This document describes the classification, method of sample preparation, certification main rules and certificate content of the EURONORM-CRMs.
It also details the sample presentation of the various producers' organizations and the distributing sources.

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ISO/Guide 35:2017 explains concepts and provides approaches to the following aspects of the production of reference materials: - the assessment of homogeneity; - the assessment of stability and the management of the risks associated with possible stability issues related to the properties of interest; - the characterization and value assignment of properties of a reference material; - the evaluation of uncertainty for certified values; - the establishment of the metrological traceability of certified property values. The guidance given supports the implementation of ISO 17034. Other approaches may also be used as long as the requirements of ISO 17034 are fulfilled. Brief guidance on the need for commutability assessment (6.11) is given in this document, but no technical details are provided. A brief introduction for the characterization of qualitative properties (9.6 to 9.10) is provided together with brief guidance on sampling such materials for homogeneity tests (Clause 7). However, statistical methods for the assessment of the homogeneity and stability of reference materials for qualitative properties are not covered. This document is also not applicable to multivariate quantities, such as spectral data.

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ISO/TR 16476:2016 investigates, discusses, and specifies further, the general principles of establishing traceability of measurement results laid down in the Joint BIPM, OIML, ILAC and ISO Declaration on Metrological Traceability [1], in particular for values assigned to (certified) reference materials. The document covers the following topics: a) a study into existing principles for, and requirements to, the traceability of the value assigned to the property of a (C)RM, with a specific view to the current definition of metrological traceability given by the 2007 edition of the VIM (published also as JCGM 200:2008[2] and ISO/IEC Guide 99:2007[21]); b) the development of a sensible, widely applicable approach to the understanding of the traceability of a value assigned to (C)RM property; c) recommendations on how traceability should be established, demonstrated, and reported on certificates and other documents accompanying (C)RM. The developed approach is exemplified for measurement procedures not covered earlier by other guidance documents on the topic.

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ISO/Guide 31:2015 is intended to help reference material (RM) producers in preparing 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 confirming the suitability of an RM or certified reference material (CRM). ISO/Guide 31:2015 also contains the minimum requirements for a label attached to the RM container.

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ISO 6142-1:2015 specifies a gravimetric method for the preparation of calibration gas mixtures in cylinders with traceable values for the amount-of-substance fraction (amount fraction) of one or more components. This part of ISO 6142 describes a method for calculating the uncertainty associated with the amount fraction of each component. This uncertainty calculation requires the evaluation of the contributions to the uncertainty due to factors including the weighing process, the purity of the components, the stability of the mixture, and the verification of the final mixture.
ISO 6142-1:2015 is only applicable to mixtures of gaseous or totally vaporized components, which may be introduced into the cylinder in the gaseous or liquid state. Both binary and multi-component gas mixtures (including natural-gas type mixtures) are covered by this part of ISO 6142. Methods for the batch production of more than one mixture in a single process are not included in this part of ISO 6142.
ISO 6142-1:2015 requires estimation of the stability of the mixture for its intended life time (maximum storage life), but it is not for use with components that react with each other unintentionally. This part of ISO 6142 also requires the impurities in each parent gas or liquid used in the preparation of the mixture to be assessed and quantified.

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ISO/TR 79:2015 summarizes the state of the art of the production and certification or characterization of qualitative property reference materials (RMs). The need for guidance documents for the production of RMs certified for qualitative properties was recognized by many experts. At the same time, the available information was found to be too immature to develop an internationally accepted guidance document. Additionally, the lack of an international vocabulary for terms and definitions for qualitative properties made it more difficult for the experts from various testing areas to communicate with each other. ISO/TR 79 summarizes the available expertise. It aims to contribute to the on-going discussion on nominal properties and the production of such RMs. The investigation of nominal properties is referred to differently in various specialized areas (examination, classification, identification, testing, observation, etc.). ISO/TR 79 tries to foster the future development of an internationally harmonized guidance document.

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ISO 6141:2015 specifies minimum requirements for the contents of certificates for homogeneous gas mixtures in gas cylinders to be used as calibration gas mixtures. Pure gases, when used as calibration gas mixtures, are also covered by this International Standard. Gases and gas mixtures produced for other purposes are not considered.
The requirements in ISO 6141:2015 deal with the metrological aspects of calibration gas mixtures. Other aspects, such as safety and legislative aspects, are not covered.
Furthermore, it specifies additional information (optional data) recommended for describing a homogeneous gas mixture, supplied under pressure in a cylinder or other container. It does not cover the field of safety-relevant data and related labelling.

