consists of the following parts, under the general title ISO and Health Canada intense smoking parameters: Part 1: Results of an international machine smoking study Part 2: Examination of factors contributing to variability in the routin

21、e measurement of TPM, water and NFDPM smoke yields of cigarettesiv ISO 2015 All rights reservedPD ISO/TR 19478-2:2015ISO/TR 19478-2:2015(E) Introduction ISO/TC 126 Working Group 10 (WG 10) was established by ISO/TC 126 in 2007 in response to a New Work Item Proposal by the British Standards Institut

22、ion (BSI) for the development of a new regime for the machine smoking of cigarettes that was more intense than the then current ISO 3308:2000, and a subsequent questionnaire sent to TC 126 members. Twenty out of 26 members of ISO/TC 126 voted in favour of the following option: “to install a Working

23、Group 10 dealing with an Intense Smoking Regime which shall start with the preparatory work. WHO is invited to participate with their technical experts. No draft Standard is expected to be presented by this group until the future method proposal of WHO has been taken into consideration”. The third s

24、ession of the Conference of the Parties (COP) to the World Health Organization (WHO) Framework Convention on Tobacco Control Durban, South Africa, 17 to 22 November 2008, requested the Convention Secretariat to invite the WHOs Tobacco Free Initiative (TFI) to undertake the following task: “validate,

25、 within five years, the analytical chemical methods for testing and measuring the cigarette contents and emissions identified as priorities in the progress report of the working group 1 using the two smoking regimens set out in paragraph 18 of that report, and inform the Conference of the Parties th

26、rough the Convention Secretariat on a regular basis of the progress made.” The two smoking regimens were specified in paragraph 18 of the report of the COP working group (FCTC/COP/3/6) as follows: Smoking regimen Puff volume (ml) Puff frequency Ventilation holes ISO 3308:2000, Routine analytical cig

27、arette-smoking machine Definitions and standard condi- tions 35 Once every 60 s No modifications Same as ISO 3308:2000 but modi- fied as indicated. 55 Once every 30 s All ventilation holes must be blocked with Mylar adhesive tape. The two regimes were those specified in ISO 3308 and by Health Canada

28、 in Method T-115. At the early meetings of WG 10, some new human smoking studies were presented and are included in Annex A for completeness of reporting, but WG 10 never considered the correlation with machine smoking regimes in detail as this brief had previously been given to ISO/TC 126/WG 9 and

29、WG 9 had produced a comprehensive report, ISO/TR 17219:2013. The WHO TFI requested the WHO Tobacco Laboratory Network (TobLabNet) to carry out the practical work of validating the two smoking regimes. In 2008, TobLabNet organized and carried out a collaborative test to measure the tar, nicotine and

30、carbon monoxide yields of cigarettes when using the Health Canada Intense (HCI) regime. The collaborative test involved 14 laboratories smoking five products (three reference cigarettes/monitor test pieces and two commercial products). Details of this collaborative were supplied to ISO/TC 126/WG 10.

31、 WG 10 had expressed a willingness from its inception to participate with the WHO groups in the development of an intense smoking regime but had not been invited to do so. It, therefore, decided at its fifth meeting in December 2009 to undertake a collaborative study to measure the tar, nicotine and

32、 carbon monoxide yields of cigarettes using both the ISO 3308:2000 and Health Canada intense smoking regimes. A steering group was established and the laboratory work was carried out in 2010 involving 35 laboratories smoking 10 products (eight commercial and two reference cigarettes/monitor test pie

33、ce). A final report on the study was approved by WG 10 and subsequently converted to a Technical Report, ISO/TR 19478-1. ISO/TR 19478-1 provided a basic analysis of the study data, drawing conclusions about the possible sources of the increased variability associated with the HCI regime. ISO 2015 Al

34、l rights reserved vPD ISO/TR 19478-2:2015ISO/TR 19478-2:2015(E) These conclusions provided the basis for the additional studies reported here and instigated to provide a more complete understanding of how the smoke yield changes with increasing smoking intensity.vi ISO 2015 All rights reservedPD ISO

35、/TR 19478-2:2015TECHNICAL REPORT ISO/TR 19478-2:2015(E) ISO and Health Canada intense smoking parameters Part 2: Examination of factors contributing to variability in the routine measurement of TPM, water and NFDPM smoke yields of cigarettes 1 Scope This part of ISO/TR 19478 extends the analysis rep

