BS PD ISO GUIDE 30-2015 Reference materials Selected terms and definitions《基准材料 选择术语和定义》.pdf

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1、BSI Standards Publication Reference materials Selected terms and definitions PD ISO GUIDE 30:2015National foreword This Published Document is the UK implementation of ISO GUIDE 30:2015. It supersedes PD ISO GUIDE 30:1992+A1:2008 which is withdrawn. The UK participation in its preparation was entrust

2、ed to Technical Committee RMI/1, Reference Materials. 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. The Bri

3、tish Standards Institution 2014 Published by BSI Standards Limited 2014 ISBN 978 0 580 59589 9 ICS 01.040.71; 71.040.30 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 Com

4、mittee on 28 February 2015. Amendments issued since publication Amd. No. Date Text affected PUBLISHED DOCUMENT PD ISO GUIDE 30:2015 ISO 2015 Reference materials Selected terms and definitions Matriaux de rfrence Termes et dfinitions choisis GUIDE 30 Third edition 2015-02-15 Reference number ISO GUID

5、E 30:2015(E) PD ISO GUIDE 30:2015 ISO GUIDE 30:2015(E)ii ISO 2015 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2015 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, incl

6、uding 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 of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 4

7、1 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland PD ISO GUIDE 30:2015 ISO GUIDE 30:2015(E)Contents Page Foreword iv Introduction v 1 Scope . 1 2 Terms and definitions . 1 2.1 Terms related to materials 1 2.2 Terms related to measurement and testing . 4 2.3 Terms relate

8、d to certification and issuance of reference materials 5 2.4 Statistical terms used in the characterization of reference materials . 6 Bibliography 8 ISO 2015 All rights reserved iii PD ISO GUIDE 30:2015 ISO GUIDE 30:2015(E) Foreword ISO (the International Organization for Standardization) is a worl

9、dwide 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 the right to be represented on

10、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 procedures used to develop this d

11、ocument 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 editorial rules of the ISO/IEC Direc

12、tives, 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 identified during the develo

13、pment 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 explanation on the meaning of ISO

14、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 document is the ISO Committee on

15、Reference Materials (REMCO), which is concerned with guidelines for the preparation, certification and use of reference materials (RMs) and certified reference materials (CRMs). The first edition of this Guide (1981) was the outcome of collaboration between REMCO and the organizations EEC, IAEA, OIM

16、L, IUPAC, IFCC and WHO, and was produced largely by Dr D. A. Lowe of WHO and Prof. Dr R. Neider of BAM. The revision leading to the second edition was undertaken because it had become apparent that some confusion existed as to what types of measurement standards or etalons should legitimately be inc

17、luded within the definition of an RM. Moreover, the recognition that CRMs are measurement standards made it desirable to examine the vocabulary of standards in metrology, as detailed in the International vocabulary of basic and general terms in metrology (VIM), currently published as ISO/IEC Guide 9

18、9:2007 and as JCGM 200:2012, with particular reference to CRMs. This third edition of ISO Guide 30 cancels and replaces ISO Guide 30:1992. It was revised principally for introducing new definitions for RMs and CRMs as well as to update other terms and definitions. The definitions for RM and CRM were

19、 developed by REMCO to incorporate the concepts of both quantitative and qualitative analysis. There exist different definitions for these terms in other sources, notably ISO/IEC Guide 99:2007 and JCGM 200:2008. It remains as a future goal to harmonize these definitions in subsequent editions of the

20、se terminology guides. The terms included in this version are limited to those required to support the principles and concepts set forth in other REMCO Guides. Existing definitions in referenced publications are used wherever possible. In other cases, some definitions are specifically tailored to en

21、hance the understanding of RMs and their uses. Where definitions from other references are used, the source is given. References to similar terms defined in other sources are indicated in a note after the prompt “See also”.iv ISO 2015 All rights reserved PD ISO GUIDE 30:2015 ISO GUIDE 30:2015(E) Int

22、roduction Reference materials (RMs) and certified reference materials (CRMs) (defined in 2.1 and 2.2) are widely used for the calibration of measuring apparatus, for the evaluation of measurement procedures and for the internal or external quality control of measurements and laboratories. They may e

23、nable the expression of functional properties, for instance in certain cases relevant for biology or material sciences, in arbitrary units. RMs and CRMs play an increasingly important role in national and international standardizing activities and in the accreditation of laboratories. This document

24、is intended to serve as a guide to terms and definitions used in connection with the production and use of RMs as described in the respective ISO guides. It should prove useful in helping to ensure a greater degree of uniformity in the terminology used by different organizations concerned with the p

25、roduction and use of RMs throughout the world. In some cases, admitted alternate terms are listed below the bold typeface defined term. ISO 2015 All rights reserved v PD ISO GUIDE 30:2015 Reference materials Selected terms and definitions 1 Scope This Guide recommends terms and definitions that shou

26、ld be used in connection with reference materials, with a particular emphasis on terms that are used in reference material product information sheets, certificates and corresponding certification reports. 2 Terms and definitions 2.1 Terms related to materials 2.1.1 reference material RM material, su

27、fficiently homogeneous and stable with respect to one or more specified properties, which has been established to be fit for its intended use in a measurement process Note 1 to entry: RM is a generic term. Note 2 to entry: Properties can be quantitative or qualitative, e.g. identity of substances or

28、 species. Note 3 to entry: Uses may include the calibration of a measurement system, assessment of a measurement procedure, assigning values to other materials, and quality control. Note 4 to entry: ISO/IEC Guide 99:2007 1has an analogous definition (5.13), but restricts the term “measurement” to ap