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ISO Guide 30:2015 recommends terms and definitions that should be assigned to them when used in connection with reference materials, with particular attention to terms that are used in reference material certificates and corresponding certification reports.

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ISO Guide 33:2015 describes good practice in using reference materials (RMs), and certified reference materials (CRMs) in particular, in measurement processes. These uses include the assessment of precision and trueness of measurement methods, quality control, assigning values to materials, calibration, and the establishment of conventional scales. This Guide also relates key characteristics of various types of RMs to the different applications. For CRMs, the metrological traceability of the property values to international scales or other measurement standards has been established. For RMs not being CRMs, this kind of traceability of property values has often not been established. Nevertheless, these RMs can still be used for assessing parts of measurement procedures, including evaluating various levels of precision Mainstream applications of RM include precision control, bias assessment, calibration, preparation of calibration RMs and maintaining conventional scales. NOTE Not all types of RMs can be used for all indicated purposes. The preparation of RMs for calibration is also part of the scope of ISO Guides 34 and 35. The treatment in this Guide is limited to the fundamentals of small-scale preparation of RMs and the value assignment, as used by laboratories to calibrate their equipment. Larger scale production of such RMs, with the possible aim of distribution is beyond the scope of this Guide. This type of activity is covered in ISO Guides 34 and 35. The development of working standards, as used in, e.g. natural gas analysis, clinical chemistry, and the pharmaceutical industry is not covered in this Guide. This type of activity is covered in ISO Guides 34 and 35.

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ISO 14595:2014 gives recommendations for single-phase certified reference materials (CRMs) used in electron probe microanalysis (EPMA). It also provides guidance on the use of CRMs for the microanalysis of flat, polished specimens. It does not cover organic or biological materials.

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ISO Guide 80 outlines the essential characteristics of reference materials for quality control (QC) purposes, and describes the processes by which they can be prepared by competent staff within the facility in which they will be used (i.e. where instability due to transportation conditions is avoided). The content of this Guide also applies to inherently stable materials, which can be transported to other locations without risk of any significant change in the property values of interest. The primary audience for this Guide is laboratory staff who are required to prepare and use materials for specific in-house quality control applications. Preparation of QCMs, where transportation is a necessary component of the supply chain, such as laboratory sites at different locations or for proficiency testing schemes, should conform to the relevant requirements of ISO Guides 34 and 35. The description of the production of reference materials (RMs), as detailed in ISO Guide 34 and ISO Guide 35 is also applicable to the preparation of quality control materials (QCMs). However, the requirements for "in-house" QCMs are less demanding than those for a certified reference material (CRM). The preparation of QCMs should involve homogeneity and stability assessments, and a limited characterization of the material to provide an indication of its relevant property values and their variation, prior to use. This document provides the quality criteria that a material should fulfil to be considered fit-for-purpose for demonstrating a measurement system is under statistical control. Guidance on uses of such materials is not included in this Guide. The layout and structure of this Guide provides general information on the preparation of QCMs in the main chapters, with specific case studies covering a range of sectors in the annexes. The case studies are not complete "process manuals" but are included to highlight some of the key considerations when preparing QCMs. The case studies vary in complexity and detail, including sector specific terminology, but provide a range of information for laboratory staff to draw from. It is expected that those involved in QCM preparation will have some knowledge of the type of material to be prepared and be aware of any potential problems due to matrix effects, contamination, etc.

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ISO/TR 11773:2013 contains an inventory of problems and recommendations related to the transport, import and export of non-nuclear, non-radioactive reference materials, specifically for the packaging, labelling, and documenting of the shipments in order to comply with legal requirements. It does not explain detailed rules such as for labelling according to the Globally Harmonized System (GHS).