36、orted in ISO/TR 19478-1:2014 and reports additional studies focused on the conclusions i) and j) from that Technical Report. It identifies and assesses factors impacting on the measurement of smoke TPM, NFDPM, nicotine, water, and carbon monoxide yields when increasing the intensity of the puffing r

37、egime from that specified in ISO 3308:2000 to the regime specified in Health Canada Method T-115. 2 T erms a nd definiti ons For the purposes of this document, the following terms and definitions apply. 2.1 cigarette coal carbonised burning tip of a tobacco rod 2.2 ISO regime puffing regime when tak

38、ing one puff of 35 ml volume and 2 s duration every 60 s as defined in ISO 3308:2000 2.3 Health Canada Intense regime HCI regime puffing regime, first described by Health Canada, when taking one puff of 55 ml volume and 2 s duration every 30 s with 100 % of the ventilation zone on the cigarette filt

39、er blocked 2.4 linear (smoking) machine smoking machine complying with the requirements of ISO 3308:2000 with each cigarette holder directly coupled to a CFH (smoke trap) Note 1 to entry: The CFH is coupled via a port to its own suction mechanism and held in a fixed position while each cigarette is

40、smoked. The most common configuration has 20 ports in line. 2.5 rotary (smoking) machine smoking machine complying with the requirements of ISO 3308:2000 with each cigarette holder coupled sequentially via a port to a single CFH (smoke trap) and suction mechanism Note 1 to entry: The most common con

41、figuration has 20 ports on a carousel sharing a single CFH and suction mechanism. ISO 2015 All rights reserved 1PD ISO/TR 19478-2:2015ISO/TR 19478-2:2015(E) 2.6 Massachussetts regime MA regime puffing regime, used in Massachusetts, USA, when taking one puff of 45 ml volume and 2 s duration every 30

42、s with 50 % of the ventilation zone on the cigarette filter blocked 2.7 option B regime puffing regime proposed by ISO/TC 126 Working Group 9 when taking one puff of 60 ml volume and 2 s duration every 30 s with 50 % of the ventilation zone on the cigarette filter blocked 3 Abbreviated terms CFH Cam

43、bridge Filter Holder CFP Cambridge Filter Pad COP Conference of the Parties to the World Health Organization Framework Convention on Tobacco Control NFDPM or tar Nicotine Free Dry Particulate Matter TNCO tar, nicotine and carbon monoxide where tar is specifically nicotine free dry particulate matter

44、 (NFDPM) TPM total particulate matter RH relative humidity SVD Saturated Vapour Density TobLabNet World Health Organization Tobacco Laboratory Network WHO World Health Organization T Reduction in the time to smoke a cigarette due to puffing, calculated as:(Time to smoulder burn the cigarette) - (Tim

45、e to burn the cigarette when puffing) 4 Principle Following the analysis of the data from the TNCO study (ISO/TR 19478-1), WG 10 decided to review the impact of increasing puffing intensity on the measurement of TPM, NFDPM, nicotine, water and carbon monoxide yields from cigarettes with particular e

46、mphasis on differences resulting from the use of rotary or linear smoking machines. The Ad Hoc Group (AHG) of WG 10 was set up to give focus to the review process. The membership of the AHG necessarily included representatives of the manufacturers of smoking machines as well as those WG 10 members w

47、ho wished to be actively involved in further studies. The review was carried out with particular reference to the conclusions from the WG 10 TNCO study which compared smoke yield data for the ISO regime, as specified in ISO 3308:2000 and ISO 4387, with that for the HCI regime, as specified in the He

48、alth Canada Method T-115. The AHG first identified a number of differences in design features between rotary and linear machines with the potential to alter the collection of smoke condensate and so increase the variation in smoke yield measurements. Individual AHG members then used their expertise

49、to create protocols to evaluate these factors in their respective laboratories. Conclusions i) and j) of ISO/TR 19478-1:2014 provided the focus for the work of the AHG, although other issues were also considered. Clauses 5 and 6 provide a summary of the understanding developed within WG 10 and the AHG of the issues identified in conclusions i) and j).2 ISO 2015 All rights reservedPD ISO/TR 19478-2:2015ISO/TR 19478-2:2015(E) The studies providing the background to this part of ISO/TR 19478 are listed in Annex A together with a summar