BS PD ISO TR 19478-1-2014 ISO and Health Canada intense smoking parameters Results of an international machine smoking study《ISO和加拿大卫生部的强烈吸烟参数 国际机器吸烟研究结果》.pdf

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1、BSI Standards Publication ISO and Health Canada intense smoking parameters Part 1: Results of an international machine smoking study PD ISO/TR 19478-1:2014National foreword This Published Document is the UK implementation of ISO/TR 19478-1:2014. The UK participation in its preparation was entrusted

2、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 does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. T

3、he British Standards Institution 2014. Published by BSI Standards Limited 2014 ISBN 978 0 580 87612 7 ICS 65.160 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was published under the authority of the Standards Policy and Strategy Committee

4、on 30 November 2014. Amendments/corrigenda issued since publication Date Text affected PUBLISHED DOCUMENT PD ISO/TR 19478-1:2014 ISO 2014 ISO and Health Canada intense smoking parameters Part 1: Results of an international machine smoking study Paramtres de fumage ISO et Sant Canada Intense Partie 1

5、: Rsultats dune tude internationale de fumage sur machine TECHNICAL REPORT ISO/TR 19478-1 Reference number ISO/TR 19478-1:2014(E) First edition 2014-11-01 PD ISO/TR 19478-1:2014 ISO/TR 19478-1:2014(E)ii ISO 2014 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2014 All rights reserved. Unless ot

6、herwise specified, 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 addres

7、s below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland PD ISO/TR 19478-1:2014 ISO/TR 19478-1:2014(E)Contents Page Foreword iv Int

8、roduction v 1 Scope . 1 2 Abbreviated terms 1 3 Objectives . 1 4 Test protocol . 2 5 Participants 2 6 Test articles 3 7 Test methods and smoking conditions 4 8 Handling of basic data sets 6 9 Results . 8 9.1 Raw smoke yield data . 8 9.2 Outliers .19 9.3 Mean smoke yields after outlier removal 20 9.4

9、 Repeatability (r) and reproducibility (R) of smoke yields .21 10 Discussion .29 10.1 Comparison of data from ISO and HCI smoking regimes 29 10.2 Comparison of linear and rotary smoking machines 40 11 Conclusions .54 Annex A (informative) Results of outlier testing .56 Bibliography .61 ISO 2014 All

10、rights reserved iii PD ISO/TR 19478-1:2014 ISO/TR 19478-1:2014(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

11、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

12、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 fo

13、r 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 right

14、s. 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

15、 document is information given for the convenience of users and does not constitute an endorsement. For an explanation 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

16、 Trade (TBT) see the following URL: Foreword - Supplementary information The committee responsible for this document 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

17、 an international machine smoking study Part 2: Examination of factors contributing to variability in the routine measurement of TPM, water and NFDPM smoke yields of cigarettesiv ISO 2014 All rights reserved PD ISO/TR 19478-1:2014 ISO/TR 19478-1:2014(E) Introduction ISO/TC 126 Working Group 10 (WG 1

18、0) was established by ISO/TC 126 in 2007 in response to a New Work Item Proposal by the British Standards Institute for the development of 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.

19、 Twenty out of 26 members of TC 126 voted in favour of the following option: “to install a Working 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

20、 this group until the future method proposal of WHO has been taken into consideration.” At its fifth meeting, in December 2009, WG 10 decided to undertake a collaborative study using both ISO 3308 and Health Canada Intense smoking regimes. A steering group was established and the laboratory work was

21、 carried out in 2010. A final report on the study was approved by WG 10 and this ISO Technical Report has been prepared at the request of WG 10 at its tenth meeting, in June 2012. ISO 2014 All rights reserved v PD ISO/TR 19478-1:2014 ISO and Health Canada intense smoking parameters Part 1: Results o

22、f an international machine smoking study 1 Scope This part of ISO/TR 19478 comprises a description of the collaborative study undertaken by WG 10 during 2010 and 2011 and an analysis of the data generated in the study. 2 Abbreviated terms C Cochran cig Cigarette CM CORESTA monitor test piece CO Carb