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ISO/TR 16268:2009 specifies a procedure for the certification of the areic dose of an ion-implanted analyte element of atomic number larger than that of silicon retained in a working reference material (WoRM) intended for surface-analytical use. The WoRM is in the form of a polished (or similarly smooth-faced) wafer (also referred to as the host), of uniform composition and nominal diameter 50 mm or more, that has been ion-implanted with nominally one isotope of a chemical element (also referred to as the analyte), not already present in the host, to a nominal areic dose normally within the range 1016 atoms/cm2 to 1013 atoms/cm2 (i.e. the range of primary interest in semiconductor technology). The areic dose of the ion-implanted analyte retained in the WoRM wafer is certified against the areic dose of the same analyte retained in an ion-implanted silicon wafer having the status of a (preferably certified) secondary reference material (SeRM). Information is provided on the concept and the procedure for certification of the WoRM. There is also a description of the requirements for the reference materials, the comparative measurements and the actual certification. Supporting information on ion implantation, ion-implantation dosimetry, wavelength-dispersive X‑ray fluorescence spectroscopy and non-certified substitutes for unobtainable SeRMs is provided in four annexes. Sources and magnitudes of uncertainties arising in the certification process are detailed in a fifth annex.

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ISO/TR 10989:2009 covers: the results of a study into, and comparison between, existing classification and categorization schemes for reference materials, the development of reference material (RM) features and characteristics upon which a harmonized and consistent categorization scheme could be based, and approaches for making the categorization scheme adaptive to new RM needs and developments. The development of a harmonized categorization scheme aims at facilitating a transparent and comparable presentation of reference materials by producers, and the identification of reference materials by users. The intended categorization scheme was conceived to meet the needs of modern forms of information presentation and retrieval, i.e. internet-based catalogues and databases, and has been developed specifically with the view to being used this way.

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This document describes the classification, method of sample preparation, certification main rules and certificate content of the EURONORM-CRMs.
It also details the sample presentation of the various producers' organizations and the distributing sources.

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ISO 6144:2003 specifies a method for the preparation of calibration gas mixtures by a static volumetric method and provides a procedure for calculating the volumetric composition of the mixture. It can be used either with binary gas mixtures (containing one calibration component in a complementary gas, which is usually nitrogen or air) or with mixtures containing more than one component in the complementary gas. This International Standard also specifies how the expanded uncertainty in the volume fraction of each calibration component in the mixture is determined by a rigorous evaluation of all the measurement uncertainties involved, including those associated with the apparatus used for the preparation of the gas mixture and those associated with the experimental procedure itself.

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This International Standard provides methods for
_ determining the composition of a calibration gas mixture by comparison with appropriate reference gas
mixtures,
_ calculating the uncertainty of the composition of a calibration gas mixture in relation to the known uncertainty of
the composition of the reference gas mixtures with which it was compared,
_ checking the composition attributed to a calibration gas mixture by comparison with appropriate reference gas
mixtures,
_ comparing the composition of several calibration gas mixtures, e.g. for the purpose of comparing different
methods of gas mixture preparation, or for testing consistency among gas mixtures of closely related
composition.
NOTE In principle, the method described in this document is also applicable to the analysis of (largely) unknown samples
instead of prospective calibration gas mixtures (i.e. gas mixtures which are intended for use as calibration gas mixtures). Such
applications, however, require appropriate care and consideration of additional uncertainty components, for example concerning
the effect of matrix differences between the reference gases used for calibration and the analysed sample.

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Specifies the requirements for three grades for the analysis of inorganic chemicals. Not applicable to organic trace analysis, analysis of surface-active agents and biological or medical analysis. The material shall be a clear, colourless liquid as assessed by inspection. Classifies according to the content: free from dissolved or colloidal ionic and organic contaminants, very low inorganic, organic or colloidal contaminants and suitable for laboratory wet chemistry work. Specifies the pH and conductivity measurement, the limit tests for oxidizable matter and for reactive silica, the measurement of absorbance and the determination of residue after evaporation at 110 °C.

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Specifies the requirements for three grades for the analysis of inorganic chemicals. Not applicable to organic trace analysis, analysis of surface-active agents and biological or medical analysis. The material shall be a clear, colourless liquid as assessed by inspection. Classifies according to the content: free from dissolved or colloidal ionic and organic contaminants, very low inorganic, organic or colloidal contaminants and suitable for laboratory wet chemistry work. Specifies the pH and conductivity measurement, the limit tests for oxidizable matter and for reactive silica, the measurement of absorbance and the determination of residue after evaporation at 110 °C.

