E3330 (version 22)

1.1 This guide is designed to explain and to clarify documentation that accompanies an RM or a certified reference material (CRM). It explains the contents of certificates of analysis for CRMs and product information documents for RMs, based on existing international standards and guides. It briefly touches on the minimum requirements for a label attached to the CRM/RM unit or unit container and to the package containing the unit or unit container.

1.2 This guide provides some basic guidance on calculation of consensus values and uncertainty estimates for CRMs and RMs with examples of approaches commonly used by national metrology institutes and suggestions for sources of information.

1.3 Units—The values stated in SI units are to be regarded as the standard, whenever applicable. Values can be traceable to other higher-order reference systems, including Rockwell Hardness, pH, and other systems defined by an international standard or peer-reviewed publication.

1.4 Contents—Sections and topics within this guide are enumerated below:

Section

Title

1

Scope

2

Referenced Documents

3

Terminology

4

Summary of Guide

5

Significance and Use

6

Contents of a Certificate of Analysis or Reference Material Documentation

7

Labels

8

Technical and Statistical Evaluations

9

Procedures for Consensus Value Calculations

10

Estimation of Uncertainty

11

Reporting Values and Uncertainty Estimates

12

International System of Units

13

Keywords

Appendix X1

Working Near Zero

Appendix X2

Working Near 100 %

Appendix X3

Censored Values

Appendix X4

Examples of Language for Sections of a Certificate of Analysis

1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.