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1、BS ISO 16055:2003 ICS 65.160 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BRITISH STANDARD Tobacco and tobacco products Monitor test piece Requirements and use Licensed CopyChinese University of Hong Kong, 11/04/2009 08:43, Uncontrolled Copy, (c) BSI This British Standard w
2、as published under the authority of the Standards Policy and Strategy Committee on 31 March 2009 BSI 2009 ISBN 978 0 580 53169 9 Amendments/corrigenda issued since publication DateComments BS ISO 16055:2003 National foreword This British Standard is the UK implementation of ISO 16055:2003. The UK pa
3、rticipation 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 does not purport to include all the necessary provisions of a contract. Users a
4、re responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Licensed CopyChinese University of Hong Kong, 11/04/2009 08:43, Uncontrolled Copy, (c) BSI BS ISO 16055:2003 Reference number ISO 16055:2003(E) ISO 2003 INTERNATIONAL STANDAR
5、D ISO 16055 First edition 2003-02-01 Tobacco and tobacco products Monitor test piece Requirements and use Tabac et produits du tabac prouvette de contrle Exigences et utilisation Licensed CopyChinese University of Hong Kong, 11/04/2009 08:43, Uncontrolled Copy, (c) BSI BS ISO 16055:2003 ISO 16055:20
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9、ISO 2003 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in t
10、he 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 ii ISO 2003 All rights reserved Licensed CopyChinese University of Hong Kong, 11/04/2009 08:43, Uncontroll
11、ed Copy, (c) BSI BS ISO 16055:2003 ISO 16055:2003(E) ISO 2003 All rights reserved iii Contents Page Forewordiv 1 Scope1 2 Normative references .1 3 Terms and definitions.1 4 Requirements 2 5 Testing2 6 Data sheet information.2 7 Use3 Annex A (informative) Control charts. 6 Bibliography .13 Licensed
12、CopyChinese University of Hong Kong, 11/04/2009 08:43, Uncontrolled Copy, (c) BSI BS ISO 16055:2003 ISO 16055:2003(E) iv ISO 2003 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work
13、 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 the right to be represented on that committee. International organizations, governmental and non-governmen
14、tal, 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. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The ma
15、in task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. At
16、tention 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. ISO 16055 was prepared by Technical Committee ISO/TC 126, Tobacco and tobacco products. Licensed CopyCh
17、inese University of Hong Kong, 11/04/2009 08:43, Uncontrolled Copy, (c) BSI BS ISO 16055:2003 INTERNATIONAL STANDARD ISO 16055:2003(E) ISO 2003 All rights reserved 1 Tobacco and tobacco products Monitor test piece Requirements and use 1 Scope This International Standard describes the requirements fo
18、r a monitor test piece as well as its use. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amen
19、dments) applies. ISO 3308, Routine analytical cigarette-smoking machine Definitions and standard conditions ISO 4387, Cigarettes Determination of total and nicotine-free dry particulate matter using a routine analytical smoking machine ISO 5725-2, Accuracy (trueness and precision) of measurement met
20、hods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method ISO 7870, Control charts General guide and introduction ISO 7873, Control charts for arithmetic average with warning limits ISO 8258:1991, Shewhart control charts ISO 103
21、15, Cigarettes Determination of nicotine in smoke condensates Gas-chromatographic method ISO 10362-1, Cigarettes Determination of water in smoke condensates Part 1: Gas-chromatographic method 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 mo
22、nitor test piece a cigarette taken from a batch produced under particularly strictly controlled manufacturing conditions NOTE The cigarettes in such a batch show the greatest possible homogeneity with regard to their physical, chemical and smoke yield characteristics. 3.2 analysis value the result,
23、based on the testing of 5 or 20 items (depending on the type of smoking machine used), of a smoking test and analysis carried out in accordance with ISO 4387, ISO 10315 and ISO 10362-1 Licensed CopyChinese University of Hong Kong, 11/04/2009 08:43, Uncontrolled Copy, (c) BSI BS ISO 16055:2003 ISO 16
24、055:2003(E) 2 ISO 2003 All rights reserved 4 Requirements 4.1 The monitor test pieces shall be produced from one production batch. 4.2 The number of monitor test pieces produced shall be sufficient to cover the needs of a period of at least 2 years. 4.3 For reasons of homogeneity, the cut tobacco us
25、ed shall be taken from one well-mixed batch (if possible, it is advisable to use a single grade of tobacco with no addition of further materials, such as stems, humectants or flavours, to avoid unnecessary heterogeneity of the blend). 4.4 The non-tobacco materials used, such as cigarette paper and f
26、ilters, shall be taken from one production batch and strict quality-control measures shall be applied during the production of the filters. 4.5 Specifications for the length and diameter of the monitor test piece, and for its filter length, tipping length and filter material, shall be set before pro
27、duction. If the design of the product includes filter ventilation, this shall also be specified prior to production. 4.6 The production tolerances on tobacco mass, circumference and draw resistance of the monitor test piece shall be controlled as precisely as possible. It will normally be necessary
28、to increase the quality-control measures and to decrease the production machine speed to obtain the required consistency in physical, chemical and smoke yields of the monitor test pieces. 4.7 The monitor test pieces in a lot shall show consistent values for the content of nicotine-free dry particula
29、te matter and for nicotine in their smoke. This consistency shall be assessed by means of a comparative study of sufficient size, the size chosen depending on whether the monitor is for local or broader use (see ISO 5725-2). 4.8 The packaged monitor test pieces shall be stored at a temperature below