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Guide 34:2009 specifies general requirements in accordance with which a reference material producer has to demonstrate that it operates, if it is to be recognized as competent to carry out the production of reference materials.
Guide 34:2009 is intended for the use by reference material producers in the development and implementation of their management system for quality, administrative and technical operations. Reference material customers, regulatory authorities and accreditation bodies may also use it in confirming and recognizing the competence of reference material producers.
Guide 34:2009 is not intended to be used as the basis for conformity assessment by certification bodies.
Guide 34:2009 sets out the management system requirements in accordance with which reference materials shall be produced. It is intended to be used as part of a reference material producer's general quality assurance (QA) procedures.
Guide 34:2009 covers the production of certified and non-certified reference materials. For non-certified reference materials, the production requirements are less stringent than for certified reference materials. The minimum requirements for the production of non-certified reference materials are specified throughout the Guide.

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ISO Guide 80 outlines the essential characteristics of reference materials for quality control (QC) purposes, and describes the processes by which they can be prepared by competent staff within the facility in which they will be used (i.e. where instability due to transportation conditions is avoided). The content of this Guide also applies to inherently stable materials, which can be transported to other locations without risk of any significant change in the property values of interest.
The primary audience for this Guide is laboratory staff who are required to prepare and use materials for specific in-house quality control applications. Preparation of QCMs, where transportation is a necessary component of the supply chain, such as laboratory sites at different locations or for proficiency testing schemes, should conform to the relevant requirements of ISO Guides 34 and 35.
The description of the production of reference materials (RMs), as detailed in ISO Guide 34 and ISO Guide 35 is also applicable to the preparation of quality control materials (QCMs). However, the requirements for "in-house" QCMs are less demanding than those for a certified reference material (CRM). The preparation of QCMs should involve homogeneity and stability assessments, and a limited characterization of the material to provide an indication of its relevant property values and their variation, prior to use. This document provides the quality criteria that a material should fulfil to be considered fit-for-purpose for demonstrating a measurement system is under statistical control. Guidance on uses of such materials is not included in this Guide.
The layout and structure of this Guide provides general information on the preparation of QCMs in the main chapters, with specific case studies covering a range of sectors in the annexes. The case studies are not complete "process manuals" but are included to highlight some of the key considerations when preparing QCMs. The case studies vary in complexity and detail, including sector specific terminology, but provide a range of information for laboratory staff to draw from.
It is expected that those involved in QCM preparation will have some knowledge of the type of material to be prepared and be aware of any potential problems due to matrix effects, contamination, etc.

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ISO Guide 35:2006 gives statistical principles to assist in the understanding and development of valid methods to assign values to properties of a reference material, including the evaluation of their associated uncertainty, and establish their metrological traceability. Reference materials (RMs) that undergo all steps described in ISO Guide 35:2006 are usually accompanied by a certificate and called a certified reference material (CRM). This Guide will be useful in establishing the full potential of CRMs as aids to ensure the comparability, accuracy and compatibility of measurement results on a national or international scale.
In order to be comparable across borders and over time, measurements need be traceable to appropriate and stated references. CRMs play a key role in implementing the concept of traceability of measurement results in chemistry, biology and physics among other sciences dealing with materials and/or samples. Laboratories use these CRMs as readily accessible measurement standards to establish traceability of their measurement results to international standards. The property values carried by a CRM can be made traceable to SI units or other internationally agreed units during production. ISO Guide 35:2006 explains how methods can be developed that will lead to well established property values, which are made traceable to appropriate stated references. It covers a very wide range of materials (matrices), ranging from gas mixtures to biological materials, and a very wide range of properties, ranging from chemical composition to physical and immunoassay properties.

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ISO/TR 10989:2009 covers:  
the results of a study into, and comparison between, existing classification and categorization schemes for reference materials,
the development of reference material (RM) features and characteristics upon which a harmonized and consistent categorization scheme could be based, and  
approaches for making the categorization scheme adaptive to new RM needs and developments.  
The development of a harmonized categorization scheme aims at facilitating a transparent and comparable presentation of reference materials by producers, and the identification of reference materials by users. The intended categorization scheme was conceived to meet the needs of modern forms of information presentation and retrieval, i.e. internet-based catalogues and databases, and has been developed specifically with the view to being used this way.

