1、BSI Standards Publication Reference materials Contents of certificates, labels and accompanying documentation PD ISO Guide 31:2015National foreword This Published Document is the UK implementation of ISO Guide 31:2015. It supersedes PD 6532-2:2000 which is withdrawn. The UK participation in its prep
2、aration was entrusted 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 a
3、pplication. The British Standards Institution 2015. Published by BSI Standards Limited 2015 ISBN 978 0 580 88654 6 I C S 0 1 . 1 2 0 ; 0 3 . 1 2 0 . 1 0 ; 1 7 . 0 2 0 ; 7 1 . 0 4 0 . 3 0 C o m p l i a n c e w i t h a B r i t i s h S t a n d a r d c a n n o t c o n f e r i m m u n i t y f r o m l e g
4、 a l o b l i g a t i o n s . This Published Document was published under the authority of the Standards Policy and Strategy Committee on 30 November 2015. Amendments/corrigenda issued since publication Date Text affected PUBLISHED DOCUMENT PD ISO Guide 31:2015 ISO 2015 Reference materials Contents o
5、f certificates, labels and accompanying documentation Matriaux de rfrence Contenu des certificats, des tiquettes et de la documentation daccompagnement GUIDE 31 Third edition 2015-11-01 Reference number ISO GUIDE 31:2015(E) PD ISO Guide 31:2015 ISO GUIDE 31:2015(E)ii ISO 2015 All rights reserved COP
6、YRIGHT PROTECTED DOCUMENT ISO 2015, Published in Switzerland 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, including photocopying, or posting on the internet or an intranet,
7、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 Ch. de Blandonnet 8 CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightiso.org www
8、.iso.org PD ISO Guide 31:2015 ISO GUIDE 31:2015(E)Foreword iv Introduction v 1 Scope 1 2 Normative reference . 1 3 Terms and definitions . 1 4 General 2 5 The contents of a product information sheet or reference material certificate 3 5.1 General . 3 5.2 The information required in the RM document .
9、 4 5.2.1 Title of the document . 5 5.2.2 Unique identifier of the RM 5 5.2.3 Name of the RM . 5 5.2.4 Name and contact details of the RM producer . 5 5.2.5 Intended use 5 5.2.6 Minimum sample size 6 5.2.7 Period of validity 6 5.2.8 Commutability . 6 5.2.9 Storage information 6 5.2.10 Instructions fo
10、r handling and use . 6 5.2.11 Page number 7 5.2.12 Document version . 7 5.3 The information required in an RM certificate . 7 5.3.1 Description of the material . 7 5.3.2 Property of interest, property value and associated uncertainty 7 5.3.3 Metrological traceability . 8 5.3.4 Measurement methods fo
11、r method dependent measurands 8 5.3.5 Name and function of the RM producers approving officer 8 5.4 Other useful information 8 5.4.1 Measurement methods for method-independent measurands 8 5.4.2 Health and safety information . 8 5.4.3 Subcontractors 8 5.4.4 Indicative values . 9 5.4.5 Legal notice .
12、 9 5.4.6 Reference to a certification report 9 6 Labels . 9 Bibliography .10 ISO 2015 All rights reserved iii Contents Page PD ISO Guide 31:2015 ISO GUIDE 31:2015(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member b
13、odies). 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 that committee. International organizations, governmental a
14、nd 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 document and those intended for its further maintenance are
15、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 Directives, Part 2 (see www.iso.org/directives). Attention is dr
16、awn 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 patent rights identified during the development of the document will be in the Introduction and/or on the
17、 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 specific terms and expressions related to conformity assessment
18、, 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 Reference Materials (REMCO), which is concerned with guidelines
19、 for the preparation, certification and use of reference materials (RMs) and certified reference materials (CRMs). This third edition cancels and replaces the second edition (ISO Guide 31:2000), which has been technically revised.iv ISO 2015 All rights reserved PD ISO Guide 31:2015 ISO GUIDE 31:2015
20、(E) Introduction The ISO Committee on Reference Materials (ISO/REMCO) published the first and second editions of this Guide in 1981 and 2000, respectively. Since the second edition was published, there has been considerable growth in the number and variety of reference materials (RMs) produced, and
21、in their use. The demand for reliability in the results obtained by analytical techniques has risen, especially due to growing concern about legal requirements, environment, and clinical applications. This has led to a need for a wide range of RMs used for quality control purposes, as well as certif
22、ied reference materials (CRMs) used in the validation of measurement methods, evaluation of the performance of new measurement procedures or laboratories, and calibration of instruments. According to the definition of an RM in ISO Guide 30, information on the homogeneity and stability of the materia
23、l is required. Moreover, it is mandatory for a CRM that all certified values are accompanied by an associated uncertainty at a stated level of confidence and a statement on the metrological traceability of these values. Therefore, guidance is required on the content and the format of the information
24、 that accompanies a reference material, whether it is certified or not. The first edition of this Guide discussed the difference between the information provided on the label, the certificate, and the certification report, and stressed the brief synoptic nature of the certificate. The second edition
25、 focused on the required content of the certificate of a CRM. This present edition introduces the concepts of a product information sheet and a reference material certificate and describes the information that should be included in these RM documents. For the purpose of this Guide, the RM document i
26、s either the product information sheet or RM certificate which accompanies the RM. ISO 2015 All rights reserved v PD ISO Guide 31:2015 Reference materials Contents of certificates, labels and accompanying documentation 1 Scope This Guide is intended to help reference material (RM) producers in prepa
27、ring clear and concise documentation to accompany an RM. It lists and explains mandatory, recommended and other categories of information to be considered in the preparation of product information sheets and RM certificates. This information can be used by RM users and other stakeholders in confirmi
