BS PD ISO GUIDE 31-2015 Reference materials Contents of certificates labels and accompanying documentation《标准样品 证书、标签和随附文档的内容》.pdf
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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 It supersedes PD 6532-2:2000 which is withdrawn.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
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