23、on monoxide CORESTA Centre de Coopration pour les Recherches Scientifiques Relative au Tabac DG Double Grubbs FTC Federal Trade Commission G Grubbs HCI Health Canada Intense (smoking machine regime) NFDPM Nicotine-free dry particulate matter r Repeatability R Reproducibility SD Standard deviation TP

24、M Total particulate matter Yield Concentration of analyte measured in the smoke (normally per cigarette) when smoked in a prescribed manner 3 Objectives The objectives of the collaborative study organized by WG 10 are the following: To measure the mainstream smoke yields of nicotine-free dry particu

25、late matter (NFDPM), nicotine and carbon monoxide (CO) from eight commercial cigarette products of different types, and two reference cigarettes/monitor test pieces (test articles) when smoked under both the ISO 3308 and the Health Canada Intense (HCI) (Health Canada, 1999) machine smoking regimes.

26、To determine intra-laboratory and inter-laboratory variability for the measured smoke yields. TECHNICAL REPORT ISO/TR 19478-1:2014(E) ISO 2014 All rights reserved 1 PD ISO/TR 19478-1:2014 ISO/TR 19478-1:2014(E) 4 Test protocol The protocol was agreed by WG 10 at its meeting on 30 thApril 2010 and is

27、 summarized here. Participants and test results were coded by the ISO/TC 126 Secretariat to make them anonymous. Ten test articles were used: 8 commercial cigarettes of different designs, one reference cigarette, one monitor test piece, with ISO NFDPM yields ranging from 1 mg to 14 mg per test artic

28、le. The following test parameters were measured and recorded: total particulate matter (TPM), nicotine, water, nicotine-free dry particulate matter (NFDPM), carbon monoxide (CO), puff count, and cigarette mass. Comparison of data from the two smoking regimes (ISO and HCI). The design was based on a

29、set number of smoked test articles and smoking runs. Both linear and rotary smoking machines were used in the study. The protocol was sent to the participants in May 2010. All test results were reported between July and September 2010 to the ISO/TC 126 Secretariat and compiled for evaluation. 5 Part

30、icipants Thirty-five participants from 21 countries took part in the study with six laboratories contributing two data sets for each smoking regime (ISO and HCI). The participating laboratories, sorted by country, are listed in Table 1. Table 1 List of participants Company or Institute Country Japan

31、 Tobacco International/kolab Austria Papierfabrik Wattens GmbH ISO 3402:1999 2 ; ISO 4387:2000 + ISO 4387 /Amd.1:2008 3 ; ISO 8454:2007 + ISO 8454/Amd.1:2009 4 ; ISO 10315:2000 + ISO 10315/Amd.1:2011 5 ; ISO 10362-1:1999 6 . For HCI smoking, in addition to the ISO standards listed above, the puffing

32、 parameters and filter ventilation characteristics were modified from those described in ISO 3308 according to those described in the Health Canada method: Health Canada Method T-115. 7 Data were analysed according to ISO 5725 (all parts). 8 Puffing parameters and vent blocking conditions for each p

33、uffing regime are summarized in Table 3.Table 2 (continued) 4 ISO 2014 All rights reserved PD ISO/TR 19478-1:2014 ISO/TR 19478-1:2014(E) Table 3 Comparison of ISO and HCI smoking methods Smoking regime Puff volume Puff interval a Puff duration Ventilation zone blocking Number of test articles per pa

34、d(ml) (s) (s) (%) ISO 35 0,3 60 0,5 2 0,2 0 5 (linear) 20 (rotary) HCI 55 0,5 30 0,5 2 0,2 100 3 (linear) 10 (rotary) aTime from the start of one puff to the start of the next puff. The total number of test articles which had to be smoked under each smoking regime for the two types of smoking machin

