1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS ISO 16055:2012Tobacco and tobacco products Monitor test piece Requirements and useBS ISO 16055:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementa
2、tion of ISO 16055:2012. Itsupersedes BS ISO 16055:2003 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee AW/40, Tobacco and tobacco products.A list of organizations represented on this committee can beobtained on request to its secretary.This publication
3、does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2012. Published by BSI StandardsLimited 2012ISBN 978 0 580 76148 5ICS 65.160Compliance with a British Standard cannot confer immunity fromlegal o
4、bligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 December 2012.Amendments issued since publicationDate Text affectedBS ISO 16055:2012 ISO 2012Tobacco and tobacco products Monitor test piece Requirements and useTabac et produits du
5、 tabac prouvette de contrle Exigences et utilisationINTERNATIONAL STANDARDISO16055Second edition2012-12-15Reference numberISO 16055:2012(E)BS ISO 16055:2012ISO 16055:2012(E)ii ISO 2012 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2012All rights reserved. Unless otherwise specified, no part of
6、 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 the country of the requester.ISO copyright officeCase postale 56 CH-1
7、211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandBS ISO 16055:2012ISO 16055:2012(E) ISO 2012 All rights reserved iiiContents PageForeword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 25 Testing . 2
8、6 Data sheet information 36.1 General . 36.2 General production specifications . 36.3 Analysis values from inter-laboratory testing . 37 Use . 37.1 General . 37.2 Practical procedures for the use of monitor test pieces 57.3 Practical use of control charts . 6Annex A (informative) Control charts . 7A
9、nnex B (informative) Monitor test piece Specification 15Bibliography .17BS ISO 16055:2012ISO 16055:2012(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is norm
10、ally 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-governmental, in liaison with ISO, also take part in t
11、he 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 main task of technical committees is to prepare I
12、nternational 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.Attention is drawn to the possibility that some of
13、 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.This second edition cancels and replaces the first edition (ISO 1
14、6055:2003), which has been technically revised.iv ISO 2012 All rights reservedBS ISO 16055:2012INTERNATIONAL STANDARD ISO 16055:2012(E)Tobacco and tobacco products Monitor test piece Requirements and use1 ScopeThis International Standard describes the requirements for a monitor test piece as well as
15、 its use.2 Normative referencesThe 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 amendments) applies.ISO 3308, Routine a
16、nalytical cigarette-smoking machine Definitions and standard conditionsISO 4387, Cigarettes Determination of total and nicotine-free dry particulate matter using a routine analytical smoking machineISO 5725-2, Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method
17、for the determination of repeatability and reproducibility of a standard measurement methodISO 7870-1, Control charts General guide and introductionISO 7873, Control charts for arithmetic average with warning limitsISO 8258:1991, Shewhart control chartsISO 8454, Cigarettes Determination of carbon mo
18、noxide in the vapour phase of cigarette smoke NDIR methodISO 10315, Cigarettes Determination of nicotine in smoke condensates Gas-chromatographic methodISO 10362-1, Cigarettes Determination of water in smoke condensates Part 1: Gas-chromatographic methodISO 10362-2, Cigarettes Determination of water
19、 in smoke condensates Part 2: Karl Fischer method3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1monitor test piecesample produced for a specific test purpose, validated to fulfil requirements within specified tolerances and intended to be used
20、for laboratory purposes only and labelled to clearly indicate that it is not for human useNote 1 to entry: A monitor test piece is a sample taken from a batch of cigarettes that show the greatest homogeneity with regard to their physical, chemical and smoke yield characteristics.3.2analysis valueres
21、ult, 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 8454, ISO 10315 and ISO 10362-1 (or ISO 10362-2) ISO 2012 All rights reserved 1BS ISO 16055:2012ISO 16055:2012(E)4 Requirements4.1 T
22、he 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 two years.4.3 For reasons of homogeneity, the cut tobacco used shall be taken from one well-mixed batch (if possible, it is
23、 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 filters, shall be taken from one production batch and strict qual
24、ity-control measures shall be applied during the production of the filters.Recommended specifications for the production of the monitor test piece are to be found in Annex B.The requirements shall now include a stable yield for carbon monoxide which is best obtained with a non-ventilated filter. The
25、refore the recommendation is that the monitor test piece is unventilated.If it is necessary to use humectants for the tobacco only glycerol is allowed. Propylene glycol cannot be used due to its high vapour pressure, which may lead to uncontrolled (undetected) loss of mass during conditioning.4.5 Th
26、e 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 to increase the quality-control measures and to decrease the production machine speed to obtain the required consistency in