29、ply to quantitative values. However, Note 3 of ISO/IEC Guide 99:2007, 5.13 (VIM), specifically includes qualitative properties, called “nominal properties”. 2.1.2 certified reference material CRM reference material (RM) characterized by a metrologically valid procedure for one or more specified prop

30、erties, accompanied by an RM certificate that provides the value of the specified property, its associated uncertainty, and a statement of metrological traceability Note 1 to entry: The concept of value includes a nominal property or a qualitative attribute such as identity or sequence. Uncertaintie

31、s for such attributes may be expressed as probabilities or levels of confidence Note 2 to entry: Metrologically valid procedures for the production and certification of RMs are given in, among others, ISO Guides 34 2and 35 3 . Note 3 to entry: ISO Guide 31 4gives guidance on the contents of RM certi

32、ficates. Note 4 to entry: ISO/IEC Guide 99:2007 1has an analogous definition (5.14). 2.1.3 candidate reference material material, intended to be produced as a reference material (RM) Note 1 to entry: A candidate material has yet to be characterized and tested to ensure that it is fit for use in a me

33、asurement process. To become an RM, a candidate material needs to be investigated to determine if it is sufficiently homogeneous and stable with respect to one or more specified properties, and is fit for its intended use in the development of measurement and test methods that target those propertie

34、s. Note 2 to entry: A candidate reference material may be an RM for other properties, and a candidate reference material for the target property. GUIDE ISO GUIDE 30:2015(E) ISO 2015 All rights reserved 1 PD ISO GUIDE 30:2015 ISO GUIDE 30:2015(E) 2.1.4 matrix reference material reference material tha

35、t is characteristic of a real sample EXAMPLE Soil, drinking water, metal alloys, blood. Note 1 to entry: Matrix reference materials may be obtained directly from biological, environmental or industrial sources. Note 2 to entry: Matrix reference materials may also be prepared by spiking the component

36、(s) of interest into an existing material. Note 3 to entry: A chemical substance dissolved in a pure solvent is not a matrix material. Note 4 to entry: Matrix materials are intended to be used in conjunction with the analysis of real samples of the same or a similar matrix. 2.1.5 primary measurement

37、 standard measurement standard that is designated or widely acknowledged as having the highest metrological qualities and whose property value is accepted without reference to other standards of the same property or quantity, within a specified context Note 1 to entry: See also ISO/IEC Guide 99:2007

38、. 1 2.1.6 secondary measurement standard measurement standard whose property value is assigned by comparison with a primary measurement standard of the same property or quantity Note 1 to entry: See also ISO/IEC Guide 99:2007. 1 2.1.7 sample portion (amount) of material taken from a batch Note 1 to

39、entry: The sample should be representative of the batch with respect to the property or properties being investigated. Note 2 to entry: The term may be used to cover either a unit of supply or a portion for analysis. Note 3 to entry: The portion taken may consist of one or more sampling units (such

40、as subsamples or units) and the batch may be considered to be the population from which the sample is taken. Note 4 to entry: See also the IUPAC Compendium of Analytical Nomenclature. 5 2.1.8 minimum sample size minimum sample intake lower limit of the amount of an RM, usually expressed as a mass qu

41、antity, that can be used in a measurement process such that the values or attributes expressed in the corresponding RM documentation are valid 2.1.9 production batch lot definite amount of material produced during a single manufacturing cycle, and intended to have uniform character and quality Note

42、1 to entry: The uniform conditions of manufacture or production of the batch or lot must be such as to ensure a homogeneous product. Note 2 to entry: In statistics, an entire batch may be considered a finite population (totality of items under consideration).2 ISO 2015 All rights reserved PD ISO GUI

43、DE 30:2015 ISO GUIDE 30:2015(E) Note 3 to entry: See also “lot” in ISO 3534-2:2006. 6 Note 4 to entry: See also the IUPAC Compendium of Analytical Nomenclature. 5 2.1.10 characterizationdetermination of the property values or attributes of a reference material, as part of the production process Note

44、 1 to entry: See also the IUPAC Compendium of Analytical Nomenclature. 5 2.1.11 value assignment process by which reference material (RM) property values or attributes obtained by characterization are combined and expressed in accompanying RM documentation 2.1.12 homogeneity uniformity of a specifie

45、d property value throughout a defined portion of a reference material (RM) Note 1 to entry: Tests for homogeneity are described in ISO Guide 35. Note 2 to entry: The defined portion may be, for example, an RM batch or a single unit within the batch. Note 3 to entry: See also IUPAC Compendium of Anal

46、ytical Nomenclature. 5 2.1.13 between-unit homogeneity uniformity of a specified property value among units of a reference material Note 1 to entry: It is understood that the term “between-unit homogeneity” applies to any type of package (e.g. vial) and other physical shapes and test pieces. 2.1.14

47、within-unit homogeneity uniformity of a specified property value within each unit of a reference material 2.1.15 stability characteristic of a reference material, when stored under specified conditions, to maintain a specified property value within specified limits for a specified period of time Not

48、e 1 to entry: See also the IUPAC Compendium of Analytical Nomenclature. 5 2.1.16 transportation stability stability of a reference material (RM) property for the time period and conditions encountered in transportation to the user of the RM. Note 1 to entry: Transportation stability has often been r

49、eferred to as “short term stability”. 2.1.17 long-term stability stability of a reference material property over an extended period of time. 2.1.18 lifetimetime interval during which RM properties retain their assigned values within their associated uncertainties Note 1 to entry: The lifetime is often determined retrospectively, i.e. after RM properties no longer retain assigned values or attributes. ISO 2015 All rights reserved 3 PD ISO GUIDE 30:2015 ISO GUIDE 30:2015(E) 2.1.19 period of validitytime interval