35、es (rotary and linear) is shown in Table 4. Table 4 Test articles to be smoked for different types of smoking machine Rotary machine Linear machine Test articles per pad Pads Days Total test articles Test articles per pad Pads Days Total test articles ISO 20 1 5 100 5 4 5 100 HCI 10 2 5 100 3 7 5 10

36、5 For ISO smoking, one test result was defined as the mean yield obtained from smoking 20 test articles in a single smoking machine run; therefore, from a rotary machine, it is the result from one run smoking 20 test articles and from a linear machine, it is the mean of four ports/channels, smoking

37、five test articles per port/channel. This was repeated on five separate days resulting in 100 test articles being smoked on both rotary and linear machines. For HCI smoking, the number of test articles smoked per Cambridge filter pad was reduced to avoid overloading the pad. Thus, one test result fr

38、om a rotary machine was the mean of two runs smoking 10 test articles each and from a linear machine, it was the mean of seven ports/channels, smoking three test articles per port/channel. This was repeated on five separate days resulting in 100 test articles being smoked on a rotary machine and 105

39、 on a linear machine. A summary of the different types of smoking machines is given in Table 5. Table 5 Smoking machines used by participants Linear machines Rotary machines Type Number Type Number SM 450 17 RM 200 4 LM20X 2 RM 200A 3 MBC 2000 2 RM 20 6 RM 20H 7 RM 20D 1 RM 20CSR 1 CR 20 1 21 (20 a

40、) 23 (22 a ) aNumber of smoking machines relevant for statistical evaluation. ISO 2014 All rights reserved 5 PD ISO/TR 19478-1:2014 ISO/TR 19478-1:2014(E) In total, 21 linear and 23 rotary smoking machines were included in this study (giving a total of 44 smoking machines). However, two participants

41、 used two different smoking machines for ISO and HCI smoking, so that the actual number for the statistical evaluation was 42. The very similar number of the two different types of smoking machine allows a formal statistical analysis of the results from different machine types (see 10.2). 8 Handling

42、 of basic data sets This clause describes the initial assessment by the organizing group of the basic measurement values provided by the participating laboratories. For the 42 smoking machines, 35 complete data sets were received. Five participants carried out a reduced smoking program due to techni

43、cal problems, lack of time, or delivery problems: No. 3: Test article I not smoked due to non-availability of 1R5F No. 7: Test article A not smoked under ISO smoking conditions No. 10: Test article D not smoked under ISO or HCI machine smoking conditions No. 12: Test article A not smoked under ISO o

44、r HCI machine smoking conditions No. 15: Test article E not smoked under ISO or HCI machine smoking conditions After reviewing the data sets No. 35 and No. 44, the following were realized by the statisticians: No. 35: HCI smoking performed under ISO regime, therefore results were not included in the

45、 evaluation No. 44: The wrong test article was used as test article I under ISO conditions, therefore results were not included in the evaluation. Furthermore, several data reports of the laboratories for the 10 test articles were not completed: No. 6: Cigarette mass: Error comment in test article G

46、 was corrected by the statisticians. No. 16: Calculation in some cells of the data sheet was carried out incorrectly. Errors were corrected by the statisticians. No. 22: ISO smoking regime: Blank cells for test articles A, B, and I which correspond to values below the limit of quantification (LOQ) w

47、ere reported by the participant. The mean was calculated by the statisticians based on the supplied number of data points. No. 26: Incorrect value for CO in test article mentioned by the authors and removed by the statisticians. No. 29: Data transfer into the data sheets not correctly carried out. I

48、t was corrected by the statisticians. No. 30: ISO smoking regime: In test article A of the original data set, one water value was below the LOQ. This value was treated as zero by the statisticians. No. 31: ISO smoking regime: In test article A, a water value was below the LOQ. This value was treated as zero by the statisticians. No. 37: ISO smoking regime: Missing data in the test articles A to E and H to J for all parameters. No. 44: HCI smoking regime: Missing values in test article B.6 ISO 2014 All rights reserved PD ISO/TR 19478-1:2014