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Specifies the gravimetric method for the preparation of reference gas mixtures in cylinders and is intended for the preparation of calibration gas mixtures whose target accuracy is defined a priori. It is applicable only to mixtures of gaseous, or totally vaporized components which do not react with each other or with the cylinder walls. A procedure is given for the preparation strategy that is based upon preset uncertainty levels of the composition of the final mixture. Multi-component gas mixtures and multiple dilution mixtures are included in this standard and are considered to be special cases of single component weighings.

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Specifies requirements for certificates for pure gases and for homogeneous gas mixtures to be used as calibration gases. Specifies the minimum information (mandatory data) required and additional information (optional data) recommended for characterizing a pure gas, or a homogeneous gas mixture, supplied under pressure in a cylinder or other container.

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This Technical Report describes the classification, method of sample preparation, certification main rules and certificate content of the EURONORM-CRMs.
It also lists the sample presentation of the corresponding producer's organizations and the distributing sources.

  • Technical report
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  • Technical report
    11 pages
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This Technical Report describes the classification, method of sample preparation, certification main rules and certificate content of the EURONORM-CRMs.
It also lists the sample presentation of the corresponding producer's organisations and the distributing sources.

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This document describes the classification, the method of sample preparation for each material, the certification main rules and certificate content of the EURONORM-CRMs.
It also lists the samples' presentation, the corresponding producer's organizations and the distributing sources.

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Guide 34:2009 specifies general requirements in accordance with which a reference material producer has to demonstrate that it operates, if it is to be recognized as competent to carry out the production of reference materials. Guide 34:2009 is intended for the use by reference material producers in the development and implementation of their management system for quality, administrative and technical operations. Reference material customers, regulatory authorities and accreditation bodies may also use it in confirming and recognizing the competence of reference material producers. Guide 34:2009 is not intended to be used as the basis for conformity assessment by certification bodies. Guide 34:2009 sets out the management system requirements in accordance with which reference materials shall be produced. It is intended to be used as part of a reference material producer's general quality assurance (QA) procedures. Guide 34:2009 covers the production of certified and non-certified reference materials. For non-certified reference materials, the production requirements are less stringent than for certified reference materials. The minimum requirements for the production of non-certified reference materials are specified throughout the Guide.

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  • Guide
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ISO Guide 35:2006 gives statistical principles to assist in the understanding and development of valid methods to assign values to properties of a reference material, including the evaluation of their associated uncertainty, and establish their metrological traceability. Reference materials (RMs) that undergo all steps described in ISO Guide 35:2006 are usually accompanied by a certificate and called a certified reference material (CRM). This Guide will be useful in establishing the full potential of CRMs as aids to ensure the comparability, accuracy and compatibility of measurement results on a national or international scale. In order to be comparable across borders and over time, measurements need be traceable to appropriate and stated references. CRMs play a key role in implementing the concept of traceability of measurement results in chemistry, biology and physics among other sciences dealing with materials and/or samples. Laboratories use these CRMs as readily accessible measurement standards to establish traceability of their measurement results to international standards. The property values carried by a CRM can be made traceable to SI units or other internationally agreed units during production. ISO Guide 35:2006 explains how methods can be developed that will lead to well established property values, which are made traceable to appropriate stated references. It covers a very wide range of materials (matrices), ranging from gas mixtures to biological materials, and a very wide range of properties, ranging from chemical composition to physical and immunoassay properties.

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ISO 14595:2003 has been developed to facilitate international exchange and compatibility of analysis data in electron probe microanalysis (EPMA). It gives guidance on evaluating and selecting reference materials (RMs), on evaluating the extent of heterogeneity and stability of RMs and it gives recommendations for the determination of the chemical composition of RMs for production as EPMA certified reference materials. ISO 14595:2003 gives recommendations for single-phase certified reference materials (CRMs) used in electron probe microanalysis (EPMA). It also provides guidance on the use of CRMs for the microanalysis of flat, polished specimens. It does not cover organic or biological materials.

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This Guide recommends terms and their meaning used in connection with reference materials, taking into account those terms which are used in reference material certificates and appropriate test reports.

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