27、 physical, chemical and smoke yields of the monitor test pieces. Mass control is critical in the production of a reliable monitor test piece. Excessive mass variation contributes to unacceptable variation in smoke yields. The standard deviation of mass of individual monitor test piece must be contro
28、lled to below 16 mg.4.6 The monitor test pieces in a lot shall show consistent values for the content of nicotine-free dry particulate matter, nicotine and carbon monoxide in their smoke yields. This consistency shall be assessed by means of a comparative study of sufficient size, the size chosen de
29、pending on whether the monitor is for local or broader use (see ISO 5725-2).4.7 The packaged monitor test pieces shall be stored at a temperature below or equal to +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
30、 of hygiene. Normally, a storage temperature of +4 C is sufficient for monitor test pieces.4.8 The product design shall ensure that the smoke yields (nicotine-free dry particulate matter, nicotine and carbon monoxide) are sufficiently high per monitor test piece (approximately 14 mg NFDPM and carbon
31、 monoxide, approximately 1,4 mg nicotine) so that the influence from a possible offset in the smoking machine settings can be distinguished from the normal variation of the smoke yields.4.9 It is essential to make the monitor test piece clearly distinguishable from commercial cigarettes. The monitor
32、 test pieces shall be packed in hard boxes of 20 which should be carrying a text.EXAMPLE CORESTA approved, Monitor No. X, for non-consumer laboratory purposes only. Not a commercial product date of production.5 TestingTesting of the lot, including determination of the values for carbon monoxide, nic
33、otine-free dry particulate matter and nicotine in the smoke, shall be carried out in accordance with ISO 8454, ISO 4387, 2 ISO 2012 All rights reservedBS ISO 16055:2012ISO 16055:2012(E)ISO 10315 and ISO 10362-1 (or ISO 10362-2) in the form of an inter-laboratory trial run in accordance with ISO 5725
34、-2. The study shall be performed by using the butt length given in the data sheet accompanying 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
35、of analytical consistency between laboratories, it is advised to use monitor test pieces 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 accordan
36、ce with ISO 5725-2.6 Data sheet information6.1 GeneralA data sheet from the source of supply of the monitor test piece shall be included. It shall contain the information set out in 6.2 and 6.3.6.2 General production specificationsThe specifications for length, diameter, filter length, tipping lengt
37、h and filter material.6.3 Analysis values from inter-laboratory testingThe results from the inter-laboratory testing of the monitor test piece, comprising: 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
38、 and standard deviation of the results for nicotine-free dry particulate matter; the average and standard deviation of the results for carbon monoxide in the smoke; the two-sided confidence interval for the mean values, with a confidence level of 95 %.7 Use7.1 GeneralMonitor test pieces are used to
39、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 machine-smoking of cigarettes described in ISO 3402, ISO 4387, ISO
40、8454, ISO 10315 and ISO 10362-1 (or ISO 10362-2) is “in statistical control” (see ISO 7870-1).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 well not conform to official d
41、eclaration 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 analytical smoking machine. The gener
42、al principle is to evaluate the consistency of the values of the essential parameters (such as puff number, carbon monoxide in the vapour phase, 1) Address: CORESTA, 11, rue du Quatre-Septembre, F-75002 Paris. www.coresta.org ISO 2012 All rights reserved 3BS ISO 16055:2012ISO 16055:2012(E)total part
43、iculate matter, nicotine and water in smoke condensate and nicotine-free dry particulate matter) by using control charts.Monitor test pieces are not to be used for calibration purposes, and the results obtained with monitor test pieces shall not be used for correcting or calculating analytical data
44、from investigation samples.The smoke yields will normally be based upon the smoking of at least 20 monitor test pieces/cigarettes as described in ISO 4387.The smoking of 20 cigarettes will give one average result from a rotary smoking machine whereas a linear smoking machine will give 4 average resu
45、lts 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 machines. For the rotary machine, the variation may be determined as a “between smoke runs” variation whereas the variation for the
46、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 “independent” single results while the variation from the linear smoking machine can be based on 4 results from one smoke run but from
47、 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 actual demands and cannot be specified to fit all needs. Annex A gives advice on, and examples of, the practical use of control ch
48、arts.NOTE 2 This advice is based on the statistical theory described in ISO 7870-1, ISO 7873 and ISO 8258 combined with practical experience from daily use.Figure 1 illustrates the use of monitor test pieces in routine smoking analysis.IMPORTANT When analysing the control chart, always test for assi
49、gnable causes in accordance with ISO 8258 and ISO 7873.4 ISO 2012 All rights reservedBS ISO 16055:2012ISO 16055:2012(E)Figure 1 Flow chart for use of monitor test pieces in routine analytical smoking7.2 Practical procedures for the use of monitor test piecesThe 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 cha