28、ng the suitability of an RM or certified reference material (CRM). This Guide also contains the minimum requirements for a label attached to the RM container. 2 Normative reference The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its
29、 application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO Guide 30, Reference materials Selected terms and definitions 3 Terms and definitions For the purposes of this document, th
30、e terms and definitions given in ISO Guide 30 and the following apply. 3.1 reference material RM material, sufficiently 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
31、 generic term. Note 2 to entry: Properties can be quantitative or qualitative, e.g. identity of substances or 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
32、 entry: ISO/IEC Guide 99:2007 1has an analogous definition (5.13), but restricts the term “measurement” to apply to quantitative values. However, Note 3 of ISO/IEC Guide 99:2007, 5.13 (VIM), specifically includes qualitative properties, called “nominal properties”. SOURCE: ISO Guide 30:2015, 2.1.1 2
33、 3.2 certified reference material CRM reference material (RM) characterized by a metrologically valid procedure for one or more specified properties, accompanied by an RM certificate that provides the value of the specified property, its associated uncertainty, and a statement of metrological tracea
34、bility Note 1 to entry: The concept of value includes a nominal property or a qualitative attribute such as identity or sequence. Uncertainties for such attributes may be expressed as probabilities or levels of confidence. GUIDE ISO GUIDE 31:2015(E) ISO 2015 All rights reserved 1 PD ISO Guide 31:201
35、5 ISO GUIDE 31:2015(E) Note 2 to entry: Metrologically valid procedures for the production and certification of RMs are given in, among others, ISO Guides 34 3and 35 4 . Note 3 to entry: ISO/IEC Guide 99:2007 has an analogous definition (5.14). SOURCE: ISO Guide 30:2015, 2.1.2, modified Note 3 has b
36、een deleted 3.3 product information sheet document containing all the information that is essential for using an RM other than a CRM SOURCE: ISO Guide 30:2015, 2.3.4 3.4 reference material certificate document containing the essential information for the use of a CRM, confirming that the necessary p
37、rocedures have been carried out to ensure the validity and metrological traceability of the stated property values SOURCE: ISO Guide 30:2015, 2.3.2, modified Note 1 has been deleted 3.5 RM document document containing all the information that is essential for using any RM Note 1 to entry: The RM doc
38、ument covers both the product information sheet and the RM certificate. 3.6 reference material producer body (organization or company, public or private) that is fully responsible for project planning and management; assignment of, and decision on property values and relevant uncertainties; authoriz
39、ation of property values; and issuance of a reference material certificate or other statements for the reference materials it produces SOURCE: ISO Guide 30:2015, 2.3.5 4 General In this document, the term reference material certificate is used for a document accompanying a CRM and the term product i
40、nformation sheet is used for a document accompanying any other type of RM. RM document covers concepts of both the reference material certificate and the product information sheet. The specifications for product information sheets, RM certificates and labels given in the following clauses of this Gu
41、ide include those mentioned in technical clauses of ISO Guide 34. An RM document shall contain information essential for the proper use of any RM, e.g. detailed information about the way the container should be opened, the minimum sample size, if applicable, that shall be taken for a measurement, pe
42、riod of validity based on the stability of the material and the way in which it should be stored. Additional information is required for an RM certificate. The RM certificate shall contain all the information that is essential for the correct use of a CRM. Issuing an RM certificate is mandatory for
43、the production of a CRM, while an RM producer may issue a product information sheet for an RM other than a CRM. In conclusion, producers of RMs should pay careful attention to the preparation of a product information sheet or RM certificate. Additional information may be provided in a separate repor
44、t or other document. The information provided on a label of an individual unit of an RM shall serve to uniquely identify the material and allow the identification of the appropriate product information sheet or RM certificate. Whenever applicable, health and safety information shall be included in c
45、ompliance with relevant legislation or directives.2 ISO 2015 All rights reserved PD ISO Guide 31:2015 ISO GUIDE 31:2015(E) 5 The contents of a product information sheet or reference material certificate 5.1 General The categories of information to be considered in the preparation of an RM document,
46、i.e. a product information sheet or an RM certificate, are indicated below. An explanation is given under each category, together with examples where clarification is considered necessary. The categories are intended to cover the required information over a wide range of RMs that may include those c
47、ertified for quantity values of physical properties, chemical composition or isotope ratios expressed in International System of Units (SI), for conventional or biological property values expressed in other international units, for properties specifying the identity of chemical or biological species
48、, etc. A summary of the information that is essential to be included in an RM document is given, in order to assist those organizations which may wish to include some parts of this Guide in their requirements. Other details are optional and may be provided if they would enhance the usefulness of the
49、 RM, e.g. the origin of a material prepared from natural sources. This clause concerns the information contained in the RM document; the order or titles of the categories may be changed to suit the preference of the RM producer. The information required for any RM document is listed in 5.2; then the essential information that is required only for an RM certificate is stated in 5.3. Finally, useful information to add in the RM document is given in 5.4. A summary of the requirements is given in Table 1. ISO