30、 +4 C until they are to be used. NOTE Other reference standards in the tobacco field require a storage temperature below 16 C for reasons of hygiene. Normally, a storage temperature of +4 C is sufficient for monitor test pieces. 5 Testing Testing of the lot, including determination of the values for
31、 nicotine-free dry particulate matter and nicotine in the smoke, shall be carried out in accordance with ISO 4387, ISO 10315 and ISO 10362-1 in the form of an inter-laboratory trial run in accordance with ISO 5725-2. The study shall be performed by using the butt length given in the data sheet accom
32、panying the monitor test piece. Monitor test pieces for daily routine use may be produced by the individual company for its own purposes. However, for the purposes of inter-laboratory comparisons or for comparison of analytical consistency between laboratories, it is advised to use monitor test piec
33、es from a common source. At present, a monitor test piece is available from CORESTA1). The CORESTA monitor test piece is tested annually for consistent smoke yields in an international comparative study in accordance with ISO 5725-2. 6 Data sheet information 6.1 General A data sheet from the source
34、of supply of the monitor test piece shall be included. It shall contain the information set out in 6.2 and 6.3. 1) Address: CORESTA, 11, rue du Quatre-Septembre, F-75002 Paris. Licensed CopyChinese University of Hong Kong, 11/04/2009 08:43, Uncontrolled Copy, (c) BSI BS ISO 16055:2003 ISO 16055:2003
35、(E) ISO 2003 All rights reserved 3 6.2 General production specifications The specifications for length, diameter, filter length, tipping length and filter material. 6.3 Analysis values from inter-laboratory testing The results from the inter-laboratory testing of the monitor test piece, comprising:
36、the butt length used; the type of smoking machine used; the average and standard deviation of the results for nicotine in the smoke; the average and standard deviation of the results for nicotine-free dry particulate matter; the two-sided confidence interval for the mean values, with a confidence le
37、vel of 95 %. 7 Use 7.1 General Monitor test pieces are used to monitor the stability of the analytical processes involved when using a cigarette-smoking machine for routine analyses in accordance with ISO 3308. In particular, they are used to assess whether the analytical process related to the mach
38、ine-smoking of cigarettes (described in ISO 4387, ISO 10315 and ISO 10362-1) is “in statistical control” (see ISO 7870). NOTE 1 As monitor test pieces are produced for process-control purposes, the product design is chosen to give smoke yields which are well suited to these purposes and thus may wel
39、l not conform to official declaration restrictions. In this context, it should be understood that the monitor test piece is not to be regarded as a commercial cigarette. The routine use of monitor test pieces may vary from laboratory to laboratory and between the two commonly used types of analytica
40、l smoking machine. The general principle is to evaluate the consistency of the values of the essential parameters (such as puff number, total particulate matter, nicotine and water in smoke condensate and nicotine-free dry particulate matter) by using control charts. Monitor test pieces are not to b
41、e used for calibration purposes, and the results obtained with monitor test pieces shall not be used for correcting or calculating analytical data from investigation samples. The smoke yields will normally be based upon the smoking of at least 20 cigarettes as described in ISO 4387. The smoking of 2
42、0 cigarettes will give one average result from a rotary smoking machine whereas a linear smoking machine will give 4 average results from smoking 5 cigarettes in each of 4 channels. This means that the variation in the smoking process has to be determined by different methods for the two smoking mac
43、hines. For the rotary machine, the variation may be determined as a “between smoke runs” variation whereas the variation for the linear machine may be determined from the 4 individual results from the 4 channels. In other words, the process variation from the rotary smoking machine is based on “inde
44、pendent” single results while the variation from the linear smoking machine can be based on 4 results from one smoke run but from 4 “independent” channels. This means that different types of control chart have to be used for the two smoking machines. The actual choice shall be made according to the
45、actual demands and cannot be specified to fit all needs. Annex A gives advice on, and examples of, the practical use of control charts. NOTE 2 This advice is based on the statistical theory described in ISO 7870, ISO 7873 and ISO 8258 combined with practical experience from daily use. Figure 1 illus
46、trates the use of monitor test pieces in routine smoking analysis. Licensed CopyChinese University of Hong Kong, 11/04/2009 08:43, Uncontrolled Copy, (c) BSI BS ISO 16055:2003 ISO 16055:2003(E) 4 ISO 2003 All rights reserved IMPORTANT: When analysing the control chart, always test for assignable cau
47、ses in accordance with ISO 8258 and ISO 7873. Figure 1 Flow chart for use of monitor test pieces in routine analytical smoking Licensed CopyChinese University of Hong Kong, 11/04/2009 08:43, Uncontrolled Copy, (c) BSI BS ISO 16055:2003 ISO 16055:2003(E) ISO 2003 All rights reserved 5 7.2 Practical p
48、rocedures for the use of monitor test pieces The practical procedures for use of monitor test pieces are based upon the condition that the consistency of a process can be evaluated by analysing control samples at chosen intervals, and comparison of the test results graphically in a control chart (se
49、e ISO 7870). The frequency at which the monitor test pieces shall be analysed cannot be specified. It depends on the local need. But the following considerations describe the importance of a practical choice (see also ISO 8258:1991, 10.4). Under the condition that the analytical process is consistent (stable), it is assumed that all the analytical results obtained between two valid results from the monitor test pieces are also valid. In contrast, results obtained during a period which begins with a v