ISO-11843-5-2008.pdf
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1、 Reference number ISO 11843-5:2008(E) ISO 2008 INTERNATIONAL STANDARD ISO 11843-5 First edition 2008-06-01 Capability of detection Part 5: Methodology in the linear and non-linear calibration cases Capacit de dtection Partie 5: Mthodologie des talonnages linaire et non linaire Copyright Internationa
2、l Organization for Standardization Provided by IHS under license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 07/25/2008 01:58:20 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 11843-5:2008(E) PDF disclaimer This PDF file may contain embedded typefaces. In ac
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4、 licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for pr
5、inting. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2008 All rights reserved. Unless otherw
6、ise 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 the country of the requester. ISO copyright
7、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 2008 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Boeing Co/59
8、10770001 Not for Resale, 07/25/2008 01:58:20 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 11843-5:2008(E) ISO 2008 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references. 2 3 Terms and definitions. 2 4 Precision profile of
9、 the net state variable 4 5 Critical value and minimum detectable value of the net state variable 5 5.1 General. 5 5.2 Calculation relating to probability . 6 5.3 Calculation relating to probability 6 5.4 Differential method. 6 6 Examples . 7 6.1 General. 7 6.2 Law of propagation of uncertainty 7 6.
10、3 Model fitting. 10 6.4 Application to competitive ELISA. 11 Annex A (normative) Symbols and abbreviations used in this part of ISO 11843 12 Annex B (informative) Derivation of Equation (9) . 13 Annex C (informative) Derivation of Equation (13) . 14 Bibliography. 15 Copyright International Organizat
11、ion for Standardization Provided by IHS under license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 07/25/2008 01:58:20 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 11843-5:2008(E) iv ISO 2008 All rights reserved Foreword ISO (the International Organization
12、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 committees. Each member body interested in a subject for which a technical committee has been established has t
13、he 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. Interna
14、tional 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 International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publicatio
15、n 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 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
16、. ISO 11843-5 was prepared by Technical Committee ISO/TC 69, Application of statistical methods, Subcommittee SC 6, Measurement methods and results. ISO 11843 consists of the following parts, under the general title Capability of detection: Part 1: Terms and definitions Part 2: Methodology in the li
17、near calibration case Part 3: Methodology for determination of the critical value for the response variable when no calibration data are used Part 4: Methodology for comparing the minimum detectable value with a given value Part 5: Methodology in the linear and non-linear calibration cases Copyright
18、 International Organization for Standardization Provided by IHS under license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 07/25/2008 01:58:20 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 11843-5:2008(E) ISO 2008 All rights reserved v Introduction Both line
19、ar and non-linear calibration functions are encountered in practice. This part of ISO 11843 treats both cases equally in the context of the capability of detection, by paying attention to the probability distributions of the net state variable (measurand), rather than the calibration functions thems
20、elves. The basic concepts of ISO 11843-2 including the probability requirements, and , and the linear calibration cases are retained by this part of ISO 11843. In the interval of values between the basic state and minimum detectable value, a linear calibration function may be applied. In this manner
21、, compatibility with ISO 11843-2 is assured. In the case that an analytical method characterized with a linear calibration function is compared with a method with a non-linear calibration function, this part of ISO 11843 is recommended. In a linear calibration case, ISO 11843-2 and this part of ISO
22、11843 are both available. ISO 11843-2 which uses the precision profile for the response variable alone will give the same result as this part of ISO 11843 which requires the precision profiles for both the response variable and net state variable, since the precision profile for the response variabl
23、e is the same as that for the net state variable in the linear case. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 07/25/2008 01:58:20 MDTNo reproduction or networking permitted without license from IHS -
24、,-,- Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 07/25/2008 01:58:20 MDTNo reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARD ISO 11843-5:2008(E) ISO 2008 All rig
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